EU regulator evaluating if COVID vaccine booster is needed

The European Medicines Agency says it has started an expedited evaluation on whether to recommend use of a booster dose of the coronavirus vaccine made by Pfizer-BioNTech

AMSTERDAM -- The European Medicines Agency says it has started an expedited evaluation on whether to recommend a booster dose of the coronavirus vaccine made by Pfizer-BioNTech. In a statement Monday, the EU drug regulator says it is considering whether a third dose of the vaccine should be given six months after people 16 and older have received two doses, “to restore protection after it has waned.” EMA’s experts are carrying out an “accelerated assessment” of data submitted by Pfizer and BioNTech, including results from an ongoing trial in which about 300 healthy adults received a booster shot about six months after their second dose. Pfizer has already submitted an application to the U.S. Food and Drug Administer for authorization of a third dose and the U.S. government said last month boosters would likely be available in late September. Israel has already started administering booster doses and the plan is under consideration in other countries for vulnerable populations, including France and Germany.