In its latest periodic report, the Medicines Agency underlines in particular “an over-representation of patients vaccinated by Janssen in intensive care” in two CHUs in Marseille and Tours. It intends to conduct “additional investigations”.
“A significant number of cases of failure of the Janssen vaccine have been reported, including severe forms [décès, réanimation] as well as an over-representation of patients vaccinated by Janssen in intensive care in two university hospitals [à Marseille et Tours]», Notes this September 13 the National Medicines Safety Agency (ANSM) in its periodic vaccine monitoring report.
Since April, around one million injections of this vaccine (the only one to be administered with a single dose) have been carried out in France. Among all the cases vaccinated with Janssen, 32 cases of Covid-19 infection have so far been reported (a rate of 3.78 per 100,000). Of these 32 cases, 29 were serious and 4 deaths were recorded (people aged 73 to 87). These seriously affected patients presented “mostly serious risk comorbidities”, according to the ANSM. For the 17 cases of infection where the variant is known, it was each time the Delta variant.
Two hospitals report abnormally high number of patients vaccinated with Janssen among people in intensive care
In addition, two hospitals reported an unusually high number of patients vaccinated with Janssen among those hospitalized in intensive care despite vaccination. In Marseille, out of 7 patients fully vaccinated but still admitted to intensive care (that is to say seriously affected), 4 had been with Janssen. In Tours, this proportion was 3 out of 6. All these elements justify “additional investigations” to check whether the failures are more important with Janssen than with the other vaccines available in France.
On August 24, the French National Authority for Health (HAS) recommended that people vaccinated with Janssen receive a booster dose with a messenger RNA vaccine (Pfizer or Moderna) from four weeks after their vaccination. Several real-life studies have indeed shown that the first dose of Pfizer or AstraZeneca vaccine provided insufficient protection against the Delta variant. No data on this point is available for Janssen, but the HAS had deemed it likely that this is also the case.