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RUSSIAN scientists said on Friday, September 4, 2020 that the Sputnik V vaccine they have developed against the coronavirus disease 2019 (Covid-19) is safe and “well tolerated” according to the results of the first two phases of clinical trials.
The vaccine also induced an immune response that is “sufficient to counteract any dose of Covid-19,” said the director of the National Center for Epidemiology and Microbiology of Gamaleya, Alexander Gintsburg, in a virtual press conference held Friday afternoon in Moscow (Friday night in the Philippines).
Based on an article published in the medical journal The Lancet Friday, the Russian vaccine induced “strong humoral and cellular immune responses” in the 76 healthy participants in its phase one and two clinical trials.
Only mild adverse reactions such as injection site pain, hyperthermia, headache, asthenia, and muscle and joint pain were reported.
However, these adverse reactions are typical of vaccines, said researchers at the National Center for Epidemiology and Microbiology in Gamaleya.
“When the safety (of the vaccine) was investigated, no serious adverse effects were identified,” said researcher Inna Dolzhikova at the same news conference.
This makes Sputnik V different from the more than 100 candidate vaccines, he added.
Dolzhikova also said that the immune response of the trial participants was greater than that of actual Covid-19 patients.
He said that the presence of immunity to pre-existing adenovirus does not affect the efficacy of Sputnik V.
“Our vaccine is based on the heterological approach of primary booster immunization … This approach allows us to overcome the possible negative impact of pre-existing adenovirus immunity on the efficacy of our vaccine,” added Dolzhikova.
Sputnik V, an adenovirus vector-based vaccine, comprises two vector components, recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5).
Gamaleya conducted clinical trials between June 18 and August 3, 2020, with a total of 76 healthy adult participants, or 38 for each phase, in two hospitals in Russia.
Phase three clinical trials were recently launched in Russia involving some 40,000 volunteers.
Sputnik V is the first Covid-19 vaccine registered on the market, having been registered by the Russian Ministry of Health on August 11, 2020.
It is named after the first space satellite of the then Soviet Union. (Marites Villamor-Ilano / SunStar Philippines)
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