A “significant number” of cases of failure of the single-dose anti-covid vaccine “Janssen” marketed by the American laboratory Johnson & Johnson (J&J), has been reported in France, said Monday the National Agency for Medicines and Drug Safety. health products (ANSM).
“To date, a large number of cases of failure of the Janssen vaccine has been reported, with in particular serious forms (death, resuscitation) as well as an overrepresentation of patients vaccinated by Janssen in intensive care in 2 CHU”, underlines the agency in its “Pharmacovigilance survey of the COVID-19 JANSSEN vaccine”.
Explorations are underway to analyze this “potential signal”, notes the Agency, adding that “the first cases of TTS (thrombosis syndrome associated with thrombocytopenia) have been observed in France, this adverse effect is already listed in the SPC (summary of product characteristics) ‘, while a signal was confirmed at European level for immune thrombocytopenia.
Since April, around one million injections of this vaccine have been carried out in France. Since the start of vaccination, 32 cases of Covid-19 infection have been observed following vaccination with Janssen, including “4 deaths as a result of ineffectiveness of the Janssen vaccine”, specifies the Agency.
The people concerned have a median age of 68 years, with multiple risk comorbidities of severe form of Covid-19, specifies the report.
The monitoring committee considers that this is a potential signal at the time when “the investigations are continuing”.
Since the beginning of September, it has been recommended that a booster dose with an mRNA vaccine be offered to people who have had a first dose with the Janssen vaccine from 4 weeks after the first injection. These elements will be shared at European level.
All these elements justify “additional investigations” to check whether the failures are more important with Janssen than with the other vaccines available in France.