Russia has not even managed to quell the suspicion of the rest of the world about Sputnik V, the first vaccine against Covid-19 to be registered in the world, and has now announced another one. Without any detour, Vladimir Putin announced this week the approval of the second vaccine approved in the country without going through conventional procedures to assess safety and efficiency.
Called EpiVacCorona, the vaccine was developed by the Vector Institute, which was a research laboratory for biological weapons in the former Soviet Union. It uses Sars-Cov-2 synthetic peptides to generate the body’s immune response.
In May, the Russian news agency Tass announced that the institute would begin clinical trials (with humans) only in June, which is not enough to conduct all three crucial stages of testing a vaccine. And, in fact, Putin says the vaccine was tested “successfully” on 100 people, which is a small sample of tests to confirm safety or effectiveness. In August, it was also reported that no relevant side effects were detected among the participants.
Russian health authorities are still analyzing the safety and quality of EpiVacCorona, but have not yet given details about the results or the assessment.
A phase 3 trial requires tens of thousands of participants with a placebo group, which allows for a clear comparison of results. The wide base of people allows us to understand well how the vaccine works in different groups, observing age, gender, ethnicity, in addition to identifying more serious and rare side effects that simply will not appear in small groups.
Precisely for this reason, even if the second Russian vaccine is really effective and safe, it will be very difficult to see it distributed outside the country, where there are stronger regulatory agencies, such as Anvisa. For international distribution, the presentation of phase 3 clinical tests is essential.
The situation is very similar to that of Sputnik V, which was approved without carrying out all the tests and without publishing any data, with tests carried out on only 76 people. After the disclosure, the scientific community questioned some apparently duplicate data, which could be indicative of fraud. After that, the researchers started phase 3 studies.
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