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Outside Analysis Sees Promise, Few Risks in Russian Vaccine

The Lancet publishes data showing antibodies were generated with mostly mild side effects
By Bob Cronin,  Newser Staff
Posted Sep 4, 2020 3:35 PM CDT

(Newser) – Experts have been skeptical about Russia's quick approval of a COVID-19 vaccine, but a bit of early validation has arrived. The Lancet published data Friday indicating that subjects given the vaccine developed antibodies to the coronavirus in phases 1 and 2 of testing. Antibody levels were at least what would be found in patients who'd recovered from the disease naturally, CNN reports. "The immune response that the volunteers have from this vaccine is sufficient to counteract any infectious dose of COVID-19 imaginable," the director of Russia's Gamaleya institute said Friday. Phase 3 results are needed next. Those trials, involving about 40,000 people, have begun, per the Wall Street Journal, and at least some results could be reported next month. Assuming all goes well, mass vaccinations are expected to begin before the end of the year.

The reports on side effects in the first two phases were encouraging. "Most adverse events were mild," the medical journal said. Half of the people in the study had fevers, and 42% dealt with headaches. Fewer than 30% had weakness or joint pain. "Safety outcomes up to now are reassuring," a Johns Hopkins expert said, "but studies to date are too small to address less common or rare serious adverse events." In the Lancet, Russian scientists conceded the limitations of the early efforts: a low number of study participants, the lack of placebo or control vaccine, and a generally young group of volunteers. "Further investigation is needed of the effectiveness of this vaccine for prevention of COVID-19," they said. (The CDC also is planning for a vaccine soon.)

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