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Sputnik V (russian: Спутник V, the brand name from
RDIF The Russian Direct Investment Fund (RDIF) is Russia's sovereign wealth fund established in 2011 by the Russian government to make investments in companies of high-growth sectors of the Russian economy. Its mandate is to co-invest alongside the ...
) or Gam-COVID-Vac (russian: Гам-КОВИД-Вак, the name under which it is legally registered and produced) is an
adenovirus Adenoviruses (members of the family ''Adenoviridae'') are medium-sized (90–100 nm), nonenveloped (without an outer lipid bilayer) viruses with an icosahedral nucleocapsid containing a double-stranded DNA genome. Their name derives from ...
viral vector vaccine for COVID-19 developed by the Gamaleya Research Institute of Epidemiology and Microbiology in
Russia Russia (, , ), or the Russian Federation, is a transcontinental country spanning Eastern Europe and Northern Asia. It is the largest country in the world, with its internationally recognised territory covering , and encompassing one-ei ...
. 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 The Ministry of Health of the Russian Federation (russian: Министерство здравоохранения Российской Федерации, in short russian: Минздрав России, translit=Minzdrav Rossii) is a ministry of ...
. 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 III studies eventually published on 4 September 2020. 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 Safety is the state of being "safe", the condition of being protected from harm or other danger. Safety can also refer to the control of recognized hazards in order to achieve an acceptable level of risk. Meanings There are two slightly di ...
and
efficacy Efficacy is the ability to perform a task to a satisfactory or expected degree. The word comes from the same roots as ''effectiveness'', and it has often been used synonymously, although in pharmacology a distinction is now often made between ...
. 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. Emergency mass-distribution of the vaccine began in December 2020 in countries including Russia,
Argentina Argentina (), officially the Argentine Republic ( es, link=no, República Argentina), is a country in the southern half of South America. Argentina covers an area of , making it the List of South American countries by area, second-largest ...
,
Belarus Belarus,, , ; alternatively and formerly known as Byelorussia (from Russian ). officially the Republic of Belarus,; rus, Республика Беларусь, Respublika Belarus. is a landlocked country in Eastern Europe. It is bordered by ...
,
Hungary Hungary ( hu, Magyarország ) is a landlocked country in Central Europe. Spanning of the Carpathian Basin, it is bordered by Slovakia to the north, Ukraine to the northeast, Romania to the east and southeast, Serbia to the south, Cr ...
,
Serbia Serbia (, ; Serbian: , , ), officially the Republic of Serbia ( Serbian: , , ), is a landlocked country in Southeastern and Central Europe, situated at the crossroads of the Pannonian Basin and the Balkans. It shares land borders with Hu ...
,
Pakistan Pakistan ( ur, ), officially the Islamic Republic of Pakistan ( ur, , label=none), is a country in South Asia. It is the world's List of countries and dependencies by population, fifth-most populous country, with a population of almost 24 ...
(in limited quantities), the
Philippines The Philippines (; fil, Pilipinas, links=no), officially the Republic of the Philippines ( fil, Republika ng Pilipinas, links=no), * bik, Republika kan Filipinas * ceb, Republika sa Pilipinas * cbk, República de Filipinas * hil, Republ ...
(in limited quantities), and the
United Arab Emirates The United Arab Emirates (UAE; ar, اَلْإِمَارَات الْعَرَبِيَة الْمُتَحِدَة ), or simply the Emirates ( ar, الِْإمَارَات ), is a country in Western Asia (Middle East, The Middle East). It is ...
. The Sputnik V is currently registered and certified in 71 countries. However, as of April 2022 less than 2.5% of the people vaccinated worldwide have taken a Sputnik V dose. In early 2022, as a result of the
2022 Russian invasion of Ukraine On 24 February 2022, in a major escalation of the Russo-Ukrainian War, which began in 2014. The invasion has resulted in tens of thousands of deaths on both sides. It has caused Europe's largest refugee crisis since World War II. A ...
, the United States and other countries placed RDIF on the list of sanctioned Russian entities and people, significantly reducing Sputnik V future commercial prospects. The Gam-COVID-Vac vaccine itself is available in two forms: frozen (
vaccine storage Vaccine storage relates to the proper vaccine storage and handling practices from their manufacture to the administration in people. The general standard is the 2–8 °C cold chain for vaccine storage and transportation. This is used for al ...
: 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).


Medical uses

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 or lower, and as a
freeze-dried Freeze drying, also known as lyophilization or cryodesiccation, is a low temperature dehydration process that involves freezing the product and lowering pressure, removing the ice by sublimation. This is in contrast to dehydration by most conve ...
(lyophlilized) powder, "Gam-COVID-Vac-Lyo", which can be stored at . The freeze-dried powder must be reconstituted with sterile water before use. The lyophilized formulation of Gam-COVID-Vac is similar to the
smallpox vaccine The smallpox vaccine is the first vaccine to be developed against a contagious disease. In 1796, British physician Edward Jenner demonstrated that an infection with the relatively mild cowpox virus conferred immunity against the deadly smallpox ...
, circumventing the need for continuous "colder chain" or cold-chain storage – as required for the Pfizer–BioNTech and
Moderna vaccine The Moderna COVID19 vaccine (INN: elasomeran), sold under the brand name Spikevax, is a COVID-19 vaccine developed by American company Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedi ...
s – and allowing transportation to remote locations with reduced risk of vaccine spoilage. 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 An immune response is a reaction which occurs within an organism for the purpose of defending against foreign invaders. These invaders include a wide variety of different microorganisms including viruses, bacteria, parasites, and fungi which coul ...
. Both doses are administered into the
deltoid muscle The deltoid muscle is the muscle forming the rounded contour of the human shoulder. It is also known as the 'common shoulder muscle', particularly in other animals such as the domestic cat. Anatomically, the deltoid muscle appears to be made up o ...
. 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 Booster may refer to: Amusement rides * Booster (Fabbri ride), a pendulum ride * Booster (HUSS ride), an evolution of the Breakdance ride * Booster (KMG ride), a pendulum ride Arts, entertainment, and media Fictional characters * Booster, a cha ...
) dose for those who have received Sputnik V at least 6 months earlier. On August 11, 2021, the developers of the Sputnik V vaccine offered its 'Sputnik Light' (Ad26) vaccine to
Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfize ...
for trial against the Delta variant.


Effectiveness

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. A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95%
confidence interval In frequentist statistics, a confidence interval (CI) is a range of estimates for an unknown parameter. A confidence interval is computed at a designated ''confidence level''; the 95% confidence level is most common, but other levels, such as 9 ...
. Effectiveness is generally expected to slowly decrease over time. On 25 August, a preliminary version of a case-control study indicated an unadjusted effectiveness 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 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 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. A large-scale study was conducted in Mexico and was published as a preprint, awaiting peer review (as of July 22, 2022). 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

The
vaccine efficacy Vaccine efficacy or vaccine effectiveness is the percentage reduction of disease cases in a Treatment group, vaccinated group of people compared to an Control group, unvaccinated group. For example, a vaccine efficacy or effectiveness of 80% in ...
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 ''The Lancet'' is a weekly peer-reviewed general medical journal and one of the oldest of its kind. It is also the world's highest-impact academic journal. It was founded in England in 1823. The journal publishes original research articles ...
'' reporting an efficacy of after the second dose for all age groups, with no unusual
side effect In medicine, a side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequence ...
s. For the age group of 60 years and older, the reported efficacy was 91.8%. 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. 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". 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. 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.


Adverse effects

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.


Pharmacology

Gam-COVID-Vac is a
viral vector Viral vectors are tools commonly used by molecular biologists to deliver genetic material into cells. This process can be performed inside a living organism (''in vivo'') or in cell culture (''in vitro''). Viruses have evolved specialized molecu ...
vaccine based on two recombinant replication-defective human
adenoviruses Adenoviruses (members of the family ''Adenoviridae'') are medium-sized (90–100 nm), nonenveloped (without an outer lipid bilayer) viruses with an icosahedral nucleocapsid containing a double-stranded DNA genome. Their name derives from the ...
: Ad26 (serotype 26) and Ad5 (serotype 5) replicated in
HEK 293 Human embryonic kidney 293 cells, also often referred to as HEK 293, HEK-293, 293 cells, or less precisely as HEK cells, are a specific immortalised cell line derived from a spontaneously miscarried or aborted fetus or human embryonic kidney cells ...
cells. The viruses contain the
gene In biology, the word gene (from , ; "...Wilhelm Johannsen coined the word gene to describe the Mendelian units of heredity..." meaning ''generation'' or ''birth'' or ''gender'') can have several different meanings. The Mendelian gene is a b ...
that encodes the full-length
spike protein In virology, a spike protein or peplomer protein is a protein that forms a large structure known as a spike or peplomer projecting from the surface of an enveloped virus. as cited in The proteins are usually glycoproteins that form dimers or ...
(S) of
SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19 (coronavirus disease 2019), the respiratory illness responsible for the ongoing COVID-19 pandemic. The virus previously had a ...
to stimulate an
immune response An immune response is a reaction which occurs within an organism for the purpose of defending against foreign invaders. These invaders include a wide variety of different microorganisms including viruses, bacteria, parasites, and fungi which coul ...
. Adenoviral vectors 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 The Janssen COVID19 vaccine, sold under the brand name Jcovden, is a COVID19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands, and its Belgian parent company Janssen Pharmaceuticals, a subsidiary of American company John ...
, it utilizes the Ad26COV2 viral vector based on the human virus Ad26. For this vaccine, the cell line PER.C6 is used to replicate the vector. Another one called Oxford–AstraZeneca COVID‑19 vaccine, it uses chimpanzee adenovirus (
ChAdOx1 ChAdOx1 is an adenoviral vector for vaccines that was developed by the Jenner Institute, University of Oxford. The vector is a chimpanzee adenovirus modified to avoid its replication. Adenoviruses are effective vectors for inducing and boosting ...
) as the vector. For both the Oxford-AstraZeneca COVID-19 and Gam-COVID-Vac vaccines the producer cells for the production of non-replicating adenoviral vectors were obtained from the HEK 293 cell line. Each dose of Gam-COVID-Vac contains (1.0 ± 0.5) × 10 virus particles. Both Ad26 and Ad5 were modified to remove the E1 gene to prevent replication outside the
HEK 293 Human embryonic kidney 293 cells, also often referred to as HEK 293, HEK-293, 293 cells, or less precisely as HEK cells, are a specific immortalised cell line derived from a spontaneously miscarried or aborted fetus or human embryonic kidney cells ...
cells. For the production of the vaccine, to propagate adenoviral vectors in which the E1 gene was deleted,
HEK 293 Human embryonic kidney 293 cells, also often referred to as HEK 293, HEK-293, 293 cells, or less precisely as HEK cells, are a specific immortalised cell line derived from a spontaneously miscarried or aborted fetus or human embryonic kidney cells ...
cells are used, which express several adenoviral genes, including E1. However, although rare, homologous recombination between the inserted cellular sequence and the vector sequence can restore the replication capacity to the vector, with less than 100 replicating adenovirus particles per dose of the vaccine.


Chemistry

The other ingredients (
excipient An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred ...
s) are the same, both quantitatively and qualitatively, in the two doses. * Tris(hydroxymethyl)aminomethane (buffer) *
Sodium chloride Sodium chloride , commonly known as salt (although sea salt also contains other chemical salts), is an ionic compound with the chemical formula NaCl, representing a 1:1 ratio of sodium and chloride ions. With molar masses of 22.99 and 35. ...
(salt) *
Sucrose Sucrose, a disaccharide, is a sugar composed of glucose and fructose subunits. It is produced naturally in plants and is the main constituent of white sugar. It has the molecular formula . For human consumption, sucrose is extracted and refine ...
(sugar) *
Magnesium chloride Magnesium chloride is the family of inorganic compounds with the formula , where x can range from 0 to 12. These salts are colorless or white solids that are highly soluble in water. These compounds and their solutions, both of which occur in natu ...
hexahydrate * Disodium EDTA dihydrate (a chelation ligand; sequestrant) *
Polysorbate 80 Polysorbate 80 is a nonionic surfactant and emulsifier often used in pharmaceuticals, foods, and cosmetics. This synthetic compound is a viscous, water-soluble yellow liquid. Chemistry Polysorbate 80 is derived from polyethoxylated sorbitan and ...
*
Ethanol Ethanol (abbr. EtOH; also called ethyl alcohol, grain alcohol, drinking alcohol, or simply alcohol) is an organic compound. It is an alcohol with the chemical formula . Its formula can be also written as or (an ethyl group linked to a ...
95% * Water No adjuvants and no other components or ingredients should be included in the vaccine.


Manufacturing

Large quantities of both adenoviruses are produced by
HEK 293 cells Human embryonic kidney 293 cells, also often referred to as HEK 293, HEK-293, 293 cells, or less precisely as HEK cells, are a specific immortalised cell line derived from a spontaneously miscarried or aborted fetus or human embryonic kidney cel ...
that have the E1 gene necessary for viral replication. Rarely, Ad5 can acquire the E1 gene from the HEK 293 cells, restoring its ability to replicate. 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. 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 Freeze drying, also known as lyophilization or cryodesiccation, is a low temperature dehydration process that involves freezing the product and lowering pressure, removing the ice by sublimation. This is in contrast to dehydration by most conve ...
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. 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 1billion 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 3–5million doses. As of March 2021, the Russian Direct Investment Fund (RDIF) has licensed production in
India India, officially the Republic of India (Hindi: ), is a country in South Asia. It is the List of countries and dependencies by area, seventh-largest country by area, the List of countries and dependencies by population, second-most populous ...
,
China China, officially the People's Republic of China (PRC), is a country in East Asia. It is the world's List of countries and dependencies by population, most populous country, with a Population of China, population exceeding 1.4 billion, slig ...
,
South Korea South Korea, officially the Republic of Korea (ROK), is a country in East Asia, constituting the southern part of the Korea, Korean Peninsula and sharing a Korean Demilitarized Zone, land border with North Korea. Its western border is formed ...
and
Brazil Brazil ( pt, Brasil; ), officially the Federative Republic of Brazil (Portuguese: ), is the largest country in both South America and Latin America. At and with over 217 million people, Brazil is the world's fifth-largest country by area ...
. In the EU, RDIF has signed production agreements. By the end of March 2021 RDIF anticipates 33million doses will have been manufactured in Russia, less than 5% of which will have been exported. An agreement for the production of over 100million 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. The RDIF announced plans to sell 100million doses to India, 35million to
Uzbekistan Uzbekistan (, ; uz, Ozbekiston, italic=yes / , ; russian: Узбекистан), officially the Republic of Uzbekistan ( uz, Ozbekiston Respublikasi, italic=yes / ; russian: Республика Узбекистан), is a doubly landlocked co ...
, and 32million to
Mexico Mexico (Spanish language, Spanish: México), officially the United Mexican States, is a List of sovereign states, country in the southern portion of North America. It is borders of Mexico, bordered to the north by the United States; to the so ...
, as well as 25million each to
Nepal Nepal (; ne, नेपाल ), formerly the Federal Democratic Republic of Nepal ( ne, सङ्घीय लोकतान्त्रिक गणतन्त्र नेपाल ), is a landlocked country in South Asia. It is ma ...
and
Egypt Egypt ( ar, مصر , ), officially the Arab Republic of Egypt, is a List of transcontinental countries, transcontinental country spanning the North Africa, northeast corner of Africa and Western Asia, southwest corner of Asia via a land bridg ...
. In India, the first dose of Sputnik V vaccine was administered on 14 May 2021 at
Hyderabad Hyderabad ( ; , ) is the capital and largest city of the Indian state of Telangana and the ''de jure'' capital of Andhra Pradesh. It occupies on the Deccan Plateau along the banks of the Musi River, in the northern part of Southern Indi ...
. Argentina became the first
Latin America Latin America or * french: Amérique Latine, link=no * ht, Amerik Latin, link=no * pt, América Latina, link=no, name=a, sometimes referred to as LatAm is a large cultural region in the Americas where Romance languages — languages derived ...
n country to produce it. Large-scale production started in June 2021. As of 31 December 2021 277 million doses were manufactured, mostly (265 million) in Russia. On 28 February 2022, as a result of the
2022 Russian invasion of Ukraine On 24 February 2022, in a major escalation of the Russo-Ukrainian War, which began in 2014. The invasion has resulted in tens of thousands of deaths on both sides. It has caused Europe's largest refugee crisis since World War II. A ...
, the United States placed RDIF and its chief executive on its list of sanctioned Russian entities and people. The
European Union The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are located primarily in Europe, Europe. The union has a total area of ...
, Ukraine, United Kingdom and Australia followed later in February and in March. This significantly reduces vaccine's future commercial prospects.


Resale controversy

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. 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.


History

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 Ras or RAS may refer to: Arts and media * RAS Records Real Authentic Sound, a reggae record label * Rundfunk Anstalt Südtirol, a south Tyrolese public broadcasting service * Rás 1, an Icelandic radio station * Rás 2, an Icelandic radio sta ...
associate member Denis Logunov, who also worked on vaccines for the Ebolavirus and the MERS-coronavirus. 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. This vaccine was given the
trade name A trade name, trading name, or business name, is a pseudonym used by companies that do not operate under their registered company name. The term for this type of alternative name is a "fictitious" business name. Registering the fictitious name w ...
"Sputnik V", after the world's first artificial satellite. During preclinical and clinical trials, 38 participants who received one or two doses of the Gam-COVID-Vac vaccine had produced
antibodies An antibody (Ab), also known as an immunoglobulin (Ig), is a large, Y-shaped protein used by the immune system to identify and neutralize foreign objects such as pathogenic bacteria and viruses. The antibody recognizes a unique molecule of ...
against SARS-CoV-2's spike protein, including potent neutralizing antibodies that inactivate viral particles. On 11 August 2020, the Russian minister of Health
Mikhail Murashko Mikhail Albertovich Murashko (russian: link=no, Михаил Альбертович Мурашко; born 9 January 1967) is a Russian physician and a politician, serving as the Minister of Health of the Russian Federation since 21 January 2020. ...
announced at a government briefing with the participation of President
Vladimir Putin Vladimir Vladimirovich Putin; (born 7 October 1952) is a Russian politician and former intelligence officer who holds the office of president of Russia. Putin has served continuously as president or prime minister since 1999: as prime min ...
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 Government of Russia exercises executive power in the Russian Federation. The members of the government are the prime minister, the deputy prime ministers, and the federal ministers. It has its legal basis in the Constitution of the Russia ...
. 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. 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. On 26 August, certificate No. ЛП-006423 (''LP-006423'') was issued for the lyophilized formulation "Gam-COVID-Vac-Lyo". On 12 June 2021, developers announced that they had developed and tested a
nasal vaccine A nasal vaccine is a vaccine administered to a person via the nose and does not require a needle. It induces immunity through the inner surface of the nose, a surface that naturally comes in contact with many airborne microbes. Administration A ...
for children aged 8 to 12, with no side effects found, and that they expected to release it on 15 September 2021.


Clinical trials


Phase I–II

A phase I safety trial began on 18 June 2020. 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. 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, 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.


Phase III

In early November 2020, Israel
Hadassah Medical Center Hadassah Medical Center ( he, הָמֶרְכָּז הָרְפוּאִי הֲדַסָּה) is an Israeli medical organization established in 1934 that operates two university hospitals in Jerusalem – one in Ein Karem and one in Mount Scopus –, ...
director-general Prof. Zeev Rotstein stated that Hadassah's branch in Moscow's Skolkovo Innovation Center was collaborating on a phase III clinical trial. 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. In 2020–2021, phase III clinical studies were also being conducted in Belarus, UAE, India and Venezuela. 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.


Variants

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. A study in Argentina found that neutralization is maintained against
Alpha Alpha (uppercase , lowercase ; grc, ἄλφα, ''álpha'', or ell, άλφα, álfa) is the first letter of the Greek alphabet. In the system of Greek numerals, it has a value of one. Alpha is derived from the Phoenician letter aleph , whi ...
and
Lambda Lambda (}, ''lám(b)da'') is the 11th letter of the Greek alphabet, representing the voiced alveolar lateral approximant . In the system of Greek numerals, lambda has a value of 30. Lambda is derived from the Phoenician Lamed . Lambda gave ri ...
and reduced against
Gamma Gamma (uppercase , lowercase ; ''gámma'') is the third letter of the Greek alphabet. In the system of Greek numerals it has a value of 3. In Ancient Greek, the letter gamma represented a voiced velar stop . In Modern Greek, this letter r ...
. The degree of reduction, however, does not necessarily imply reduced protection. A small study of 12 serum samples found that antibodies from the vaccine effectively
neutralize Neutralization may refer to: * Neutralization (chemistry), a chemical reaction where a base and an acid react to form a salt * Neutralisation (immunology), pathogen neutralization caused by antibodies * Neutralisation (sociology) * Neutralizatio ...
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).


Authorizations

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. As of December 2020, Belarus and Argentina granted
emergency use authorization An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, includ ...
for the vector-based vaccine. On 21 January 2021,
Hungary Hungary ( hu, Magyarország ) is a landlocked country in Central Europe. Spanning of the Carpathian Basin, it is bordered by Slovakia to the north, Ukraine to the northeast, Romania to the east and southeast, Serbia to the south, Cr ...
became the first European Union country to register the shot for emergency use, as well as the United Arab Emirates in the
Persian Gulf The Persian Gulf ( fa, خلیج فارس, translit=xalij-e fârs, lit=Gulf of Fars, ), sometimes called the ( ar, اَلْخَلِيْجُ ٱلْعَرَبِيُّ, Al-Khalīj al-ˁArabī), is a mediterranean sea in Western Asia. The bo ...
region. On 19 January 2021, the Russian authorities applied for the registration of Sputnik V in the European Union, according to the RDIF. 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. On 4 March 2021, the
Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regardin ...
(CHMP) of the EMA started a rolling review of Sputnik V. The EU applicant is R-Pharm Germany GmbH. 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. As of June 2021, Sputnik V is under rolling review process by EMA, but the marketing authorisation application was not submitted yet. Emergency use has also been authorized in Algeria, Bolivia, Serbia, the Palestinian territories, and Mexico. On 25 January 2021, Iran approved the vaccine, with
Foreign Minister A foreign affairs minister or minister of foreign affairs (less commonly minister for foreign affairs) is generally a cabinet minister in charge of a state's foreign policy and relations. The formal title of the top official varies between co ...
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 Sayyid Ali Hosseini Khamenei ( fa, سید علی حسینی خامنه‌ای, ; born 19 April 1939) is a Twelver Shia '' marja and the second and current Supreme Leader of Iran, in office since 1989. He was previously the third president ...
banned the government from importing vaccines from the
United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country Continental United States, primarily located in North America. It consists of 50 U.S. state, states, a Washington, D.C., ...
and
United Kingdom The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a country in Europe, off the north-western coast of the continental mainland. It comprises England, Scotland, Wales and ...
. 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. 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. 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. On 18 March 2021, German regional leaders including State Premiers and the mayor of
Berlin Berlin ( , ) is the capital and largest city of Germany by both area and population. Its 3.7 million inhabitants make it the European Union's most populous city, according to population within city limits. One of Germany's sixteen constitu ...
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". On 19 March 2021, the
Philippine The Philippines (; fil, Pilipinas, links=no), officially the Republic of the Philippines ( fil, Republika ng Pilipinas, links=no), * bik, Republika kan Filipinas * ceb, Republika sa Pilipinas * cbk, República de Filipinas * hil, Republ ...
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
granted emergency use authorization for Sputnik V, the fourth COVID-19 vaccine to be given authorization. The
Philippine government The Government of the Philippines ( fil, Pamahalaan ng Pilipinas) has three interdependent branches: the legislative, executive, and judicial branches. The Philippines is governed as a unitary state under a presidential representative and d ...
planned to buy 20million doses of the vaccine. On 12 April 2021, India approved the use of Sputnik V vaccine for emergency use against COVID-19 based on strong immunogenicity data. As of 12 April 2021, 62 countries had granted Sputnik V emergency use authorization. On 27 April 2021, Bangladesh approved the use of Sputnik V vaccine for emergency use. On 30 April 2021, Turkey and Albania approved the use of Sputnik V vaccine for emergency use.


Slovakia

On 1 March 2021, Slovakia bought 2million 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 1million doses were set to arrive in May and June. 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''. 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. Russian Direct Investment Fund replied that Slovakian laboratory which tested the vaccine was not certified by the EU. Slovak Prime Minister
Igor Matovič Igor Matovič (born May 11, 1973) is a Slovak politician and former businessman. He previously served as Deputy Prime Minister of Slovakia and Minister of Finance from April 2021 to December 2022 and Prime Minister from March 2020 to March 2021. ...
resigned on 30 March, due to the political crisis started by the order of the Sputnik V vaccine. On 6 April 2021, the RDIF asked to return the delivered first batch of the vaccine due to "multiple contract violations". On 29 April 2021, the Slovak Ministry of Health published the Sputnik V contract. According to the contract, the RDIF as a seller is not liable for any
adverse event An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can ther ...
s following administering of the vaccine, nor its effectiveness. According to the Slovak lawyers, the contract is explicitly disadvantageous for Slovakia. On 8 May 2021, the
Russian Direct Investment Fund The Russian Direct Investment Fund (RDIF) is Russia's sovereign wealth fund established in 2011 by the Russian government to make investments in companies of high-growth sectors of the Russian economy. Its mandate is to co-invest alongside the wo ...
sent a letter to the ''
Denník N Denník N is a Slovak daily newspaper and a news website which was founded by the former members of the editorial board of SME in 2014. History In 2014, the Namav, a subject subvenced by the Penta Investments group, announced the purchase o ...
'' newspaper requesting the removal of the statements of the drug regulator, calling them "unsubstantiated and false" and "fake news". RDIF threatened the newspaper with legal action if they didn't comply with the demand by 9 May. The editors of
Denník N Denník N is a Slovak daily newspaper and a news website which was founded by the former members of the editorial board of SME in 2014. History In 2014, the Namav, a subject subvenced by the Penta Investments group, announced the purchase o ...
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", 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. Vaccinations started on 7 June, but without significant interest in the Sputnik V vaccine. Slovakia has no plans to order new batches and plans to sell or donate unused vaccines to
Balkans The Balkans ( ), also known as the Balkan Peninsula, is a geographical area in southeastern Europe with various geographical and historical definitions. The region takes its name from the Balkan Mountains that stretch throughout the who ...
countries. 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. Temporary government approval for Sputnik V expired on 31 August 2021. In total, 18,500 people have been vaccinated. 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.


Brazil

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. Anvisa attributed its decision to a number of issues with the samples provided by Gamaleya for accreditation: * 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. 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. Virologist
Angela Rasmussen Angela Lynn Rasmussen is an American virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Canada. Education and early career During graduate school, Rasmussen worked in the laboratory of Vincent ...
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 Immunodeficiency, also known as immunocompromisation, is a state in which the immune system's ability to fight infectious diseases and cancer is compromised or entirely absent. Most cases are acquired ("secondary") due to extrinsic factors that a ...
individuals. Medicinal chemist
Derek Lowe Derek Christopher Lowe (born June 1, 1973) is an American former professional baseball pitcher. During his career, he played in Major League Baseball (MLB) for the Seattle Mariners, Boston Red Sox, Los Angeles Dodgers, Atlanta Braves, Cleveland I ...
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, 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. Anvisa said that the import ban can be reversed if Gamaleya clarifies the issues.
Adenovirus Adenoviruses (members of the family ''Adenoviridae'') are medium-sized (90–100 nm), nonenveloped (without an outer lipid bilayer) viruses with an icosahedral nucleocapsid containing a double-stranded DNA genome. Their name derives from ...
infections cause only mild colds in healthy individuals, but they can cause life-threatening illnesses in immunodeficient individuals. 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 CoronaVac, also known as the Sinovac COVID-19 vaccine, is a whole inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech. It was Phase III clinical trialled in Brazil, Chile, Indonesia, the Philippines, and Turk ...
. 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. As of 16 June, the same import conditions were extended to a total of 13 states. 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.


Further development


Heterologous prime-boost vaccination

On 21 December 2020 the
Russian Direct Investment Fund The Russian Direct Investment Fund (RDIF) is Russia's sovereign wealth fund established in 2011 by the Russian government to make investments in companies of high-growth sectors of the Russian economy. Its mandate is to co-invest alongside the wo ...
(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. 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 Azerbaijan (, ; az, Azərbaycan ), officially the Republic of Azerbaijan, , also sometimes officially called the Azerbaijan Republic is a transcontinental country located at the boundary of Eastern Europe and Western Asia. It is a part of th ...
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. On February 20, 2021, in the official Sputnik V
Twitter Twitter is an online social media and social networking service owned and operated by American company Twitter, Inc., on which users post and interact with 280-character-long messages known as "tweets". Registered users can post, like, and ...
account it was stated that clinical trials have already started.


Society and culture


Economics


In Russia

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 An mRNA vaccine is a type of vaccine that uses a copy of a molecule called messenger RNA (mRNA) to produce an immune response. The vaccine delivers molecules of antigen-encoding mRNA into immune cells, which use the designed mRNA as a blueprin ...
from other manufacturers. Kirill Dmitriev, head of the fund, told reporters that over 1billion doses of the vaccine are expected to be produced in 2021 outside of Russia. 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. 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. Later on, the Russian Ministry of Health registered the maximum ex-factory price equal to 1,942 rubles for two components and included it into The National List of
Essential medicines Essential medicines, as defined by the World Health Organization (WHO), are the medicines that "satisfy the priority health care needs of the population". These are the medications to which people should have access at all times in sufficient a ...
. There were also suggestions to include the vaccine in the National Immunisation Calendar of Russia. 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). Doctors and other medical workers, teachers, and social workers were given priority due to their highest risk of exposure to the disease. Initially the vaccine was only offered to people over 60 years of age, later this restriction was lifted. 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. 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. 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. Forty thousand of those were volunteers in Sputnik V's Phase 3 trials, another 60,000 nurses and doctors had also taken the vaccine. The head of the Russian Direct Investment Fund, Kirill Dmitriev, said in an interview with the BBC that Russian medics expected to give about 2million people coronavirus vaccinations in December 2020. Up to the beginning of December 2020, ''Generium'' (which is supervised by
Pharmstandard JSC Pharmstandard (russian: ПАО "Фармстандарт", PAO "Farmstandart") is a Russian multinational pharmaceutical company. It is headquartered in Dolgoprudny, Moscow Oblast. Pharmstandard's makes and exports over 400 generic and propri ...
) and ''Binnopharm'' (which is supervised by
AFK Sistema AFK Sistema PAO is a large Russian conglomerate company, founded by Vladimir Yevtushenkov, who was chairman of the corporation's board of directors until 2022. In April, Yevtushenkov's shareholding in Sistema has decreased to 49.2%, and he also s ...
) companies produced Gam-COVID-Vac on a large scale. On 10 December,
Deputy Prime Minister A deputy prime minister or vice prime minister is, in some countries, a government minister who can take the position of acting prime minister when the prime minister is temporarily absent. The position is often likened to that of a vice president, ...
Tatyana Golikova Tatiana Alexeyevna Golikova (Russian: Татьяна Алексеевна Голикова; born 9 February 1966) is a Russian politician and economist who serves as the Deputy Prime Minister of Russia for Social Policy, Labour, Health and Pe ...
announced that approximately 6.9million doses of the Sputnik V vaccine would enter civilian circulation in Russia before the end of February 2021. Moscow Mayor
Sergei Sobyanin Sergey Semyonovich Sobyanin (russian: link=no, Сергей Семёнович Собянин; born 21 June 1958) is a Russian politician, serving as the 3rd Mayor of Moscow since 21 October 2010. Sobyanin previously served as the Governor of ...
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 10million doses a month. As of March 2021, vaccination rates in Russia were below those of other developed nations. In May 2021
Sergei Sobyanin Sergey Semyonovich Sobyanin (russian: link=no, Сергей Семёнович Собянин; born 21 June 1958) is a Russian politician, serving as the 3rd Mayor of Moscow since 21 October 2010. Sobyanin previously served as the Governor of ...
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. 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. 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. In June 2021, with the increase in
Delta variant The Delta variant (B.1.617.2) was a variant of SARS-CoV-2, the virus that causes COVID-19. It was first detected in India in late 2020. The Delta variant was named on 31 May 2021 and had spread to over 179 countries by 22 November 2021. The ...
cases, several Russian city governments introduced strict measures to overcome vaccine hesitancy, such as requiring vaccine QR codes from customers in cafes.


Outside Russia

Russia is pursuing deals to supply its vaccine abroad. According to the Russian Direct Investment Fund, they had received orders for more than 1.2billion 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. In August 2020, according to the Russian authorities, there were at least 20 countries that wanted to obtain the vaccine. The Israeli Hadassah Medical Center signed a commercial memorandum of understanding to obtain 1.5–3million doses. Argentina agreed to buy 25million doses of Russia's COVID-19 vaccine, subject to its clearing clinical trials; the vaccine was registered and approved in Argentina in late December 2020. The Brazilian state of
Bahia Bahia ( , , ; meaning "bay") is one of the 26 states of Brazil, located in the Northeast Region of the country. It is the fourth-largest Brazilian state by population (after São Paulo, Minas Gerais, and Rio de Janeiro) and the 5th-larges ...
signed an agreement to conduct Phase III clinical trials of the Sputnik V vaccine and planned to buy 50million doses to market in northeastern Brazil. On 21 January 2021, Argentine president
Alberto Fernández Alberto Ángel Fernández (; born 2 April 1959) is an Argentine politician, lawyer and professor, serving as president of Argentina since 2019. Born in Buenos Aires, Fernández attended the University of Buenos Aires, where he earned his law ...
became the first Latin American leader to be inoculated with Sputnik V, shortly after it was approved for use in the country. Two months after being vaccinated he developed fever and headache, and tested positive for COVID-19. 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. 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. Due to the delay in shipping of doses from Italy and the European Union,
San Marino San Marino (, ), officially the Republic of San Marino ( it, Repubblica di San Marino; ), also known as the Most Serene Republic of San Marino ( it, Serenissima Repubblica di San Marino, links=no), is the fifth-smallest country in the world an ...
imported doses of the Sputnik V vaccine (not approved by the EMA) and started a mass vaccination on 28 February of its healthcare workers. 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.


Scientific assessment

On 11 August 2020, a
World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level o ...
(WHO) spokesperson said, "... prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data". 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". Francois Balloux, a geneticist at
University College London , mottoeng = Let all come who by merit deserve the most reward , established = , type = Public research university , endowment = £143 million (2020) , budget = ...
, called the Russian government's approval of Gam-COVID-Vac a "reckless and foolish decision". Professor
Paul Offit Paul Allan Offit (born March 27, 1951) is an American pediatrician specializing in infectious diseases, vaccines, immunology, and virology. He is the co-inventor of a rotavirus vaccine. Offit is the Maurice R. Hilleman Professor of Vaccinology, ...
, the director of the Vaccine Education Center at
Children's Hospital of Philadelphia The Children's Hospital of Philadelphia (CHOP) is a children's hospital in Philadelphia, Pennsylvania, with its primary campus located in the University City neighborhood of West Philadelphia in the campus of the University of Pennsylvania. The ...
, characterized the announcement as a "political stunt", and stated that the untested vaccine could be very harmful. Stephen Griffin, Associate Professor in the School of Medicine,
University of Leeds , mottoeng = And knowledge will be increased , established = 1831 – Leeds School of Medicine1874 – Yorkshire College of Science1884 - Yorkshire College1887 – affiliated to the federal Victoria University1904 – 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. 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. "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. Ian Jones, a professor of virology at the
University of Reading The University of Reading is a public university in Reading, Berkshire, England. It was founded in 1892 as University College, Reading, a University of Oxford extension college. The institution received the power to grant its own degrees in 192 ...
, 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." On 12 May 2021, a group of
biostatisticians Biostatistics (also known as biometry) are the development and application of statistical methods to a wide range of topics in biology. It encompasses the design of biological experiments, the collection and analysis of data from those experimen ...
published an article in
The Lancet ''The Lancet'' is a weekly peer-reviewed general medical journal and one of the oldest of its kind. It is also the world's highest-impact academic journal. It was founded in England in 1823. The journal publishes original research articles ...
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. Two preliminary studies, one from Argentina and one from San Marino, found mostly mild adverse events and no vaccine-associated deaths. 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. 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%. 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.Jarynowski A, Semenov A, Kamiński M, Belik V (18 May 2021
Mild Adverse Events of Sputnik V Vaccine in Russia: Social Media Content Analysis of Telegram via Deep Learning.
'Journal of Medical Internet Research'', 23(11):e30529


Public opinion polls

An
opinion poll An opinion poll, often simply referred to as a survey or a poll (although strictly a poll is an actual election) is a human research survey of public opinion from a particular sample. Opinion polls are usually designed to represent the opinion ...
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. In June 2021, according to a poll conducted by (''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. 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. In May 2021, the
Levada Center The Levada Center is a Russian independent, nongovernmental polling and sociological research organization. It is named after its founder, the first Russian professor of sociology Yuri Levada (1930–2006). The center traces back its history to 1 ...
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.


References


Further reading

*


External links

* {{DEFAULTSORT:Sputnik V Covid-19 Vaccine Adenoviridae Clinical trials Gamaleya Research Institute of Epidemiology and Microbiology Medical controversies in Russia Products introduced in 2020 Russian COVID-19 vaccines Science and technology in Russia Vaccine controversies Viral vector vaccines