Suspended for 10 days for booster doses in France, will the Moderna vaccine come back anytime soon?
In any case, a step seems to have been taken.
The European Medicines Agency (EMA) announced on Monday that it had approved the American firm's product for booster injections in people aged at least 18 years.
The dose should be half as concentrated as that used during the primary vaccination.
"A third dose of Moderna administered 6 to 8 months after the second dose resulted in an increase in antibody levels in adults whose antibody levels decreased", justifies the EMA.
Friday, October 15, the High Authority of Health (HAS) had recommended the suspension of booster vaccinations with Moderna, while awaiting this European opinion.
In question ?
A possible increased risk of myocarditis with this vaccine than with Pfizer, especially in adolescents and young adults.
Several Scandinavian countries had launched the alert in early October, deciding to advise against, or even suspend, all injections with Moderna in those under 18 or under 30.
“Similar” risk of adverse effects
A week later, after having scrutinized the French data in detail, the National Agency for the Safety of Medicines and Health Products had also pointed out a potential risk of such post-vaccination cardiac problems.
According to the data currently available, the side effects after the booster are "similar" to what occurs after the second dose, indicates for its part the EMA.
"The risk of inflammatory heart disease or other very rare side effects after a booster is carefully monitored," said the agency, adding that it will continue to review "all data on the safety and effectiveness of the vaccine Moderna ”.
Read also Booster vaccinations: is the risk of side effects greater?
The HAS must now say whether it in turn validates the booster vaccinations with Moderna in France.
2.5 million people received an additional dose on October 24, or about 40% of the eligible population on that date (elderly, frail, and caregivers vaccinated at least six months ago).