Healthcare

EU approves Novavax COVID-19 vaccine

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A European Union agency on Monday granted conditional authorization for the COVID-19 vaccine made by Novavax, making it the fifth coronavirus vaccine to be authorized for use in the EU.

The two-dose immunization has been approved for use in the EU in people over the age of 18.

“After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality,” the European Medicines Agency (EMA) said.

According to the agency, clinical trials of more than 45,000 adults found that the Novavax COVID-19 vaccine was effective at preventing coronavirus infections. One study conducted in Mexico found a 90.4 percent reduction in symptomatic COVID-19 cases following injection. A second study conducted in the U.K. found that the vaccine had an efficacy rate of 89.7 percent.

When the studies were conducted, the alpha and beta strains of COVID-19 were the most prevalent, meaning it is unclear how effective the Novavax vaccine is against other variants of concerns like the delta and omicron strains.

Unlike the Moderna and Pfizer coronavirus vaccines, which inject mRNA to teach the immune system how to identify the COVID-19 virus, Novavax’s vaccine works by injecting a modified version of the spike proteins found on the surface of the virus. It also contains an “adjuvant” that enhances the efficacy and immune response of the shot.

Last month, Novavax’s vaccine received approval from a country for the first time when Indonesia’s National Agency of Drug and Food Control granted emergency approval for the shot. The Philippines soon followed in granting approval. Novavax has yet to apply for authorization in the U.S.

Novavax, which is based in the U.S., has said that it is working on developing a vaccine that will be effective against the omicron variant as well.

Tags Clinical trials COVID-19 vaccine COVID-19 vaccine clinical research European Medicines Agency European Union Novavax Novavax COVID-19 vaccine

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