Как правильно пишется вакцина гам ковид вак

Гам-КОВИД-Вак — инструкция по применению

Синонимы, аналоги

Статьи

Комбинированная векторная вакцина для профилактики коронавирусной инфекции, вызываемой вирусом SARS-CoV-2

Данный лекарственный препарат зарегистрирован по процедуре регистрации препаратов, предназначенных для применения в условиях угрозы возникновения, возникновения и ликвидации чрезвычайных ситуаций. Инструкция подготовлена на основании ограниченного объема клинических данных по применению препарата и будет дополняться по мере поступления новых данных. Применение препарата возможно только в условиях медицинских организаций, имеющих право осуществлять вакцинопрофилактику населения в установленном законодательством порядке.

Регистрационный номер:

ЛП-006395

Торговое наименование:

Гам-КОВИД-Вак, Комбинированная векторная вакцина для профилактики коронавирусной инфекции, вызываемой вирусом SARS-CoV-2

Международное непатентованное или группировочное наименование:

Вакцина для профилактики новой коронавирусной инфекции (COV1D-19)

Лекарственная форма:

раствор для внутримышечного введения

Состав

Состав на 1 дозу (0,5 мл):

Компонент I содержит:
Действующее вещество: рекомбинантные аденовирусные частицы 26 серотипа, содержащие ген белка S вируса SARS-CoV-2, в количестве (1,0±0,5)×10¹¹ частиц/доза.
Вспомогательные вещества: Трис(гидроксилметил)аминометан – 1,21 мг, натрия хлорид – 2,19 мг, сахароза – 25,0 мг, магния хлорида гексагидрат – 102,0 мкг, ЭДТАдинатриевая соль дигидрат – 19,0 мкг, полисорбат 80 – 250 мкг, этанол 95% – 2,5 мкл, вода для инъекций до 0,5 мл.

Компонент II содержит:

Действующее вещество: рекомбинантные аденовирусные частицы 5 серотипа, содержащие ген белка S вируса SARS-CoV-2, в количестве (1,0±0,5)×10¹¹ частиц/доза.
Вспомогательные вещества: Трис(гидроксилметил)аминометан – 1,21 мг, натрия хлорид – 2,19 мг, сахароза – 25,0 мг, магния хлорида гексагидрат – 102,0 мкг, ЭДТАдинатриевая соль дигидрат – 19,0 мкг, полисорбат-80 – 250 мкг, этанол 95% – 2,5 мкл, вода для инъекций до 0,5 мл.

Описание:

Компонент I. Раствор замороженный. Представляет собой плотную затвердевшую беловатого цвета массу. После размораживания: однородный бесцветный или с желтоватым оттенком слегка опалесцирующий раствор.

Компонент II. Раствор замороженный. Представляет собой плотную затвердевшую беловатого цвета массу. После размораживания: однородный бесцветный или с желтоватым оттенком слегка опалесцирующий раствор.

Характеристика:

Вакцина получена биотехнологическим путем, при котором не используется патогенный для человека вирус SARS-CoV-2. Препарат состоит из двух компонентов: компонент I и компонент II. В состав компонента I входит рекомбинантный аденовирусный вектор на основе аденовируса человека 26 серотипа, несущий ген белка S-вируса SARS-CoV-2, в состав компонента II входит вектор на основе аденовируса человека 5 серотипа, несущий ген белка S вируса SARS-CoV-2.

Фармакотерапевтическая группа:

МИБП-вакцина.

Код ATX:

J07B

Фармакологические свойства

Вакцина индуцирует формирование гуморального и клеточного иммунитета в отношении коронавирусной инфекции, вызываемой вирусом SARS-CoV-2.

Иммунологическая эффективность

Иммунологические свойства и безопасность вакцины изучали в клиническом исследовании у взрослых здоровых добровольцев обоего пола в возрасте от 18 до 60 лет: 9 добровольцев получали компонент I, 9 – компонент II и 20 – в режиме прайм-буст. Иммуногенность оценивали по уровню специфических IgG-антител к белку S коронавируса SARS-CoV-2 и вируснейтрализущих антител, а также по образованию специфических Т-хелперных (CD4+) и цитотоксических (CD8+) лимфоцитов.

Оценку уровня специфических IgG проводили в сравнении с исходным уровнем антител (до иммунизации). У всех участников исследования, получавших препарат, образовались специфические антитела. На 42 сутки среднегеометрическое значение титра составило – 14 703, при 100% сероконверсии. Также на 42 сутки от начала вакцинации в сыворотке крови всех добровольцев детектированы вируснейтрализующие антитела к вирусу SARS-CoV-2 со средним титром 49,3.

Активность клеточного иммунитета оценивали в тесте лимфопролиферации СD4+ и CD8+, а также по приросту концентрации интерферона гамма в ответ на стимуляцию митогеном (гликопротеин S).

Иммунизация препаратом Гам-КОВИД-Вак, вызвала формирование напряженного антиген-специфического клеточного противоинфекционного иммунитета у 100% добровольцев (формирование антиген-специфичных клеток обоих популяций Т лимфоцитов: Т хелперных (CD4+) и Т киллерных (CD8+) и достоверному повышению секреции ИФНγ).

Защитный титр антител в настоящее время неизвестен. Продолжительность защиты неизвестна. Клинические исследования по изучению эпидемиологической эффективности не проводились.

Показания к применению:

Профилактика новой коронавирусной инфекции (COVID-19) у взрослых 18-60 лет

Противопоказания:

• Гиперчувствительность к какому-либо компоненту вакцины или вакцины, содержащей аналогичные компоненты;
• тяжелые аллергические реакции в анамнезе;
• острые инфекционные и неинфекционные заболевания, обострение хронических заболеваний – вакцинацию проводят через 2-4 недели после выздоровления или ремиссии. При нетяжелых ОРВИ, острых инфекционных заболеваниях ЖКТ-вакцинацию проводят после нормализации температуры;
• беременность и период грудного вскармливания;
• возраст до 18 лет (в связи с отсутствием данных об эффективности и безопасности)

Противопоказания для введения компонента II

• тяжелые поствакцинальные осложнения (анафилактический шок, тяжелые генерализованные аллергические реакции, судорожный синдром, температура выше 40 °С и т.д.) на введение компонента I вакцины;

С осторожностью

При хронических заболеваниях печени и почек, выраженных нарушениях функции эндокринной системы (сахарный диабет), тяжелых заболеваниях системы кроветворения, эпилепсии, инсультах и других заболеваниях ЦНС, заболеваниях сердечно-сосудистой системы (инфарктах миокарда в анамнезе, миокардитах, эндокардитах, перикардитах, ишемической болезни сердца), первичных и вторичных иммунодефицитах, аутоиммунных заболеваниях, заболеваниях легких, астме и ХОБЛ, у пациентов с диабетом и метаболическим синдромом, с аллергическими реакциями, атопией, экземой.

Места, где проводится вакцинация, должны быть оснащены средствами противошоковой терапии в соответствии с Приказом Министерства здравоохранения РФ от 20 декабря 2012 г. N 1079н «Об утверждении стандарта скорой медицинской помощи при анафилактическом шоке).

В день проведения вакцинации пациент должен быть осмотрен врачом: обязательным является общий осмотр и измерение температуры тела, в случае если температура превышает 37 °С, вакцинацию не проводят.

Применение при беременности и в период грудного вскармливания

Препарат противопоказан при беременности и в период грудного вскармливания, так как его эффективность и безопасность в этот период не изучались.

Способ применения и дозы

Вакцина предназначена только для внутримышечного введения. Строго запрещено внутривенное введение препарата. Вакцину вводят в дельтовидную мышцу (верхнюю треть наружной поверхности плеча). При невозможности введения в дельтовидную мышцу – препарат вводят в латеральную широкую мышцу бедра. Вакцинацию проводят в два этапа: вначале компонентом I, затем через 3 недели компонентом II.

Препарат вводят внутримышечно: вначале компонент I в дозе 0,5 мл, затем через 3 недели компонент II в дозе 0,5 мл.

Перед введением препарат (компонент) необходимо достать из холодильной камеры и выдержать при комнатной температуре до полного размораживания не более 30 минут; перед применением перемешать, осторожно покачивая флакон (ампулу). Не допускается резко встряхивать препарат.

Хранение вскрытого флакона (ампулы) не допускается!

Повторное замораживание препарата не допускается!

Не пригоден к применению препарат во флаконах и ампулах с нарушенной целостностью и маркировкой, при изменении физических свойств (мутность, окрашивание), при истекшем сроке годности, неправильном хранении.

После введения вакцины пациент должен находиться под наблюдением медицинских работников в течение 30 минут.

Информация для медицинских работников, выполняющих вакцинацию лекарственным препаратом: данный лекарственный препарат зарегистрирован по особой процедуре регистрации, в связи, с чем необходимо уведомлять Федеральную службу по надзору в сфере здравоохранения о каждом факте применения лекарственного препарата путем внесения информации в соответствующей раздел информационной системы ЕГИСЗ

Побочное действие

Нежелательные явления, характерные для применения вакцины, выявленные в рамках клинических исследований, а также исследований других вакцин на основе аналогичной технологической платформы, бывают преимущественно легкой или средней степени выраженности, могут развиваться в первые-вторые сутки после вакцинации и разрешаются в течение 3-х последующих дней. Чаще других могут развиться кратковременные общие (непродолжительный гриппоподобный синдром, характеризующийся ознобом, повышением температуры тела, артралгией, миалгией, астенией, общим недомоганием, головной болью) и местные (болезненность в месте инъекции, гиперемия, отечность) реакции). Рекомендуется назначение нестероидных противовоспалительных средств (НПВС) при повышении температуры после вакцинации. Реже отмечаются тошнота, диспепсия, снижение аппетита, иногда – увеличение регионарных лимфоузлов. У некоторых пациентов возможно развитие аллергических реакций, кратковременное повышение уровня печеночных трансаминаз, креатинина и креатинфосфокиназы в сыворотке крови.

В открытом клиническом исследовании безопасности, переносимости и иммуногенности препарата Гам-КОВИД-Вак нежелательные явления (НЯ) по частоте встречаемости могут быть расценены как встречающиеся часто и очень часто, определить более точно встречаемость нежелательных явлений не представляется возможным из-за ограниченности выборки участников исследования. После вакцинации были зарегистрированы следующие НЯ:

«Общие нарушения и реакции в месте введения»: относились: гипертермия, боль, отек, зуд в месте вакцинации, астения, боль, недомогание, пирексия, повышение температуры кожи в месте вакцинации, снижение аппетита. «Нарушения со стороны нервной системы»: головная боль, диарея. «Нарушения со стороны дыхательной системы, органов грудной клетки и средостения»: боль в ротоглотке, заложенность носа, першение в горле, ринорея.

«Лабораторные и инструментальные данные»; разнонаправленные отклонения показателей иммунологического статуса: повышение числа Т-лимфоцитов, увеличение процентного содержания лимфоцитов, снижение числа естественных клеток-киллеров, увеличение количества СD4-лимфоцитов, снижение количества СD4-лимфоцитов, повышение числа В-лимфоцитов, снижение числа В-лимфоцитов, повышение числа естественных клеток-киллеров, повышение количества СD8-лимфоцитов, повышение уровня иммуноглобулина Е (IgE) в крови, увеличение соотношения CD4/CD8, уменьшение соотношения CD4/CD8, повышение уровня иммуноглобулина A (IgA) в крови, уменьшение процентного содержания лимфоцитов CD8. Отклонения в общем анализе крови: увеличение процентного содержания лимфоцитов, снижение показателя гематокрита, увеличение числа лимфоцитов, повышение скорости оседания эритроцитов, повышение числа лейкоцитов, повышение числа моноцитов, повышение числа тромбоцитов, снижение числа нейтрофилов, снижение числа тромбоцитов. Отклонения в общем анализе мочи: эритроциты в моче. Большинство НЯ завершились выздоровлением без последствий (144 НЯ). На 42 день исследования не завершились 31 НЯ (исход был неизвестен для – НЯ и шел процесс выздоровления – 4 НЯ) – лабораторные отклонения иммунологических показателей, что не имеет клинического значения (не нуждается в проведении дополнительных диагностических процедур и назначения терапии).

Передозировка

О случаях передозировки не сообщалось.

Учитывая, что отпуск лекарственного препарата допускается только для лечебно-профилактических учреждений, а сама вакцинация проводится только квалифицированным медицинским персоналом, риск передозировки крайне низок.

Однако можно предположить, что при случайной передозировке возможно развитие указанных выше токсических и токсико-аллергических реакций в более тяжелой степени.

Специфических антидотов к препарату не существует.

Терапевтические мероприятия в данном случае будут включать симптоматическую терапию в соответствии с показаниями (жаропонижающие/ НПВС и десенсибилизирующие средства), кортикостероиды – парентерально при выраженном токсико-аллергическом синдроме). Режим назначения препаратов должен быть выбран согласно рекомендациям по применению и дозировкам данного лекарственного средства.

Взаимодействие с другими лекарственными средствами

Не изучалось.

Особые указания

У пациентов, получающих иммуносупрессивную терапию и пациентов с иммунодефицитом может не развиться достаточный иммунный ответ. Поэтому прием препаратов, угнетающих функцию иммунной системы, противопоказан как минимум за 1 месяц до и после вакцинации из-за риска снижения иммуногенности.

Влияние на способность управлять транспортными средствами, механизмами

Исследования по изучению влияния вакцины на способность управлять транспортными средствами и потенциально опасными механизмами не проводились.

Форма выпуска

Раствор для внутримышечного введения, компонент I – 0,5 мл/доза + компонент II – 0,5 мл/доза.

При производстве ФГБУ «НИЦЭМ им. Н.Ф. Гамалеи» Минздрава России (филиал «Медгамал» ФГБУ «НИЦЭМ им. Н.Ф. Гамалеи» Минздрава России): по 0,5 мл (1 доза) каждого компонента препарата во флаконы нейтрального стекла первого гидролитического класса (типа 2R, 4R), герметично укупоренных пробками из резины, обжатых алюминиевыми или алюмопластиковыми колпачками.
На флаконы наклеивают этикетку из бумаги писчей по ГОСТ 18510-87 или этикеточной по ГОСТ 7625-86, или этикетку из самоклеящегося материала по ТУ 13.96.17-001-90585582-2019 или аналогичного качества.
1 флакон компонента I с инструкцией по применению помещают в пачку картонную по ОСТ 64-071-89 или в пачку из картона коробочного марки хром-эрзац или А по ГОСТ 7973-89; 1 флакон компонента II с инструкцией по применению помещают в пачку картонную по ОСТ 64-071-89 или в пачку из картона коробочного марки хром-эрзац или А по ГОСТ 7973-89

При производстве АО «Биннофарм»:
По 0,5 мл (1 доза) каждого компонента препарата в ампулы по ISO 9187 или ТУ 9462-001-53908805-2006 из бесцветного стекла 1-го гидролитического класса вместимостью 1 мл с цветной точкой. На каждую ампулу наклеивают этикетку.
По 5 ампул каждого компонента препарата помещают в контурную ячейковую упаковку из пленки поливинилхлоридной.
По 1 контурной ячейковой упаковке вместе с инструкцией по применению помещают в пачку из картона по ГОСТ 33781-2016.

Условия хранения:

Хранить в защищенном от света месте, при температуре не выше минус 18°С. Не допускается хранение размороженного препарата более 30 минут! Хранить в недоступном для детей месте.

Условия транспортирования:

Транспортирование препарата при температуре не выше минус 18 °С. Применим способ транспортировки с сухим льдом.

Срок годности:

6 месяцев. Не применять по истечении срока годности.

Условия отпуска:

для лечебно-профилактических учреждений.

Производитель

Наименования и адреса производственных площадок производителя лекарственного препарата:

1) ФГБУ «НИЦЭМ им. Н.Ф. Гамалеи» Минздрава России (филиал «Медгамал» ФГБУ «НИЦЭМ им. Н.Ф. Гамалеи» Минздрава России), Россия, 123098, г. Москва, улица Гамалеи, д. 18. (все стадии производства):

2) АО «Биннофарм», Россия, 124460, г. Москва, г. Зеленоград, ул. Конструктора Гуськова, д. 3, стр. 1 (очистка, розлив (первичная упаковка), упаковка (вторичная потребительская упаковка)

Владелец регистрационного удостоверения/организация, принимающая претензии потребителя:

ФГБУ «Национальный исследовательский центр эпидемиологии и микробиологии имени почетного академика Н.Ф. Гамалеи» Министерства здравоохранения Российской Федерации (ФГБУ «НИЦЭМ им. Н.Ф. Гамалеи» Минздрава России).
Россия, 123098, г. Москва, улица Гамалеи, д. 18

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(видны только специалистам, верифицированным редакцией МЕДИ РУ)

«Sputnik V» redirects here. For the Soviet satellite known as Sputnik 5, see Korabl-Sputnik 2.

Russian Ministry of Health image of Gam-COVID-Vac vials
Vaccine description
Target	SARS-CoV-2
Vaccine type	Viral vector
Clinical data
Trade names	Sputnik V[1] Спутник V
Other names	Gam-COVID-Vac Гам-КОВИД-Вак
License data	EU EMA: by INN
Routes of administration	Intramuscular
ATC code	J07BX03 (WHO)
Legal status
Legal status	BR: Exceptional import [2] RU: Registered on 11 August 2020 Full list of Sputnik V vaccine authorizations
Identifiers
DrugBank	DB15848

Sputnik V (Russian: Спутник V, the brand name from RDIF) or Gam-COVID-Vac (Russian: Гам-КОВИД-Вак, the name under which it is legally registered and produced^[3]) is an adenovirus viral vector vaccine for COVID-19 developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Russia. It is the world’s first registered combination vector vaccine for the prevention of COVID-19, having been registered on 11 August 2020 by the Russian Ministry of Health.^[4][5]

Gam-COVID-Vac was initially approved for distribution in Russia and then in 59 other countries (as of April 2021) on the preliminary results of Phase I–II studies eventually published on 4 September 2020.^[6] Approval in early August of Gam-COVID-Vac was met with criticism in mass media and discussions in the scientific community as to whether approval was justified in the absence of robust scientific research confirming safety and efficacy.^{[4][5][7][8][9]} A large-scale Brazilian study from Dec. 2020 to May 2021 confirmed its effectiveness and safety, as of Oxford–AstraZeneca’s, i.e. above Sinopharm BIBP’s.^[10]

Emergency mass-distribution of the vaccine began in December 2020 in countries including Russia, Argentina, Belarus, Hungary, Serbia, Pakistan (in limited quantities), the Philippines (in limited quantities), and the United Arab Emirates. The Sputnik V is currently registered and certified in 71 countries.^[11] However, as of April 2022 less than 2.5% of the people vaccinated worldwide have taken a Sputnik V dose.^[12] In early 2022, as a result of the 2022 Russian invasion of Ukraine, the United States and other countries placed RDIF on the list of sanctioned Russian entities and people,^[13][14] significantly reducing Sputnik V future commercial prospects.^[13][12]

The Gam-COVID-Vac vaccine itself is available in two forms: frozen (vaccine storage: below –18 °C) and liquid (vaccine storage: from +2 to +8 °C, produced a little). In addition to the main vaccine, vaccines and its derivatives were also registered: Gam-COVID-Vac-Lyo (Russian: Гам-КОВИД-Вак-Лио, no data on use), Sputnik Light (Russian: Спутник Лайт, used for revaccination, as well as vaccination of foreigners in Russia), Gam-COVID-Vac-M (Russian: Гам-КОВИД-Вак-М, for vaccination of adolescents 12–17 years old^[15]).

Medical uses[edit]

The vaccine can be formulated in two ways: as a ready-to-use solution in water that is frozen at the common home-freezer storage temperature of −18 °C or 0 °F or lower, and as a freeze-dried (lyophlilized) powder, «Gam-COVID-Vac-Lyo», which can be stored at 2–8 °C or 36–46 °F. The freeze-dried powder must be reconstituted with sterile water before use.^[16] The lyophilized formulation of Gam-COVID-Vac is similar to the smallpox vaccine, circumventing the need for continuous «colder chain» or cold-chain storage – as required for the Pfizer–BioNTech and Moderna vaccines – and allowing transportation to remote locations with reduced risk of vaccine spoilage.^[17][18]

The first dose (based on Ad26) is administered on the first day, and the second dose (based on Ad5) is administered on the 21st day to boost immune response.^[19][20][21] Both doses are administered into the deltoid muscle.

Sputnik Light is a registered single-dose vaccine consisting of only the first dose of Sputnik V. It is intended for areas with acute outbreaks and it will be used as a third (booster) dose for those who have received Sputnik V at least 6 months earlier.^[22]

On August 11, 2021, the developers of the Sputnik V vaccine offered its ‘Sputnik Light’ (Ad26) vaccine to Pfizer for trial against the Delta variant.^[23][24]

Effectiveness[edit]

The effectiveness of COVID-19 vaccines, or any other vaccine, is determined in a mass vaccination in a «real-world» setting (not in clinical trials). This is an assessment of how well the vaccine protects people from outcomes such as infection, symptomatic illness, hospitalization, and death. Effectiveness is evaluated outside of clinical trials, which by contrast, evaluate the efficacy of the vaccine.^[25][26] A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.^[27] Effectiveness is generally expected to slowly decrease over time.^[28]

On 25 August, a preliminary version of a case-control study indicated an unadjusted effectiveness^[25][26] of about 50% against symptomatic disease. The authors expected that adjusting for age and sex would increase the estimate, citing an increase from 66% to 81% when adjusting the data for effectiveness against hospitalization.^[A]

A large-scale study in Buenos Aires from December 29, 2020, to May 15, 2021, with 663,602 participants aged 60 and older who received Spunik V, the Oxford–AstraZeneca vaccine, or the Sinopharm BIBP vaccine observed an overall efficacy of 98% (95% CI, 95–99%) against COVID-19-related deaths. The study noted that the three vaccines showed a similar effectiveness against death, and that the effectiveness against infection was similar to that of the Oxford-Astrazeneca vaccine and greater than that of the Sinopharm BIBP vaccine.^[10]

A large-scale study was conducted in Mexico and was published as a preprint, awaiting peer review (as of July 22, 2022).^[32] The study,  compared 793,487 adults vaccinated with different vaccines with 4,792,338 unvaccinated adults between December 24, 2020, and September 27, 2021.The results were as follows:

Efficacy[edit]

The vaccine efficacy of a COVID-19 vaccine or any other vaccine is evaluated in controlled clinical trials. It is an estimate of how many people who received the vaccine got the disease compared to how many people who got a placebo had the same outcome. On 2 February 2021, an interim analysis from the Moscow trial was published in The Lancet reporting an efficacy of 91.6% (95% CI, 85.6–95.2%) after the second dose for all age groups, with no unusual side effects.^[33] For the age group of 60 years and older, the reported efficacy was 91.8%.^[34] On 12 May, a group of biostatisticians from Russia, the US, France, Italy and the Netherlands questioned the efficacy results in a correspondence in The Lancet, highlighting data discrepancies, substandard reporting, apparent errors and numerical inconsistencies and a very unlikely homogeneity in vaccine efficacy across age groups.^[35]

The authors responded by saying that they had provided the regulatory authorities with all the data necessary for obtaining approval, and that the data included with the paper were enough for readers to confirm the reported vaccine efficacy. They also addressed the protocol queries, and said numerical inconsistencies were «simple typing errors that were formally corrected».^[36]

In June 2022 a group of biostatisticians from Australia and Singapore published a paper suggesting that the almost identical efficacy for every age group from the Lancet paper is very unlikely to occur in genuine experimental data.^[37] The group called for a thorough investigation of the Lancet article, as well as the immediate release of anonymized individual patient data to an unbiased statistical expert, and suggested the Lancet article should be retracted. The Lancet Group recognized the concerns about the validity of data published in Lancet article and invited the authors of the article to respond to these latest questions.^[38][39]

Adverse effects[edit]

Side effects are mostly mild and similar to other adenovirus vector vaccines such as the Oxford-AstraZeneca and the Janssen vaccines. However, unlike the Oxford-AstraZeneca and Janssen vaccines, and Pfizer, evidence does not suggest a risk of vaccine-induced immune thrombotic thrombocytopenia.^[40]

Pharmacology[edit]

Gam-COVID-Vac is a viral vector vaccine based on two recombinant replication-defective human adenoviruses: Ad26 (serotype 26) and Ad5 (serotype 5) replicated in HEK 293 cells. The viruses contain the gene that encodes the full-length spike protein (S) of SARS-CoV-2 to stimulate an immune response.^[6][19][41] Adenoviral vectors^[42][43] for expression of the SARS-CoV-2 spike protein have also been used in two other COVID-19 vaccines. One is called Janssen COVID-19 vaccine, it utilizes the Ad26COV2 viral vector based on the human virus Ad26. For this vaccine, the cell line PER.C6^[44][45] is used to replicate the vector. Another one called Oxford–AstraZeneca COVID‑19 vaccine, it uses chimpanzee adenovirus (ChAdOx1) as the vector. For both the Oxford-AstraZeneca COVID-19^[45] and Gam-COVID-Vac vaccines the producer cells for the production of non-replicating adenoviral vectors were obtained from the HEK 293 cell line.^[46] Each dose of Gam-COVID-Vac contains (1.0 ± 0.5) × 10¹¹ virus particles.^[34]

Both Ad26 and Ad5 were modified to remove the E1 gene to prevent replication outside the HEK 293 cells.^[47] For the production of the vaccine, to propagate adenoviral vectors in which the E1 gene was deleted, HEK 293 cells are used, which express several adenoviral genes, including E1.^[48][49] However, although rare, homologous recombination between the inserted cellular sequence and the vector sequence can restore the replication capacity to the vector,^[50] with less than 100 replicating adenovirus particles per dose of the vaccine.^[47]

Chemistry[edit]

The other ingredients (excipients) are the same, both quantitatively and qualitatively, in the two doses.^[51][52]

• Tris(hydroxymethyl)aminomethane (buffer)
• Sodium chloride (salt)
• Sucrose (sugar)
• Magnesium chloride hexahydrate
• Disodium EDTA dihydrate (a chelation ligand; sequestrant)
• Polysorbate 80
• Ethanol 95%
• Water

No adjuvants^[53] and no other components or ingredients should be included in the vaccine.^[1]

Manufacturing[edit]

Large quantities of both adenoviruses are produced by HEK 293 cells that have the E1 gene necessary for viral replication.^[48][49][50] Rarely, Ad5 can acquire the E1 gene from the HEK 293 cells, restoring its ability to replicate.^[50] Gamaleya has set an acceptable limit of 5,000 replicating virus particles per vaccine dose, and quality control documents state that tested batches contain less than 100 replicating virus particles per dose.^[47]

The production of the frozen liquid formulation was developed for large-scale use, it is cheaper and easier to manufacture. The production of the freeze-dried formulation takes much more time and resources, although it is more convenient for storage and transportation. It was developed with vaccine delivery to hard-to-reach regions of Russia in mind.^[6]

According to Russian media, the mass production of the Gam-COVID-Vac was launched by 15 August. By that moment, the Russian Federation has already received applications from 20 countries for the supply of 1 billion doses of vaccine. Three facilities were able to produce about a million doses per month at each with a potential doubling of capacity by winter. By the end of 2020, Gamaleya Research Institute’s production, according to an interview with the organization’s spokesperson, was planned to produce 3–5 million doses.^[54][55]

As of March 2021, the Russian Direct Investment Fund (RDIF) has licensed production in India, China, South Korea and Brazil. In the EU, RDIF has signed production agreements. By the end of March 2021 RDIF anticipates 33 million doses will have been manufactured in Russia, less than 5% of which will have been exported.^[56]

An agreement for the production of over 100 million doses of vaccine in India was made with Dr. Reddy’s Laboratories, which on 11 January 2021 submitted mid-stage trial data to the Indian regulator and recommended moving onto late-stage trials.^[57] The RDIF announced plans to sell 100 million doses to India, 35 million to Uzbekistan, and 32 million to Mexico, as well as 25 million each to Nepal and Egypt.^[58] In India, the first dose of Sputnik V vaccine was administered on 14 May 2021 at Hyderabad.^[59] Argentina became the first Latin American country to produce it.^[60] Large-scale production started in June 2021.^[61] As of 31 December 2021 277 million doses were manufactured, mostly (265 million) in Russia.^[62]

On 28 February 2022, as a result of the 2022 Russian invasion of Ukraine, the United States placed RDIF and its chief executive on its list of sanctioned Russian entities and people.^[63][14] The European Union, Ukraine, United Kingdom and Australia followed later in February and in March.^[64] This significantly reduces vaccine’s future commercial prospects.^[63][12]

Resale controversy[edit]

Under a resale arrangement, the Russian Direct Investment Fund (RDIF) offered Abu Dhabi-based firm, Aurugulf Health Investments the exclusive rights to sell the Sputnik V coronavirus vaccine. According to media reports, the vaccine was intended to be sold to a host of countries at huge premiums. As per documents reviewed by the Moscow Times, Emirati Sheikh Ahmed Dalmook al-Maktoum, a Dubai royal, worked as the middleman for reselling millions of Sputnik V vaccine doses to countries in dire need of COVID-19 vaccine at a higher premium.
Corporate registry data showed that one of the two entities controlling Aurugulf is Royal Group, a conglomerate headed by UAE national security advisor, Sheikh Tahnoon bin Zayed al-Nahyan. Acquired documents, interviews with officials and buyer data showed that countries like Pakistan, Guyana, which were on the receiving end of the vaccine from the UAE, were coerced to pay more than double the price advertised by Russia.^[65]
The same deal was further used for reselling 1 million Sputnik V vaccine doses by the Emirati royal Sheikh Ahmed Dalmook al-Maktoum to Kenya for huge mark-ups. However, the deal eventually failed as Nairobi learnt of the first shipment consisting of 75,000 doses not coming directly from Russia.^[66]

History[edit]

The Gam-COVID-Vac vaccine was developed by a cellular microbiologists team of the government-backed Gamaleya Research Institute of Epidemiology and Microbiology. The group was led by MD and RAS associate member Denis Logunov, who also worked on vaccines for the Ebolavirus and the MERS-coronavirus.^{[citation needed]}

In May 2020, the Gamaleya Research Institute of Epidemiology and Microbiology announced that it had developed the vaccine without serious side effects. By August 2020, phases I and II of two clinical trials (involving 38 patients each) were completed. Only one of them used the formulation which later obtained marketing authorization under limited conditions.^[67][68] This vaccine was given the trade name «Sputnik V», after the world’s first artificial satellite.^[5][8][69]

During preclinical and clinical trials, 38 participants who received one or two doses of the Gam-COVID-Vac vaccine had produced antibodies against SARS-CoV-2’s spike protein, including potent neutralizing antibodies that inactivate viral particles.^[4] On 11 August 2020, the Russian minister of Health Mikhail Murashko announced at a government briefing with the participation of President Vladimir Putin regulatory approval of the vaccine for widespread use. The state registration of the vaccine was carried out «conditionally» with post-marketing measures according to the decree of the Government of the Russian Federation. The registration certificate for the vaccine stated that it could not be used widely in Russia until 1 January 2021, and before that, it may be provided to «a small number of citizens from vulnerable groups», such as medical staff and the elderly, according to a Ministry of Health spokesperson.^[5] The license under register number No. ЛП-006395 (LP-006395) was issued on 11 August by the Russian Ministry of Health. Although the announcement was made even before the vaccine candidate had been entered into Phase III trials, the practice of marketing authorization «on conditions» also exists in other countries.^[70][71] On 26 August, certificate No. ЛП-006423 (LP-006423) was issued for the lyophilized formulation «Gam-COVID-Vac-Lyo».^{[4][5][8][72][6]}

On 12 June 2021, developers announced that they had developed and tested a nasal vaccine for children aged 8 to 12, with no side effects found, and that they expected to release it on 15 September 2021.^[73]

Clinical trials[edit]

Phase I–II[edit]

A phase I safety trial began on 18 June 2020.^[4] On 4 September 2020, data on 76 participants in a phase I–II trial were published, indicating preliminary evidence of safety and an immune response.^[6] The results were challenged by international vaccine scientists as being incomplete, suspicious, and unreliable when identical data were reported for many of the trial participants,^[74] but the authors responded that there was a small sample size of nine, and the measured results of titration could only take discrete values (800, 1600, 3200, 6400). Coupled with the observation that values tended to reach a plateau after three to four weeks, they contend that it is not unlikely that several participants would show identical results for days 21 to 28.^[75]

Phase III[edit]

In early November 2020, Israel Hadassah Medical Center director-general Prof. Zeev Rotstein stated that Hadassah’s branch in Moscow’s Skolkovo Innovation Center was collaborating on a phase III clinical trial.^[76]

The ongoing phase III study is a randomised, double-blind, placebo-controlled, multi-centre clinical trial involving 40,000 volunteers in Moscow, and is scheduled to run until May 2021.^[77] In 2020–2021, phase III clinical studies were also being conducted in Belarus,^[78] UAE,^[79] India^[80] and Venezuela.^[81]

On April 13, 2021, India’s health ministry said its drug regulator had found that safety and immunogenicity data from a local trial of Sputnik V coronavirus vaccine was comparable to that of a late-stage trial done in Russia.^[82]

Variants[edit]

In May 2021, a study by researchers of the National University of Córdoba, Argentina, found that the vaccine produced antibodies capable of neutralizing the Gamma variant.^[83]

A study in Argentina found that neutralization is maintained against Alpha and Lambda and reduced against Gamma. The degree of reduction, however, does not necessarily imply reduced protection.^[84]

A small study of 12 serum samples found that antibodies from the vaccine effectively neutralize the Alpha variant, with moderately reduced neutralization against the E484K substitution (median 2.8 fold reduction). However, neutralization of the Beta variant was markedly reduced (median 6.1 fold reduction).^[85]

[edit]

In August 2020, British and American officials stated that the Gam-COVID-Vac vaccine would likely be rejected due to concerns that the normally rigorous process of vaccine clinical testing was not followed.^[86]

As of December 2020, Belarus and Argentina granted emergency use authorization for the vector-based vaccine.^[87] On 21 January 2021, Hungary became the first European Union country to register the shot for emergency use, as well as the United Arab Emirates in the Persian Gulf region.^{[88][89][90][91][92]}

On 19 January 2021, the Russian authorities applied for the registration of Sputnik V in the European Union, according to the RDIF.^[93] On 10 February, the European Medicines Agency (EMA) said that they had «not received an application for a rolling review or a marketing authorisation for the vaccine». The developers have only expressed their interest that the vaccine be considered for a rolling review, but EMA’s Human Medicines Committee (CHMP) and the COVID-19 EMA pandemic Task Force (COVID-ETF) need to give their agreement first before developers can submit their application for initiation of the rolling review process.^[94] On 4 March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the EMA started a rolling review of Sputnik V.^[95] The EU applicant is R-Pharm Germany GmbH.^[95] On 16 June, Reuters reported that approval of Sputnik V will be delayed at least until September because not all the necessary clinical data has been submitted by the deadline.^[96] As of June 2021, Sputnik V is under rolling review process by EMA, but the marketing authorisation application was not submitted yet.^[97]

Emergency use has also been authorized in Algeria, Bolivia, Serbia, the Palestinian territories,^[57] and Mexico.^[98]

On 25 January 2021, Iran approved the vaccine, with Foreign Minister Mohammad Javad Zarif saying the country hopes to begin purchases and start joint production of the shot «in the near future», after Supreme Leader Ayatollah Ali Khamenei banned the government from importing vaccines from the United States and United Kingdom.^[99][100]

The Czech Republic is also considering buying Sputnik V, and Prime Minister Andrej Babis dismissed the minister of health, Jan Blatný, who was a loud opponent to the use of Sputnik V.^{[101][102][103]}

On 4 March 2021, EMA’s human medicines committee (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology.^[104] When asked about the prospect of Austria giving Sputnik V the approval (as some other European countries chose to do), EMA management board chair Christa Wirthumer-Hoche pointed to the fact there was not yet sufficient safety data about those who had already been given the vaccine. «We could have Sputnik V on the market in future, when we’ve examined the necessary data,» she said, adding that the vaccine needed to match up to European criteria on quality control and efficacy.^[105]

On 18 March 2021, German regional leaders including State Premiers and the mayor of Berlin called for the swift approval of the Russian vaccine by the European Medicines Agency to counteract the acute shortages of effective vaccines in Europe. German medical experts have recommended its approval also, and consider the Sputnik Vaccine «clever» and «highly safe».^[106]

On 19 March 2021, the Philippine Food and Drug Administration granted emergency use authorization for Sputnik V, the fourth COVID-19 vaccine to be given authorization. The Philippine government planned to buy 20 million doses of the vaccine.^[107][108]

On 12 April 2021, India approved the use of Sputnik V vaccine for emergency use against COVID-19 based on strong immunogenicity data.^[109][110]

As of 12 April 2021, 62 countries had granted Sputnik V emergency use authorization.^[111]

On 27 April 2021, Bangladesh approved the use of Sputnik V vaccine for emergency use.^[112]

On 30 April 2021, Turkey and Albania approved the use of Sputnik V vaccine for emergency use.^[113][114]

Slovakia[edit]

On 1 March 2021, Slovakia bought 2 million doses of the Sputnik V vaccine. Slovakia received the first batch of 200,000, and expected to receive another 800,000 doses in March and April. Another 1 million doses were set to arrive in May and June.^[115]

On 8 April, Slovakia’s drug regulator said that the Sputnik V vaccine it received did «not have the same characteristics and properties» as the version endorsed by The Lancet.^[116] The Slovak State Institute for Drug Control stated that Sputnik V has not yet been approved for use, as the first 200,000 doses received on the 31st of March were different from the product currently being reviewed by the EMA as well as from the vaccine used in studies published in The Lancet. The producers have failed to reply to requests for documentation, and approximately 80% of the data was not supplied even after repeated requests. Due to the inconsistencies, it was not possible to review the safety and efficacy of the vaccine.^[117][118] Russian Direct Investment Fund replied that Slovakian laboratory which tested the vaccine was not certified by the EU.

Slovak Prime Minister Igor Matovič resigned on 30 March, due to the political crisis started by the order of the Sputnik V vaccine.^[119] On 6 April 2021, the RDIF asked to return the delivered first batch of the vaccine due to «multiple contract violations».^[117][120]

On 29 April 2021, the Slovak Ministry of Health published the Sputnik V contract.^[121] According to the contract, the RDIF as a seller is not liable for any adverse events following administering of the vaccine, nor its effectiveness.^[121][122] According to the Slovak lawyers, the contract is explicitly disadvantageous for Slovakia.^[122][123]

On 8 May 2021, the Russian Direct Investment Fund sent a letter to the Denník N newspaper requesting the removal of the statements of the drug regulator, calling them «unsubstantiated and false» and «fake news».^[124][125] RDIF threatened the newspaper with legal action if they didn’t comply with the demand by 9 May.^[126] The editors of Denník N refused to remove said statements.

After the samples were sent to the EU-certified laboratory in Hungary and it was stated that «the results were satisfactory»,^[127] the Slovakian government approved the vaccine, and announced that vaccination with Sputnik V would begin in June 2021, despite the negative review by Slovakia’s drug regulator.^[128][129] Vaccinations started on 7 June,^[130] but without significant interest in the Sputnik V vaccine.^[131][132] Slovakia has no plans to order new batches^[131] and plans to sell or donate unused vaccines to Balkans countries.^[133] The registrations for vaccination were closed on 30 June. In July 2021, 160,000 doses of the vaccine from the first batch of 200,000 were shipped back to Russia.^[134] Temporary government approval for Sputnik V expired on 31 August 2021.^[135][136] In total, 18,500 people have been vaccinated.^[137]

Purchase of Sputnik V, which led to a political crisis and contributed to a fall of Igor Matovič’s Cabinet was investigated by Slovak Police Force with the investigation levered against Marek Krajčí. No violation of the law was found in October 2022.^[138]

Brazil[edit]

On 26 April 2021, the Brazilian health regulator Anvisa rejected the use of Sputnik V, alleging a lack of consistent and reliable data and the presence of replicating adenovirus in the vaccine. RDIF and Sputnik V’s official Twitter account said the decision may be politically motivated, pointing to a recent report by the United States government that tried to persuade Brazil to reject the vaccine. Several Brazilian states in the North and Northeast regions had already signed contracts for the acquisition of more than 30 million doses.^{[139][140][141]} Anvisa attributed its decision to a number of issues with the samples provided by Gamaleya for accreditation:^{[142][143][144]}

• the adenovirus carrier in all samples was actually able to replicate in spite of manufacturer’s declaration it was incapacitated
• the methodology used by Gamaleya to check immune system response was unreliable and documentation provided made its verification impossible
• the procedure of registering adverse effects was insufficient
• Anvisa delegation was also not allowed into the Gamaleya laboratory for inspection
• all presented studies were performed on vaccine doses produced in laboratory, rather than in the manufacturing facility supplying vaccine for the mass market, which makes the results not representative
• Anvisa found issues in one of the factories in Russia that could impact sterility of the doses.^[143]

On April 29, 2021, the developers of Sputnik V said that Anvisa admitted not testing Sputnik V and that they would sue Anvisa in Brazil for defamation. At a press conference, Anvisa officials said that Gamaleya’s own documents indicated multiple times the presence of replication-competent adenoviruses (RCAs) in ready vaccine batches and that the specifications accepted a level of RCAs 300 times greater than any other regulatory threshold. Anvisa presented the video of a meeting with representatives from Russia and Brazil where, when asked about the presence of RCAs, a representative from Russia reported problems with the cells and said that the vaccine could have been redeveloped, but it would take too long, so the developers instead chose to continue the research imposing an acceptable level of RCAs.^[145][146] Virologist Angela Rasmussen described this problem as a quality control issue that is not important for healthy people because adenoviruses are not important pathogens, but added that it could produce serious adverse effects in immunocompromised individuals.^[147] Medicinal chemist Derek Lowe commented that the presence of replicating adenoviruses is unlikely to cause any major problems, but it is a «completely unnecessary risk», that it certainly will harm some people, and that providing a product different from the one described in studies undermines the credibility of all manufacturing and quality control processes,^[148] adding that some posts on the official Sputnik V Twitter account constitute «aggressive political marketing» and some make invalid claims regarding the performance of competing vaccines, such as the Pfizer-BioNTech vaccine.^[149] Anvisa said that the import ban can be reversed if Gamaleya clarifies the issues. Adenovirus infections cause only mild colds in healthy individuals, but they can cause life-threatening illnesses in immunodeficient individuals.^[47] The director of the Public Health Institute of Chile (ISP), Heriberto Garcia, said that the ISP would not necessarily reject the vaccine, even if it had replicating adenoviruses, because the risk of getting a common cold from the vaccine must be seen in light of the risk of contracting COVID-19 when not vaccinated. He also said that real-world data from Argentina and Mexico showed no adverse effects greater than those seen in people vaccinated with the Pfizer-BioNTech vaccine or CoronaVac.^[150]

On June 4, Anvisa approved exceptional imports of Sputnik V, restricting it mainly to healthy adults and limiting it to only 1% of the population of 6 importing states, in order to manage risks through control and supervision of side effects. Anvisa said that the concern with replicating viruses has not been fully resolved, but that additional documents received indicate a substantially reduced acceptable amount. The new parameter would be in an FDA manual, which was not found. Anvisa also said that impurity and quality controls are insufficient and that the manufacturing plants must undergo corrections to meet WHO quality standards.^{[2][151][152]} As of 16 June, the same import conditions were extended to a total of 13 states.^[153] On August 5, the consortium of northeastern Brazilian states, corresponding to 7 of the 13 states, suspended the import of 37 million doses due to the restrictions imposed by Anvisa. These doses will supply Mexico, Argentina and Bolivia.^[154]

Further development[edit]

Heterologous prime-boost vaccination[edit]

On 21 December 2020 the Russian Direct Investment Fund (RDIF), the Gamaleya National Center, AstraZeneca and R-Pharm signed an agreement aimed at the development and implementation of a clinical research program to assess the immunogenicity and safety of the combined use of one of the components of the Sputnik V vaccine developed by the Gamaleya Center, and one of the components of the Oxford–AstraZeneca vaccine.^[155] The study program will last 6 months in several countries, and it is planned to involve 100 volunteers in each study program. On 9 February 2021, the Ministry of Health of the Republic of Azerbaijan allowed clinical studies in the country for the combined use of the Oxford–AstraZeneca vaccine and Sputnik Light, stating that the trials would begin before the end of February 2021.^[156][157] On February 20, 2021, in the official Sputnik V Twitter account it was stated that clinical trials have already started.^[158]

Society and culture[edit]

Economics[edit]

In Russia[edit]

The vaccine is free of charge to users in Russia and Kazakhstan. The cost per dose would be less than US$10 (US$20 for the required two doses) on international markets, much less than the cost of mRNA vaccines from other manufacturers. Kirill Dmitriev, head of the fund, told reporters that over 1 billion doses of the vaccine are expected to be produced in 2021 outside of Russia.^[159][160]

The head of the Gamaleya Research Institute Alexander Ginzburg estimated that it would take 9–12 months to vaccinate the vast majority of the Russian population, assuming in-country resources were adequate.^[161][162]

The commercial release of the Gam-COVID-Vac was first scheduled for September 2020. In October, Mikhail Murashko said that the Gam-COVID-Vac would be free for all Russian citizens after the launching of mass production.^[163][164] Later on, the Russian Ministry of Health registered the maximum ex-factory price equal to 1,942 roubles for two components and included it into The National List of Essential medicines.^[165] There were also suggestions to include the vaccine in the National Immunisation Calendar of Russia.^[165]

In the beginning of December 2020, Russian authorities announced the start of a large-scale free of charge vaccination with Gam-COVID-Vac for Russian citizens: the immunization program was launched on 5 December 2020 (with 70 medical centers in Moscow providing vaccinations).^[166]

Doctors and other medical workers, teachers, and social workers were given priority due to their highest risk of exposure to the disease.^[167] Initially the vaccine was only offered to people over 60 years of age, later this restriction was lifted.^[168]

Potential recipients were notified via text messaging, which said «You are working at an educational institution and have top-priority for the COVID-19 vaccine, free of charge». Patients were asked a few general health questions before receiving the vaccine.^{[169][170][171]} People with certain underlying health conditions, pregnant women, and those who have had a respiratory illness for the past two weeks were barred from vaccination.^[167] The vaccine vial was removed from medical centre’s freezer about 15 minutes before use.

In early December 2020, the Minister of Health, Mikhail Murashko, said that Russia had already vaccinated more than 100,000 high-risk people.^[172] Forty thousand of those were volunteers in Sputnik V’s Phase 3 trials, another 60,000 nurses and doctors had also taken the vaccine.^[173] The head of the Russian Direct Investment Fund, Kirill Dmitriev, said in an interview with the BBC that Russian medics expected to give about 2 million people coronavirus vaccinations in December 2020.^[174]

Up to the beginning of December 2020, Generium (which is supervised by Pharmstandard) and Binnopharm (which is supervised by AFK Sistema) companies produced Gam-COVID-Vac on a large scale.

On 10 December, Deputy Prime Minister Tatyana Golikova announced that approximately 6.9 million doses of the Sputnik V vaccine would enter civilian circulation in Russia before the end of February 2021.^[175] Moscow Mayor Sergei Sobyanin announced that the newly opened Moscow-based «R-Pharm» will become a leading manufacturer of Russia’s Sputnik V coronavirus vaccine. Working at full capacity, the factory will produce up to 10 million doses a month.^[176]

As of March 2021, vaccination rates in Russia were below those of other developed nations.^[177]

In May 2021 Sergei Sobyanin complained that only 1.3 million Moscow residents out of 12 million had received the first dose (10.2%). Only 9.5% of Russians had received a vaccine.^[178] Forbes Russia established that Russia committed to export 205 millions of doses of «Sputnik V» to other countries, and as of May 16.3 millions (8%) were so far delivered.^[179] A survey found that 62% of the Russian population felt hesitant, with 55% not afraid of getting sick and some willing to wait for CoviVac.^[180]

In June 2021, with the increase in Delta variant cases, several Russian city governments introduced strict measures to overcome vaccine hesitancy, such as requiring vaccine QR codes from customers in cafes.^[180]

Outside Russia[edit]

Russia is pursuing deals to supply its vaccine abroad.^[181]

According to the Russian Direct Investment Fund, they had received orders for more than 1.2 billion doses of the vaccine as of December 2020. Over 50 countries had made requests for doses, with supplies for the global market being produced by partners in India, Brazil, China, South Korea, Hungary, and other countries.^[182][183] In August 2020, according to the Russian authorities, there were at least 20 countries that wanted to obtain the vaccine.^[184]

The Israeli Hadassah Medical Center signed a commercial memorandum of understanding to obtain 1.5–3 million doses.^[185]

Argentina agreed to buy 25 million doses of Russia’s COVID-19 vaccine, subject to its clearing clinical trials;^[186] the vaccine was registered and approved in Argentina in late December 2020.^[187] The Brazilian state of Bahia signed an agreement to conduct Phase III clinical trials of the Sputnik V vaccine and planned to buy 50 million doses to market in northeastern Brazil.^[188]

On 21 January 2021, Argentine president Alberto Fernández became the first Latin American leader to be inoculated with Sputnik V, shortly after it was approved for use in the country.^[189][190] Two months after being vaccinated he developed fever and headache, and tested positive for COVID-19.^[191] He was asymptomatic ten days later, was discharged from medical treatment subject to medical follow-up as usual for former COVID-19 patients, and resumed his normal activities.^[192]

According to The New York Times sources, in February 2021, Israel agreed to finance a supply of the Sputnik V vaccine to Syria in order to secure the release of an Israeli civilian held in Syria.^[193]

Due to the delay in shipping of doses from Italy and the European Union, San Marino imported doses of the Sputnik V vaccine (not approved by the EMA) and started a mass vaccination on 28 February of its healthcare workers.^[194]

April 14, 2021, Armenia agreed with Russia on purchase of 1 million doses of coronavirus vaccines Sputnik V. This was the decision of Armenian health minister Anahit Avanesyan. The Armenian authorities have begun negotiations with Russia on the production of the Sputnik V coronavirus vaccine. Head of the Armenian Ministry of Health Anahit Avanesyan stated this at a press conference on March 12, 2021.^[195]

Scientific assessment[edit]

On 11 August 2020, a World Health Organization (WHO) spokesperson said, «… prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data».^[9] A WHO assistant director said, «You cannot use a vaccine or drugs or medicines without following through all of these stages, having complied with all of these stages».^[196]

Francois Balloux, a geneticist at University College London, called the Russian government’s approval of Gam-COVID-Vac a «reckless and foolish decision».^[4] Professor Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, characterized the announcement as a «political stunt», and stated that the untested vaccine could be very harmful.^[9]

Stephen Griffin, Associate Professor in the School of Medicine, University of Leeds, said «that we can be cautiously optimistic that SARS-CoV2 vaccines targeting the spike protein are effective.» Moreover, as the Sputnik antigen is delivered via a different modality, namely using a disabled Adenovirus rather than formulated RNA, this provides flexibility in terms of perhaps one or other method providing better responses in certain age-groups, ethnicities, etc., plus the storage of this vaccine ought to be more straightforward.^[197]

In November 2020, public health expert Talha Khan Burki said the quick approval of Gam-COVID-Vac by the Russian government was «cutting corners», and may harm public confidence if the vaccine proves to be unsafe or ineffective.^[8] «There is a huge risk that confidence in vaccines would be damaged by a vaccine that received approval and was then shown to be harmful», said immunologist Peter Openshaw.^[8]

Ian Jones, a professor of virology at the University of Reading, and Polly Roy, professor and Chair of Virology at The London School of Hygiene and Tropical Medicine, commenting on phase III results published in the Lancet in February 2021, said «The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency. But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of COVID-19.»^[198]

On 12 May 2021, a group of biostatisticians published an article in The Lancet about data discrepancies and substandard reporting of interim data of the Sputnik V phase-III trial. According to the article, the lack of transparency of the trial results raises serious concerns. Data inconsistencies were found, including a very low probability of homogeneity of vaccine efficacy across age groups.^[35]

Two preliminary studies, one from Argentina and one from San Marino, found mostly mild adverse events and no vaccine-associated deaths.^[40] Another study carried out in San Marino has concluded a high tolerability profile in the population aged ≥60 years in terms of short-term adverse events following immunization.^[199]

An article published by the journal Nature on 6 July 2021 cited data released by the United Arab Emirates on some 81,000 individuals who had received Sputnik V, according to which the vaccine demonstrated an efficacy of 97.8% in preventing symptomatic COVID-19, and 100% efficacy in preventing severe complications. The figures echoed similar findings from unpublished data on 3.8 million Russians, according to which Sputnik V demonstrated an efficacy of 97.7%.^[200]

A study published by the Journal of Medical Internet Research analyzed the dataset consisted of 11,515 self-reported Sputnik V vaccine adverse events posted on Telegram. Telegram users complained mostly about pain, fever, fatigue, and headache.^[201]

Public opinion polls[edit]

An opinion poll of Canadians conducted by Léger in August 2020 found that a majority (68%) would not take the Russian vaccine if offered a free dose, compared to 14% who said they would take it.
When Americans were asked the same question, 59% would not take the Russian vaccine if offered a free dose, compared to 24% who said they would take it.^[202][203] In June 2021, according to a poll conducted by Ost-Ausschuss der Deutschen Wirtschaft [de] (German Eastern Business Association), a majority (60%) of Germans would use the Russian vaccine Sputnik V if they had the opportunity to do so. With 71% approval, the values in East Germany are significantly higher, but with 58% of the respondents there is also a solid majority in West Germany. 38% of respondents, on the other hand, would not want to use Sputnik V.^[204]

In July 2020, opinion polls suggested around 90% of the Russian population had doubts about the vaccine but by September this had dropped to around half the Russian population.^[205] In May 2021, the Levada Center released a poll of 1,614 respondents from 50 regions which showed that 26% of Russians were prepared to be vaccinated with Sputnik V, while 62% were not prepared to be vaccinated. Ten percent of respondents had already been vaccinated.^[206]

References[edit]

Further reading[edit]

External links[edit]

• Official website

«Sputnik V» redirects here. For the Soviet satellite known as Sputnik 5, see Korabl-Sputnik 2.

Russian Ministry of Health image of Gam-COVID-Vac vials
Vaccine description
Target	SARS-CoV-2
Vaccine type	Viral vector
Clinical data
Trade names	Sputnik V[1] Спутник V
Other names	Gam-COVID-Vac Гам-КОВИД-Вак
License data	EU EMA: by INN
Routes of administration	Intramuscular
ATC code	J07BX03 (WHO)
Legal status
Legal status	BR: Exceptional import [2] RU: Registered on 11 August 2020 Full list of Sputnik V vaccine authorizations
Identifiers
DrugBank	DB15848

Sputnik V (Russian: Спутник V, the brand name from RDIF) or Gam-COVID-Vac (Russian: Гам-КОВИД-Вак, the name under which it is legally registered and produced^[3]) is an adenovirus viral vector vaccine for COVID-19 developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Russia. It is the world’s first registered combination vector vaccine for the prevention of COVID-19, having been registered on 11 August 2020 by the Russian Ministry of Health.^[4][5]

Gam-COVID-Vac was initially approved for distribution in Russia and then in 59 other countries (as of April 2021) on the preliminary results of Phase I–II studies eventually published on 4 September 2020.^[6] Approval in early August of Gam-COVID-Vac was met with criticism in mass media and discussions in the scientific community as to whether approval was justified in the absence of robust scientific research confirming safety and efficacy.^{[4][5][7][8][9]} A large-scale Brazilian study from Dec. 2020 to May 2021 confirmed its effectiveness and safety, as of Oxford–AstraZeneca’s, i.e. above Sinopharm BIBP’s.^[10]

Emergency mass-distribution of the vaccine began in December 2020 in countries including Russia, Argentina, Belarus, Hungary, Serbia, Pakistan (in limited quantities), the Philippines (in limited quantities), and the United Arab Emirates. The Sputnik V is currently registered and certified in 71 countries.^[11] However, as of April 2022 less than 2.5% of the people vaccinated worldwide have taken a Sputnik V dose.^[12] In early 2022, as a result of the 2022 Russian invasion of Ukraine, the United States and other countries placed RDIF on the list of sanctioned Russian entities and people,^[13][14] significantly reducing Sputnik V future commercial prospects.^[13][12]

The Gam-COVID-Vac vaccine itself is available in two forms: frozen (vaccine storage: below –18 °C) and liquid (vaccine storage: from +2 to +8 °C, produced a little). In addition to the main vaccine, vaccines and its derivatives were also registered: Gam-COVID-Vac-Lyo (Russian: Гам-КОВИД-Вак-Лио, no data on use), Sputnik Light (Russian: Спутник Лайт, used for revaccination, as well as vaccination of foreigners in Russia), Gam-COVID-Vac-M (Russian: Гам-КОВИД-Вак-М, for vaccination of adolescents 12–17 years old^[15]).

Medical uses[edit]

The vaccine can be formulated in two ways: as a ready-to-use solution in water that is frozen at the common home-freezer storage temperature of −18 °C or 0 °F or lower, and as a freeze-dried (lyophlilized) powder, «Gam-COVID-Vac-Lyo», which can be stored at 2–8 °C or 36–46 °F. The freeze-dried powder must be reconstituted with sterile water before use.^[16] The lyophilized formulation of Gam-COVID-Vac is similar to the smallpox vaccine, circumventing the need for continuous «colder chain» or cold-chain storage – as required for the Pfizer–BioNTech and Moderna vaccines – and allowing transportation to remote locations with reduced risk of vaccine spoilage.^[17][18]

The first dose (based on Ad26) is administered on the first day, and the second dose (based on Ad5) is administered on the 21st day to boost immune response.^[19][20][21] Both doses are administered into the deltoid muscle.

Sputnik Light is a registered single-dose vaccine consisting of only the first dose of Sputnik V. It is intended for areas with acute outbreaks and it will be used as a third (booster) dose for those who have received Sputnik V at least 6 months earlier.^[22]

On August 11, 2021, the developers of the Sputnik V vaccine offered its ‘Sputnik Light’ (Ad26) vaccine to Pfizer for trial against the Delta variant.^[23][24]

Effectiveness[edit]

The effectiveness of COVID-19 vaccines, or any other vaccine, is determined in a mass vaccination in a «real-world» setting (not in clinical trials). This is an assessment of how well the vaccine protects people from outcomes such as infection, symptomatic illness, hospitalization, and death. Effectiveness is evaluated outside of clinical trials, which by contrast, evaluate the efficacy of the vaccine.^[25][26] A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.^[27] Effectiveness is generally expected to slowly decrease over time.^[28]

On 25 August, a preliminary version of a case-control study indicated an unadjusted effectiveness^[25][26] of about 50% against symptomatic disease. The authors expected that adjusting for age and sex would increase the estimate, citing an increase from 66% to 81% when adjusting the data for effectiveness against hospitalization.^[A]

A large-scale study in Buenos Aires from December 29, 2020, to May 15, 2021, with 663,602 participants aged 60 and older who received Spunik V, the Oxford–AstraZeneca vaccine, or the Sinopharm BIBP vaccine observed an overall efficacy of 98% (95% CI, 95–99%) against COVID-19-related deaths. The study noted that the three vaccines showed a similar effectiveness against death, and that the effectiveness against infection was similar to that of the Oxford-Astrazeneca vaccine and greater than that of the Sinopharm BIBP vaccine.^[10]

A large-scale study was conducted in Mexico and was published as a preprint, awaiting peer review (as of July 22, 2022).^[32] The study,  compared 793,487 adults vaccinated with different vaccines with 4,792,338 unvaccinated adults between December 24, 2020, and September 27, 2021.The results were as follows:

Efficacy[edit]

The vaccine efficacy of a COVID-19 vaccine or any other vaccine is evaluated in controlled clinical trials. It is an estimate of how many people who received the vaccine got the disease compared to how many people who got a placebo had the same outcome. On 2 February 2021, an interim analysis from the Moscow trial was published in The Lancet reporting an efficacy of 91.6% (95% CI, 85.6–95.2%) after the second dose for all age groups, with no unusual side effects.^[33] For the age group of 60 years and older, the reported efficacy was 91.8%.^[34] On 12 May, a group of biostatisticians from Russia, the US, France, Italy and the Netherlands questioned the efficacy results in a correspondence in The Lancet, highlighting data discrepancies, substandard reporting, apparent errors and numerical inconsistencies and a very unlikely homogeneity in vaccine efficacy across age groups.^[35]

The authors responded by saying that they had provided the regulatory authorities with all the data necessary for obtaining approval, and that the data included with the paper were enough for readers to confirm the reported vaccine efficacy. They also addressed the protocol queries, and said numerical inconsistencies were «simple typing errors that were formally corrected».^[36]

In June 2022 a group of biostatisticians from Australia and Singapore published a paper suggesting that the almost identical efficacy for every age group from the Lancet paper is very unlikely to occur in genuine experimental data.^[37] The group called for a thorough investigation of the Lancet article, as well as the immediate release of anonymized individual patient data to an unbiased statistical expert, and suggested the Lancet article should be retracted. The Lancet Group recognized the concerns about the validity of data published in Lancet article and invited the authors of the article to respond to these latest questions.^[38][39]

Adverse effects[edit]

Side effects are mostly mild and similar to other adenovirus vector vaccines such as the Oxford-AstraZeneca and the Janssen vaccines. However, unlike the Oxford-AstraZeneca and Janssen vaccines, and Pfizer, evidence does not suggest a risk of vaccine-induced immune thrombotic thrombocytopenia.^[40]

Pharmacology[edit]

Gam-COVID-Vac is a viral vector vaccine based on two recombinant replication-defective human adenoviruses: Ad26 (serotype 26) and Ad5 (serotype 5) replicated in HEK 293 cells. The viruses contain the gene that encodes the full-length spike protein (S) of SARS-CoV-2 to stimulate an immune response.^[6][19][41] Adenoviral vectors^[42][43] for expression of the SARS-CoV-2 spike protein have also been used in two other COVID-19 vaccines. One is called Janssen COVID-19 vaccine, it utilizes the Ad26COV2 viral vector based on the human virus Ad26. For this vaccine, the cell line PER.C6^[44][45] is used to replicate the vector. Another one called Oxford–AstraZeneca COVID‑19 vaccine, it uses chimpanzee adenovirus (ChAdOx1) as the vector. For both the Oxford-AstraZeneca COVID-19^[45] and Gam-COVID-Vac vaccines the producer cells for the production of non-replicating adenoviral vectors were obtained from the HEK 293 cell line.^[46] Each dose of Gam-COVID-Vac contains (1.0 ± 0.5) × 10¹¹ virus particles.^[34]

Both Ad26 and Ad5 were modified to remove the E1 gene to prevent replication outside the HEK 293 cells.^[47] For the production of the vaccine, to propagate adenoviral vectors in which the E1 gene was deleted, HEK 293 cells are used, which express several adenoviral genes, including E1.^[48][49] However, although rare, homologous recombination between the inserted cellular sequence and the vector sequence can restore the replication capacity to the vector,^[50] with less than 100 replicating adenovirus particles per dose of the vaccine.^[47]

Chemistry[edit]

The other ingredients (excipients) are the same, both quantitatively and qualitatively, in the two doses.^[51][52]

• Tris(hydroxymethyl)aminomethane (buffer)
• Sodium chloride (salt)
• Sucrose (sugar)
• Magnesium chloride hexahydrate
• Disodium EDTA dihydrate (a chelation ligand; sequestrant)
• Polysorbate 80
• Ethanol 95%
• Water

No adjuvants^[53] and no other components or ingredients should be included in the vaccine.^[1]

Manufacturing[edit]

Large quantities of both adenoviruses are produced by HEK 293 cells that have the E1 gene necessary for viral replication.^[48][49][50] Rarely, Ad5 can acquire the E1 gene from the HEK 293 cells, restoring its ability to replicate.^[50] Gamaleya has set an acceptable limit of 5,000 replicating virus particles per vaccine dose, and quality control documents state that tested batches contain less than 100 replicating virus particles per dose.^[47]

The production of the frozen liquid formulation was developed for large-scale use, it is cheaper and easier to manufacture. The production of the freeze-dried formulation takes much more time and resources, although it is more convenient for storage and transportation. It was developed with vaccine delivery to hard-to-reach regions of Russia in mind.^[6]

According to Russian media, the mass production of the Gam-COVID-Vac was launched by 15 August. By that moment, the Russian Federation has already received applications from 20 countries for the supply of 1 billion doses of vaccine. Three facilities were able to produce about a million doses per month at each with a potential doubling of capacity by winter. By the end of 2020, Gamaleya Research Institute’s production, according to an interview with the organization’s spokesperson, was planned to produce 3–5 million doses.^[54][55]

As of March 2021, the Russian Direct Investment Fund (RDIF) has licensed production in India, China, South Korea and Brazil. In the EU, RDIF has signed production agreements. By the end of March 2021 RDIF anticipates 33 million doses will have been manufactured in Russia, less than 5% of which will have been exported.^[56]

An agreement for the production of over 100 million doses of vaccine in India was made with Dr. Reddy’s Laboratories, which on 11 January 2021 submitted mid-stage trial data to the Indian regulator and recommended moving onto late-stage trials.^[57] The RDIF announced plans to sell 100 million doses to India, 35 million to Uzbekistan, and 32 million to Mexico, as well as 25 million each to Nepal and Egypt.^[58] In India, the first dose of Sputnik V vaccine was administered on 14 May 2021 at Hyderabad.^[59] Argentina became the first Latin American country to produce it.^[60] Large-scale production started in June 2021.^[61] As of 31 December 2021 277 million doses were manufactured, mostly (265 million) in Russia.^[62]

On 28 February 2022, as a result of the 2022 Russian invasion of Ukraine, the United States placed RDIF and its chief executive on its list of sanctioned Russian entities and people.^[63][14] The European Union, Ukraine, United Kingdom and Australia followed later in February and in March.^[64] This significantly reduces vaccine’s future commercial prospects.^[63][12]

Resale controversy[edit]

Under a resale arrangement, the Russian Direct Investment Fund (RDIF) offered Abu Dhabi-based firm, Aurugulf Health Investments the exclusive rights to sell the Sputnik V coronavirus vaccine. According to media reports, the vaccine was intended to be sold to a host of countries at huge premiums. As per documents reviewed by the Moscow Times, Emirati Sheikh Ahmed Dalmook al-Maktoum, a Dubai royal, worked as the middleman for reselling millions of Sputnik V vaccine doses to countries in dire need of COVID-19 vaccine at a higher premium.
Corporate registry data showed that one of the two entities controlling Aurugulf is Royal Group, a conglomerate headed by UAE national security advisor, Sheikh Tahnoon bin Zayed al-Nahyan. Acquired documents, interviews with officials and buyer data showed that countries like Pakistan, Guyana, which were on the receiving end of the vaccine from the UAE, were coerced to pay more than double the price advertised by Russia.^[65]
The same deal was further used for reselling 1 million Sputnik V vaccine doses by the Emirati royal Sheikh Ahmed Dalmook al-Maktoum to Kenya for huge mark-ups. However, the deal eventually failed as Nairobi learnt of the first shipment consisting of 75,000 doses not coming directly from Russia.^[66]

History[edit]

The Gam-COVID-Vac vaccine was developed by a cellular microbiologists team of the government-backed Gamaleya Research Institute of Epidemiology and Microbiology. The group was led by MD and RAS associate member Denis Logunov, who also worked on vaccines for the Ebolavirus and the MERS-coronavirus.^{[citation needed]}

In May 2020, the Gamaleya Research Institute of Epidemiology and Microbiology announced that it had developed the vaccine without serious side effects. By August 2020, phases I and II of two clinical trials (involving 38 patients each) were completed. Only one of them used the formulation which later obtained marketing authorization under limited conditions.^[67][68] This vaccine was given the trade name «Sputnik V», after the world’s first artificial satellite.^[5][8][69]

During preclinical and clinical trials, 38 participants who received one or two doses of the Gam-COVID-Vac vaccine had produced antibodies against SARS-CoV-2’s spike protein, including potent neutralizing antibodies that inactivate viral particles.^[4] On 11 August 2020, the Russian minister of Health Mikhail Murashko announced at a government briefing with the participation of President Vladimir Putin regulatory approval of the vaccine for widespread use. The state registration of the vaccine was carried out «conditionally» with post-marketing measures according to the decree of the Government of the Russian Federation. The registration certificate for the vaccine stated that it could not be used widely in Russia until 1 January 2021, and before that, it may be provided to «a small number of citizens from vulnerable groups», such as medical staff and the elderly, according to a Ministry of Health spokesperson.^[5] The license under register number No. ЛП-006395 (LP-006395) was issued on 11 August by the Russian Ministry of Health. Although the announcement was made even before the vaccine candidate had been entered into Phase III trials, the practice of marketing authorization «on conditions» also exists in other countries.^[70][71] On 26 August, certificate No. ЛП-006423 (LP-006423) was issued for the lyophilized formulation «Gam-COVID-Vac-Lyo».^{[4][5][8][72][6]}

On 12 June 2021, developers announced that they had developed and tested a nasal vaccine for children aged 8 to 12, with no side effects found, and that they expected to release it on 15 September 2021.^[73]

Clinical trials[edit]

Phase I–II[edit]

A phase I safety trial began on 18 June 2020.^[4] On 4 September 2020, data on 76 participants in a phase I–II trial were published, indicating preliminary evidence of safety and an immune response.^[6] The results were challenged by international vaccine scientists as being incomplete, suspicious, and unreliable when identical data were reported for many of the trial participants,^[74] but the authors responded that there was a small sample size of nine, and the measured results of titration could only take discrete values (800, 1600, 3200, 6400). Coupled with the observation that values tended to reach a plateau after three to four weeks, they contend that it is not unlikely that several participants would show identical results for days 21 to 28.^[75]

Phase III[edit]

In early November 2020, Israel Hadassah Medical Center director-general Prof. Zeev Rotstein stated that Hadassah’s branch in Moscow’s Skolkovo Innovation Center was collaborating on a phase III clinical trial.^[76]

The ongoing phase III study is a randomised, double-blind, placebo-controlled, multi-centre clinical trial involving 40,000 volunteers in Moscow, and is scheduled to run until May 2021.^[77] In 2020–2021, phase III clinical studies were also being conducted in Belarus,^[78] UAE,^[79] India^[80] and Venezuela.^[81]

On April 13, 2021, India’s health ministry said its drug regulator had found that safety and immunogenicity data from a local trial of Sputnik V coronavirus vaccine was comparable to that of a late-stage trial done in Russia.^[82]

Variants[edit]

In May 2021, a study by researchers of the National University of Córdoba, Argentina, found that the vaccine produced antibodies capable of neutralizing the Gamma variant.^[83]

A study in Argentina found that neutralization is maintained against Alpha and Lambda and reduced against Gamma. The degree of reduction, however, does not necessarily imply reduced protection.^[84]

A small study of 12 serum samples found that antibodies from the vaccine effectively neutralize the Alpha variant, with moderately reduced neutralization against the E484K substitution (median 2.8 fold reduction). However, neutralization of the Beta variant was markedly reduced (median 6.1 fold reduction).^[85]

[edit]

In August 2020, British and American officials stated that the Gam-COVID-Vac vaccine would likely be rejected due to concerns that the normally rigorous process of vaccine clinical testing was not followed.^[86]

As of December 2020, Belarus and Argentina granted emergency use authorization for the vector-based vaccine.^[87] On 21 January 2021, Hungary became the first European Union country to register the shot for emergency use, as well as the United Arab Emirates in the Persian Gulf region.^{[88][89][90][91][92]}

On 19 January 2021, the Russian authorities applied for the registration of Sputnik V in the European Union, according to the RDIF.^[93] On 10 February, the European Medicines Agency (EMA) said that they had «not received an application for a rolling review or a marketing authorisation for the vaccine». The developers have only expressed their interest that the vaccine be considered for a rolling review, but EMA’s Human Medicines Committee (CHMP) and the COVID-19 EMA pandemic Task Force (COVID-ETF) need to give their agreement first before developers can submit their application for initiation of the rolling review process.^[94] On 4 March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the EMA started a rolling review of Sputnik V.^[95] The EU applicant is R-Pharm Germany GmbH.^[95] On 16 June, Reuters reported that approval of Sputnik V will be delayed at least until September because not all the necessary clinical data has been submitted by the deadline.^[96] As of June 2021, Sputnik V is under rolling review process by EMA, but the marketing authorisation application was not submitted yet.^[97]

Emergency use has also been authorized in Algeria, Bolivia, Serbia, the Palestinian territories,^[57] and Mexico.^[98]

On 25 January 2021, Iran approved the vaccine, with Foreign Minister Mohammad Javad Zarif saying the country hopes to begin purchases and start joint production of the shot «in the near future», after Supreme Leader Ayatollah Ali Khamenei banned the government from importing vaccines from the United States and United Kingdom.^[99][100]

The Czech Republic is also considering buying Sputnik V, and Prime Minister Andrej Babis dismissed the minister of health, Jan Blatný, who was a loud opponent to the use of Sputnik V.^{[101][102][103]}

On 4 March 2021, EMA’s human medicines committee (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology.^[104] When asked about the prospect of Austria giving Sputnik V the approval (as some other European countries chose to do), EMA management board chair Christa Wirthumer-Hoche pointed to the fact there was not yet sufficient safety data about those who had already been given the vaccine. «We could have Sputnik V on the market in future, when we’ve examined the necessary data,» she said, adding that the vaccine needed to match up to European criteria on quality control and efficacy.^[105]

On 18 March 2021, German regional leaders including State Premiers and the mayor of Berlin called for the swift approval of the Russian vaccine by the European Medicines Agency to counteract the acute shortages of effective vaccines in Europe. German medical experts have recommended its approval also, and consider the Sputnik Vaccine «clever» and «highly safe».^[106]

On 19 March 2021, the Philippine Food and Drug Administration granted emergency use authorization for Sputnik V, the fourth COVID-19 vaccine to be given authorization. The Philippine government planned to buy 20 million doses of the vaccine.^[107][108]

On 12 April 2021, India approved the use of Sputnik V vaccine for emergency use against COVID-19 based on strong immunogenicity data.^[109][110]

As of 12 April 2021, 62 countries had granted Sputnik V emergency use authorization.^[111]

On 27 April 2021, Bangladesh approved the use of Sputnik V vaccine for emergency use.^[112]

On 30 April 2021, Turkey and Albania approved the use of Sputnik V vaccine for emergency use.^[113][114]

Slovakia[edit]

On 1 March 2021, Slovakia bought 2 million doses of the Sputnik V vaccine. Slovakia received the first batch of 200,000, and expected to receive another 800,000 doses in March and April. Another 1 million doses were set to arrive in May and June.^[115]

On 8 April, Slovakia’s drug regulator said that the Sputnik V vaccine it received did «not have the same characteristics and properties» as the version endorsed by The Lancet.^[116] The Slovak State Institute for Drug Control stated that Sputnik V has not yet been approved for use, as the first 200,000 doses received on the 31st of March were different from the product currently being reviewed by the EMA as well as from the vaccine used in studies published in The Lancet. The producers have failed to reply to requests for documentation, and approximately 80% of the data was not supplied even after repeated requests. Due to the inconsistencies, it was not possible to review the safety and efficacy of the vaccine.^[117][118] Russian Direct Investment Fund replied that Slovakian laboratory which tested the vaccine was not certified by the EU.

Slovak Prime Minister Igor Matovič resigned on 30 March, due to the political crisis started by the order of the Sputnik V vaccine.^[119] On 6 April 2021, the RDIF asked to return the delivered first batch of the vaccine due to «multiple contract violations».^[117][120]

On 29 April 2021, the Slovak Ministry of Health published the Sputnik V contract.^[121] According to the contract, the RDIF as a seller is not liable for any adverse events following administering of the vaccine, nor its effectiveness.^[121][122] According to the Slovak lawyers, the contract is explicitly disadvantageous for Slovakia.^[122][123]

On 8 May 2021, the Russian Direct Investment Fund sent a letter to the Denník N newspaper requesting the removal of the statements of the drug regulator, calling them «unsubstantiated and false» and «fake news».^[124][125] RDIF threatened the newspaper with legal action if they didn’t comply with the demand by 9 May.^[126] The editors of Denník N refused to remove said statements.

After the samples were sent to the EU-certified laboratory in Hungary and it was stated that «the results were satisfactory»,^[127] the Slovakian government approved the vaccine, and announced that vaccination with Sputnik V would begin in June 2021, despite the negative review by Slovakia’s drug regulator.^[128][129] Vaccinations started on 7 June,^[130] but without significant interest in the Sputnik V vaccine.^[131][132] Slovakia has no plans to order new batches^[131] and plans to sell or donate unused vaccines to Balkans countries.^[133] The registrations for vaccination were closed on 30 June. In July 2021, 160,000 doses of the vaccine from the first batch of 200,000 were shipped back to Russia.^[134] Temporary government approval for Sputnik V expired on 31 August 2021.^[135][136] In total, 18,500 people have been vaccinated.^[137]

Purchase of Sputnik V, which led to a political crisis and contributed to a fall of Igor Matovič’s Cabinet was investigated by Slovak Police Force with the investigation levered against Marek Krajčí. No violation of the law was found in October 2022.^[138]

Brazil[edit]

On 26 April 2021, the Brazilian health regulator Anvisa rejected the use of Sputnik V, alleging a lack of consistent and reliable data and the presence of replicating adenovirus in the vaccine. RDIF and Sputnik V’s official Twitter account said the decision may be politically motivated, pointing to a recent report by the United States government that tried to persuade Brazil to reject the vaccine. Several Brazilian states in the North and Northeast regions had already signed contracts for the acquisition of more than 30 million doses.^{[139][140][141]} Anvisa attributed its decision to a number of issues with the samples provided by Gamaleya for accreditation:^{[142][143][144]}

• the adenovirus carrier in all samples was actually able to replicate in spite of manufacturer’s declaration it was incapacitated
• the methodology used by Gamaleya to check immune system response was unreliable and documentation provided made its verification impossible
• the procedure of registering adverse effects was insufficient
• Anvisa delegation was also not allowed into the Gamaleya laboratory for inspection
• all presented studies were performed on vaccine doses produced in laboratory, rather than in the manufacturing facility supplying vaccine for the mass market, which makes the results not representative
• Anvisa found issues in one of the factories in Russia that could impact sterility of the doses.^[143]

On April 29, 2021, the developers of Sputnik V said that Anvisa admitted not testing Sputnik V and that they would sue Anvisa in Brazil for defamation. At a press conference, Anvisa officials said that Gamaleya’s own documents indicated multiple times the presence of replication-competent adenoviruses (RCAs) in ready vaccine batches and that the specifications accepted a level of RCAs 300 times greater than any other regulatory threshold. Anvisa presented the video of a meeting with representatives from Russia and Brazil where, when asked about the presence of RCAs, a representative from Russia reported problems with the cells and said that the vaccine could have been redeveloped, but it would take too long, so the developers instead chose to continue the research imposing an acceptable level of RCAs.^[145][146] Virologist Angela Rasmussen described this problem as a quality control issue that is not important for healthy people because adenoviruses are not important pathogens, but added that it could produce serious adverse effects in immunocompromised individuals.^[147] Medicinal chemist Derek Lowe commented that the presence of replicating adenoviruses is unlikely to cause any major problems, but it is a «completely unnecessary risk», that it certainly will harm some people, and that providing a product different from the one described in studies undermines the credibility of all manufacturing and quality control processes,^[148] adding that some posts on the official Sputnik V Twitter account constitute «aggressive political marketing» and some make invalid claims regarding the performance of competing vaccines, such as the Pfizer-BioNTech vaccine.^[149] Anvisa said that the import ban can be reversed if Gamaleya clarifies the issues. Adenovirus infections cause only mild colds in healthy individuals, but they can cause life-threatening illnesses in immunodeficient individuals.^[47] The director of the Public Health Institute of Chile (ISP), Heriberto Garcia, said that the ISP would not necessarily reject the vaccine, even if it had replicating adenoviruses, because the risk of getting a common cold from the vaccine must be seen in light of the risk of contracting COVID-19 when not vaccinated. He also said that real-world data from Argentina and Mexico showed no adverse effects greater than those seen in people vaccinated with the Pfizer-BioNTech vaccine or CoronaVac.^[150]

On June 4, Anvisa approved exceptional imports of Sputnik V, restricting it mainly to healthy adults and limiting it to only 1% of the population of 6 importing states, in order to manage risks through control and supervision of side effects. Anvisa said that the concern with replicating viruses has not been fully resolved, but that additional documents received indicate a substantially reduced acceptable amount. The new parameter would be in an FDA manual, which was not found. Anvisa also said that impurity and quality controls are insufficient and that the manufacturing plants must undergo corrections to meet WHO quality standards.^{[2][151][152]} As of 16 June, the same import conditions were extended to a total of 13 states.^[153] On August 5, the consortium of northeastern Brazilian states, corresponding to 7 of the 13 states, suspended the import of 37 million doses due to the restrictions imposed by Anvisa. These doses will supply Mexico, Argentina and Bolivia.^[154]

Further development[edit]

Heterologous prime-boost vaccination[edit]

On 21 December 2020 the Russian Direct Investment Fund (RDIF), the Gamaleya National Center, AstraZeneca and R-Pharm signed an agreement aimed at the development and implementation of a clinical research program to assess the immunogenicity and safety of the combined use of one of the components of the Sputnik V vaccine developed by the Gamaleya Center, and one of the components of the Oxford–AstraZeneca vaccine.^[155] The study program will last 6 months in several countries, and it is planned to involve 100 volunteers in each study program. On 9 February 2021, the Ministry of Health of the Republic of Azerbaijan allowed clinical studies in the country for the combined use of the Oxford–AstraZeneca vaccine and Sputnik Light, stating that the trials would begin before the end of February 2021.^[156][157] On February 20, 2021, in the official Sputnik V Twitter account it was stated that clinical trials have already started.^[158]

Society and culture[edit]

Economics[edit]

In Russia[edit]

The vaccine is free of charge to users in Russia and Kazakhstan. The cost per dose would be less than US$10 (US$20 for the required two doses) on international markets, much less than the cost of mRNA vaccines from other manufacturers. Kirill Dmitriev, head of the fund, told reporters that over 1 billion doses of the vaccine are expected to be produced in 2021 outside of Russia.^[159][160]

The head of the Gamaleya Research Institute Alexander Ginzburg estimated that it would take 9–12 months to vaccinate the vast majority of the Russian population, assuming in-country resources were adequate.^[161][162]

The commercial release of the Gam-COVID-Vac was first scheduled for September 2020. In October, Mikhail Murashko said that the Gam-COVID-Vac would be free for all Russian citizens after the launching of mass production.^[163][164] Later on, the Russian Ministry of Health registered the maximum ex-factory price equal to 1,942 roubles for two components and included it into The National List of Essential medicines.^[165] There were also suggestions to include the vaccine in the National Immunisation Calendar of Russia.^[165]

In the beginning of December 2020, Russian authorities announced the start of a large-scale free of charge vaccination with Gam-COVID-Vac for Russian citizens: the immunization program was launched on 5 December 2020 (with 70 medical centers in Moscow providing vaccinations).^[166]

Doctors and other medical workers, teachers, and social workers were given priority due to their highest risk of exposure to the disease.^[167] Initially the vaccine was only offered to people over 60 years of age, later this restriction was lifted.^[168]

Potential recipients were notified via text messaging, which said «You are working at an educational institution and have top-priority for the COVID-19 vaccine, free of charge». Patients were asked a few general health questions before receiving the vaccine.^{[169][170][171]} People with certain underlying health conditions, pregnant women, and those who have had a respiratory illness for the past two weeks were barred from vaccination.^[167] The vaccine vial was removed from medical centre’s freezer about 15 minutes before use.

In early December 2020, the Minister of Health, Mikhail Murashko, said that Russia had already vaccinated more than 100,000 high-risk people.^[172] Forty thousand of those were volunteers in Sputnik V’s Phase 3 trials, another 60,000 nurses and doctors had also taken the vaccine.^[173] The head of the Russian Direct Investment Fund, Kirill Dmitriev, said in an interview with the BBC that Russian medics expected to give about 2 million people coronavirus vaccinations in December 2020.^[174]

Up to the beginning of December 2020, Generium (which is supervised by Pharmstandard) and Binnopharm (which is supervised by AFK Sistema) companies produced Gam-COVID-Vac on a large scale.

On 10 December, Deputy Prime Minister Tatyana Golikova announced that approximately 6.9 million doses of the Sputnik V vaccine would enter civilian circulation in Russia before the end of February 2021.^[175] Moscow Mayor Sergei Sobyanin announced that the newly opened Moscow-based «R-Pharm» will become a leading manufacturer of Russia’s Sputnik V coronavirus vaccine. Working at full capacity, the factory will produce up to 10 million doses a month.^[176]

As of March 2021, vaccination rates in Russia were below those of other developed nations.^[177]

In May 2021 Sergei Sobyanin complained that only 1.3 million Moscow residents out of 12 million had received the first dose (10.2%). Only 9.5% of Russians had received a vaccine.^[178] Forbes Russia established that Russia committed to export 205 millions of doses of «Sputnik V» to other countries, and as of May 16.3 millions (8%) were so far delivered.^[179] A survey found that 62% of the Russian population felt hesitant, with 55% not afraid of getting sick and some willing to wait for CoviVac.^[180]

In June 2021, with the increase in Delta variant cases, several Russian city governments introduced strict measures to overcome vaccine hesitancy, such as requiring vaccine QR codes from customers in cafes.^[180]

Outside Russia[edit]

Russia is pursuing deals to supply its vaccine abroad.^[181]

According to the Russian Direct Investment Fund, they had received orders for more than 1.2 billion doses of the vaccine as of December 2020. Over 50 countries had made requests for doses, with supplies for the global market being produced by partners in India, Brazil, China, South Korea, Hungary, and other countries.^[182][183] In August 2020, according to the Russian authorities, there were at least 20 countries that wanted to obtain the vaccine.^[184]

The Israeli Hadassah Medical Center signed a commercial memorandum of understanding to obtain 1.5–3 million doses.^[185]

Argentina agreed to buy 25 million doses of Russia’s COVID-19 vaccine, subject to its clearing clinical trials;^[186] the vaccine was registered and approved in Argentina in late December 2020.^[187] The Brazilian state of Bahia signed an agreement to conduct Phase III clinical trials of the Sputnik V vaccine and planned to buy 50 million doses to market in northeastern Brazil.^[188]

On 21 January 2021, Argentine president Alberto Fernández became the first Latin American leader to be inoculated with Sputnik V, shortly after it was approved for use in the country.^[189][190] Two months after being vaccinated he developed fever and headache, and tested positive for COVID-19.^[191] He was asymptomatic ten days later, was discharged from medical treatment subject to medical follow-up as usual for former COVID-19 patients, and resumed his normal activities.^[192]

According to The New York Times sources, in February 2021, Israel agreed to finance a supply of the Sputnik V vaccine to Syria in order to secure the release of an Israeli civilian held in Syria.^[193]

Due to the delay in shipping of doses from Italy and the European Union, San Marino imported doses of the Sputnik V vaccine (not approved by the EMA) and started a mass vaccination on 28 February of its healthcare workers.^[194]

April 14, 2021, Armenia agreed with Russia on purchase of 1 million doses of coronavirus vaccines Sputnik V. This was the decision of Armenian health minister Anahit Avanesyan. The Armenian authorities have begun negotiations with Russia on the production of the Sputnik V coronavirus vaccine. Head of the Armenian Ministry of Health Anahit Avanesyan stated this at a press conference on March 12, 2021.^[195]

Scientific assessment[edit]

On 11 August 2020, a World Health Organization (WHO) spokesperson said, «… prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data».^[9] A WHO assistant director said, «You cannot use a vaccine or drugs or medicines without following through all of these stages, having complied with all of these stages».^[196]

Francois Balloux, a geneticist at University College London, called the Russian government’s approval of Gam-COVID-Vac a «reckless and foolish decision».^[4] Professor Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, characterized the announcement as a «political stunt», and stated that the untested vaccine could be very harmful.^[9]

Stephen Griffin, Associate Professor in the School of Medicine, University of Leeds, said «that we can be cautiously optimistic that SARS-CoV2 vaccines targeting the spike protein are effective.» Moreover, as the Sputnik antigen is delivered via a different modality, namely using a disabled Adenovirus rather than formulated RNA, this provides flexibility in terms of perhaps one or other method providing better responses in certain age-groups, ethnicities, etc., plus the storage of this vaccine ought to be more straightforward.^[197]

In November 2020, public health expert Talha Khan Burki said the quick approval of Gam-COVID-Vac by the Russian government was «cutting corners», and may harm public confidence if the vaccine proves to be unsafe or ineffective.^[8] «There is a huge risk that confidence in vaccines would be damaged by a vaccine that received approval and was then shown to be harmful», said immunologist Peter Openshaw.^[8]

Ian Jones, a professor of virology at the University of Reading, and Polly Roy, professor and Chair of Virology at The London School of Hygiene and Tropical Medicine, commenting on phase III results published in the Lancet in February 2021, said «The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency. But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of COVID-19.»^[198]

On 12 May 2021, a group of biostatisticians published an article in The Lancet about data discrepancies and substandard reporting of interim data of the Sputnik V phase-III trial. According to the article, the lack of transparency of the trial results raises serious concerns. Data inconsistencies were found, including a very low probability of homogeneity of vaccine efficacy across age groups.^[35]

Two preliminary studies, one from Argentina and one from San Marino, found mostly mild adverse events and no vaccine-associated deaths.^[40] Another study carried out in San Marino has concluded a high tolerability profile in the population aged ≥60 years in terms of short-term adverse events following immunization.^[199]

An article published by the journal Nature on 6 July 2021 cited data released by the United Arab Emirates on some 81,000 individuals who had received Sputnik V, according to which the vaccine demonstrated an efficacy of 97.8% in preventing symptomatic COVID-19, and 100% efficacy in preventing severe complications. The figures echoed similar findings from unpublished data on 3.8 million Russians, according to which Sputnik V demonstrated an efficacy of 97.7%.^[200]

A study published by the Journal of Medical Internet Research analyzed the dataset consisted of 11,515 self-reported Sputnik V vaccine adverse events posted on Telegram. Telegram users complained mostly about pain, fever, fatigue, and headache.^[201]

Public opinion polls[edit]

An opinion poll of Canadians conducted by Léger in August 2020 found that a majority (68%) would not take the Russian vaccine if offered a free dose, compared to 14% who said they would take it.
When Americans were asked the same question, 59% would not take the Russian vaccine if offered a free dose, compared to 24% who said they would take it.^[202][203] In June 2021, according to a poll conducted by Ost-Ausschuss der Deutschen Wirtschaft [de] (German Eastern Business Association), a majority (60%) of Germans would use the Russian vaccine Sputnik V if they had the opportunity to do so. With 71% approval, the values in East Germany are significantly higher, but with 58% of the respondents there is also a solid majority in West Germany. 38% of respondents, on the other hand, would not want to use Sputnik V.^[204]

In July 2020, opinion polls suggested around 90% of the Russian population had doubts about the vaccine but by September this had dropped to around half the Russian population.^[205] In May 2021, the Levada Center released a poll of 1,614 respondents from 50 regions which showed that 26% of Russians were prepared to be vaccinated with Sputnik V, while 62% were not prepared to be vaccinated. Ten percent of respondents had already been vaccinated.^[206]

References[edit]

Further reading[edit]

External links[edit]

• Official website

https://ria.ru/20210701/sputnikv-1739169613.html

«Спутник V». Все о первой российской вакцине от коронавируса

Гам-КОВИД-Вак (Спутник V) — что это за вакцина, противопоказания, отзывы привитых

«Спутник V». Все о первой российской вакцине от коронавируса

Гам-КОВИД-Вак», известная также как «Спутник V», — первая зарегистрированная в мире вакцина для профилактики COVID-19. По оценкам разработчиков, препарат… РИА Новости, 02.07.2021

2021-07-01T08:00

2021-07-01T08:00

2021-07-02T18:17

наука

министерство здравоохранения рф (минздрав россии)

федеральная служба по надзору в сфере защиты прав потребителей и благополучия человека (роспотребнадзор)

здоровье

российский фонд прямых инвестиций

биология

вакцины

нии им. гамалеи (национальный исследовательский центр эпидемиологии и микробиологии имени почетного академика н.ф.гамалеи)

https://cdnn21.img.ria.ru/images/07e4/0c/1c/1591207795_0:147:3072:1875_1920x0_80_0_0_b1334d2c50f7aef1b5466f0485702743.jpg

МОСКВА, 1 июл — РИА Новости. «Гам-КОВИД-Вак», известная также как «Спутник V», — первая зарегистрированная в мире вакцина для профилактики COVID-19. По оценкам разработчиков, препарат эффективен против всех выявленных штаммов коронавируса SARS-CoV-2, а ее облегченный вариант «Спутник Лайт» идеально подходит для ревакцинации.Что такое «Гам-КОВИД-Вак»»Гам-КОВИД-Вак», или «Спутник V», — первая российская вакцина против ковида, созданная в Центре эпидемиологии и микробиологии имени Н. Ф. Гамалеи. Она относится к классу векторных вакцин. Зарегистрирована 11 августа 2020 года. Состав вакцины «Спутник V»Вакцина состоит из неспособного размножаться аденовируса человека. Этот возбудитель не опасен, он вызывает лишь легкую простуду. В его ДНК встроен ген белка-шипа коронавируса SARS-CoV-2. Белок связывается с рецепторами на поверхности клеток и помогает вирусу проникнуть внутрь. Именно на белок-шип реагирует наш иммунитет. Аденовирусный вектор при этом служит средством доставки.В вакцине используют вектор на основе двух разных штаммов аденовируса человека — 26-го и пятого серотипа (Ad26, Ad5). Выпускают препарат в виде раствора со вспомогательными веществами: например, трис, хлориды натрия и магния, сахароза, полисорбат, магний хлористый гексагидрат, ЭДТА, этанол, вода.Принцип действия и отличия от других вакцинРаствор вводят в мышцу, вскоре в месте укола начинается небольшое воспаление — организм распознает чужеродные вещества и отправляет туда лимфоциты. Аденовирус проникает в них и заставляет вырабатывать коронавирусный белок-шип. В свою очередь иммунитет отвечает целым коктейлем из антител.Антитела — это сигнальные белки, которые дают команды защитной системе организма. Если произойдет встреча с реальным SARS-CoV-2, они помогут его уничтожить. В результате человек не заболеет либо коронавирусная инфекция будет перенесена в легкой форме.В мире есть несколько векторных вакцин от коронавируса. Например, американская компания Johnson & Johnson создала препарат на основе аденовируса человека Ad26, а китайская CanSino Biologics — Ad5. Обе вводят однократно. В отличие от них «Спутник V» делают в два приема. После первой дозы, или, как говорят ученые, праймирующей иммунизации, у привитых формируется первичный, а после второй, бустерной, — вторичный иммунный ответ. Уникальность российской технологии в том, что в первой и второй дозах использованы разные вирусные векторы — сначала Ad26, затем Ad5. При такой схеме общий уровень иммунизации намного выше.Еще одну векторную вакцину разработала англо-шведская компания AstraZeneca. Однако в ней в качестве вектора используют аденовирус шимпанзе.По результатам клинических исследований, которые прошли международную оценку и опубликованы в журнале The Lancet, эффективность вакцины «Спутник V» против COVID-19 составляет 91,6 процента. И в ста процентах случаев она предотвращает развитие тяжелой формы ковида. Анализ данных о заболеваемости коронавирусом среди россиян, привитых обоими компонентами препарата в период с 5 декабря 2020-го по 31 марта 2021-го, показал, что реальная эффективность «Гам-КОВИД-Вак» еще выше — 97,6 процента.Инструкция по применениюПодготовка к вакцинацииНет никаких особенных требований при подготовке в прививке. Роспотребнадзор указывает — перед вакцинацией нет необходимости делать ПЦР-тест, чтобы исключить ковид, или анализ на антитела. Главное, в день вакцинации самочувствие должно быть хорошим.Однако, по мнению ряда экспертов, реакция организма на введение любой вакцины очень индивидуальна. Поэтому людям с серьезными хроническими болезнями нужно предварительно сходить на прием к лечащему врачу и убедиться, что их заболевание в стадии ремиссии и они сейчас не принимают никаких препаратов, которые могут помешать выработке иммунитета.Как делается прививка от коронавируса»Спутник V» предназначен для внутримышечного введения. Укол делают в дельтовидную мышцу плеча. Перед процедурой флакон или ампулу с компонентом I или II достают из морозильной камеры и выдерживают при комнатной температуре до полного размораживания, чтобы не осталось включений льда. Затем протирают снаружи спиртовой салфеткой и осторожно перемешивают содержимое, не допуская встряхивания. Размороженный препарат необходимо использовать в течение двух часов, снова замораживать его нельзя.Для выявления противопоказаний пациента перед вакцинацией должен осмотреть врач. Он опрашивает о самочувствии и контактах с инфицированными, измеряет температуру тела и уровень кислорода в крови. Если температура выше 37 градусов, прививку откладывают.Что нельзя делать после прививкиРекомендуют один день до и два дня после прививки воздержаться от употребления алкоголя, не переутомляться, избегать тяжелых физических нагрузок, снизить уровень стресса, хорошо высыпаться, не злоупотреблять солнечными ваннами, а в сам день вакцинации не посещать бани и бассейны, не купаться в природных водоемах.Ученые советуют есть побольше белковых продуктов — молочных, рыбы, нежирного мяса, поскольку они дают организму необходимый строительный материал для формирования защитных антител, а также богатые пищевыми волокнами пребиотики — овощи, цельнозерновые крупы, бобовые, зелень — и пробиотики — кефир, йогурт, простоквашу, квашеную капусту. Они нужны для поддержания кишечной микрофлоры, которая вносит большой вклад в выработку иммунного ответа на вакцину.Также важно после прививки соблюдать стандартные защитные меры: носить маски в людных местах, тщательно мыть руки, использовать антисептики. Интервал между прививкамиВакцинацию проводят в два этапа с интервалом 21 день: вначале компонентом I в дозе 0,5 миллилитров, затем, через три недели, — компонентом II в дозе 0,5 миллилитров.Когда появятся антитела к коронавирусуПо оценкам ученых, полноценный иммунитет возникает в среднем через 40 дней после первого укола. До истечения этого срока важно не только избежать заражения коронавирусом, но и не подхватить другую ОРВИ, энтеровирус или прочие инфекции. Они могут помешать эффективной выработке иммунитета после вакцинации. Побочные эффекты от вакцины «Спутник V»Клинические исследования показали, что чаще всего после вакцинации возникает гриппоподобный синдром — боль, отек и зуд в месте введения, общее недомогание, озноб, повышение температуры, боль и ломота в мышцах и суставах, головная боль, снижение аппетита. Состояние может длиться от одного до трех дней.Реже проявляются нарушения со стороны дыхательной системы — боль в ротоглотке, заложенность носа, першение в горле. Возможны головокружения, обмороки, тошнота, рвота, диспепсия. В памятке Минздрава указано, что при повышении температуры можно принять нестероидные противовоспалительные препараты, а при покраснении, отечности и болезненности места укола — антигистаминные средства. Никаких серьезных последствий, в том числе тяжелых аллергических реакций, не наблюдалось.Продолжительность действияПока точно не установлено, на какой срок защищает вакцина. Согласно предварительной оценке, антитела класса G у сотрудников Центра Гамалеи, получивших вакцину в порядке эксперимента в марте 2020-го, сохранялись и через девять месяцев. При этом титр антител был выше, чем у переболевших. Противопоказания для вакцинацииПротивопоказания к применению у «Спутника V» примерно такие же, как у всех остальных вакцин: тяжелые формы аллергии, инфекционные и неинфекционные заболевания в острой форме, грудное вскармливание. Прививаться можно всем взрослым старше 18 лет, без верхнего ограничения по возрасту. Детей пока не прививают — из-за отсутствия клинических испытаний, подтверждающих эффективность и безопасность вакцины для людей младше 18. Центр Гамалеи планирует в ближайшее время начать исследование по применению «Спутника V» у детей. Соответствующую заявку ученые подали в Минздрав России.Недавно ведомство разрешило «Спутник V» для беременных женщин с высоким риском тяжелого течения COVID-19. Инструкция рекомендует с осторожностью применять вакцину при хронических заболеваниях печени и почек, тяжелых заболеваниях системы кроветворения, эпилепсии и других заболеваниях центральной нервной системы, остром коронарном синдроме и остром нарушении мозгового кровообращения, миокардитах, эндокардитах, перикардитах, а также при некоторых эндокринных заболеваниях, таких как выраженные нарушения функции щитовидной железы и сахарный диабет в стадии декомпенсации.Отмечено, что вакцинация может представлять определенный риск для пациентов со злокачественными новообразованиями и тяжелыми аутоиммунными заболеваниями, так как стимуляция иммунной системы может привести к обострению.А вот пациентам с сердечно-сосудистыми заболеваниями, диабетом, бронхиальной астмой, гепатитом С и онкозаболеваниями в стадии ремиссии, по мнению ученых, вакцинироваться необходимо.РевакцинацияОжидают, что коронавирус станет сезонным и прививаться от него нужно будет ежегодно. А во время обострения эпидемии — раз в шеть месяцев.Специалисты Центра Гамалеи и Минздрава рекомендуют проводить ревакцинацию «Спутником Лайт», которая в ближайшее время поступит в гражданский оборот. Ранее глава РФПИ Кирилл Дмитриев и владелец компании «Р-Фарм» — одного из производителей «Гам-КОВИД-Вак» — заявляли, что ревакцинироваться можно и первым компонентом «Спутника V».Отзывы привитых «Спутником V»»Сегодня привился «Спутником V». Чувствую себя хорошо. Коронавирусом я переболел, есть антитела. Но прививка необходима независимо от уровня титров. Все, кто еще не вакцинировался, — самое время это сделать», — написал врио главы Мордовии Артем Здунов в инстаграме.Врио губернатора Хабаровского края Михаил Дегтярев сделал прививку от ковида повторно. «Первый раз вакциной «Гам-Ковид-Вак» прививался в июле и августе прошлого года. По прошествии 11 месяцев количество антител в крови существенно снизилось, поэтому решил не рисковать ни своим здоровьем, ни здоровьем людей, с которыми работаю и с которыми встречаюсь каждый день», — рассказал он в Telegram-канале.Народные отчеты от вакцинации «Спутником V» публикуются в Telegram-канале @Sputnik_results. Вот несколько отзывов: «М 43, здоров. ГамКовидВакV1 — 16.03 без побочек, V2-07.04 легкая слабость на след день. Антитела на 28.06″.»Ж 22 года V1 28.06.21. В день прививки легкая слабость и сонливость, боль в месте укола».»М 65, системный васкулит (гранулематоз Вегенера) в ремиссии, V2 28.06.21, никаких симптомов, как и после первой дозы».Сертификация вакцины «Спутник V» в других странахВакцина одобрена в 67 странах с общим населением свыше 3,4 миллиарда человек. Так, имея сертификат о прививке «Спутником V», можно въезжать, например, в Грецию, Хорватию, на Кипр, в Турцию, Грузию. Пакет документов о сертификации «Спутника V» также предоставлен ВОЗ. Разработчики ожидают положительное решение в скором времени. В случае одобрения вакцинированные получат цифровые сертификаты, которые облегчат перемещение по странам ЕС.

https://ria.ru/20201225/vaktsina-1590616868.html

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министерство здравоохранения рф (минздрав россии), федеральная служба по надзору в сфере защиты прав потребителей и благополучия человека (роспотребнадзор), здоровье, российский фонд прямых инвестиций, биология, вакцины, нии им. гамалеи (национальный исследовательский центр эпидемиологии и микробиологии имени почетного академика н.ф.гамалеи), коронавирус covid-19, вакцина «спутник v», вакцинация россиян от covid-19, вакцина «спутник лайт»

Содержание

Действующее вещество

ATX

Владелец РУ

ФГБУ НИЦЭМ им. Н.Ф. Гамалеи МЗ РФ (филиал «Медгамал»)

Условия хранения

В защищенном от света месте, при температуре не выше минус 18 °C.

Хранить в недоступном для детей месте.

Срок годности

1 год.

Не применять по истечении срока годности, указанного на упаковке.

Источники информации

ГРЛС, 2022.

Фармакологическая группа

Характеристика

Фармакология

Показания к применению

Профилактика коронавирусной инфекции (COVID-19) у взрослых старше 18 лет.

Противопоказания

Применение при беременности и кормлении грудью

Побочные действия

Взаимодействие

Специальных исследований лекарственного взаимодействия не проводилось.

Передозировка

Способ применения и дозы

Интраназально, с помощью дозирующего устройства, в один носовой ход на вдохе, в два этапа с интервалом 3 нед. Допускается отдельное введение компонентов.

Меры предосторожности

Предупреждения

Состав вакцины

Состав Гам-КОВИД-Вак указан на одну дозу, которая составляет 0.5 мл.

Компонент 1 содержит:

• активное вещество: рекомбинантные аденовирусные частицы 26 серотипа, в которых содержится ген белка S вируса SARS-CoV-2, по 1 x 10¹¹ частиц с погрешностью 0.5 x 10¹¹ частиц;
• вспомогательные компоненты: магния хлорида гексагидрат (102 мкг), трис(гидроксиметил)аминометан (1.21 мг), сахароза (25 мг), хлорид натрия (2.19 мг), ЭДТА динатриевая соль дигидрат (19 мкг), вода для инъекции (до 0.5 мл), этанол 95% (2.5 мкл), полисорбат 80 (250 мкг).

Компонент 2 содержит:

• активное вещество: аденовирусные рекомбинантные частицы 5 серотипа, которые содержат ген белка S вируса SARS-CoV-2, по 1 x 10¹¹ частиц в дозе с погрешностью 0.5 x 10¹¹ частиц;
• вспомогательные вещества те же, что в первом компоненте.

В составе Гам-КОВИД-Вак-Лио содержится аналогичное количество активного компонента и вспомогательные элементы: магния хлорида гексагидрат (20.4 мкг), трис(гидроксиметил)аминометан (0.24 мг), сахароза (73.5 мг), хлорид натрия (1.4 мг), ЭДТА динатриевая соль дигидрат (3.8 мкг), полисорбат 80 (0.05 мг).

Производители

На данный момент известны следующие производители Гам-КОВИД-Вак:

• ФГБУ «НИЦЭМ им. Н.Ф. Гамалеи» Минздрава России;
• АО «Биннофарм»;
• АО «ГЕНЕРИУМ»;
• АО «Р-Фарм»;
• ЗАО «БИОКАД»;
• ЗАО «ЛЕККО»;
• ОАО «Фармстандарт-УфаВИТА».

Владельцем регистрационного удостоверения на производство вакцины Спутник V является ФГБУ «Национальный исследовательский центр микробиологии и эпидемиологии им. почетного академика Н.Ф. Гамалеи» Мин. здравоохранения РФ.

Когда вакцина зарегистрирована?

Вакцина от коронавируса Гам-КОВИД-Вак была зарегистрирована 11 августа 2020 года.

Форма выпуска

Препарат Гам-КОВИД-Вак (Спутник V) выпускают в форме раствора для внутримышечного введения из двух компонентов, по 0.5 мл раствора каждого компонента на 1 дозу.

Замороженный препарат

Оба компонента препарата в виде замороженного раствора — беловатая твердая плотная масса. После разморозки — однородный раствор, бесцветный или слегка желтоватый.

Производство ФГБУ «НИЦЭМ им. Н.Ф. Гамалеи»:

• Препарат во флаконах, закрытых резиновой пробкой, обжатый алюмопластиковым колпаком. По 0.5 мл (1 доза) каждого компонента во флаконе. Флакон каждого компонента вместе с инструкцией помещен в пачку из картона.

Производство АО «Биннофарм»:

• Препарат в прозрачных ампулах с цветной точкой. По 0.5 мл (1 доза) каждого компонента в ампуле. По 5 ампул каждого компонента помещены в ячейковую контурную упаковку из поливинилхлоридной пленки, по 1 ячейковой упаковке вместе с инструкцией в картонной пачке.

Производство АО «ГЕНЕРИУМ» и ЗАО «ЛЕККО»:

• Препарат во флаконах, закрытых резиновой пробкой, обжатый алюмопластиковым колпаком с контролем первого вскрытия. По 3 мл (5 доз) каждого компонента во флаконе. Флакон каждого компонента вместе с инструкцией помещен в пачку из картона.

Производство ЗАО «БИОКАД»:

• Препарат во флаконах, закрытых резиновой пробкой, обжатый алюминиевым колпаком с пластиковой крышкой типа «flip-off». По 3 мл (5 доз) или по 0.5 мл (1 доза) каждого компонента во флаконе. Флакон 6R каждого компонента вместе с инструкцией помещен в пачку из картона. Флакон 2R каждого компонента в контурной ячейковой упаковке из ПВХ пленки вместе с инструкцией помещен в пачку из картона.

Производство ОАО «Фармстандарт-УфаВИТА»:

• Препарат в прозрачных ампулах. По 0.5 мл (1 доза) каждого компонента в ампуле. По 5 ампул каждого компонента помещены в ячейковую контурную упаковку из поливинилхлоридной пленки, по 1 ячейковой упаковке вместе с инструкцией в картонной пачке.
• Препарат во флаконах, закрытых резиновой пробкой, обжатый алюмопластиковым колпаком с контролем первого вскрытия. По 3 мл (5 доз) каждого компонента во флаконе. Флакон каждого компонента вместе с инструкцией помещен в пачку из картона.

Жидкий препарат

Оба компонента препарата в виде однородного раствора, бесцветного или слегка желтоватого оттенка.

Производство ОАО «Фармстандарт-УфаВИТА»:

• Препарат в прозрачных ампулах. По 0.5 мл (1 доза) каждого компонента в ампуле. По 5 ампул каждого компонента помещены в ячейковую контурную упаковку из поливинилхлоридной пленки, по 1 ячейковой упаковке вместе с инструкцией в картонной пачке.

Производство АО «ГЕНЕРИУМ» и ЗАО «ЛЕККО»:

• Препарат во флаконах, закрытых резиновой пробкой, обжатый алюмопластиковым колпаком с контролем первого вскрытия. По 3 мл (5 доз) каждого компонента во флаконе. Флакон каждого компонента в контурной ячейковой упаковке вместе с инструкцией помещен в пачку из картона.

Фармакологическое действие

Комбинированная векторная вакцина Гам-КОВИД-Вак применяется в качестве иммунологического средства.

Фармакодинамика и фармакокинетика

Согласно исследованиям препарата в институте Гамалеи вакцина способствует формированию клеточного и гуморального иммунитета по отношению к вирусной инфекции, ассоциированной SARS-CoV-2. Обладает иммунологической активностью. Безопасность и иммунологические свойства изучались в клинических исследованиях у взрослых пациентов обоих полов. Возраст испытываемых составлял от 18 до 60 лет. При этом 9 человек получали первый компонент и 9 — второй, 20 человек проходили вакцинацию в режиме прайм-буст.

Иммуногенность средства была оценена по уровню спец. антител к белку коронавируса и уровню нейтрализующих вирус антител. У всех пациентов, принимающих участие в исследовании в результате образовывались специфические агенты. Через 42 дня в сыворотке крови всех добровольцев были обнаружены антитела к вирусу.

В центре Гамалеи оценку уровня иммуноглобулинов проводили по сравнению с исходным уровнем до иммунизации. Степень активности клеточного иммунитета была оценена в тесте лимфопролиферации CD8+ и CD4+, по скорости прироста интерферонов гамма в ответ на стимуляцию гликопротеином S.

После проведения вакцинации Спутником V был сформирован напряженный ангитен-специфический клеточный противоинфекционный иммунитет у всех добровольцев. Формировались антиген-специфичные клетки Т-хелперов, Т-киллеров, наблюдалось повышение уровня ИФНγ.

На данный момент испытания вакцины Cпутник V продолжаются, а защитный титр антител достоверно неизвестен. Испытания должны выявить продолжительность защиты организма. Также, пока не проводились клинические исследования по изучению эпидемиологической эффективности средства.

Показания к применению

Применяют для профилактики новой коронавирусной инфекции COVID-19 у взрослых пациентов в возрасте от 18 до 60 лет.

Вакцина Спутник V, противопоказания

Были выявлены следующие противопоказания на Спутник Ви:

• сверхчувствительность к компонентам средства или к вакцинам, содержащим аналогические ингредиенты;
• наличие тяжелых аллергических реакций у пациента ранее;
• неинфекционные и инфекционные острые заболевания;
• обострение хронического заболевания (вакцинацию рекомендуется проводит не ранее, чем через 2-4 недели после полного выздоровления или достижения ремиссии);
• кормление грудью и беременность;
• возраст до 18 и более 60 лет.

Перед тем, как сделать прививку 2 компонентом нужно выяснить у пациента, не возникали ли тяжелые осложнения (аллергические реакции, анафилактический шок, судороги, повышение температуры выше 40 градусов) после инъекции 1 компонента.

Осторожность следует соблюдать:

• при хронических заболеваниях почек и печени;
• пациентам с сахарным диабетом и выраженными нарушениями работы эндокринной системы;
• при тяжелых заболеваниях системы кроветворения;
• больным эпилепсией;
• после инсульта или с другими заболеваниями центральной нервной системы;
• при патологиях сердечно-сосудистой системы, инфаркте в анамнезе, миокардите, перикардите, эндокардите, ишемической болезни;
• пациентам с первичным и вторичным иммунодефицитом;
• при аутоимунных заболеваниях;
• больным астмой, с заболеваниями легких, ХОБЛ;
• при метаболическом синдроме;
• пациентам с атопией, аллергическими реакциями, экземой.

В учреждении, где проводят вакцинацию должны быть в наличии средства противошоковой терапии. В день проведения прививки пациента необходимо осмотреть, измерить температуру. Нельзя делать укол, если у пациента температура выше 37 градусов.

Вакцина Спутник V, побочные эффекты

Побочные эффекты Гам-КОВИД-Вак были выявлены в рамках клинических испытаний и исследований прочих вакцин, разработанных по аналогичной технологии. Реакции бывают легкими или среднетяжелыми. Чаще всего возникают в 1-2 день после прививки и проходят в течение следующих 3 дней. Рекомендуют проводить симптоматические лечение, при необходимости принимать НПВС после вакцинации.

Обычно наблюдаются кратковременные общие и местные реакции:

• гриппоподобный синдром, озноб, рост температуры тела, миалгия, артралгия, общая слабость;
• астения, головные боли, недомогание;
• боли в месте инъекции, отечность и повышение температуры в месте укола.

Реже возникает:

• тошнота, несварение желудка, потеря аппетита;
• увеличение лимфоузлов, аллергические реакции;
• рост уровня ферментов печени, креатинина, трансаминаз, креатинфосфокиназы в крови.

В открытом клиническом исследовании безопасности вакцины не удалось точно определить встречаемость нежелательных реакций, так как выборка участников исследования была ограниченной.

Во время таких исследований выявили следующие побочные эффекты:

• боль, отек, зуд в месте введения вакцины;
• понос, боли в ротоглотке, заложенность носа и першение в горле, ринорея;
• рост уровня Т-лимфоцитов, CD4-лимфоцитов и процентного их содержания;
• снижение числа естественных «киллеров», СD8;
• отклонения в общем анализе мочи, наличие в ней эритроцитов.

Вакцина Гам-КОВИД-Вак (Спутник V), инструкция по применению

Прививка Спутник V от коронавируса проводится внутримышечно. Внутривенное ведение средства строго запрещено. Инъекцию производят в дельтовидную мышцу или в латеральную широкую мышцу бедра.

Лиофилизат необходимо растворить в 1,0 мл воды для инъекций. После чего флакон встряхивают, пока его содержимое полностью не растворится.

Перед введением готового препарата его достают из холодильной камеры и нагревают при комнатной температуре в течение получаса. Раствор перемешивают осторожно покачивая ампулу. Нельзя резко встряхивать средство.

Нельзя использовать препарат, если целостность флакона была нарушена, смазалась маркировка, вещество изменило свои физические свойства, изменился цвет, появились механические включения, истек срок годности.

Лекарственный препарат был зарегистрирован по особой процедуре, и при каждом применении вакцины необходимо уведомлять Федеральную службу по надзору в сфера здравоохранения. Информацию нужно вносить в соответствующий раздел инф. системы ЕГИСЗ.

Вакцинация проводится в 2 этапа. Вначале вводят компонент 1, затем через 3 недели — компонент 2.

Если дальнейшие инъекции были отложены по какой-либо причине, то можно хранить вскрытый флакон по 3 мл не более 2 часов при комнатной температуре.

Передозировка

Нет данных о передозировке Спутник Ви. Вакцина от ковида выпускается для использования в лечебно-профилактических учреждениях, процедура проводится только квалифицированными мед. персоналом и вероятность передозировки крайне мала.

Предполагается, что при случайной передозировке могут возникнуть токсические и токсико-аллергические реакции, указанные в пункте «побочные действия» в более тяжелой форме. Рекомендуется симптоматическая терапия, прием жаропонижающих препаратов и НПВС, кортикостероидов парентерально.

Взаимодействие

Неизвестно вступает ли вакцина от коронавируса Спутник V во взаимодействие с другими препаратами.

Условия продажи

Пока лекарство нельзя приобрести в аптеке самостоятельно.

Условия хранения векторной вакцины Гам-КОВИД-Вак

Раствор для внутримышечного введения хранят в защищенном от света месте при температуре не более 18 °C. Не допустимо хранение размороженного препарата для флаконов по 0,5 мл.

Для флаконов по 3,0 мл — средство можно хранить более 2 часов при комнатной температуре. Держать вакцину дальше от детей.

Срок годности

Срок хранения составляет пол года для всех лек. форм и обоих компонентов средства.

Особые указания

Пациенты, получающие иммуносупрессивную терапию или больные иммунодефицитом могут не получить достаточного иммунного ответа. Поэтому применение средств, угнетающих работу иммунной системы противопоказано за 30 дней до и 30 дней после вакцинации. Пренебрежение правилом может привести к снижению иммуногенности.

Неизвестно, влияет ли инъекция препарата на способность управлять транспортом и опасными механизмами.

Узнать подробности о лекарстве можно на официальном сайте института Гамалеи.

Аналоги

Совпадения по коду АТХ 4-го уровня:

В октябре 2020 года в РФ прошла регистрацию вторая вакцина под названием ЭпиВакКорона. Лекарство было разработано в новосибирском научном центре «Вектор» и представляет собой искусственно синтезированные короткие фрагменты вирусных пептидов, «обучающие» иммунную систему бороться с вирусом. Сейчас препарат также проходит третий этап клинических испытаний.

Также, в феврале 2021 года прошла регистрацию третья вакцина КовиВак исследовательского центра им. Чумакова, в ее состав включен цельный инактивированный вирус.

На данный момент сложно предугадать, какая из вакцин окажется наиболее эффективной.

Детям

Вакцина от ковида Спутник Ви не применяется в возрасте до 18 лет.

При беременности и лактации

Делать прививки нельзя беременным женщинам и во время грудного вскармливания.

Вакцина Спутник V, отзывы

Известно, что в Российской Федерации разработкой лекарства от новой коронавирусной инфекции занялся институт Гамалеи. Вакцина от коронавируса получила уже широко известное название «Спутник V». Перед тем, как проводить иммунизацию массово, лекарству необходимо пройти стадию клинических испытаний. И на данный момент средство проходит этот этап пострегистрационного исследования в Москве. Сделать прививку в тестовом режиме планируется 40 тысячам человек, четверть из них получат плацебо. Параллельно уже началась иммунизация мед. работников и врачей.

Сейчас среди скептически настроенного населения идут горячие споры об эффективности вакцины Спутник V, учитывая тот факт, что некоторые добровольцы, которым делали уколы Гам-КОВИД-Вак, заразились уже на следующий день после прививки. В общем известно около 20 подобных случаев. Это объясняется тем, что большинство заболевавших не успели получить второй укол и иммунитет у них выработаться тоже не успел. Ведь, как известно, устойчивость у вирусу развивается только на 42 день после проведения полного цикла вакцинации. Именно так объяснил данные инциденты директор Института трансляционной медицины и биотехнологии Сеченовского университета Минздрава РФ Вадим Тарасов, который подчеркивает высокую эффектность Спутник V.

Отзывы врачей о препарате в большинстве своем положительные. При этом медики подчеркивают, что вакцина не призвана защитить от болезни на все 100%, она также должна предотвратить развитие тяжелой формы заболевания и летальный исход. Допускается, что после применения лекарства болезнь будет просто протекать в легкой форме и без осложнений.

Интерес также вызывают отзывы привитых добровольцев, которые приняли участие в третьей фазе клинических испытаний. Рандомизированное двойное слепое плацебо-контролируемое клиническое исследование началось 26 августа 2020 года.

Некоторые интересуются, как правильно называть препарат, Спутник Ви или Спутник 5? Правильный ответ — Спутник Ви.

Отзывы добровольцев:

• «… Решила попробовать эту вакцину на себе. На второй день после первой инъекции начала болеть рука, а к вечеру третьего дня поднялась температура 37,5. На пятый день температура спала. После второго укола температура была выше, до 38 Градусов и ощущала я себя, как при гриппе. Через три дня все вроде прошло. Потом сдавала кровь на антитела, уровень IgG составил 11,3, непонятно почему так мало».
• «… Записался на вакцинацию как только узнал, что так можно. Во время прививки покалывало руку, а так не заметил каких-либо побочных реакций. Чувствую себя хорошо пока, вторая прививка тоже прошла нормально. Буду ждать теста на антитела«.
• «… После вакцинации ощущаю себя так, будто переболела гриппом, была высокая температура, головные боли и ломило суставы. Еще болел левый бок. Сбивала температуру 2 недели. К сожалению после болезни антител у меня нет, что странно«.

После прохождения последнего этапа планируется наладить массовое производство вакцины Спутник V и провести иммунизацию достаточного количества населения страны, чтобы сформировать коллективный иммунитет.

Вакцина Спутник V, цена, где купить вакцину Спутник V в Москве

На данный момент указать даже примерную стоимость Спутник Ви сложно. Есть сообщения о том, что предельная стоимость препарата составит не более 1942 рублей за оба компонента. Однако, пока Гам-КОВИД-Вак не появилась в свободной продаже, говорить о точной цене рано.