Russia’s vaccine is safe, according to study

Scientists impressed by immune response in trials but say it is far too soon to be granted a licence

Russia’s “fast-track” Covid-19 vaccine is safe and produces two forms of immune response against the virus, according to a study in The Lancet. The findings appear to justify some of the claims made early last month by President Vladimir Putin, and follow weeks of demands for transparency from the scientific community. But the study of two early-phase trials reveals that the drug has so far only been tested on a total of 76 people − and not by the most rigorous of methods.

RUSSIA’S “fast-track” Covid-19 vaccine is safe and produces two forms of immune response against the virus, according to a study published in The Lancet medical journal.

The findings appear to justify some of the claims made last month by Vladimir Putin, the Russian president, and follow weeks of demands for transparency from the international scientific community.

However, the study of two earlyphase trials discloses that the drug has so far only been tested on a total of 76 people − and not by the most rigorous of methods.

This means it will need to progress to a much larger “phase three” trial, involving thousands of participants, before experts can know how well it works.

British scientists last night called on Moscow’s Gamaleya Centre, where the vaccine is being developed, to resist political pressure to release doses to the general public before all the results are known. Nevertheless, they welcomed data suggesting that the “Sputnik V’ candidate stimulates an antibody and T-cell response.

Antibodies have been the focus of many of the prominent vaccine candidates, but virologists have always warned that coronavirus antibodies may only last a matter of months and that there is no guarantee they prevent infection.

Far less is known about T-cells, but there is some emerging evidence to suggest they do provide good protection and last far longer.

The Russian vaccine is behind other candidates including the jab developed by researchers at Oxford University who are already conducting international phase three trials.

Lasting 42 days, one part of the Gamaleya trial studied a frozen formulation of the vaccine − envisaged for large-scale use − while the other analysed a freeze-dried formulation intended for hard-to-reach regions as it is more stable.

The drug was judged to have a good safety profile at 42 days. Mild sideeffects included pain at the injection site, a high temperature and headaches − findings that appear to correspond with President Putin’s account of one of his daughters trying the vaccine.

“After the first injection her temperature was 38C, the next day 37.5C, and that was it. After the second injection her temperature went up slightly, then back to normal,” he told a press conference in August.

Yesterday, independent experts said results were weakened by the fact the trial was both open-label and non-randomised, meaning participants knew they were getting a vaccine, raising the chance of a placebo effect.

Lead author Dr Denis Logunov, of the Gamaleya Centre, explained that when adenovirus vaccines enter cells, they deliver the Sars-cov-2 spike protein genetic code.

“This helps teach the immune system to recognise and attack the Sarscov-2 virus,” he said. “To form a powerful immune response against Sars-cov-2, it is important that a booster vaccination is provided.”

Dr Michael Head, of the University of Southampton, said the jab “appears to be a promising vaccine candidate” but public confidence in the quality of any new vaccine was “vital”.

He said: “Phase one and phase two trials have been carried out, and there is sufficient reason to scale up into much larger phase three trials.”

He added: “Concerns do remain around some of the previously made ambiguous comments that this vaccine is about to be formally approved and licensed.

“At this stage, we do not know if the vaccine actually works – that is what the phase three trials will tell us.”