Faced with the higher risk of myocardial infarction linked to the Janssen vaccine, the government has decided to follow the advice of the High Authority for Health (HAS) by restricting its use.
- According to the Ministry of Health, 54,183,496 people have received at least one injection as of February 20, 2022
- 53,150,528 people now have a complete vaccination schedule (i.e. 78.8% of the total population)
Faced with the increased risk of myocardial infarction, the government has decided to follow the opinion of the High Authority for Health (HAS). During a press briefing organized on Tuesday, the Ministry of Health announced that the Janssen vaccine would now only be reserved for people with a contraindication to messenger RNA vaccines. This means that mRNA vaccines should be preferred for first administration, as well as for the booster dose.
A “cautious attitude” necessary
Authorized in the European Union since March 11, 2021, the Janssen vaccine is, unlike those developed by Pfizer/BioNtech and Moderna, a viral vector vaccine comprising an adenovirus which must be injected in a single dose.
Monday, February 21, the High Authority for Health issued an opinion in which it underlines that the Janssen vaccine causes “a slight increase in the risk of myocardial infarction within two weeks” injection in adults under 75 years of age. It is based on the conclusions of the EPI-flagship study, made public on January 18, 2022.
Pending pharmacovigilance conclusions from the European Medicines Agency (EMA), the independent public authority therefore recommends postponing the planned injections with the Janssen vaccine, except in people at risk of a severe form of the disease who present a contraindication to messenger RNA (mRNA) vaccines.
Despite the increased risk of heart attack, the executive wants to be reassuring. “There is a weak signal, but it is a signal all the same, so it leads to an attitude of caution”declared during the press briefing Alain Fischer, who chairs the Council for the orientation of the vaccine strategy.
An opinion shared by the HAS which recalls in its opinion that“To date, the pharmacovigilance data available worldwide […] are reassuring and no signal related to the risk of myocardial infarction has been identified at the European level or at the level of the United States”.
A new “classic” vaccine now available
This sidelining of the Janssen vaccine comes as the Nuvaxovid vaccine developed by Novavax is now available in France. It is based on a “classic” recombinant protein technology, which, according to HAS, has “the proof of its effectiveness and safety in the production used for a long time”especially against whooping cough and hepatitis B.
It arises above all as an effective vaccine alternative for those refractory to mRNA vaccines. Currently benefiting from an MA in adults aged 18 and over, the Novavax vaccine can only be administered as a primary vaccination, and not as a booster dose. The vaccination schedule requires the administration of 2 doses spaced 3 weeks apart, intramuscularly, preferably in the muscle of the arm.
It remains to be seen whether this new vaccine will find its audience. A total of 3.2 million doses of Nuvaxovid are expected in the first quarter in France and a “option has been activated for 3.2 million additional doses in the second quarter of 2022” said the Ministry of Health. Of these doses, 600,000 are intended for overseas France, where vaccination coverage is much lower than in mainland France.
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