As more countries move to offer a third dose of the vaccine, Europe’s medicines regulator said Monday it has started an expedited evaluation of whether it should recommend booster shots in the region, a decision it said could come “within the next few weeks.”
The European Medicines Agency (EMA) said in a statement posted to its website that it has started “evaluating” an application for booster shot approval sent in by vaccine maker Pfizer.
The “accelerated assessment” will look at whether the shot is necessary “to restore protection after it has waned” about six months after vaccination for people 16 years and older.
To make this decision, regulators will look at the results from an ongoing trial in which roughly 300 adults with health immune systems received a booster shot.
The EMA also said it is “separately” assessing data on the use of an additional dose of mRNA vaccines for people with weak immune systems, though it did not specify a timeline for that decision.
The regulatory agency highlighted that it does “not consider the need for Covid-19 vaccine booster doses to be urgent in the general population,” but is “evaluating the present application to ensure evidence is available to support further doses as necessary.”
A growing number of countries, including the U.S., have moved to approve and supply Covid-19 booster shots following evidence suggesting the protection of vaccines wanes over time. Some studies have indicated vaccines become less effective at preventing infection months after inoculation, though they still remain highly protective against severe illness, hospitalization and death.
The World Health Organization (WHO) has criticized countries offering booster shots while other nations have barely started vaccinations. WHO Director-General Tedros Adhanom Ghebreyesus late last month called for a two-month moratorium on boosters, questioning the necessity of a third jab and highlighting the risk of “more potent” variants emerging in countries with “low vaccination coverage.”