EU reviewing data on Moderna’s COVID-19 booster shot By Reuters
(Reuters) -The European Union’s (EU) drug regulator said on Monday it was evaluating whether a booster dose of Moderna (NASDAQ:)’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.
After announcing last week it would decide whether it will endorse a booster dose of Pfizer BioNTech vaccine in October, almost a month ago, the European Medicines Agency’s (EMA) review is now complete.
Although European authorities have not yet approved booster doses of coronavirus vaccines, unlike the U.S counterparts, they may be forced to do so due to rising infections and other factors.
The EU regulator stated that although EMA and ECDC do not believe the public needs for COVID-19 booster vaccine doses are urgent, EMA was evaluating the application and determining if additional evidence could be provided.
Spikevax has submitted the application to the U.S.-based firm for Moderna vaccination. It also includes the results of an ongoing clinical trial.
Many EU nations have chosen to give a booster dose despite the higher legal risk. There is not yet an official approval from the EMA. However, the regulatory body believes the decision has merits.
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