Russia approves 2nd virus vaccine after early trials

PTI, Oct 15, 2020, 9:28 AM IST

Moscow: 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 on Wednesday, during a televised meeting with government 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.

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 completed 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.

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.

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 advance 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 government on Aug. 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 scientific protocol, much broader studies among tens of thousands of people were needed to ensure the safety and effectiveness 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.

Speaking at this year’s U.N. General Assembly, Putin offered to provide the Sputnik-V vaccine to U.N. staff for free. He described the offer as a response to popular demand: “Some colleagues from the U.N. have asked about this, and we will not remain indifferent to them.” Russia has the world’s fourth largest coronavirus caseload with over 1.3 million infections. It has also reported over 23,000 deaths.

The outbreak in the country appeared to slow down in the summer, but the number of new infections started to grow rapidly last month. Over the past 11 days, Russian health officials have been reporting over 10,000 new cases every day. They registered a record number of 14,231 new cases on Wednesday.