(UPDATED) Russian scientists on Friday, September 4, 2020, said the Sputnik V vaccine they have developed against coronavirus disease 2019 (Covid-19) is safe and “well-tolerated” based on 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” and could last for at least two years, Gamaleya National Center of Epidemiology and Microbiology head Alexander Gintsburg said in a virtual press conference held Friday afternoon in Moscow (Friday evening in the Philippines).
Kirill Dmitriev, director general of Russian Direct Investment Fund (RDIF), said the antibodies produced by the vaccine are 1.5 times higher than those produced by recovered Covid-19 patients.
“The Gamaleya Institute managed to demonstrate that the vaccine V demonstrate 1.5 (times) higher level of antibodies as compared to those who were infected with the Covid-19,” Dimitriev said.
“We see much more efficacy of Sputnik V vaccine. That is also due to the fact that two various adenovirus vectors are used,” he added.
RDIF is Russia's sovereign wealth fund which is financing the mass production of the vaccine.
The Lancet article
Gamaleya’s findings from phases one and two clinical trials were published in medical journal The Lancet Friday, nearly a month after the vaccine was registered in Russia.
Sputnik V, which was named after the first space satellite by the then Soviet Union, was registered by the Russian Ministry of Health on August 11, 2020, making it the first registered Covid-19 vaccine on the market.
Based on the article on The Lancet, the Russian vaccine induced “strong humoral and cellular immune responses” in all the 76 healthy participants in its phase one and two clinical trials.
Only mild adverse reactions were reported such as pain at the injection site, hyperthermia, headache, asthenia, and muscle and joint pain.
These adverse reactions are, however, typical for vaccines, Gamaleya researchers said.
Gamaleya held 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.
Sputnik V is an adenovirus vector-based vaccine with two vector components, recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5).
In The Lancet article, the researchers said they administered either one dose of rAd26-S or one dose of rAd5-S on each subject and assessed the vaccine’s safety for 28 days under phase one.
In phase two, which began five days after phase one, the researchers administered a prime-boost vaccination, with rAd26-S given on day 0 and rAd5-S on day 21.
To compare the immune response after vaccination with natural immunity, the researchers said they collected convalescent plasma from Covid-19 patients who have recovered.
No adverse effects
During the press conference Friday, researcher Inna Dolzhikova said they did not monitor any serious adverse effects.
“When the safety (of the vaccine) was researched, there was no serious adverse effect identified,” said in the same press conference.
This makes Sputnik V different from the over 100 other vaccine candidates, she added.
Aside from the greater immune response, Dolzhikova said they have also found that the vaccine worked even in those who have adenovirus immunity.
Adenoviruses cause fever, cough, sore throat, diarrhea, and pink eye.
Dolzhikova said the presence of pre-existing adenovirus immunity does not impact on the efficacy of Sputnik V.
“Our vaccine is based on the heterological approach of prime-boost immunization...This approach enables us to overcome the potential negative impact of pre-existing adenovirus immunity on the efficacy of our vaccine,” Dolzhikova added.
Gamaleya has launched phase three clinical trials involving 40,000 volunteers.
Gintsburg said the clinical trials will last for six months, during which researchers will double check the safety and immunogenicity as well as the epidemiological efficacy of the vaccine.
Vaccine production
Dmitriev said around 40 countries have expressed interest in locally producing the Sputnik V vaccine.
He said the RDIF was developing partnerships with other countries to allow technology transfer and local production of the vaccine since Russia would be focused on mass producing the vaccine for its domestic market.
In India, which produces around 60 percent of the global vaccine supply, Dmitriev said they were engaged in a “very close dialogue with the corresponding ministries and leading manufacturers”.
“And we have achieved certain agreements with the leading companies and we do recognize India and its potential to become one of the hubs for the production of vaccine indeed not just for the Indian market, but also for other countries,” he said.
Earlier, Russian Federation Ambassador to the Philippines Igor Khovaev said the Philippines could also become a regional hub for the production of the vaccine and a potential supplier to other countries.
Read: Russia’s envoy to PH: Vaccine may be produced locally
Khovaev said technology transfer from Gamaleya to manufacturers in the Philippines will open up new horizons for bilateral economic and scientific cooperation.
He also said Russian and Filipino experts have started exchanging opinions on the technical aspects of conducting phase three clinical trials in the Philippines. (Marites Villamor-Ilano/SunStar Philippines)