EU reviewing data on Moderna's COVID-19 booster shot
Reuters
Published Sep 27, 2021 16:31
(Reuters) - The European Union's (EU) drug regulator said on Monday it was evaluating whether a booster dose of Moderna (NASDAQ:MRNA)'s COVID-19 vaccine could be given at least six months after the second shot of the two-dose course in people over 12 years of age.
The review by the European Medicines Agency (EMA) comes after its statement last week that it aims to decide in early October whether to endorse a booster for Pfizer-BioNTech vaccine, nearly a month after it started the evaluation process.
While European authorities have yet to approve any booster shots for coronavirus vaccines unlike their U.S. counterpart, surging cases and breakthrough infections may prompt them to take additional precautionary measures.
"Although EMA and ECDC (European Centre for Disease Prevention and Control) do not consider the need for COVID-19 vaccine booster doses to be urgent in the general population, EMA is evaluating the present application to ensure evidence is available to support further doses as necessary," the EU regulator said.
The application for the Moderna vaccine, called Spikevax, has been submitted by the U.S.-based company and includes results from an ongoing trial.
Many EU countries have decided to administer a booster dose despite facing higher legal risks as there is no formal approval from the EMA, a decision the regulator thinks has merits.
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Written By: Reuters
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