Russian scientist behind Covid-19 vaccine defends 'wartime' roll-out

Moscow

RUSSIA plans to share the preliminary results of its Covid-19 vaccine trial, based on the first six weeks of monitoring participants, raising the tempo in an already-frenzied global race to end the pandemic.

Alexander Gintsburg, head of the Gamaleya Institute behind the Sputnik V vaccine, said the pace of its development was necessary under the "wartime" conditions of a pandemic, but that no corners were being cut.

Russia has pushed ahead with its potential Covid-19 vaccine at top speed with mass public vaccinations alongside the main human trial, raising concerns among some observers that it was prioritising national prestige over solid science and safety.

Mr Gintsburg said: "People are dying just like during a war. But this fast-tracked pace is not synonymous, as some media have suggested, with corners being cut. No way."

He said his team had been set a deadline to produce a vaccine, but all the guidelines for testing Sputnik V's safety and efficacy had been followed. The plan to publish interim results based on the first 42 days of monitoring volunteers means Russia has a high chance of becoming the first worldwide to announce data from a final-stage trial, known as Phase III.

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The first of 5,000 volunteers were vaccinated on Sept 9. Russia's sovereign wealth fund, which invested in the vaccine's roll-out, has said it expects interim results to be out in October or November.

Several Western developers are conducting final-stage trials, but have not published any interim results. They have said they would wait until they have enough infections to get a reliable read-out from the data before publication.

Mr Gintsburg said there was a public interest argument for sharing interim results after 42 days as the data would show a general trend.

He said volunteers would be monitored for 180 days after the last of 40,000 participants was vaccinated.

In parallel with the trial, Russia began inoculating members of the general public considered at high risk on Sept 8, in another unconventional move by Moscow. There are about 400 people in this sample. They undergo a less rigorous medical exam than trial volunteers, though they can submit data on their health following inoculation via an online platform.

A government source said that the interim Phase III trial results would likely inform a decision on whether to expand this mass inoculation drive, starting with those over 60.

Mr Gintsburg said no serious side-effects had been reported during the Phase III trial so far, while minor, anticipated side-effects had occurred among 14 to 15 per cent of the volunteers. A quarter of the participants receive a placebo.

He also defended the vaccine's early registration for public use, saying it was the most ethical approach.

"The choice was between giving people the opportunity to protect themselves, or letting them play roulette with this deadly infection." He also said Russia was aiming for the vaccine to be about 75 per cent more effective than a placebo, which is above the 50 per cent threshold for Covid-19 vaccines set by the US Food and Drug Administration.

Mr Gintsburg said having 40,000 trial participants meant the trial would be effective, even with low levels of Covid-19 transmission in the Russian capital.

Moscow registered 642 new cases of Covid-19 the day the trial began. The infection rate has risen since, with 2,217 new cases on Monday, though that is still well below a peak of around 6,000 daily infections in the capital in early May.

Other vaccine-makers have launched mass trials in countries such as Brazil, South Africa and the United States; they are interested in places where the disease is still rife after the epidemic came down from its peak in Europe.

Drug-makers have also pledged to ensure that their larger clinical trials include diverse sets of volunteers in terms of race, ethnicity, gender, age and other factors.

British drugmaker AstraZeneca launched a Phase III trial for its vaccine in May and has not yet disclosed any trends; US pharmaceutical giant Pfizer, which is developing a vaccine with German partner BioNTech, and US vaccine maker Moderna both began trials in late July. Neither has made preliminary disclosures yet. REUTERS