The European Union’s drugs watchdog said on Thursday it plans to decide in early October whether or not to approve Pfizer / BioNTech COVID-19 vaccine recalls for those over 16.
A decision on further injections of the Pfizer and Moderna vaccines for those at risk and the elderly is expected at the same time, the European Medicines Agency (EMA) said.
Protection against the coronavirus is expected to wane in the months following the first jabs, Marco Cavaleri, head of vaccine strategy for the Amsterdam-based regulator, told a press conference.
“The available data shows that immunity to COVID-19 from the initial vaccination wanes over time, and that protection against infections and symptomatic illnesses wanes in different parts of the world,” Cavaleri said.
As a result, the EMA is currently evaluating Pfizer’s application for the use of a third booster dose at least six months after the second dose in people 16 years of age or older.
“The result of this assessment is expected in early October, unless further information is needed,” Cavaleri said.
The EMA expert also said that “the evidence is becoming clearer” on the need for boosters soon after the first vaccines for people with weakened immune systems who “respond poorly” to the initial vaccination.
Hospitalization rates among the elderly were starting to increase as the initial blows wore off, Cavaleri said.
The watchdog “will review by early October whether a specific recommendation can be included in the product information” for Moderna and Pfizer vaccines for these people, Cavaleri said.
Some EU countries were starting to give reminders to those at risk ahead of a possible winter peak in Covid cases before clearance, Cavaleri said.
The EMA “recognized and understood” this decision, he added.
The watchdog, meanwhile, expects to make decisions on approving Covid vaccines for young children in the coming months.
Pfizer is due to submit trial data for children ages 5 to 11 in early October and Moderna in November, with decisions likely four weeks later in each case, Cavaleri said.
The regulator has currently approved four vaccines for use in the EU27: Pfizer and Moderna, which use messenger RNA technology, and AstraZeneca and Johnson & Johnson, which use viral vector technology.
Only Pfizer and Moderna have so far been approved for use in children 12 years of age and older.
(Except for the title, this story was not edited by DAILYNEWSCATCH staff and is posted from a syndicated feed.)