European regulators evaluating whether to recommend COVID-19 boosters

The European Union’s drug regulator has begun evaluating whether to recommend COVID-19 booster shots.

In a statement Monday, the European Medicines Agency (EMA) said it has been evaluating the use of a booster dose for Pfizer and BioNTech’s two-dose coronavirus vaccine, named Comirnaty, to be given six months after the second dose in people aged 16 and older.

The agency’s human medicines committee (CHMP) will carry out an accelerated assessment of data on the vaccine, which should be concluded “within the next few weeks.”

The evaluation will include data from an ongoing trial of 300 adults with healthy immune systems who received a booster dose roughly six months after the second dose. 

The EMA said it was separately assessing data from the literature for the use of the third dose of an mRNA vaccine— including vaccines from Pfizer and Moderna—in severely immunocompromised people. 

The issue of booster shots has become a concern amid concerns about the rapidly spreading delta variant.

The EMA released a joint statement with the European Center for Disease Prevention and Control (ECDC) last Thursday, in which the agencies say there is “no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population.”

However, it said additional doses should be considered for people with severely weakened immune systems.

Pfizer has filed for approval from the U.S. Food and Drug Administration (FDA) for the third dose of its vaccine.

Anthony Fauci, the nation’s top infectious disease expert, told CBS’s “Face the Nation” on Sunday that the third dose will likely be approved by Sept. 20, when the Biden administration plans to roll out booster shots for most fully-vaccinated Americans.

The World Health Organization has called for a moratorium on booster shots, saying that officials should prioritize inoculating those who are currently unvaccinated.