Russia Coronavirus Vaccine Is Safe And Induces Immune Response, Early Trials Suggest
Russia’s coronavirus vaccine is reportedly safe and induces an immune response, as per the results of preliminary trials.
Back in August, the Kremlin announced the vaccine for COVID-19 – known as Sputnik V – would go into mass production, despite international concern regarding the quickness at which it was produced.
It’s reported that the vaccine, developed by Moscow’s Gamaleya Research Institute, causes no major adverse effects and managed to induce antibodies in all participants in two early rounds of testing.
The results of the trials were published in medical journal The Lancet today, September 4. However, as reported by The Independent, experts not involved in the study said the ‘encouraging but small’ results didn’t fully prove the vaccine was safe or effective.
Russian President Vladimir Putin gave regulatory approval to Sputnik V on August 11, earlier claiming that shortened trials had ‘showed it was safe and formed long-term immunity’.
As per The Telegraph, Putin earlier described the vaccine as a ‘very important step for the world’, saying: ‘I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks.’
The Lancet’s results illustrate phase one and two of testing, which saw 76 volunteers – all healthy adults between the ages of 18 and 60 – take part, all of whom remained in hospital for 28 days after vaccination. Two variants of the vaccine were trialled: a frozen formulation designed for global-scale use and a freeze-dried alternative for more remote regions.
Within 21 days, Sputnik V reportedly induced an antibody response, with no adverse effects over the duration of 42 days. The vaccine also seemingly triggered a T cell response, beneficial in the long-term against the virus.
Dr Ohid Yaqub, senior lecturer at the University of Sussex’s Science Policy Research Unit, commented:
Normally, such a study would be the basis for debating whether to proceed into larger trials and the costs that entails. In that context, the study results are encouraging in terms of safety and possible efficacy.
However, in the context of regulatory approval, the design and size of a phase one/two 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.
Dr Naor Bar-Zeev, of Baltimore’s International Vaccine Access Centre, echoed concerns, writing in a piece published alongside the study: ‘The immunogenicity bodes well, although nothing can be inferred on immunogenicity in older age groups, and clinical efficacy for any COVID-19 vaccine has not yet been shown.’
He added: ‘Safety outcomes up to now are reassuring, but studies to date are too small to address less common or rare serious adverse events.’
Phase three of testing has already started, with around 40,000 volunteers set to be injected with the vaccine.
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CreditsThe Lancet and 2 others