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
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.
Several studies have showed that protection from authorized COVID-19 vaccines against the highly infectious delta variant drops months after people have been immunized, but the shots still offer strong protection against severe disease, hospitalization and death.
The Amsterdam-based EMA said it expects to make a decision about whether or not to recommend a third dose of the Pfizer vaccine in the next few weeks.
It said it was also reviewing the use of a third dose of the COVID-19 vaccines made by Pfizer-BioNTech and Moderna in people with weak immune systems. It said those people might need an extra dose “as part of their primary vaccination” programs.
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