Due to the new opinion of the European Medicines Agency and the Epi-Phare report confirming the risk of myocarditis and pericarditis, the French National Authority for Health (Haute Autorité de Santé) advises against the Moderna vaccine for certain segments of the population.
In a press release published on November 8, 2021, the French National Authority for Health “clarifies the place of Spikevax® in the vaccination strategy”.
A euphemism for advising against the Moderna vaccine for people under 30 years of age because of the side effects observed in several northern European countries and confirmed by a recent French study Epi-Phare.
Created at the end of 2018 by the French National Agency for the Safety of Medicines and the National Health Insurance Fund, EPI-PHARE conducts, pilots and coordinates pharmaco-epidemiology studies using complex and massive data from the National Health Data System (SNDS), to inform public authorities in their decision-making.
Within seven days after vaccination
Here is the gist of the HAS communication: ” The latest pharmaco-epidemiological data transmitted by the ANSM and the French Health Insurance in the framework of the Epi-PHARE study confirm the risk of occurrence of very rare cases of myocarditis with a favorable outcome. In the population under 30 years of age, this risk appears to be approximately 5 times lower for Pfizer’s Comirnaty® vaccine than for Moderna’s Spikevax® vaccine (100 µg) in the 12-29 year age group, the age group for which the excess of cases per million is the highest (131.6 per million cases for Moderna versus 26.7 for Pfizer). These results are consistent with those from the US data. These cases occurred primarily within 7 days of vaccination, more often after the second dose, and more often in men under 30 years of age.
A lack of hindsight
This is why, pending additional data on the risk of myocarditis and the conclusions of the PRAC expected in the coming weeks, and given the lack of experience with the risk of myocarditis with the Spikevax® vaccine used in half-dose for the booster (50 µg) due to the limited number of people included in the trials, the HAS recommends, for the population under 30 years of age and as soon as it is available, the use of the Comirnaty® vaccine, whether it is a primary or booster vaccination. “