A new possible protection for newborns. The High Health Authority (HAS) announced this Thursday, June 13, the approval of a second vaccine against bronchiolitis in infants, in a press release. It will be aimed at women who are at least 8 months pregnant and will be available starting next September.
This new vaccine will be marketed in France by Pfizer under the name Abrysvo, after a first marketing authorization at European level in August 2023.
It should help reduce bronchiolitis in babies. This infection, caused “in almost three quarters of cases by the respiratory syncytial virus (RSV),” affects “almost 30% of children under two years of age” each year, according to the HAS.
Abrysvo is the second vaccine aimed at preventing bronchiolitis in infants approved by the HAS, after Beyfortus, from Sanofi, in 2023.
Reduction of infections and hospitalizations
According to the High Health Authority, the tests carried out show “a significant reduction in serious respiratory infections related to RSV: 81.8% at 3 months, 69.4% at 6 months”, after vaccination with Abrysvo.
“There is also a reduction in hospitalizations: 67.7% at 3 months, 56.8% at 6 months,” the statement indicates. “No increase in serious adverse events in either the mother or the newborn has been reported” in relation to the vaccine.
“These data validate the benefit of vaccination and lead the HAS to integrate it into the strategy for preventing RSV infections in infants,” concludes the health agency.
The choice between two vaccines
The HAS specifies that the Abrysvo vaccine is recommended for pregnant women during the eighth month of pregnancy.
“With the arrival of this vaccine, parents will be able to choose, starting in September, between two possibilities to protect their child against infections caused by RSV”, Abrysvo or Beyfortus, underlines the High Authority.
Compared to Beyfortus, the new vaccine has the advantage of not requiring injection in babies and protecting them from birth.
On the contrary, Beyfortus, if recommended for babies “as soon as possible after birth”, has the advantage of being able to be injected into a child up to 2 years old. Its “effectiveness” and “safety” have also been “confirmed in real life in several countries in 2023-2024,” underlines the health authority.
The HAS indicates that vaccination with Beyfortus remains “preferable” in children “when vaccination is unlikely to be effective”, in particular when a premature birth is expected, but also “in case of a new pregnancy of a previously vaccinated mother” . “due to the lack of available data on the safety and efficacy of an additional dose of vaccine”, “with regard to immunocompromised women, due to the lack of data on the efficacy and immunogenicity of the vaccine in this population.”
The two serums offered to parents from September
“The HAS recommends the simultaneous implementation of the vaccination campaign for mothers with Abrysvo and the immunization campaign for newborns and infants with Beyfortus”, that is, between next “September” and “January”.
“It recommends making both medications (vaccine and monoclonal antibodies) accessible in maternity hospitals to optimize mobilization and acceptability by health professionals and parents,” the statement adds.
Two studies, by the Pasteur Institute and French Public Health, showed that Beyfortus had prevented the hospitalization of between 3,700 and 7,800 babies in recent months. In the fall of 2023, more than 200,000 doses of this vaccine were administered in France.
Source: BFM TV
