EMA’s Committee for Medicinal Products for Human Use (CHMP) supported the approval based on the data from two randomised, placebo-controlled, pivotal trials
Pfizer receives positive CHMP opinion for Abrysvo. (Credit: Pfizer Inc.)
European Union’s European Medicines Agency (EMA) has supported the approval of Pfizer’s Abrysvo vaccine to protect infants up to six months of age and older adults against respiratory syncytial virus (RSV).
Abrysvo is a bivalent vaccine made from two recombinant RSV fusion surface glycoproteins selected to maximise protection against RSV A and B strains.
Upon receiving the marketing authorisation in the European Union (EU), Abrysvo can become the first and only vaccine for both older adults and administration to pregnant individuals to help protect their infants.
EMA’s Committee for Medicinal Products for Human Use (CHMP) supported the approval based on the data from two randomised, placebo-controlled, pivotal trials.
In the first trial, 3,695 pregnant women between 24-36 weeks were given Abrysvo, while 3,697 were given a placebo. According to the evaluation, the vaccine was successful in lowering both severe medically attended lower respiratory tract illnesses and those that occurred within 180 days after birth.
In the second research, a placebo was given to 18,479 participants while 18,488 persons aged 60 and older received the vaccine. The study’s findings showed that Abrysvo was effective in reducing lower respiratory tract disease caused by RSV which had two or more symptoms and three or more symptoms.
Pfizer Vaccine Research and Development SVP and chief scientific officer Annaliesa Anderson said: “If approved, our RSV vaccine candidate for pregnant individuals would help protect infants immediately at the time of birth through six months of age, when they are at highest risk of severe RSV disease and complications.
“This, along with an approval for older adults, would mark meaningful public health progress for RSV disease prevention throughout Europe.”
The CHMP’s opinion represents a preliminary step in Abrysvo’s journey for patient access. The opinion will now be forwarded to the European Commission for marketing authorisation in the EU.
Following the marketing clearance, decisions about price and reimbursement will be made at the level of each Member State, considering the potential role and use of this medication within the framework of that nation’s national health system.
Last month, the European Commission approved the region’s first RSV vaccine, branded Arexvy, from UK-based GSK for older people.