After initially recommending both the Pfizer and Moderna vaccines for third doses, France’s independent regulator, the Haute Autorité de Santé (HAS), is now advising against using the Moderna vaccine, it announced on October 15th.
The health authority did not exclude future use of the Moderna jab, which is yet to receive regulatory approval to be used for third doses in the EU, but said it would wait for a ruling from the European Medicines Agency.
“The announcements from various health authorities have brought to light the unknowns which remain around the dose and target population for the Spikevax (Moderna) booster jab, and justify waiting for the European authority to provide clarification concerning regulatory approval currently under examination,” the HAS wrote in a press release.
The decision follows announcements from several Scandinavian countries since the beginning of October that they were suspending use of the Moderna vaccine for certain groups due to reports of a rare cardiovascular side effect.
Finland has suspended the Moderna vaccine for men under 30, while Norway is recommending that demographic opt for the Pfizer vaccine instead, Reuters reported. Swedish and Danish health authorities have also paused the American-developed vaccine for all young adults and children, and Iceland has completely suspended its use for booster doses.
Those countries cited reports of myocarditis (inflammation of the heart muscle), and pericarditis (inflammation of the lining outside the heart).
“In any hypothesis, these remain rare and resolve themselves in almost all cases,” the HAS wrote in its decision, but said it would adopt a “position of caution” while awaiting clarification over potential age limits and whether patients should receive a full dose or half a dose.
Moderna is the second most widely used vaccine in France, but a large majority of people have received the Pfizer jab. The same applies to booster doses, as the below chart of daily third injections from Le Parisien journalist Nicolas Berrod shows.
Le ministère de la Santé n'a pas confirmé suivre cette recommandation, mais il le fait généralement.
Quel impact cela aurait-il ? Moderna est moins utilisé que Pfizer pour des troisièmes doses (voir graphique), mais il est désormais davantage livré en France.
— Nicolas Berrod (@nicolasberrod) October 15, 2021
In the meantime, the HAS has said the Pfizer vaccine can be used for booster injections “regardless of the vaccine used for the first doses”.
The third dose campaign in France currently covers over-65s, the immunocompromised and their close friends and relatives, people with comorbidities, and healthcare workers.