Novavax COVID-19 Vaccine Approved by European Regulator

After a series of delays, Novavax’s COVID-19 vaccine has been approved for 18-year-olds and older by the European Medicines Agency (EMA), and is now ready to be administered by European governments, Reuters reports. 

The approval could be a game changer for the continent, which is currently having to reckon with the highly infectious Omicron variant. It is hoped that Novavax’s protein-based, and thus more traditional, vaccine could persuade holdouts who worry about the current mRNA vaccine’s safety profile to get vaccinated. It would add a fifth vaccine to the EU’s arsenal, next to those of Pfizer-BioNTech, Moderna, AstraZeneca and Johnson & Johnson.

Two large studies indicate an efficacy of around 90%, but the EMA was quick to add that there was currently limited data on how it would fare against variants of concern, including Omicron. “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 regulator said.

The EU Commission did not hesitate for long and entered into a contract with Novavax, which said it will start shipping vaccines to the EU’s 27 member states in January. It guarantees a supply of up to 200 million doses. Member states have ordered around 27 million doses for the first quarter of 2022, enough to inoculate about 13.5 million people, the Commission said.