Russian COVID-19 vaccine 'Sputnik V' trial results show strong immune response: Study

Preliminary results from two early-phase non-randomised trials of the Russian vaccine candidate, Sputnik V, showed no major side effects over 42 days and induce antibody responses within 21 days, said the study published in The Lancet. The leading peer-reviewed medical journal said that the doctors conducted trials for the two-part vaccine which contains a recombinant adenovirus type 26 (rAd26) vector and a recombinant adenovirus type 5 (rAd5) vector.

The primary outcome measures for the trials were safety and immunogenicity of the potential COVID-19 vaccine and the secondary outcome measures were antigen-specific cellular immunity, also known as T-cell responses, and change in neutralising antibodies. The researchers performed two open, non-randomised phase 1/2 studies at two hospitals in Russia and enrolled healthy adult volunteers aged 18–60 years to both studies. 

“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.

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Secondary outcomes from the trial suggested that the vaccines also produce a T cell and neutralising antibody response within 28 days. However, the authors stressed that 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.

World’s first clinically approved COVID-19 vaccine

The world’s first clinically approved vaccine against the novel coronavirus has been manufactured by the Gamaleya Research Institute in collaboration with the Russian Health Ministry. Last month, Russian Health Minister Mikhail Murashko told the meeting that it is one of the first registered vaccines in the world to prove its effectiveness and safety.

The United States has been sceptical over the Russian vaccine and US Health Secretary Alex Azar told a news conference that it is more essential to have a safe and effective COVID-19 vaccine than acing the race. Murashko said that foreign colleagues are sensing the specific competitive advantages of the Russian drug and are trying to express “groundless” doubts.

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