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

The European Medicines Agency approved Monday a third booster dose COVID vaccine Pfizer / BioNTech for people over 18, because of the fear that protection will decrease after the first injections.

“Booster doses of Comirnaty can be considered for people 18 years of age or older, at least six months after the second doseThe European Medicines Agency said in a statement, referring to Pfizer’s brand of vaccine. The statement added that Moderna’s booster dose is still being evaluated.

In exchange, for immunocompromised people, like organ transplant recipients, who have shown an insufficient initial immune response to vaccines to protect them from COVID, the Committee concluded that an additional dose of Pfizer or Moderna can be applied at least 28 days after the second dose.

“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 EMA will continue to monitor any information on its effectiveness, ”the statement said.

Experts from the Committee for Medicinal Products for Human Use (CHMP) meet at the agency’s headquarters in Amsterdam to discuss available information, including clinical data shared by pharmaceutical companies, to understand the protection offered by mRNA vaccines (Pfizer and Moderna) and its reduction over time, also depending on the results of vaccination campaigns.

The EMA announced on September 23 that it planned to rule on the need for a booster of the Pfizer vaccine in people over 16 years of age “in early October”, following an accelerated assessment of the data presented, including including the results of an ongoing clinical trial in which approximately 300 adults with healthy immune systems received a third dose six months after the recommended regimen.

On the 27th, he received a request from Moderna asking the CHMP to evaluate his data to authorize a booster dose of his Spikevax vaccine, which would be given at least six months after the second dose in people over 12 years old, although It’s not clear whether the EMA will also announce its findings on Moderna’s vaccine today.

Marco Cavalieri, head of vaccine strategy at the EMA, already recognized two weeks ago that “the evidence is increasingly clear on the need to consider additional doses for people likely to respond poorly to the vaccine” because a third injection is “able to increase the response” and protection against disease caused by SARS-CoV-2.

However, he warned that the EMA “is strictly following the route” of “not rushing to give booster doses if there is no clear indication that they are needed” and for the regulator. European Union, it is “important” to always base your decision on “scientific evidence and without any pressure”.

Although he planned to make an official recommendation on the third dose on Monday, The EMA supported the European Center for Disease Prevention and Control (ECDC) more than a month ago, in which an ‘extra dose’ should be injected in immunocompromised people, but ‘did not consider the need of a booster dose as urgent ”. the general population.

The EMA offers advice to member countries, but it remains the prerogative of the technical advisory groups in each country in the European Union to decide how the covid-19 vaccines should be administered, and the EMA urged to “consider preparatory plans to administer a booster and additional doses” if necessary.

As for the Janssen single-dose vaccine, the agency expects the pharmaceutical company, a subsidiary of the American Johnson & Johnson, to transmit information from the clinical trials it has conducted on a second dose, administered two months after the first , to “understand if a recommendation can be made” in this regard, but there is still no date for its conclusions.

(With information from AFP and EFE)

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