EMA begins assessment of Novavax vaccine

EMA begins assessment of Novavax vaccine
Credit: Belga

The European Medicines Agency (EMA) announced on Wednesday that it had started assessing an application for EU authorisation of the Covid vaccine from US pharmaceutical company Novavax, saying an opinion could be issued in “a few weeks”.

“EMA has started evaluating an application for conditional marketing authorisation for Novavax’s COVID-19 vaccine, Nuvaxovid (also known as NVX-CoV2373),” the EU regulator said in a statement.

“The assessment will proceed under an accelerated timeline, and an opinion on the marketing authorisation could be issued within weeks,” the EMA said.

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The vaccine, which could become the fifth licensed in the European Union, uses a different technology from vaccines already widely approved worldwide, Belga News Agency reports. It is a so-called ‘subunit vaccine,’ based on proteins that trigger an immune response without a virus. It can be stored at a temperature of between 2 and 8°C, facilitating its distribution.

The European Commission announced in August that it had entered into a contract with Novavax for the advance purchase of 200 million doses of its vaccine once the EMA approves it.  In early November, Indonesia became the first country to approve Novavax’s vaccine.


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