European Medicines Agency approved third dose of Pfizer vaccine for people over 18

The European Medicines Agency (EMA) on Monday approved a third booster dose of vaccine against the Pfizer / BioNTech coronavirus for people over 18, with fears that protection will wane after the first two injections.

“Booster doses of Comirnaty may be considered for people 18 years of age and over, at least six months after the second dose“the EMA said in a statement, citing Pfizer’s trade name for the vaccine.

The agency also said it was supporting the administration of a third dose of the Pfizer-BioNTech or Moderna vaccine to people with severely weakened immune systems, at least 28 days after the second injection.

The recommendations are addressed to the health authorities of the 27 EU Member States. Some countries have already started giving booster shots.

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 various factors, such as the progress of the vaccination campaign and the availability doses.

However, the EMA noted that “the risk of inflammatory heart disease is not known or other very rare side effects after a booster dose and is being closely monitored, “something the agency will continue to monitor as part of its oversight of the safety and effectiveness of vaccines and drugs.

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

On the other hand, the recommendation for an additional dose in people with severely weakened immune systems comes after the CHMP reviewed studies showing that a third dose of mRNA vaccines “Increased ability to produce antibodies against the coronavirus in organ transplant patients ”.

While there is no direct evidence that the ability to produce antibodies in these patients protects against COVID-19, the extra dose is expected to increase protection in at least some patients, the agency added.

With information from the AFP and EFE agency