Russia plans to announce the preliminary results of the Sputnik V vaccine test at the end of October, after the first six weeks of follow-up.
The global Covid-19 vaccine race is more exciting than ever as Russia has a high chance of becoming the first country to publish data on phase 3 vaccine trials.
With 5,000 volunteers injected with the Sputnik V test on 9/9, preliminary data could be released after October 21. The Russian National Investment Fund – a direct investor in the vaccine project – expects results to be released in October or November.
Alexander Gintsburg, head of the Gamaleya Institute where vaccines were developed, said Russia had made Sputnik V “at wartime speed”, but made sure not to go off any stage.
“People died as much as they did wartime,” Gintsburg said. “Our team has very strict vaccine production timelines, but we always follow the guidelines for testing the safety and efficacy of Sputnik V.”
On September 29, Gintsburg said no serious side effects were reported in the Sputnik V phase 3 trial. Only 15% of the volunteers had mild, predictable side effects after vaccination. . 25% received a placebo.
Gintsburg also defended its plan to register for early use of the vaccine, asserting it as the most ethical approach. “You have two options, you give people the chance to protect themselves, or let them play a bet on this deadly infectious disease.”
Russia targets Sputnik V to be 75% more effective than a placebo, exceeding the 50% threshold set by the US Food and Drug Administration (FDA).
With 40,000 volunteers, he stressed, the clinical trials will still be effective, ensuring important statistical data are produced, despite the low levels of nCoV infection in Moscow.
Russia’s plan to publish preliminary results after 42 days of testing is contested by the public’s interests. Many pharmaceutical companies announced that they will wait until there are enough cases and reliable data sources for analysis to make the announcement, instead of setting a specific date. They also argue that the larger sample clinical trial, comprising diverse groups of race, ethnicity, sex, age, and other factors, will produce more comprehensive results.
Meanwhile, Russia set a third-stage test quota according to age to ensure enough elderly people participate, not creating other special groups. Among the volunteers, 20% were over 50 years old.
The infection rate among the volunteers influenced the timing of the preliminary results publication intended by many pharmaceutical companies. A certain amount of Covid-19 infection needs to be reported before the first data can be shared.
Gintsburg said volunteers will be monitored 180 days after the last person is vaccinated. After 6 months, the group plans to review the final results, then publish the results in an international journal. Previously, the group’s first phase test results were published in The Lancet.
Parallel to the trial, Russia began vaccinating people “at high risk of nCoV infection” on September 8, a move that was deemed unusual in the vaccine race.
According to data from the Russian Ministry of Health, up to now, about 400 people have been vaccinated against Sputnik V. These people undergo medical check-ups with less rigor than volunteers,
Preliminary test results can help inform a decision whether or not to extend the mass immunization, starting with people over 60 years of age.
Le Hang (Follow Reuters)