Friday, January 21, 2022

EU Medicines Regulator Launches Review of New Coronavirus Vaccine

GAGA, Netherlands (AP) – The European Union regulator said Thursday that it has begun an ongoing review of a new coronavirus vaccine created by French start-up Valneva, a first step towards giving the vaccine the green light for use in 27 countries. EU.

The European Medicines Agency approval will add another vaccine to the EU’s COVID-19 arsenal as the unit ramps up its injections and some countries prepare to deliver Pfizer vaccines to children ages 5-11.

Last month, the EU’s executive commission approved a contract with Valneva for member states to purchase nearly 27 million doses in 2022. The contract also included the ability to adapt the vaccine to new variants of the coronavirus and purchase up to 33 million more doses in 2023.

The current review is a fast-track way of evaluating new drugs that allows European Medical Agency experts to review data from ongoing studies as they become available. Once sufficient data has been obtained, the company can then file a formal application for an EMA Marketing Authorization.

The Amsterdam-based agency did not provide a timeline for a possible approval of Valneva’s vaccine.

In September, the UK government canceled an agreement with Valneva, in part because it was clear that the company’s COVID-19 vaccine would not be approved by UK regulators, the UK Health Minister said.

The EMA is currently conducting regular reviews of four COVID-19 vaccines, including Russia’s Sputnik and China’s Sinovac.


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