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, told Reuters that the pace of its development was necessary under the “wartime” conditions of a pandemic but 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.
“People are dying just like during a war,” said Gintsburg, holding a crystal model of a coronavirus in his hand. “But this fast-tracked pace is not synonymous, as some media have suggested, with corners being cut. No way.”
PUBLIC INTEREST
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.
Drugmakers have said they would wait until they have enough infections to get a reliable read-out from the data before publication, rather than assigning a specific date.
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.
RUSSIAN ROULETTE
Gintsburg said no serious side-effects had been reported during the Phase III trial so far, while minor, anticipated side-effects had occurred among just 14% to 15% of the volunteers. A quarter of the participants receive a placebo.
Other vaccine-makers have launched mass trials in countries such as Brazil, South Africa and the United States, searching for places where the disease is still rife after the epidemic came down from its peak in Europe.Russia also plans to test in several countries, including Belarus, Brazil and India.
IMPOSSIBLE AND UNETHICAL
Drugmakers have also pledged to ensure their larger clinical trials include diverse sets of volunteers in terms of race, ethnicity, gender, age and other factors.
Russia is setting Phase III quotas by age to ensure a sufficient number of elderly participants, Gintsburg said, but no other special groups were being formed. Over a fifth of those vaccinated in the trial so far have been over 50, he said.
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