Continental green light for the Pfizer-BioNTech “booster”. The European Medicines Agency (EMA) approved, Monday, October 4, the administration, for those over 18, of a third dose of the vaccine developed by the alliance between the American giant and German biotech. “Booster doses of Comirnaty [le nom commercial du produit] may be considered for people aged 18 and over at least six months after the second dose ‘, estimates the European regulator in a press release. He specifies that the data at his disposal show an increase in the level of antibodies in 18-55 year olds when this booster dose is inoculated within this period.
In fact, these data, provided by the manufacturer, “Remain fairly summary”, specifies Jean-Daniel Lelièvre, head of the clinical immunology service at Henri-Mondor hospital and expert with the High Authority for Health (HAS). “On the other hand, the AEM has Israeli data on the general population”, he continues. These have indeed demonstrated the significant increase in the concentration of neutralizing antibodies after the booster. But above all, they observed a gradual decline over time in vaccine efficacy. In addition, the appearance of the Delta variant slightly attenuated the observed level of protection.
These are all elements that prompted the AEM to issue its authorization. The European regulator stresses that, while it has data on effectiveness, it is lacking for safety. Here again, the Israeli example, as well as the first reminders already made in the United States and in France, seems reassuring. Corn “The risk of inflammatory heart disease or other very rare side effects after a booster is not known and is carefully monitored”, reports the press release. The AEM specifies that it will soon decide on the Moderna vaccine, ” being evaluated “.
Generalize 3e dose or find a middle route?
With this announcement, it is now up to the public health authorities of the member countries to decide. In France, the HAS should issue a new opinion on Wednesday October 6. In August, she had already voted in favor of the administration of a third dose to people over 65 years of age as well as to people with severe co-morbidities. “An opinion which was conditional on obtaining an authorization from the AEM”, we specify. The health ministry had chosen not to wait and to launch the recall campaign.
So what will the announcement of the AEM, which is equivalent to an extension of the marketing authorization, change? On the one hand, it makes it possible to put the vaccination campaign more strictly in the regulatory nails. But it will also give HAS the opportunity to say whether it is appropriate to extend the recommendation. Since the European Medicines Agency does not restrict the use of a third dose, should it be generalized to all adults? Should we stick to the first indication, namely the people most at risk, especially those over 65? Or should we find a middle way, for example by offering the recall to health personnel, particularly exposed to the virus, and to those around the immunodeficient people, in this strategy called “cocooning”? The technical committee on vaccination, first, then the HAS college should decide on Tuesday.
You have 24.8% of this article left to read. The rest is for subscribers only.