HAS explains its “prudence position” by the marketing authorization procedure, which still concerns the vaccine on its use during the recall campaigns.
Le Monde
For the third dose of VVID-19 vaccine, the French health authorities have recommended, Friday, October 15, to use the Pfizer-Biontech vaccine and to wait for a review of the European Medicines Agency for the use of the Moderna vaccine.
The Reminder Campaign in France concerns over 65 years old, immunocompromised and their loved ones, people at risk, such as obese and diabetics, as well as caregivers. In each case, you have to have been vaccinated for at least six months. In its last opinion, which dates from October 6th, the High Authority of Health (HAS) recommended for this reminder the use of the Pfizer vaccine, without definitively dismissing the use of that of Moderna, which has not yet obtained from Marketing Authorization (AMM) for reminder.
“The announcements of various health authorities have highlighted the unknowns that remain on the target dose and population for the recall by Spikevax [Moderna vaccine] and justify waiting for the European authority to provide the expected details in the framework of the AMM under review “, Now writes the has in a communicated on Friday
” A position prudence “
In early October, the Scandinavian countries suspended vaccination with the product of Moderna for the youngest; In Iceland, for all adults. They announced that they would bring to the knowledge of the European Medicines Agency for a possible increased risk of myocarditis and pericarditis linked to the use of this vaccine. In any event, these diseases remain “rare and spontaneously resolving in almost all cases,” the HAS highlights.
“But this context, the currently moderate circulation of the virus and the ongoing work at the European Medicines Agency to define the target population [which age limit] and especially the dosage [whole or half dose] Drive the has to come back more strictly to a prudence position, “she says. It therefore recommends waiting for the opinion of the European Medicines Agency before continuing vaccination with Spikevax.
In contrast, in the United States, an expert committee recommended this week a return dose of the Moderna vaccine for certain population categories, one month after taking the same decision for the Pfizer-Biontech vaccine.