EU regulator starts reviewing Novavax COVID-19 vaccine
European Medicines Agency expected to deliver opinion within weeks on US-developed jab
By Agnes Szucs
BRUSSELS (AA) – The European Medicines Agency (EMA) started the authorization procedure for US biotechnological company Novavax’s COVID-19 vaccine, the EU regulator announced on Wednesday.
“EMA has started evaluating an application for conditional marketing authorization for Novavax’s COVID-19 vaccine, Nuvaxovid,” the EU agency wrote in a press statement.
Based on scientific data, the EMA will evaluate if the benefits of the jab outweigh its risks in protecting against COVID-19.
In case of a positive opinion, the European Commission, which has signed in August an advanced purchase agreement with the company, will grant the marketing authorization.
The EU regulator promised to deliver its assessment within weeks since it has already started to review the available information on the request of Novavax.
Nuvaxovid is a traditional vaccine that prepares the body’s immune system to defend against COVID-19 by using a tiny protein particle of the virus produced in a laboratory.
After vaccination, people start to produce antibodies and immune cells that can kill the virus.
Through its deal with Novavax, the EU secured in total 200 million vaccines to be delivered between 2021 and 2023.
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