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Sputnik V COVID-19 vaccine

Sputnik V COVID-19 vaccine
See caption
Russian Ministry of Health image of Gam-COVID-Vac vials
Vaccine description
Target diseaseCOVID-19
Clinical data
Trade names
  • Sputnik V[1]
  • Спутник V
Other names
  • Gam-COVID-Vac
  • Гам-КОВИД-Вак
Routes of
administration
Intramuscular
ATC code
  • None
Legal status
Legal status
  • Registered in Russia on 11 August 2020
    AE, AG, DZ, BO, BY, HU, IR, PS, RS: EUA only
Identifiers
DrugBank

Sputnik V (Russian: Спутник V), is a COVID-19 vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology, and registered on 11 August 2020 by the Russian Ministry of Health as Gam-COVID-Vac (Russian: Гам-КОВИД-Вак, romanizedGam-KOVID-Vak).[2][3] It is an adenovirus viral vector vaccine. On 2 February 2021, an interim analysis from the trial was published in The Lancet, indicating 91.6% efficacy without unusual side effects.[4]

Gam-COVID-Vac was initially approved for distribution in Russia on the preliminary results of Phase III 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]

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, twenty one countries have granted Sputnik V emergency use authorization[9] while over a billion doses of the vaccine were ordered for immediate distribution globally.

Technology

See caption
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 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.[10][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 is −18 °C or 0 °F) and freeze-dried ("Gam-COVID-Vac-Lyo", storage temperature is 2–8 °C or 36–46 °F) dosage forms. 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.[10] 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.[16][17]

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,[18] 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.[19]

Phase III

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.[20]

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.[21] In 2020–2021, phase III clinical studies were also being conducted in Belarus,[22] UAE,[23] India[24] and Venezuela.[25]

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.[26] 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.[4][27]

Sputnik–AstraZeneca COVID-19 vaccine trials

On December 21, 2020 the Russian Direct Investment Fund, 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.[28] The study program will last 6 months in several countries, and it is planned to involve 100 volunteers in each study program. On February 9, 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.[29][30]

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.[31][32] This vaccine was given the trade name "Sputnik V", after the world's first artificial satellite.[3][7][33]

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 August 11, 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 August 11 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.[34][35] On August 26, certificate No. ЛП-006423 (LP-006423) was issued for the lyophilized formulation "Gam-COVID-Vac-Lyo".[2][3][7][36][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.[37][38] 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.[39] There were also suggestions to include the vaccine in the National Immunisation Calendar of Russia.[39]

According to Russian media, the mass production of the Gam-COVID-Vac was launched by August 15. 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.[40][41]

Scientific assessment

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".[42]

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, who is the director of the Vaccine Education Center at Children's Hospital of Philadelphia, stated that the announcement was a "political stunt", and that the untested vaccine could be very harmful.[8]

Balram Bhargava, director of the Indian Council of Medical Research, said that Russia has managed to fast track a COVID-19 vaccine candidate through its early phases.[43]

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.[44][failed verification]

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."[44]

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."[45]

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."[46]

Hildegund C. J. Ertl, a vaccine scientist at the Wistar Institute, called the phase III results published on February 2, 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?"[47]

According to preliminary review by experts, the lyophilized formulation of Gam-COVID-Vac is similar to the smallpox vaccine, circumventing the need for continuous cold chain storage – as required for the Pfizer–BioNTech and Moderna vaccines – and allowing transportation to remote locations with reduced risk of vaccine spoilage.[48][49]

Distribution, vaccination and public perception

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 early December 2020, the federal authorities announced the start of a large-scale free of charge vaccination with Gam-COVID-Vac for Russian citizens. The immunization started at 70 Moscow-based medical centers on December 5, 2020.[50]

Doctors and other medical workers, teachers, and social workers are given priority due to their highest risk of exposure to the disease.[51] The age for those receiving shots was initially capped at 60, later this restriction was lifted.[52] Potential recipients were notified via text message, with one reading “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, which is removed from deep freeze around 15 minutes before use. A 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.[53][54][55] 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.[51]

According to public opinion polls, only half of the Russian population would take the vaccine voluntarily.[56] An opinion poll of Canadians conducted by Léger found that a majority (68%) would not take the Russian vaccine if offered a free dose, compare 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.[57] 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.[58] 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]

In early December, the Minister of Health, Mikhail Murashko, said that Russia had already vaccinated more than 100,000 high-risk people.[59] Forty thousand of those are volunteers in Sputnik V's Phase 3 trials, another 60,000 medics and doctors have also taken the vaccine.[60] 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.[61]

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. It is expected that the vaccine also will be produced by the BIOCAD Company. According to Russian media, the suppliers will release 500,000 vaccines into circulation by the end of December 2020. On December 10, 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.[62] 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.[63]

Abroad

In dark green are the countries that ordered millions of Sputnik V doses. In light green are the countries that have shown interest in obtaining the vaccine or that are already testing it.

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.[64][65] In August 2020, according to the Russian authorities, there were at least 20 countries that wanted to obtain the vaccine.[66]

While free in Russia, the cost per dose would be less than US$10 (or less than $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.[67][68]

The Israeli Haddasah Medical Center has signed a commercial memorandum of understanding to obtain 1.5–3 million doses.[69] Argentina agreed to buy 25 million doses of the vaccine.[70] The vaccine was registered and approved in Argentina in late December.[71] 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.[72]

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.[73] 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 to Nepal and Egypt each.[74]

On January 21, 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.[75][76]

Emergency use authorization

As of December 2020, Belarus and Argentina granted emergency use authorization for the vector-based vaccine.[77] On January 21, 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.[78][79][80][81][82]

On 19 January 2021, the Russian authorities applied for the registration of Sputnik V in the European Union, according to the RDIF.[83] Emergency use has also been authorized in Algeria, Bolivia, Serbia, the Palestinian territories,[73] and Mexico.[84]

On January 25, 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.[85][86]

As of February 2021, twenty one countries have granted Sputnik V emergency use authorization.[9]

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