Sputnik V 

Gam-COVID-Vac

Gamaleya

SARS-CoV-2

• Gam-COVID-Vac Lyo

Gam-COVID-Vac was created by Gamaleya Research Institute of Epidemiology and MIcrobiology in Russia. The vaccine candidate is a heterologous COVID-19 vaccine containing two components, recombinant adenovirus type 26 (rAd26) vector and recombinant adenovirus type 5 (rAd5) vector which both carry the SARS-CoV-2 spike glycoprotein. The vaccine is offered in both a frozen (Gam-COVID-Vac) and freeze-dried formulation (lyophilizate; Gam-COVID-Vac Lyo). Phase 1/2 human trials with 76 participants evaluated the safety, tolerability, and immunogenicity of both frozen (Gam-COVID-Vac;NCT04436471) and freeze-dried (Gam-COVID-Vac Lyo;NCT04437875) vaccine candidates in June 2020, and were completed in early August 2020. Preliminary results suggested that all participants developed antibodies to the SARS-CoV-2 glycoproteins with a good safety profile in both trials.

Sputnik V (Russian: Спутник V, literally Traveler V) is a COVID-19 vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology. Registered on 11 August 2020 by the Russian Ministry of Health as Gam-COVID-Vac (Russian: Гам-КОВИД-Вак, romanized: Gam-KOVID-Vak),^[2][3] Sputnik V is an adenovirus viral vector vaccine. The “V” in the name is the letter V, not the Roman numeral for five.^[4]

Gam-COVID-Vac was initially approved for distribution in Russia on the preliminary results of Phase I–II studies eventually published on 4 September 2020.^[5] The quick approval in early August of Gam-COVID-Vac was met with criticism in mass media and precipitated discussions in the scientific community whether this decision was justified in the absence of robust scientific research confirming the safety and efficacy of the vaccine.^{[2][3][6][7][8]} On 2 February 2021, an interim analysis from the trial was published in The Lancet, indicating 91.6% efficacy without unusual side effects.^[9]

Emergency mass-distribution of the vaccine began in December 2020 in multiple countries including Russia, Argentina, Belarus, Hungary, Serbia and the United Arab Emirates. As of February 2021, over a billion doses of the vaccine were ordered for immediate distribution globally.^[10]

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Technology

 President Putin‘s meeting with government members, on 11 August 2020 via videoconference, at which he announced a conditionally registered vaccine against COVID-19.^[2][3] Medical worker in Moscow with the vaccineSee also: COVID-19 vaccine

Gam-COVID-Vac is a viral two-vector vaccine based on two human adenoviruses – a common cold virus – containing the gene that encodes the full-length spike protein (S) of SARS-CoV-2 to stimulate an immune response.^[5][11][12] 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.^[13]

The recombinant adenovirus types 26 and 5 are both used as vectors in the vaccine. They were biotechnology-derived and contain the SARS-CoV-2 S protein cDNA. Both of them are administered into the deltoid muscle: the Ad26-based vaccine is used on the first day and the Ad5 vaccine is used on the 21st day to boost immune response.^[11][14][15]

The vaccine can be formulated as frozen (storage temperature must be −18 °C or 0 °F or lower) and freeze-dried (“Gam-COVID-Vac-Lyo”, storage temperature is 2–8 °C or 36–46 °F) dosage forms.^[16] The first formulation was developed for large-scale use, it is cheaper and easier to manufacture. The production of a lyophilized formulation takes much more time and resources, although it is more convenient for storage and transportation. Gam-COVID-Vac-Lyo was developed especially for vaccine delivery to hard-to-reach regions of Russia.^[17] The head of the Gamaleya Research Institute Alexander Ginzburg estimates that it will take 9–12 months to vaccinate the vast majority of the Russian population, assuming in-country resources are adequate.^[18][19] A single-dose version is also being developed to speed up vaccination outside Russia. It will offer less protection than the two-dose versions, but it is still expected to reach an efficacy of 85%.^[20][21]

Clinical research

Phase I–II

A phase I safety trial began on 18 June.^[2] On 4 September, data on 76 participants in a phase I–II trial were published, indicating preliminary evidence of safety and an immune response.^[5] 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,^[22] 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.^[23]

Phase III

 Sputnik V, efficacy for different conditions. The error bars indicate the confidence interval containing the efficacy with 95% probability

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.^[24]

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.^[25] In 2020–2021, phase III clinical studies were also being conducted in Belarus,^[26] UAE,^[27] India^[28] and Venezuela.^[29]

On 2 February 2021, an interim analysis from the Moscow trial was published in The Lancet, indicating 91.6% efficacy (95% CI 85.6–95.2) after the second vaccination, without unusual side effects.^[30] The trial started on 7 September 2020 using the frozen liquid form of the vaccine, and data was analysed up to the second database lock on 24 November 2020. The over-60-years-old group in the trial (oldest participant was 87) had essentially the same efficacy (91.8%) as for all ages. The lowest age participants were 18 years old.^[9][31]

Sputnik–AstraZeneca COVID-19 vaccine trials

On 21 December 2020 the Russian Direct Investment Fund (RDIF), the Gamaleya National Center, AstraZeneca and R-Pharm have 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 AZD1222 vaccine, developed by AstraZeneca and the University of Oxford.^[32] 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 Sputnik V vaccine and the vaccine developed by AstraZeneca, stating that the trials would begin before the end of February 2021.^[33][34]

Composition

The Gam-COVID-Vac is a two-vector vaccine.^[1] The active component for both vectors is a modified (recombinant) replication-defective adenovirus of a different serotype (Serotype 26 for the first vaccination and serotype 5 for the second vaccination), which has been modified to include the protein S-expressing gene of SARS-CoV-2.^[1]

The other ingredients (excipients) are the same, both quantitatively and qualitatively, in the two components.^[35]

• Tris(hydroxymethyl)aminomethane
• Sodium chloride
• Sucrose
• Magnesium chloride hexahydrate
• Disodium EDTA dihydrate (buffer)
• Polysorbate 80
• Ethanol 95%
• Water

As per the official datasheet, no further components or ingredients, including other adjuvants, should be included in the vaccine.^[1]

History

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.^[36][37] This vaccine was given the trade name “Sputnik V”, after the world’s first artificial satellite.^[3][7][38]

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.^[2] 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.^[3] 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.^[39][40] On 26 August, certificate No. ЛП-006423 (LP-006423) was issued for the lyophilized formulation “Gam-COVID-Vac-Lyo”.^{[2][3][7][41][5]}

The commercial release of the Gam-COVID-Vac was first scheduled for September 2020. In October, Mikhail Murashko said that the Gam-COVID-Vac will be free for all Russian citizens after the launching of mass production.^[42][43] Later on, Russian Ministry of Health registered maximum ex-factory price equal to 1,942 rubles for two components and included them into The National List of Essential medicines.^[44] There were also suggestions to include the vaccine in the National Immunisation Calendar of Russia.^[44]

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.^[45][46]

On 9 March 2021, an agreement was signed by the RDIF sovereign wealth fund and Swiss-based pharmaceutical company Adienne to produce the vaccine in Italy. Kirill Dmitriev, RDIF’s head, told Russian state TV his fund had also struck deals with production facilities in Spain, France and Germany for local manufacturing of the vaccine.^[47]

Scientific assessment

Balram Bhargava, director of the Indian Council of Medical Research, said that Russia had managed to fast-track a COVID-19 vaccine candidate through its early phases.^[48]

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”.^[8]

• 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”.^[49]
• Francois Balloux, a geneticist at University College London, called the Russian government’s approval of Gam-COVID-Vac a “reckless and foolish decision”.^[2] Professor Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, characterized the announcement was a “political stunt”, and stated that the untested vaccine could be very harmful.^[8]

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.^{[50][failed verification][51]}

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said “the data [is] compatible with the vaccine being reasonably effective … These results are consistent with what we see with other vaccines, because the really big message for global health scientists is that this disease [COVID-19] is able to be addressed by vaccines.”^[50]

Julian Tang, clinical virologist at the University of Leicester, said: “Despite the earlier misgivings about the way this Russian Sputnik V vaccine was rolled out more widely – ahead of sufficient Phase 3 trial data – this approach has been justified to some extent now.”^[52]

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.”^[53]

Hildegund C. J. Ertl, a vaccine scientist at the Wistar Institute, called the phase-III results published on 2 February 2021 “great”: “Good safety profile, more than 90% efficacy across all age groups, 100% efficacy against severe disease or death, can be stored in the fridge and low cost. What more would we want?”^[54]

According to preliminary review by experts,^[who?] 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 respectively – and allowing transportation to remote locations with reduced risk of vaccine spoilage.^[55][56]

On 6 March 2021, Director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), Anthony Fauci, said that the data from Sputnik V “looked pretty good” to him.^[57]

Distribution, vaccination and public perception

Early perception

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.^[58][59]

• At that time, 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.^[60] One public health expert 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.^[7] “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.^[7]

As for early September 2020, according to public opinion polls, only half of the Russian population would take the vaccine voluntarily.^[61]

In Russia

 Vaccination of military personnel and civilian specialists of the Northern Fleet with the second component of the drug “Gam-COVID-Vac” (“Sputnik V”).

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 Moscow-based medical centers providing vaccinations).^[62]

Doctors and other medical workers, teachers, and social workers were given priority due to their highest risk of exposure to the disease.^[63] The age for those receiving shots was initially capped at 60, later this restriction was lifted.^[64]

Potential recipients were notified via text messaging, which says “You are working at an educational institution and have top-priority for the COVID-19 vaccine, free of charge”. Patients are asked a few general health questions before getting the vaccine. Program’s leaflet is handed to the patient, which warns of possible side effects, suggesting those are most likely to be mild and last a couple of days at most.^[65][66][67] People with certain underlying health conditions, pregnant women, and those who have had a respiratory illness for the past two weeks are barred from vaccination.^[63] Vaccine vial is 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.^[68] Forty thousand of those are volunteers in Sputnik V’s Phase 3 trials, another 60,000 medics and doctors have also taken the vaccine.^[69] The head of the Russian Direct Investment Fund, Kirill Dmitriev, said in an interview with the BBC that Russian medics expect to give about 2 million people coronavirus vaccinations in December.^[70]

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 will enter civilian circulation in Russia before the end of February 2021.^[71] 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.^[72]

Outside of Russia

 In dark green are the countries that ordered (Russian or licensed domestic production; China also plans to produce Sputnik V on its territory.) or approved Sputnik V vaccine against COVID-19 (w/disputed Crimea). In light green are the countries that have shown interest in obtaining the vaccine.

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.^[73][74] In August 2020, according to the Russian authorities, there were at least 20 countries that wanted to obtain the vaccine.^[75]

While free in Russia, the cost per dose would be less than US$10 (or less than US$20 for the two doses needed to vaccinate one person) on international markets, which makes it much more affordable compared to 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.^[76][77]

The Israeli Hadassah Medical Center has signed a commercial memorandum of understanding to obtain 1.5–3 million doses.^[78]

• According to The New York Times’ sources,^[79] to secure the release of an Israeli civilian held in Syria, Israel agreed to finance a supply of Russian-made Covid-19 vaccines for Damascus.

Argentina had agreed to buy 25 million doses of Russia’s Covid-19 vaccine.^[80] The vaccine was registered and approved in Argentina in late December 2020.^[81] The Brazilian state of Bahia has also signed an agreement to conduct Phase III clinical trials of the Sputnik V vaccine and plans to buy 50 million doses to market in northeastern Brazil.^[82]

On 21 January 2021, the Argentine president Alberto Fernández became the first Latin American leader to be inoculated against the disease via the then recently approved Sputnik V.^[83][84]

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 E.M.A.) and started a mass vaccination on 28 February of its healthcare workers.^[85]

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. ^[86] Asked about the prospect of Austria taking the same step (as some other European countries chose to do), EMA management board chair Christa Wirthumer-Hoche told Austria’s ORF broadcaster: “It’s somewhat comparable to Russian roulette. I would strongly advise against a national emergency authorisation,” she said, pointing to the fact that 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.^[87]

Although vaccination rates in Russia are below those of other developed nations (as of March 2021),^[88] Russia is pursuing deals to supply its vaccine abroad.^[89]

Emergency use authorization

As of December 2020, Belarus and Argentina granted emergency use authorization for the vector-based vaccine.^[145] 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 Gulf region.^{[146][147][148][149][150]}

On 19 January 2021, the Russian authorities applied for the registration of Sputnik V in the European Union, according to the RDIF.^[151] 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.^[152] On 4 March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the EMA started a rolling review of Sputnik V.^[153] The EU applicant is R-Pharm Germany GmbH.^[153]

Emergency use has also been authorized in Algeria, Bolivia, Serbia, the Palestinian territories,^[154] and Mexico.^[155]

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.^[156][157]

On 1 March 2021, Slovakia bought two million Sputnik V vaccines. Slovakia received the first batch of 200,000 vaccines, and expects to receive another 800,000 doses in March and April. Another 1 million vaccines are set to arrive in May and June.^[158] The Czech Republic is also considering buying Sputnik V.^[159]

On 18 March 2021, German regional leaders including State Premiers and the major 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”.^[160]

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 is planning to buy 20 million doses of the vaccine.^[161][162]

As of March 23, 2021, 56 countries have granted Sputnik V emergency use authorization.^[163]

Production

As of March 2021, RDIF has licensed production in India, China, South Korea and Brazil. In the EU, RDIF has signed production agreements, subject to European Medicines Agency approval, with companies in Germany, Spain and France, and is in negotiations with a Swiss/Italian company. 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.^[164]

An agreement for the production of over 100 million doses of vaccine in India has been made with Dr. Reddy’s Laboratories, who on 11 January 2021 submitted mid-stage trial data to the Indian regulator and recommended moving onto late-stage trials.^[154] 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.^[165]

In March 2021, the Italian-Russian Chamber of Commerce announced that Italy would be the first EU country to manufacture the two-dose COVID-19 vaccine under license. From July to the end of 2021, the Italian-Swiss pharmaceutical company Adienne in Caponago will manufacture 10 million doses. The announcement came in a time of acute vaccine shortages in Europe while the Sputnik V vaccine was still under review by the European Medicines Agency. Russian authorities said they would be able to provide a total of 50 million doses to European countries beginning in June 2021.^[166]

The Sputnik V doses to be manufactured in South Korea are not for domestic use. The vaccine is to be exported to Russia, Algeria, Argentina, Hungary, Iran and the United Arab Emirates.^[167]

References

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