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According to the communication of the EMA Based on the initial results of laboratory tests and clinical trials, the EU agency decided to launch a continuous review procedure.
The launch of the study means that the test data and results will be evaluated by the agency before a formal application for marketing authorization is submitted, shortening the process, they said.
Novavax has not yet submitted a formal marketing authorization application to the EMA. Marketing of the vaccine in the European Union must be formally authorized by the European Commission with a positive recommendation from the EMA based on the results of the post-submission study.
The European Commission concluded discussions with Novavax in mid-December regarding the acquisition of a possible coronavirus vaccine. the planned contract would allow the European Union to buy 100 million doses or even 100 million additional doses of vaccine.
According to a statement issued by the American company at the end of January, the vaccine could be 95.6 percent effective against the original coronavirus and 85.6 percent against the new British variant.
Based on the company’s calculation methodology, the efficacy of the Novavax vaccine for the overall study group was 89.3 percent. However, the Novavax vaccine has been reported to be less effective against the South African version of the virus.
So far, the Pfizer / BioNTech, Moderna and AstraZeneca vaccines are available in all 27 member states of the European Union.
The Sputnik V developers applied for the European vaccine registration on January 20, and the phase-out process for the first Russian vaccine against Covid-19 could begin in February.
Cover Image Source: Sarah Silbiger / Bloomberg via Getty Images
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