The marketing authorisation was based on the findings of the MATISSE and RENOIR clinical trials and follows a positive opinion from the EMA’s Committee for Medicinal Products for Human Use
EC approves Pfizer’s ABRYSVO RSV vaccine for infants and older adults. (Credit: Pfizer Inc.)
Pfizer has received marketing authorisation from the European Commission (EC) for ABRYSVO to protect infants through maternal immunisation and older adults from respiratory syncytial virus (RSV).
ABRYSVO is a bivalent RSV prefusion F (RSVpreF) vaccine.
It is now approved for passive immunity against RSV-causing lower respiratory tract disease (LRTD) in infants from birth to six months of age following maternal immunisation during pregnancy.
It is also now authorised for active immunisation of people 60 years of age and older to prevent RSV-related LRTD.
ABRYSVO’s marketing authorisation in the European Union (EU) is based on the findings of the MATISSE (MATernal Immunisation Study for Safety and Efficacy) and RENOIR (RSV vaccine Efficacy study iNOlder adults Immunised against RSV disease) clinical trials.
Both Phase 3 trials are global, randomised, double-blind, placebo-controlled studies.
RENOIR evaluated the efficacy, immunogenicity, and safety of the vaccine candidate’s single dose in adults aged 60 years and more.
MATISSE assessed the safety, efficacy, and immunogenicity of the RSVpreF candidate against LRTD and severe LRTD caused by RSV in infants born to healthy individuals vaccinated in pregnancy.
Pfizer vaccine research and development head and senior vice president Annaliesa Anderson said: “The approval of ABRYSVO in Europe marks significant progress in the scientific community’s efforts to provide meaningful protection against RSV, a common respiratory virus that could potentially be severe and even life-threatening, especially for infants and older adults.
“Last year’s significant number of newborns, children, and adults being hospitalized across Europe demonstrated the immense need for protection against severe RSV cases.
“The approval of the vaccine for both older adults and infants through maternal immunisation is a triumph for public health and we hope to see a tremendous impact for future seasons.”
The EC authorisation follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Recently, Pfizer’s RSV vaccine was approved by the US Food and Drug Administration (FDA) to prevent LRTD and severe LRTD due to RSV in infants from birth up to six months of age by active immunisation of pregnant adults.