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EU regulator begins review of Chinas Sinovac vaccine COVID-19




The European Medicines Agency said Tuesday that it has launched a review of the Chinas Sinovac COVID-19 vaccine to assess its effectiveness and safety, the first step towards a possible strike authorization in the 27-member bloc.

The EMA said the decision to start the review was based on preliminary results from laboratory and clinical studies suggesting that the vaccine induces the production of antibodies that target the SARS-CoV-2 virus and may help protect against the disease it causes, COVID-19. Preliminary data have not yet been 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. The review will continue until there is sufficient evidence 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 for him foreclose COVID-19 vaccine developed by healthcare company Johnson & Johnson JNJ,
+ 1.55%
from his immunization program, related to blood clotting concerns. Last month, Denmark also permanently banned the use of the vaccine developed by the Swedish drug company MB-AstraZeneca AZN,

citing similar concerns.

The J&J vaccine is one of four that have received emergency use authorization from the EMA, along with the goal jointly developed by German biotechnology BioNTech BNTX,
and the American drug company Pfizer PFE,
+ 0.30%,
developed by modern US MRNA biotechnology,
and that made by AstraZeneca in collaboration with Oxford University.

The agency is also conducting repeated reviews of three other vaccines: one developed by German biotechnology CureVac CVAC,
he from the American vaccine developer Novavax NVAX,
and the Russians Sputnik V.

Rotation reviews are designed to speed up the approval process by allowing researchers to submit real-time data, until there is sufficient evidence to file a formal marketing authorization request.

Read: BioNTech and Pfizer seek regulation in Europe to extend vaccine authorization to 12 to 15 year olds

The EMA did not provide a timeline for the Sinovacs flip review, but said it would take less than normal to assess due to work done during the flip review.

The World Health Organization is expected to make a final decision on the list of emergency uses by Sinovac and the COVID-19 vaccine developed by Chinas Sinopharm 1099,
by the end of this week.

Read: The senior official acknowledges that Chinas COVID-19 vaccines have low efficacy

The Sinovacs vaccine has shown efficacy rates between 50% and 90% in various studies and is currently authorized for use in China, Indonesia, Brazil and Turkey. It contains inactivated or dead versions of the SARS-CoV-2 virus to help the human body’s immune system produce antibodies.

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