Russia plans to share preliminary results from the first six weeks of monitoring of its volunteer trials for COVID-19 vaccine Sputnik V.
Justifying pace of development, Gamaleya Institute Head Alexander Gintsburg, said the “wartime” conditions warranted it, adding that no corners are being cut. The Gamaleya Institute produces Sputnik V.
There has been global concern after Russia pushed ahead with mass vaccinations alongside human trials of Sputnik V. Some critics accused the country of prioritising “national prestige over solid science and safety,”
But Gintsburg defended the move, saying “People are dying just like during a war. But this fast-tracked pace is not synonymous, as some media have suggested, with corners being cut. No way.”
He also called early public use of the vaccine “the most ethical approach,” adding that the choice was between “giving people an opportunity to protect themselves, or letting them play roulette with this deadly infection.”
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
On side-effects, Gintsburg said no serious ones have been reported so far during Phase III, and 14-15 percent volunteers have had “anticipated side-effects”, while 25 percent received placebo.
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Acknowledging the tight deadline, Gintsburg emphasised that all guidelines for testing safety and efficacy had been followed. He added that they plan to publish interim results from the first 42 days of monitoring – as there is an argument for public interest for it. “For me, for example, it is too short. But for people who are interested in how things are going, it is already too long.”
If done, Russia would be the first to announce data from final-stage or Phase III vaccine trial.
The results are expected sometime after October 21 as the first 5,000 volunteers were vaccinated on September 9, and Russia’s sovereign wealth fund (investor) said it could come in October or November.
Further speaking about the trial observation period, Gintsburg said volunteers are to be monitored for 180 days after the last of 40,000 participants was vaccinated. The final result from this will also be published in an international journal in six months, he said.
Notably, Russia’s early-stage trial results for Sputnik V were peer-reviewed and published in The Lancet.