EU's top drug regulator endorses approval for Novavax COVID-19 vaccine

Dec. 20 (UPI) -- The European Union's top drug regulator on Monday recommended approval for Novavax's COVID-19 vaccine, which has so far seen limited authorization worldwide in favor of other coronavirus vaccines from companies like Pfizer and Moderna.

The European Medicines Agency issued its official recommendation for the vaccine developed by Maryland-based Novavax and the Serum Institute of India for use in the European Union.

The EMA recommendation came two days after the World Health Organization granted emergency authorization for the vaccine in low-income countries. Indonesia, the fourth most-populated country in the world, was the first country to approve the vaccine for emergency use last month.

The EMA recommended approval for adults over the age of 18, citing recent trials conducted in Mexico, the United States and Britain.

The Mexico-U.S. study, published in the New England Journal of Medicine, showed the vaccine had a 90.4% efficacy in reducing symptomatic COVID-19 cases. The British study, also published in the journal, showed an efficacy of 89.7%.

The EMA noted Monday that both studies were done when only the Alpha and Beta coronavirus variants were dominant and that there's limited data for how Novavax's vaccine behaves against the more transmissible Delta and Omicron variants.

The Novavax vaccine is the fifth vaccine to receive EMA authorization, after those from Pfizer, Moderna, AstraZeneca and Johnson & Johnson. If approved, it would be the first protein-based COVID-19 vaccine in the EU, the company said in a statement.

The Novavax vaccine, which was the ninth to be approved by the WHO, is expected to make up a large chunk of the world's vaccine supply because of its ability to be stored and shipped at normal refrigeration temperatures.

"This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10%of their populations, while 98 countries have not reached 40%," Dr. Mariangela Simao, WHO assistant director general for access to medicines, said in a statement.