OVERDRIVE: Ad Sputnik V.
Muzes citovat pls? Konkretne string "FDA" mi to nenachazi.
Naopak tam vidim napsano:
"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."
K tomu z Wiki:
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 March 2021,
thirty nine countries have granted Sputnik V emergency use authorization[9] while over a billion doses of the vaccine were ordered for immediate distribution globally.[10]
Sputnik V COVID-19 vaccine - Wikipedia
https://en.wikipedia.org/wiki/Sputnik_V_COVID-19_vaccine#Scientific_assessment
Scientific assessment:
Nejdriv pochyby:
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.[43]
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".[7]
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".[44]
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.[7]
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.[45][failed verification]
Pozdeji optimismus:
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."[45]
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."[46]
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."[47]
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?"[48]
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.[49][50] "