EU drug agency to decide on COVID boosters in weeks

THE HAGUE, Netherlands — The EU’s drug watchdog said Thursday it expects to decide in early October whether to approve boosters of the Pfizer/BioNTech coronavirus vaccine for all people aged over 16.

A decision on further doses of both the Pfizer and Moderna vaccines for at-risk people and the elderly is due at the same time, the European Medicines Agency (EMA) said.

Protection against the disease is shown to decrease in the months following the first jabs, the Amsterdam-based regulator’s head of vaccine strategy Marco Cavaleri told a news conference.

“The available data are showing that immunity against COVID-19 from initial vaccination wanes over time, and the protection from infection and symptomatic disease is decreasing in different parts of the world,” Cavaleri said.

As a result, the EMA is now evaluating Pfizer’s application for the use of a third booster dose at least six months after the second dose in people aged 16 or older.

“The outcome of this evaluation is expected in early October unless supplementary information is needed,” Cavaleri said.

The announcement comes a week after the US Food and Drug Administration rejected Pfizer’s application to expand the booster program to the general population, instead recommending it only for older Americans and those considered high-risk.

Israel, which was the first country to offer the booster to everyone over the age of 12, had presented a study to the FDA showing that the effectiveness of the shot wanes after six months, though some have questioned some of Israel’s data.

Cavaleri said the “evidence was becoming clearer” on the need for boosters shortly after the first jabs for people with weakened immune systems who “respond poorly” to the initial vaccination.

The watchdog would “consider by early October if any specific recommendation can be included in product information” for the Moderna and Pfizer vaccines for such people, Cavaleri said.

“It is acknowledged and understood that some member states are already rolling out additional doses for these people,” he said.