EU regulator to decide on Pfizer booster dose by start of October

The EU regulator has said it will decide on a Pfizer booster dose by the start of October.

The European Medicines Agency (EMA) will decide in early October on the possible use of a booster dose of the Pfizer-BioNTech COVID-19 vaccine, according to a report from Reuters. It will be the EMA’s first decision on boosters after the U.S. Food and Drug Administration on Wednesday, September 22, authorised a third dose of Pfizer for those 65 and older, all people at high risk of severe disease, and others who are regularly exposed to the virus. read more

The EU regulator issued a statement on September 6 that it had begun its evaluation of data submitted by Pfizer and BioNTech for a booster dose to be given six months after the second dose in people 16 years of age and older. The ECDC has said crucial data on the need and safety of boosters are still missing, in part because it is not yet fully clear how long vaccines protect against the virus.

The European Centre for Disease Prevention and Control (ECDC) said there was no urgent need to administer booster doses to fully vaccinated individuals in the general population. However, it did note that additional doses should already be considered for people with severely weakened immune systems as part of their primary vaccination.

Many EU states have already decided to administer a booster dose despite facing higher legal risks without a formal decision to do so by the EMA.  The EU signed three deals in 2021 with Pfizer and BioNTech for a total of 2.4 billion doses of their vaccines.

The latest contract covers the supply of at least 900 million shots, a large part of which is likely to be needed only if boosters are considered necessary, or if new virus variants emerge against which existing vaccination is not effective.

Over 70% of the total EU’s adult population has already been fully vaccinated, with the bloc securing ample supplies of vaccines from several manufacturers.

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