Much broader studies needed to ensure the vaccine’s efficacy and safety, say experts
Russian authorities have given regulatory approval to a second coronavirus vaccine after early-stage studies, two months after a similar move prompted widespread criticism from scientists both at home and abroad.
Russian President Vladimir Putin made the announcement last Wednesday, during a televised meeting with govern-ment officials.
“We now need to increase production of the first vaccine and the second vaccine,” Putin said, adding that the priority was to supply the Russian market with the vaccines.
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The peptide-based, two-shot vaccine, EpiVacCorona, was developed by the Vector Institute in Siberia and tested among 100 volunteers in early-stage, placebo-controlled human trials, which lasted more than two months and were complet-ed two weeks ago. The volunteers were between 18 and 60 years old.
The scientists have yet to publish the results of the study. In comments to the media, scientists developing the vaccine said that it produced enough antibodies to protect the person who had it from the virus and that the immunity it creates could last for up to six months.
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An advanced study involving tens of thousands of volunteers that is necessary to establish safety and effectiveness of the vaccine was scheduled to start in November or December.
Vaccination of risk groups
Deputy Prime Minister Tatyana Golikova, who said earlier this week she took part in the early trials as a volunteer, said Wednesday that 40,000 people will take part in the advanced studies of EpiVacCorona. It remained unclear whether the vaccine would be offered for a wider use while the trials are still ongoing.
Russia’s first vaccine, Sputnik V, was developed by the Moscow-based Gamaleya Institute and approved by the govern-ment on August 11, after early trials among 76 volunteers were completed. Just like on Wednesday, Putin personally broke the news on national television and said one of his daughters had already been vaccinated, experienced slight side effects and developed antibodies.
As Russia boasted about being the first in the world to approve a vaccine, experts said that in line with established scien-tific protocol, much broader studies among tens of thousands of people were needed to ensure the safety and effec-tiveness of the vaccine before it is given widely.
Russian health authorities announced advanced trials of Sputnik V among 40,000 volunteers two weeks after it received government approval. Officials also said that vaccination of risk groups, such as doctors and teachers, will be carried out in parallel to the studies.
Golikova said Wednesday that 13,000 volunteers have so far enrolled in the studies of the Sputnik V vaccine.
The international criticism didn’t stop Russia from promoting Sputnik V abroad. Kirill Dmitriev, head of the Russian Direct Investment Fund that bankrolled the effort, said last month that the fund already has agreements with Mexico, India and Brazil, which ordered a total of 200 million doses, and dozens of other countries are interested in getting the vaccine.
Source; PTI Moscow