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Sputnik V COVID-19 vaccine

Russian Ministry of Health image of Gam-COVID-Vac vials
Vaccine description
Target	COVID-19
Clinical data
Trade names	Sputnik V
Routes of administration	Intramuscular
Legal status
Legal status	Registered in Russia on 11 August 2020

Gam-COVID-Vac (Template:Lang-ru), trade-named Sputnik V (V for vaccine), 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. Gam-COVID-Vac was approved for distribution in Russia, despite having been tested only in a small number of people in early-stage clinical trials that lasted two months, normally a process requiring a year or more of clinical assessment for proof of vaccine safety and efficacy against viral disease.

The quick approval of Gam-COVID-Vac was initially criticized as premature, in order to claim being the first country to produce a COVID-19 vaccine. Protests developed in the international scientific community over announcement of the vaccine registration, mainly because there was initially no publication of results from clinical trials on Gam-COVID-Vac.

Although Phase I-II results were eventually published on 4 September 2020, the pivotal Phase III trial – a necessary scientific step to prove vaccine safety and efficacy in thousands of individuals – had not yet been completed in its entirety. At the time of Gam-COVID-Vac registration in Russia after early trials, several other vaccine candidates were already being evaluated in interventional Phase III trials involving thousands of participants. In most countries following guidelines of the World Health Organization, vaccine candidates are not approved or licensed until safety and efficacy data from Phase III trials are assessed and confirmed internationally by regulators. In December 2020, the Gamaleya Institute published preliminary data on 22,714 participants of its phase III trials.

Technology

Gam-COVID-Vac is a viral two-vector vaccine based on two human adenoviruses — a common cold virus — containing the gene that encodes the spike protein (S) of SARS-CoV-2 to stimulate an immune response. The Gam-COVID-Vac vaccine was developed by a government organisation that worked on previous coronavirus vaccine candidates. The recombinant adenovirus type-5 (rAd5) and adenovirus type-26 (rAd26) are both used as vectors in the vaccine. The Ad26 based vaccine is used on the first day and the Ad5 vaccine is used on the 21st day to boost response.

The liquid form of the vaccine must be stored at −18 °C (0 °F), and a freeze-dried form is currently being tested that would allow storage at the standard temperature of 2–8 °C (36–46 °F).

Development and registration

This section needs expansion. You can help by adding to it. (September 2020)

In May 2020, the Gamaleya Research Institute of Epidemiology and Microbiology announced that it had developed the vaccine. The vaccine was given the trade name "Sputnik V", after the world's first artificial satellite.

On 11 August, Russian President Vladimir Putin announced regulatory approval of the vaccine, even before the vaccine candidate had been entered into Phase III trials to prove it is safe and effective against COVID-19, and prevents infection in the general population. According to Deutsches Ärzteblatt, only 38 participants had been studied in two small trials before the registration was issued, leading to criticism by a spokesperson for the German Federal Ministry of Health that there had been no publication of data in a peer-reviewed journal before the registration was issued. The registration certificate for the vaccine stated that it cannot 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.

Early government approval of the vaccine candidate resulted in international protest that clinical safety guidelines had not been followed, and that vaccine candidates for an infectious disease in a Phase I-II trial (the stage of research where Gam-COVID-Vac was reported in July 2020) have a success rate of only 16%. A vaccine candidate has only a 40% and 7% chance of passing from a Phase I trial to regulatory approval for industry-sponsored and non-industry-sponsored vaccine development programs, respectively. Without Phase III trials, it is unknown whether the vaccine is effective or safe for vaccinating the public.

Preliminary clinical research

A Phase I safety trial began on 18 June. On 4 September, 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.

On November 4, 2020, Israel Hadassah Medical Center director-general Prof. Zeev Rotstein stated in The Jerusalem Post "Hadassah’s branch in Moscow’s Skolkovo Innovation Center has been collaborating on a Phase III clinical trial... should be complete in the next month or two. That trial is testing the vaccine on some 40,000 people in Russia and several other countries. Tens of thousands of volunteers have already received the vaccine."

On December 10, 2020, Ramil Khabriev of the Russian National Research Institute of Public Health, claims that the phase III trials of the Spunik V vaccine is "successfully coming to an end".

On December 11, 2020, AstraZeneca announced they would start clinical trials to test a combination of its experimental COVID-19 vaccine, AZD1222, with Russia’s Sputnik V. AstraZeneca said it was considering how it could assess combinations of different vaccines, and would soon begin exploring with Russia’s Gamaleya Institute, developer of Sputnik V, whether two vaccines based on a common-cold virus could be successfully combined.

On December 14, 2020, the Gamaleya Institute published data on 22,714 participant in the phase III trials.

Scientific assessment

On 11 August 2020, a World Health Organization spokesperson said, "Prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data... You cannot use a vaccine or drugs or medicines without following through all of these stages, having complied with all of these stages."

Vaccine scientists Peter Hotez and Francois Balloux have called the Russian government's approval of Gam-COVID-Vac "worrying", "reckless" and "foolish". 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.

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.

Dr 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.

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said "The data compatible with the vaccine being reasonably effective".

Ian Jones, a professor of virology at the University of Reading, said "These results are consistent with what we see with other vaccines, because the really big message for global health scientists is that this disease is able to be addressed by vaccines. I see no reason to doubt it ," Jones told CBC News in an interview. "I agree that their initial results caused consternation, but I don't think it's because they weren't valid. They were released a bit soon. I think it's going to be a useful vaccine."

As of October 2020, the developers claim it to be the “best vaccine” against COVID-19.

Potential distribution, pricing and public perception

The Russian Direct Investment Fund reported that at least 50 countries were interested in obtaining the Russian vaccine and Russia will be able to produce more than one billion doses a year in five countries.

For Russian citizens, inoculation will be free of charge. In international markets, the vaccine will cost under US$20 (equivalent to $23.55 in 2023) per person.

According to public opinion polls, only half of the Russian population would take the vaccine voluntarily.

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. 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. 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. "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.

Some of Russian officials and media pundits have decried the scepticism as evidence of an inherent "Western bias" against anything Russian and have accused U.S. and U.K. media of staging a smear campaign to steal away potential international customers.

Mass deployment

Russian President Vladimir Putin ordered a large-scale voluntary vaccination program against COVID-19 to begin on December 7 across the country, though the date was then pushed to December 5, with doctors and other medical workers, teachers and social workers given priority due to their highest risk of exposure to the disease. The age for those receiving shots is capped at 60. 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.

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

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. The vaccine is administered in two injections, the second dose given 21 days after the first, in around 70 clinics.

The head of the Russian Direct Investment Fund (RDIF), Kirill Dmitriev, said in an interview with the BBC, that Russia expects to give the vaccine to about 2 million people by the end of December.

Abroad

According to the Russian Direct Investment Fund, they had received orders for more than 1.2 billion doses of the vaccine. 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.

While free in Russia, the cost per dose would be less than $10 (or less than USD 20 for the two doses needed to vaccinate one person) on international markets. 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.

The Israeli Haddasah Medical Center has signed a commercial memorandum of understanding to obtain 1.5-3 million doses. Argentina agreed to buy 25 million doses of the vaccine, receiving an initial 10 million doses by as early as December, should it clear clinical trials. 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.

The RDIF also 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.

See also

• RNA vaccine

References

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External links

• Official website

v t e Gamaleya Research Institute of Epidemiology and Microbiology
Named for Nikolay Gamaleya and founded by Felix Blyumental
Directors	Alexander Gintsburg (since 1997) Sergey Prozorovsky (1982–1997)
Vaccines	Sputnik Light (COVID-19) Gam-COVID-Vac / Sputnik V (COVID-19) GamEvac-Combi (Ebola) BVRS-GamVac (MERS)
Notable employees	Garry Abelev Yuliya Ananyina [ru] Otar Andzhaparidze [ru] Oganes Baroyan [ru] Lev Gromashevsky [ru] Natalya Murashkevich Sergey Drozdov [ru] Zinaida Yermolyeva Felix Yershov [ru] Viktor Zhdanov Pavel Zdrodovsky [ru] Lev Zilber Nikolay Kaverin [ru] Eduard Korenberg [ru] Dmitry Lvov [ru] Alexey Olovnikov Yevgeny Pavlovsky Adelina-Victoria Skavronskaya [ru] Anatoly Smorodintsev [ru] Valentin Solovyov [ru] Vladimir Timakov [ru] Viktor Troitsky [ru] Alexander Fridenshteyn [ru] Mikhail Chumakov
Medical and health organizations based in Russia

• COVID-19 pandemic in Russia
• COVID-19 vaccines
• Medical controversies in Russia
• Products introduced in 2020
• Science and technology in Russia
• Vaccine controversies