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Europe’s regulatory agency on Thursday announced it started a rolling review of Russia’s Sputnik V coronavirus vaccine ahead of a submitted application.
The review was spurred by data from laboratory and clinical studies, which found the vaccine induced an immune response against the virus, which could help protect against disease, per a statement from the European Medicines Agency (EMA).
“EMA will evaluate data as they become available to decide if the benefits outweigh the risks,” the statement reads. “The rolling review will continue until enough evidence is available for formal marketing authorisation application.”
A Russian medical worker, right, administers a shot of Russia’s Sputnik V coronavirus vaccine to a patient in a vaccination center in Moscow, Russia, Wednesday, Jan. 20, 2021.
(AP Photo/Pavel Golovkin)
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The agency said it will review the candidate under the usual standards for safety, efficacy and quality. EMA has attributed rapid decisions for previous COVID-19 vaccines to its rolling review process, and again, expects an expedited decision once an application is submitted.
Meanwhile, a decision is pending for an application submitted by Johnson & Johnson for its single-dose coronavirus vaccine, which could come on March 11, per reports.
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A positive opinion from the agency is not final, it still requires approval from the European Commission. Vaccines developed by Pfizer, Moderna and Oxford-AstraZeneca have already been authorized for use in Europe.
Russia’s Sputnik V vaccine had a 91.6% efficacy against COVID-19 disease in a late-stage trial, according to interim results published in February. The results are in stark contrast to messaging from U.S. health officials, including Dr. Anthony Fauci, who sowed serious doubt over the jab after it was rolled out in Russia ahead of advanced studies on safety and efficacy.
The findings, published in The Lancet, drew from a double-blind trial across 25 sites in Moscow, and revealed a 91.6% efficacy against COVID-19 disease 21 days after the first dose, and 100% effectiveness against moderate-to-severe COVID-19 disease among some 19,800 adult participants.
“Our interim analysis of this phase 3 trial of Gam-COVID-Vac has shown promising results,” study authors wrote, later writing, “Our interim analysis of the randomised, controlled, phase 3 trial of Gam-COVID-Vac in Russia has shown high efficacy, immunogenicity, and a good tolerability profile in participants aged 18 years or older.”
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