Polina Ivanova, Andrew Osborne
MOSCOW (Reuters) – Russia's Sputnik V coronavirus vaccine has elicited an immune response in all early-stage trial participants, according to results published by the medical journal The Lancet, which Moscow called a response to critics.
The results of clinical studies conducted in June-July this year, which involved 76 people, showed that 100% of the volunteers developed antibodies to the new coronavirus, while no serious side effects were found.
Russia's announcement of the registration of a new vaccine Sputnik V, made in August after less than two months of human testing, has caused alarm among global health experts: in their opinion, without complete test results, the vaccine is difficult to trust.
“Two 42-day studies – each involving 38 healthy adults – did not identify any serious adverse events among the participants and confirmed that the experimental vaccines elicit an immune response,” The Lancet told The Lancet.
“Extensive, long-term studies, including placebo comparisons, and further monitoring are needed to ensure the long-term safety and efficacy of the vaccine in preventing COVID-19 infection.”
Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), said that the first publication of the results in an international peer-reviewed journal and the post-registration studies on 40,000 volunteers launched last week are a response to foreign criticism.
“With this (publication) we are answering all the questions from the West that have been diligently asked over the past three weeks, with the explicit aim of tarnishing the Russian vaccine,” Dmitriev said.
“Now … we're going to start asking questions about some Western vaccines,” he said.
At least 3,000 people have already been recruited for large-scale vaccine trials, Dmitriev said, and the first results are expected in October or November this year.
Mass vaccination of people at risk from coronavirus in Russia is scheduled to begin after November-December 2020, state agencies reported earlier, citing Health Minister Mikhail Murashko.
Governments and major pharmaceutical companies are trying to develop a vaccine to cope with the coronavirus pandemic, which has claimed more than 850,000 lives worldwide. The number of cases of infection in the world is about 26 million.
The Lancet reported that tests showed that the Russian vaccine produced a T-cell response in volunteers.
Scientists are studying the role of T cells in the fight against coronavirus infection, and recent results have shown that these cells may provide longer lasting protection than antibodies.
A vaccine developed by the Moscow National Research Center for Epidemiology and Microbiology named after N.F. Gamalea is administered in two doses, each based on a vector that commonly causes the common cold: human adenoviruses Ad5 and Ad26.
Some experts have previously said that using this mechanism could make the COVID-19 vaccine less effective, as many people have already been exposed to the Ad5 adenovirus and have developed immunity to it.
Denis Logunov, one of the vaccine developers at the Gamaleya Center, told Reuters the vaccine uses a dose of Ad5 strong enough to overcome previous immunity without posing a threat.
Russia said it plans to produce between 1.5 and 2 million doses of vaccine per month by the end of the year, gradually increasing production to 6 million doses per month.
(Andrew Osborne and Polina Ivanova; Translated by Anna Rzhevkina. Editor Marina Bobrova)