The Buzz | Novavax asks EU drug regulator to OK its COVID vaccine

The European Union’s drug regulator said it received an application from Novavax to authorize the American biotechnology company’s coronavirus vaccine, a request that could significantly boost the continent’s vaccine supplies if it’s granted.
In a statement yesterday [Macau time], the European Medicines Agency said it had begun evaluating data submitted by Novavax for its two-dose vaccine. An expedited review process could produce a decision within weeks “if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the vaccine,” the agency said.
Novavax’s COVID-19 vaccine is made using a different technology than others currently on the market, including those made by AstraZeneca and Johnson & Johnson, and the messenger RNA vaccines produced by Moderna and Pfizer-BioNTech.
Novavax’s shot is made with lab-grown copies of the spike protein that coats the coronavirus, which then trigger an immune response.
In June, Maryland-based Novavax announced the vaccine had proven about 90% effective against symptomatic COVID-19 in a study of nearly 30,000 people in the United States and Mexico. It also worked against variants circulating in those countries at the time, the company said.

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