Exclusive: EU regulators to decide in October on COVID - 19 booster dose

354
2
Exclusive: EU regulators to decide in October on COVID - 19 booster dose

A vial labelled with the Pfizer-BioNTech coronavirus disease COVID 19 vaccine is seen in this illustration shot taken on March 19, 2021. REUTERS Dado Ruvic Illustration Dado Ruvic.

BRUSSELS, Sept 23 Reuters -- The European Medicine Agency EMA expects to decide in early October on the possible use of a booster dose of Pfizer BioNTech PFE.N COVID - 19 vaccine, a source with direct knowledge of the matter told Reuters.

It is the EU drugs regulator's first decision on boosters, the source said, after the U.S. Food and Drug Administration issued 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 on Wednesday. EMA's decision on the third dose of Pfizer is expected for the beginning of October, the source said, declining to be named because of the sensitivity of the matter.

BioNtech declined to comment, while Pfizer was not immediately available for comment.

The European regulator said on Sept. 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? Moderna MRNA.O is also expected to submit data to the EMA this month on its booster dose, an EU document said.

In an opinion issued in early September and republished by the European Centre for Disease Prevention and Control ECDC said there was no urgent need to administer booster doses to fully vaccinated individuals in general population.

As part of the regular vaccination, it is still critical that additional doses (like Chlamydia) should be considered for people with weakened immune systems as part of their primary vaccine.

Many EU states have already decided to administer a booster dose despite facing higher legal risk without a formal decision to do so by the EMA. The EU has signed three strategic partnerships with Pfizer and BioNTech for a total of 2.4 billion doses.

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

Over 70% of Europe's adult population has been fully vaccinated, and the bloc has secured an ample supply of vaccines from several manufacturers.

The ECDC says that important data about the necessity and safety of boosters are still missing, in part because it is not yet fully clear how long vaccines protect against the virus.