Russia’s Sputnik V vaccine clears early trial test
LONDON: Russia’s Covid-19 vaccine candidate Sputnik V has shown antibody response and did not trigger serious side effects, according to the first peer-reviewed data for what is till now the only coronavirus vaccine to be approved anywhere in the world despite studies being only in early stages.
The study published in The Lancet corresponds to phase 1 and 2 trials of the vaccine, which was administered in two parts. The trial was a non-randomised study with 38 volunteers in each phase, and the vaccines were used in two formulations.
The authors said all participants produced antibodies and after 28 days, they detected T cell response which indicates the adaptive, and the more precise, component of the immune system also kicked into action.
The vaccine candidate uses two adenoviruses, recombinant human adenovirus type 26 (rAd26-S) and recombinant human adenovirus type 5 (rAd5-S), which have been modified to express the spike protein - the portion of the Sars-Cov-2 that latches on to human cells. Sars-CoV-2 causes Covid-19.
The authors noted that more research is needed to evaluate the vaccine in different populations, including older age groups, individuals with underlying medical conditions, and people in at-risk groups.
International experts remained cautious over the Rusand sian vaccine’s effectiveness and safety.
The paper reported the findings from two small phase 1/2 trials lasting 42 days - one studying a frozen formulation of the vaccine, and another involving a lyophilised (freeze-dried) formulation of the vaccine, which has been developed by the Gamaleya Institute.
Dr Ohid Yaqub, senior lecturer at the Science Policy Research Unit at the University of Sussex, said the limited study size was not enough for regulatory approval, which the vaccine received last month. “The design
size of (an early) study is not anywhere near sufficient for widely recognised standards of approval. The study was not randomised, and it was not large enough to detect rarer safety issues,” Yaqub said, according to AP.
The trials took place in two hospitals in Russia, involving healthy adults aged 18-60 years, who self-isolated as soon as they were registered for the trial and remained in hospital for the first 28 days of the trial, from when they were first vaccinated.
Sputnik V is among 34 vaccine candidates in human trials, a process in which the UK’s AZD1222, developed by Oxford University and AstraZeneca, and the United States’ Moderna-developed mRNA vaccine are leading at present.