Russia has given regulatory consent to a secondary Covid-19 vaccine—even though the drug has yet to begin wide-scale Phase-III trials — two months after it passed a green signal on the next vaccine, experts expressed caution over lack of appropriate safety and efficacy data.
Key Facts
- Russian President Vladimir Putin stated the second vaccine at a government conference on Wednesday, Reuters reported.
- The peptide-based drug, named EpiVacCorona, has been produced by the Vector Institute in Siberia.
- A placebo-controlled test had 100 volunteers within the ages of 18, and 60 obtain the shot in Novosibirsk.
- Completing those early-stage trials is yet to be announced, and large-scale Phase-III trials, which help secure safety and efficacy, have not yet started.
- Putin stated that Russia would boost both the vaccines that have been certified by the government and projects to work with “foreign partners” to sell the vaccine abroad.
Backgrounder
In August, Russia became the first country to grant regulatory approval to a Covid-19 vaccine, despite limited testing. That vaccine, named-Sputnik-V, was developed by Moscow’s Gamaleya Institute. Scientists expressed concern that there was no way of knowing if the vaccine was effective or safe without proper trial data. Still, the Russian President declared that the drug was both safe and effective, remarking that it had now been given to one of his daughters. Numbers of people who work in a place that puts them at high risk for becoming infected with the coronavirus have been injected with the Sputnik-V shot. The vaccine, though, is not yet in everyday use. When Sputnik-V was announced, former FDA Commissioner Scott Gotlieb said that Russia was “certainly not” leading of the U.S. on Covid-19 vaccine progress, noting that the U.S. would not allow mass administration of a drug had been only tested on a few hundred patients at most.
The Number
213. That’s the total number of Covid-19 vaccines that are presently in development. Only nine of these, including the other Russian vaccine, Sputnik-V, have officially begun large-scale ‘Phase-III’ clinical trials.
Contiguous
Earlier this month, the WHO Director-General Tedros Adhanom Ghebreyesus hoped that a vaccine would be ready by the end of the year. However, experts cautioned that the WHO head’s timeline might be a bit too optimistic, remarking that there may be some emergency approval that offers some availability for high-risk individuals like health care workers by the end of 2020.
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