EU regulator begins ‘continuous review’ of China’s Sinovac COVID-19 vaccine

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The European Medicines Agency said on Tuesday that it began an ongoing review of China’s Sinovac COVID-19 vaccine to assess its effectiveness and safety, the first step towards the possible authorization of the injection in the 27-member bloc. The EMA said the decision to initiate the review was based on preliminary results from clinical and laboratory studies suggesting that the vaccine triggers the production of antibodies that target the SARS-CoV-2 virus and may help protect against the disease that cause, COVID-19. . Preliminary data has yet to be published in a peer-reviewed medical journal.

“The EMA will evaluate the data as it becomes available to decide whether the benefits outweigh the risks. Ongoing review will continue until sufficient evidence is available for a formal application for marketing authorization, ”the agency said in a statement. Read: Denmark Says It Will Not Use J&J COVID-19 Vaccine Due To Blood Clotting Concerns The news comes a day after Denmark became the first country to exclude the COVID-19 vaccine developed by healthcare company Johnson & Johnson JNJ, + 0.54% of its immunization program, for blood clot problems. Last month, Denmark also permanently stopped using the vaccine developed by the Swedish-British pharmaceutical company AstraZeneca AZN, -1.51% AZN, -1.00%, citing similar concerns. The J&J vaccine is one of the four that have received emergency use authorization from the EMA, together with the vaccine jointly developed by the German biotechnology company BioNTech BNTX, -15.66% and the American pharmaceutical company Pfizer PFE, + 0.58% , the one developed by the American Modern biotechnology MRNA, -6.00%, and the one elaborated by AstraZeneca in collaboration with the University of Oxford. The agency is also conducting ongoing reviews of three other vaccines: that developed by German biotech CureVac CVAC, -9.58%, that of American vaccine developer Novavax NVAX, -10.11%, and ongoing reviews Sputnik V. from Russia are designed to speed up the approval process by allowing researchers to submit data in real time, until there is sufficient evidence to submit a formal application for marketing authorization. Read: BioNTech and Pfizer seek regulatory approval in Europe to extend vaccine authorization to 12-15 year olds The EMA did not provide a time frame for ongoing review of Sinovac, but said it “should take less time than normal evaluate … due to the work done during ongoing review. “The World Health Organization is expected to make a final decision on the emergency use listing requests for both Sinovac and the COVID-19 vaccine developed by Sinopharm 1099 from China, -4.31% by the end of this week. Read: Senior official admits that China’s COVID-19 vaccines have low effectiveness. Sinovac’s vaccine has shown efficacy rates between 50% and 90% in different studies, and currently It is licensed for use in China, Indonesia, Brazil, and Turkey Contains inactivated or killed versions of the SARS-CoV-2 virus to help the human body’s immune system produce antibodies.