Gam-COVID-Vac

Gam-COVID-Vac (Russian: Гам-КОВИД-Вак, romanized Gam-KOVID-Vak), nicknamed Sputnik V, is a COVID-19 vaccine candidate.[3][4] It was developed by Gamaleya Research Institute of Epidemiology and Microbiology and had limited[1][2] registration in Russia on 11 August 2020 by the Russian Ministry of Health.[3] As of 8 August 2020, no reputable scientific report on the Gam-COVID-Vac candidate had been published.[3][5] Russian officials claimed that at least 20 countries are interested in obtaining the Russian vaccine.[6] According to the Russian Direct Investment Fund, Russia will be able to produce more than 500 million doses a year in five countries.[7]

Gam-COVID-Vac
Russian Ministry of Health image of Gam-COVID-Vac vials
Vaccine description
Target diseaseCOVID-19
TypeViral vector vaccine candidate based on human Adenovirus
Clinical data
Routes of
administration		intramuscular
Legal status
Legal status
  • Limited registration (Russia 08.2020-12.2020[1][2])

Protest developed in the international scientific community over the announcement of the vaccine registration in Russia, mainly because there has been no publication of results from clinical trials on Gam-COVID-Vac.[3][5] There exists no evidence for the safety, effective dose, biomarkers of an immune response, or efficacy against COVID-19 infection.[3][8] While it was announced that Gam-COVID-Vac would begin Phase III testing during 2020, no Phase I or Phase II results have been published under peer review, while six other vaccine candidates are already in interventional Phase III trials,[5] and 26 vaccine candidates in total are in various stages of human trials.[8] In most countries, vaccine candidates are not approved or licensed until safety and efficacy are reviewed internationally by regulators.[9]

Development
President Putin's meeting with Government members, on 11 August 2020 via videoconference, at which he announced a registered vaccine against COVID-19.[3][4]

In May 2020, the Gamaleya Research Institute of Epidemiology and Microbiology announced that it had developed the vaccine.[10] Preliminary human trials began on 18 June, with nine volunteers on the main vaccine and nine receiving the booster dose.[3] If successful in early human studies, a Phase III may begin in August.[11] On 11 August 2020, Russian President Vladimir Putin announced regulatory approval of the vaccine, even before the vaccine candidate had been entered into Phase II or III trials to prove it is safe and effective against COVID-19, and prevents infection in the general population.[3][4][12] Mass production in Russia is expected to start by the end of the year 2020, and the vaccine will be called "Sputnik V".[4][13] According to a registration certificate for the vaccine, 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.[4]

On 10 August 2020, media reported that Russia's Association of Clinical Trials Organizations made a proposal to postpone the state registration of the vaccine until successful completion of a Phase III clinical trial.[4] Early approval resulted in calls to follow safety guidelines from experts in Russia and abroad,[3][5] as vaccine candidates for an infectious disease in a Phase I-II trial (the stage of research where Gam-COVID-Vax was reported in July 2020) have a success rate of only 16%.[14] A vaccine candidate passing Phase II review and reaching a Phase III trial has only a 40% chance of success.[15] Without Phase III trials, it is unknown whether the vaccine is effective or safe for administration.[3][4]

Description
See also: COVID-19 vaccine

Gam-COVID-Vac is a viral vector vaccine based on the human adenovirus — a common cold virus — fused with the spike protein of SARS-CoV-2 to stimulate an immune response.[16] The Gam-COVID-Vac vaccine candidate was developed by a government organization that worked on previous coronavirus vaccine candidates.[17] The recombinant adenovirus type-5 (Ad5) and adenovirus type-26 (Ad26) are both used as vectors in the vaccine candidate. The Ad26 based vaccine is used on the first day and the Ad5 vaccine is used on the 21st day to boost response.[18]

Responses

British and American vaccine scientists called the Russian government's approval of Gam-COVID-Vac "dangerous", "reckless", and "foolish".[3][4] 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] A spokesperson for the Association of Clinical Research Organizations in Russia said, "I feel only shame for our country. Accelerated registration will no longer make Russia a leader in this race, it will only expose end users of the vaccine, citizens of the country of the Russian Federation, to unnecessary danger."[4]

"You cannot use a vaccine or drugs or medicines without following through all of these stages, having complied with all of these stages," a World Health Organization (WHO) spokesman said on 11 August 2020.[8][19] The US Secretary of Health and Human Services Alex Azar said that "The point is not to be first (...) The point is to have a vaccine that is safe and effective for the American people and the people of the world."[20]

The Indian Council of Medical Research (ICMR) noted that Russia has managed to fast track a COVID-19 vaccine quite successfully in its early phases. Also media reported that the Government of India acknowledged Russia's success in its early phases of developing a vaccine.[21]

Serbian President Aleksandar Vučić said "I will be the first to take the vaccine when Serbian specialists say it’s good. I am happy if Russians created a vaccine that was expected before November. Our specialists must just confirm to us that it is safe and reliable. It is important that the vaccine appears as soon as possible because it will save our economy," he noted.[22]

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References
  1. "Временная регистрация Гам-Ковид-Вак, полученная на таких условиях, действует до конца 2020 года."
  2. регистрация «на условиях», то есть ограниченная = Russia’s vaccine has received the same limited “provisional approval” - Meduza, 2020-08-12
  3. Callaway, Ewen (11 August 2020). "Russia's fast-track coronavirus vaccine draws outrage over safety". Nature. doi:10.1038/d41586-020-02386-2. PMID 32782400. Retrieved 11 August 2020. This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population.
  4. Cohen, Jon (11 August 2020). "Russia's approval of a COVID-19 vaccine is less than meets the press release". Science. Retrieved 13 August 2020.
  5. Kate Kelland (11 August 2020). "Scientists ask: Without trial data, how can we trust Russia's COVID vaccine?". Reuters. Retrieved 11 August 2020.
  6. Morales, Neil Jerome (7 August 2020). "Russia offers to supply Philippines with COVID-19 vaccine". Reuters. Manila. Retrieved 11 August 2020.
  7. Meyer, Henry; Arkhipov, Ilya. "Russia Defends First Covid-19 Vaccine as Safe Amid Skepticism". Bloomberg News. Retrieved 12 August 2020.
  8. Lovelace Jr., Berkeley (11 August 2020). "Scientists worry whether Russia's Sputnik V' coronavirus vaccine is safe and effective". CNBC. Retrieved 11 August 2020.
  9. "Vaccine and immunization quality and safety". World Health Organization. 20 July 2020. Retrieved 11 August 2020.
  10. "Russia plans to start producing coronavirus vaccine in September". Daily Sabah. dpa. 13 June 2020. Retrieved 10 August 2020.
  11. Ivanova, Polina (13 July 2020). "Russia may start Phase III trial of COVID-19 vaccine in mid-August: RIA". Reuters. Retrieved 12 August 2020.
  12. "Coronavirus: Putin says vaccine has been approved for use". BBC. 11 August 2020. Retrieved 11 August 2020.
  13. Tétrault-Farber, Gabrielle; Soldatkin, Vladimir (11 August 2020). "Russia becomes first country to approve a COVID-19 vaccine, says Putin". Reuters. Moscow. Retrieved 11 August 2020.
  14. "Clinical development success rates, 2006–2015" (PDF). BIO Industry Analysis. June 2016. Archived (PDF) from the original on 12 September 2019. Retrieved 23 March 2020.
  15. Lo, Andrew; Siah, Kien; Wong, Chi (14 May 2020). "Estimating probabilities of success of vaccine and other anti-infective therapeutic development programs". Harvard Data Science Review. MIT Press (Special Issue 1 - COVID-19). doi:10.1162/99608f92.e0c150e8. Retrieved 11 August 2020.
  16. "Coronavirus Vaccine Trials Advance in Race for Covid-19 Protection". Bloomberg News. Retrieved 10 August 2020.
  17. "Russia's RDIF & Prominent Government Lab Progress COVID-19 Vaccine: Production Facility Readied in the Moscow Region". TrialSite News. 10 June 2020. Retrieved 10 August 2020.
  18. "An Open Study of the Safety, Tolerability and Immunogenicity of the Drug 'Gam-COVID-Vac' Vaccine Against COVID-19". ClinicalTrials.gov. 22 June 2020.
  19. Stephanie Nebehay (11 August 2020). "WHO says discussing new COVID-19 vaccine with Russia". Reuters. Retrieved 11 August 2020.
  20. Walters, Joanna (11 August 2020). "Coronavirus: health secretary Alex Azar expects US vaccine by December". The Guardian. Retrieved 12 August 2020.
  21. "Russia has successfully fast tracked Covid-19 vaccine development, says India". Mint. 14 July 2020. Retrieved 11 August 2020.
  22. "Serbian leader Vucic says ready to be first to take Russian coronavirus vaccine". TASS. Retrieved 12 August 2020.
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