No major negative side effects of the use of Russia’s potential coronavirus vaccine was found in early results from trials according to a recent study published in the peer-reviewed medical journal The Lancet revealed on Friday.
The Lancet article said that the trial for the vaccine was conducted on 76 healthy volunteers aged 18 to 60 and it was “two open, non-randomised phase 1/2 studies at two hospitals in Russia”.
The vaccine formulations tested were “safe and well tolerated”, the article said.
“The two 42-day trials – including 38 healthy adults each – did not find any serious adverse effects among participants, and confirmed that the vaccine candidates elicit an antibody response,” the study’s authors wrote.
“Large, long-term trials including a placebo comparison, and further monitoring are needed to establish the long-term safety and effectiveness of the vaccine for preventing COVID-19 infection,” it added.
With editorial offices in New York, London and Beijing, The Lancet is one of the world’s oldest medical journals.
After the Russian vaccine that has been named “Sputnik V” by the Russians was approved by the country’s health regulators last month which made it the first in the world to be registered as a vaccine against Cvoid-19.
At that time, the Russian President Vladimir Putin had said that the country was poised to begin full-scale production of the vaccine in September.
There were concerns and criticism of the safety and efficacy of the vaccine after Russia announced the approval of the vaccine. At the time when the vaccine was approved, only rapid Phase 1 and 2 clinical trials on a small number of people had been conducted. The developers had also not published the data of the trials.
The publication of the study about the vaccine in The Lancet also is the first time that the trial results have been published in a well-respected international publication.
The support of The Lancet for the vaccine was described as a validation of his country’s efforts according to Kirill Dmitriev, the chief of Russian sovereign wealth fund RDIF which is backing the vaccine.
“We had lots of interest in the Russian vaccine (with) publication in the Lancet, which is one of key Western magazines on medicine,” Dmitriev said. “It is very important to share information with the world … the results have been very good but basically the study showed there is very strong both antibodies and cell immune response.”
By November, Russia would be able to provide exports of the vaccine, he said and added that the developers of the vaccine would provide data to the world at the end of October of the more robust Phase 3 human trials.
“Right now we have 40,000 clinical trials going on in Russia, we started it at the end of August, and there will also be clinical trials in the UAE, Saudi Arabia, Philippines and many other markets,” Dmitriev said. “So basically we’re on track to have registration not only available in Russia … but also available to key other countries already around November.”
(Adapted from CNBC.com)