EMA authorizes third dose of Pfizer for people over 18 years

The European Medicines Agency (EMA) approved a third booster dose of the Pfizer / BioNTech COVID vaccine for people over 18 years of age, out of concern that protection will decline after the first two injections.

“Comirnaty booster doses can be considered for people 18 years of age and older, at least six months after the second dose,” the EMA said in a statement, citing the brand name of the Pfizer vaccine.

For the booster dose, which is intended for the general population with a healthy immune system, the Committee for Human Medicines (CHMP) has evaluated the data presented by Pfizer / BioNTech, which show an increase in antibody levels when a third dose about six months after the second dose in people 18 to 55 years old.

The EMA recalls that it is the public health organizations at the national level that will make the official recommendation on the use of this third dose of Pfizer depending on different factors, such as the progress of the vaccination campaign and the availability of doses.

It also noted that “the risk of inflammatory heart disease or other very rare side effects after a booster dose is not known and is being carefully monitored,” something the agency will continue to monitor as part of its monitoring of the safety and efficacy of vaccines and medications.

The EMA is currently evaluating data to support a general population booster dose with Moderna’s vaccine (Spikevax, as a trade name), and has no date to report its conclusions.