The government will follow the advice of the High Authority for Health, by temporarily restricting the use of this vaccine.
The executive will apply the recommendations of the High Authority for Health (HAS). During a press briefing on Tuesday, February 22, the Ministry of Health announced that it wanted to follow the advice of the HAS, by reserving vaccination by Janssen for certain very specific cases. This means that mRNA vaccines should be preferred for first administration, as well as for the booster dose.
Recommendation to postpone scheduled injections
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 (non-pathogenic virus to provoke an immune response) which must be injected as 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”.
Janssen remains little used in France, with just over a million doses administered since April 2021, including very few after September. Public Health France has only counted about ten doses of this vaccine administered every day for several months. The decision to suspend its use should therefore only moderately influence the pace of the vaccination campaign.