Russia to publish early test results of its Covid-19 vaccine Sputnik V
Russia plans to share 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 that produced the Sputnik V vaccine, said the pace of its development was necessary under the “wartime” conditions of a pandemic but that no corners had been 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 science and safety.
Gintsburg said his team had been set a tight 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 any data from a final-stage trial, known as Phase III.
The first batch of 5,000 volunteers was vaccinated on September 9. Russia’s sovereign wealth fund, which has invested in the vaccine’s rollout, said it expected interim results to be published in October or November.
Several Western developers are conducting final-stage trials that have already been going on for more than 42 days but have not published any interim results.
Gintsburg said there was a public interest argument for sharing interim results after 42 days as they would show the general trend in the data.
He said volunteers would be monitored for 180 days. Six months on, his team planned to tally up final results and then publish them in an international journal.
Their early-stage trial results were peer-reviewed and published in The Lancet.
Russia began inoculating members of the public considered at high risk on September 8, another unconventional move.
A government source said the interim Phase III trial results would likely inform a decision on whether to expand this mass inoculation drive, starting with people over 60.
Gintsburg said no serious side-effects had been reported during the Phase III trial so far, while minor, anticipated sideeffects had occurred among just 14% to 15% of the volunteers.
Other vaccine-makers have launched mass trials in countries such as Brazil, SA and the US. —