The Janssen vaccine, which was supposed to protect against Covid-19 with a single injection and which uses viral vector technology is questioned by the National Medicines Safety Agency (ANSM) in its latest report. What are the consequences of these observations when “additional investigations“are going to be carried out?
1 What does the ANSM report say?
Monday, September 13, the National Medicines Safety Agency (ANSM) notes that “a large number of cases of failure of the Janssen vaccine have been reported, with in particular serious forms (death, resuscitation) as well as an overrepresentation of patients vaccinated with Janssen in intensive care in two university hospitals“, in Marseille and Tours.
In detail, the ANSM has identified 32 cases of Covid-19 infection among the million people over the age of 55 who have received their single dose of Janssen since April 24 (date on which he received the fire green from the European Medicines Agency). Of these 32 cases, 29 presented with severe forms of the disease (people aged 73 to 87) and 4 died. The ANSM also specifies that these patients presented “mostly serious risk comorbidities“. The Janssen Vaccine Monitoring Committee considers”that this is a potential signal and that investigations are continuing“.
2Why is the second dose strongly recommended to fight against severe forms?
Already, on August 23, the High Authority for Health (HAS) warned of the drop in the effectiveness of vaccines, including Janssen, over the long term and in particular against the Delta variant. To respond to this, the HAS recommended a vaccination booster campaign in fully vaccinated people aged 65 and over, as well as for all people with comorbidities.
Originally, the efficacy of the single dose of the Janssen vaccine was evaluated at 66.9% on moderate to severe forms of Covid-19, against 91% for the Pfizer and Moderna vaccines. But the latest ANSM data confirms the drop in effectiveness of the Janssen vaccine against the Delta variant and this is why the Directorate General of Health (DGS) wished to recall the importance of this booster vaccination campaign for patients. first-vaccinated with Janssen.
3Which second vaccine is recommended for those first vaccinated with Janssen?
The DGS confirms, Tuesday, September 14, that people who have received their single dose of Janssen, will have to receive a second dose mRNA vaccine: Pfizer or Moderna, therefore. You will have to wait at least four weeks after your first injection of Janssen to receive your second dose.
The DGS also specifies that the sanitary pass for first-time vaccinated with Janssen will remain valid with or without a booster, but it strongly recommends that over 65s, nursing home residents, people at risk and severely immunocompromised people to do this second. dose.
4Where are the deliveries of Janssen vaccines?
While deliveries of the Janssen vaccine had been stopped since July 4, they resumed this week with the delivery of 350,000 new doses.
Since April, France had already received 1.8 million doses of the Janssen vaccine, but with a use rate of only 56%. However, France should receive 30 million doses by the end of the year in particular to increase the volume of donations to Covax. The agreement with Covax and Janssen has been in negotiation for several months and should be concluded in October. In the meantime, the doses will continue to be used as part of the vaccination campaign or given directly to other countries, as was the case last July with the shipment of 500,000 doses to Tunisia.