News (1) to (5) / Research, editing : Gan Yung Chyan, KUCINTA SETIA / Image courtesy : Olga Maltseva / AFP via Getty Images
News (1)
Sputnik V passes Phase III trial
Sputnik V, the foremost covi vaccine of Russia has passed the Phase III trial. Results of the trial are published in interim form in February 2021. In this trial, 14,964 adults were randomized to receive the two-dose vaccine and 5,476 to receive two doses of placebo. Only 16 subjects in the vaccine group developed symptomatic COVID-19, compared with 62 in the placebo group, representing a vaccine efficacy of 91.6%. Furthermore, there were no cases of moderate to severe disease in the vaccine group, but 20 in the placebo group.
Unpublished data from 3.8 million Russians vaccinated with two doses also point to an efficacy of 97.6%, according to an April press release from the Gamaleya Institute.
Russia’s Phase III study also found that even one dose was 73.6% effective at preventing moderate to severe disease. This led the Russian health authorities to approve the one-dose Sputnik Light — which uses the rAd26 vector — in May, on the basis of data from the country’s own vaccination programme, which suggested it was 79.4% effective at preventing symptomatic covid.
News (2)
UAE Ministry of Health: Sputnik V prevents severe covid by 100%
Figures released by the United Arab Emirates Ministry of Health from some 81,000 individuals who had received two doses of the vaccine, suggested 97.8% efficacy in preventing symptomatic COVID-19 and 100% efficacy in preventing severe disease.
News (3)
Argentina: Sputnik V reduces covid hospitalizations by 87.6%
Since then, an as-yet unpublished study from the Buenos Aires Ministry of Health in Argentina, involving 40,387 vaccinated and 146,194 unvaccinated people aged 60–79, found that a single dose of Sputnik Light reduced symptomatic infections by 78.6%, hospitalizations by 87.6% effective and deaths by 84.7%.
News (4)
No blood clots after Sputnik V vaccination
Sputnik’s side effects are also becoming clearer; studies so far suggest that they are similar to those of the other adenovirus vaccines, with the notable exception of rare blood-clotting conditions. Unlike for both the Oxford–AstraZeneca and Johnson & Johnson vaccines, there have been no reports of these disorders from Russian health authorities or from the other nations using Sputnik V.
A preprint3 from the Italian Hospital of Buenos Aires in Argentina reported no cases of clotting disorders or adverse events of special interest among 683 health-care workers vaccinated with Sputnik V. And an analysis of 2.8 million doses of Sputnik V administered in Brazil reported no deaths associated with vaccination, and mostly mild adverse events. Furthermore, a study posted as a pre-print in May, from the republic of San Marino, found no serious adverse events in 2,558 adults who received one dose of Sputnik V and 1,288 who received two doses4.
Virologist Alyson Kelvin at Dalhousie University in Halifax, Canada, says there is a theory that the clotting disorder is associated with viral vector vaccines, but adds, “I don’t think we have exact causation of what component of those vaccines are causing it”, or whether Sputnik might also be affected. She notes that although the phase III study of Sputnik V enrolled only 21,977 people, and thus was too small to pick up rare adverse events, the vaccine is now in widespread use globally, which means that reports should appear “if a safety signal comes up”.
News (5)
Russian doctors might not connect a stroke caused by blood clots to a vaccination
It is not clear whether Russia is in a position to detect such rare events. Those associated with the Oxford–AstraZeneca vaccine first came to light through adverse-event monitoring in Austria, which prompted the EMA to review the vaccine’s safety.
Russia’s adverse-event monitoring might be less effective, Kulish argues, partly because of a cultural resistance to seeking medical care. “Most Russian people will call [the] doctor only when they cannot breathe any more,” he quips. Furthermore, doctors in remote regions of Russia might not connect a stroke caused by blood clots, for example, to a recent vaccination, he says.
Argentina has not reported any clotting events, despite receiving more than four million doses of the vaccine, Kulish notes. Serbia, which has also been using Sputnik V widely, has so far reported no cases of the blood-clotting condition reported with other adenovirus vaccines.
About Sputnik V
Sputnik V, also known as Gam-COVID-Vac , is the first covi vaccine to be registered for use in any nation, and it has since been approved in 68 countries, including Argentina, Brazil, Hungary, India, the Philippines and Mongolia. The vaccine and its one-dose sibling Sputnik Light has yet to receive approval for emergency use from the European Medicines Agency (EMA) or the World Health Organization (WHO). Approval by the WHO is crucial for widespread distribution through the COVID-19 Vaccines Global Access (COVAX) initiative, which is providing doses for lower-income nations.
Developed by scientists at the Gamaleya National Research Center of Epidemiology and Microbiology in Moscow, the vaccine is authorized for use by the Russian Ministry of Health on 11 August 2020.
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