Sputnik V COVID-19 vaccine: Difference between revisions

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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 trial]]s on Gam-COVID-Vac.<ref name=nature/><ref name=reuters/> There exists no evidence for the safety, [[Effective dose (pharmacology)|effective dose]], [[biomarker]]s of an [[immune response]], or efficacy against COVID-19 infection.<ref name=nature/><ref name="lovelace">{{cite news |first=Berkeley |last=Lovelace Jr.|title=Scientists worry whether Russia's Sputnik V' coronavirus vaccine is safe and effective |url=https://www.cnbc.com/2020/08/11/scientists-worry-whether-russias-sputnik-v-coronavirus-vaccine-is-safe-and-effective.html |accessdate=11 August 2020 |work=CNBC |date=11 August 2020 |language=en}}</ref> While it was announced that Gam-COVID-Vac would begin [[Phases of clinical research|Phase III]] testing during 2020, [[Phases of clinical research|Phase I]] or [[Phases of clinical research|Phase II]] results were published on 4 September 2020<ref name=":0">{{Cite journal|last=|first=|date=4 September 2020|title=Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia |journal=[[The Lancet]] |volume=|pages=1-11 |doi=10.1016/S0140-6736(20)31866-3 |doi-access=free }}</ref> , while six other vaccine candidates are already in interventional Phase III trials,<ref name=reuters/> and 26 vaccine candidates in total are in various stages of human trials.<ref name=lovelace/> In most countries, vaccine candidates are not approved or licensed until safety and efficacy are reviewed internationally by regulators.<ref>{{cite web |title=Vaccine and immunization quality and safety |url=https://www.who.int/immunization/quality_safety/en/ |publisher=World Health Organization |accessdate=11 August 2020 |date=20 July 2020}}</ref>
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 trial]]s on Gam-COVID-Vac.<ref name=nature/><ref name=reuters/> There exists no evidence for the safety, [[Effective dose (pharmacology)|effective dose]], [[biomarker]]s of an [[immune response]], or efficacy against COVID-19 infection.<ref name=nature/><ref name="lovelace">{{cite news |first=Berkeley |last=Lovelace Jr.|title=Scientists worry whether Russia's Sputnik V' coronavirus vaccine is safe and effective |url=https://www.cnbc.com/2020/08/11/scientists-worry-whether-russias-sputnik-v-coronavirus-vaccine-is-safe-and-effective.html |accessdate=11 August 2020 |work=CNBC |date=11 August 2020 |language=en}}</ref> While it was announced that Gam-COVID-Vac would begin [[Phases of clinical research|Phase III]] testing during 2020, [[Phases of clinical research|Phase I]] or [[Phases of clinical research|Phase II]] results were published on 4 September 2020<ref name=":0">{{Cite journal|last=|first=|date=4 September 2020|title=Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia |journal=[[The Lancet]] |volume=|pages=1-11 |doi=10.1016/S0140-6736(20)31866-3 |doi-access=free }}</ref> , while six other vaccine candidates are already in interventional Phase III trials,<ref name=reuters/> and 26 vaccine candidates in total are in various stages of human trials.<ref name=lovelace/> In most countries, vaccine candidates are not approved or licensed until safety and efficacy are reviewed internationally by regulators.<ref>{{cite web |title=Vaccine and immunization quality and safety |url=https://www.who.int/immunization/quality_safety/en/ |publisher=World Health Organization |accessdate=11 August 2020 |date=20 July 2020}}</ref>


On 4 September 2020, in [[The Lancet]], findings from two phase 1/2 of the vaccine were presented. The researchers enrolled 76 healthy adult volunteers (aged 18–60 years) into the two studies (38 people in each study). The primary outcome measures of the studies were safety and immunogenicity.<ref>{{cite web |last1=Bar-Zeev |first1=Naor |last2=Inglesby |first2=Tom |title=COVID-19 vaccines: early success and remaining challenges |url=https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31867-5/fulltext |website=The Lancet |accessdate=6 September 2020 |language=English |doi=10.1016/S0140-6736(20)31867-5 |date=4 September 2020}}</ref>
== Development ==
== Development ==
[[File:Совещание с членами Правительства (В. Путин; 11 августа 2020) – (01).jpg|240px|thumb|President [[Vladimir Putin|Putin]]'s meeting with Government members, on 11 August 2020 via videoconference, at which he announced a conditionally registered [[COVID-19 vaccine|vaccine against COVID-19]].<ref name=nature/><ref name=cohen/>]]
[[File:Совещание с членами Правительства (В. Путин; 11 августа 2020) – (01).jpg|240px|thumb|President [[Vladimir Putin|Putin]]'s meeting with Government members, on 11 August 2020 via videoconference, at which he announced a conditionally registered [[COVID-19 vaccine|vaccine against COVID-19]].<ref name=nature/><ref name=cohen/>]]

Revision as of 10:30, 6 September 2020

Template:Use Commonwealth English

Sputnik V COVID-19 vaccine
See caption
Russian Ministry of Health image of Gam-COVID-Vac vials
Vaccine description
TargetCOVID-19
Clinical data
Trade namesSputnik V
Routes of
administration		intramuscular
Legal status
Legal status

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

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.[1][3] There exists no evidence for the safety, effective dose, biomarkers of an immune response, or efficacy against COVID-19 infection.[1][6] While it was announced that Gam-COVID-Vac would begin Phase III testing during 2020, Phase I or Phase II results were published on 4 September 2020[7] , while six other vaccine candidates are already in interventional Phase III trials,[3] and 26 vaccine candidates in total are in various stages of human trials.[6] In most countries, vaccine candidates are not approved or licensed until safety and efficacy are reviewed internationally by regulators.[8]

On 4 September 2020, in The Lancet, findings from two phase 1/2 of the vaccine were presented. The researchers enrolled 76 healthy adult volunteers (aged 18–60 years) into the two studies (38 people in each study). The primary outcome measures of the studies were safety and immunogenicity.[9]

Development

President Putin's meeting with Government members, on 11 August 2020 via videoconference, at which he announced a conditionally registered vaccine against COVID-19.[1][2]

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.[1] According to Deutsches Ärzteblatt, 38 volunteers were involved in the first two small trials before the emergency registration in Russia. It quotes a Federal Ministry of Health spokesperson's criticism of no publication of data or articles in peer-reviewed journals.[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 III trials to prove it is safe and effective against COVID-19, and prevents infection in the general population.[1][2][12]

The vaccine was given the trade name, "Sputnik V".[2][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.[2]

Early approval resulted in calls to follow safety guidelines from some experts in Russia and abroad,[1][3] 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 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 programmes, respectively.[15] Without Phase III trials, it is unknown whether the vaccine is effective or safe for administration.[1][2]

Description

See also: COVID-19 vaccine
File:SputnikV.png
Proposed technology of Gam-COVID-Vac

Gam-COVID-Vac is a viral two-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 organisation 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. The Ad26 based vaccine is used on the first day and the Ad5 vaccine is used on the 21st day to boost response.[18]

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."[6][19]

Vaccine scientists have called the Russian government's approval of Gam-COVID-Vac "dangerous", "reckless", and "foolish".[1][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.[6] 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."[2]

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]

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.[21]

Public perception

A scientific 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.[22]

References

  1. ^ a b c d e f g h i j k 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.
  2. ^ a b c d e f g h 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.
  3. ^ a b c d Kate Kelland (11 August 2020). "Scientists ask: Without trial data, how can we trust Russia's COVID vaccine?". Reuters. Retrieved 11 August 2020.
  4. ^ Morales, Neil Jerome (7 August 2020). "Russia offers to supply Philippines with COVID-19 vaccine". Reuters. Manila. Retrieved 11 August 2020.
  5. ^ Meyer, Henry; Arkhipov, Ilya. "Russia Defends First Covid-19 Vaccine as Safe Amid Skepticism". Bloomberg News. Retrieved 12 August 2020.
  6. ^ a b c d Lovelace Jr., Berkeley (11 August 2020). "Scientists worry whether Russia's Sputnik V' coronavirus vaccine is safe and effective". CNBC. Retrieved 11 August 2020.
  7. ^ "Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia". The Lancet: 1–11. 4 September 2020. doi:10.1016/S0140-6736(20)31866-3.
  8. ^ "Vaccine and immunization quality and safety". World Health Organization. 20 July 2020. Retrieved 11 August 2020.
  9. ^ Bar-Zeev, Naor; Inglesby, Tom (4 September 2020). "COVID-19 vaccines: early success and remaining challenges". The Lancet. doi:10.1016/S0140-6736(20)31867-5. Retrieved 6 September 2020.
  10. ^ "Russia plans to start producing coronavirus vaccine in September". Daily Sabah. dpa. 13 June 2020. Retrieved 10 August 2020.
  11. ^ "Russland lässt Impfstoff gegen SARS-CoV-2 zu". Deutsches Ärzteblatt (in German). 11 August 2020. Retrieved 22 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 (Special Issue 1 - COVID-19). MIT Press. 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. ^ Cyr, Émilie (24 August 2020). "Leger's Weekly Survey" (PDF). leger360.com. Retrieved 5 September 2020.

External links

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