European Commission authorizes Abrisvo to protect infants and older adults against RSV through maternal vaccination

European Commission has given permission Marketing authorization for AbrisvoBivalent respiratory syncytial virus (RSV) F preinfusion vaccine (RSVPREF) developed by Pfizer. To help protect infants through maternal immunization, the vaccine is indicated in both older adults and pregnant women as a single dose, given between 24 and 36 weeks of pregnancy. have approval Valid in 27 EU member states (EU) plus Iceland, Liechtenstein and Norway.

The decision comes after the Committee for Medicinal Products for Human Use (CHMP, for its short name in English) recommended its approval at its last meeting in July, and the Food and Drug Administration (FDA, for its short name in English) announced its authorization in the US territory just three years ago. Days later recommended its approval. “Approval of Abrisvo in Europe marks significant progress in the efforts of the scientific community To provide significant protection against RSV, a common respiratory virus that can be potentially serious and even life-threatening, especially in infants and older adults,” said Pfizer Senior Vice President and Vaccine Research and head of development Annalisa Anderson said.

Marketing authorization of the vaccine in the European Union is based on evidence from two Phase III clinical trials: Renoir and Matisse. The first of these is a global, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, immunogenicity and safety of a single dose of vaccine in adults 60 years of age and older. On its part, MATISSE is a global, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety and immunogenicity of RSVpreF. lower respiratory tract disease (LRTD) and RSV-related severe LRTD in infants born to healthy individuals vaccinated during pregnancy.

In ongoing international randomized placebo-controlled clinical studies, Safety and efficacy of Abrisvo evaluated for immunization of pregnant women, compared to about 3,500 pregnant women who received the vaccine, compared to about 3,500 pregnant women who received a placebo, Abrisvo reduced the risk of severe LRTD by 81.8 percent at 90 days after birthand 69.4 percent at 180 days after birth.

Pfizer has initiated two additional clinical trials to evaluate Abrisvo., One of them is being done in children ages 2 to 18 who are at high risk of getting RSV disease, while the other is evaluating adults ages 18 to 60 who are at high risk of contracting it because of therapy. There is more danger. conditions. Those with underlying medical conditions such as asthma, diabetes and COPD, as well as immunocompromised adults 18 years of age or older and at high risk of contracting RSV. The company also plans to conduct post-marketing studies and monitoring programs to further characterize the safety of the vaccine.

,This is our first licensed RSV vaccine in the EU Which not only protects the elderly but also babies from birth. Stella concluded that given the upcoming fall and winter season, this vaccine could help prevent the serious consequences of RSV for some of our most vulnerable citizens. KyriakidesEuropean commissioner for health and food safety.

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