The European Medicine Agency authorizes the administration of a repletion of the Pfizer vaccine, six months after the second injection. The High Health Authority should make a new review Wednesday.
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Continental green light for the “booster” of Pfizer-Biontech. The European Medicine Agency (AEM) approved, Monday, October 4, the administration, for over the age of 18, a third dose of the vaccine developed by the Alliance between the American giant and the German biotech. “Comirnaty’s recall doses [the trade name of the product] can be considered for people aged 18 and over at least six months after the second dose,” says the European regulator in a statement.
It says that the data it has shows show an increase in the level of antibodies in 18-55 years when this return dose is inoculated within that period.
In reality, this data, supplied by the manufacturer, “remain rather summary”, says Jean-Daniel Lelièvre, head of the clinical immunology department at Hénri-Mondor Hospital, Créteil, and expert with the high Health authority (HAS).
“On the other hand, the AEM has Israeli data in general population,” he continues. These have indeed highlighted the significant increase in neutralizing antibody concentration after recall. But above all, they found a gradual decline in time of vaccine efficiency. In addition, the appearance of the Delta variant has slightly attenuated the level of protection observed.
As many elements that pushed the AEM to deliver its authorization. The European regulator emphasizes that, if it has data on efficiency, it lacks for security.
Again, the Israeli example, as well as the first reminders already made in the United States and France, seems reassuring. But “the risk of inflammatory heart disease or other very rare side effects after a reminder is not known and is carefully monitored”, reports the statement. The EMA states that it will soon decide on the modern vaccine, “being evaluated”.
Generalize the third dose or find a median path?
With this announcement, it is now up to the public health authorities of the member countries to determine.
In France, the has should make, Wednesday, October 6, a new opinion. In August, she had already spoken in favor of the administration of a third dose for more than 65 people as well as people with severe comorbidities. “An opinion that was conditioned to obtain an AEM authorization,” says. The Ministry of Health had chosen not to wait and launch the reminder campaign.
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