U.S. and EU regulators to expedite reviews of Pfizer’s RSV vaccine

USA — Pfizer has announced that regulatory authorities in the US and Europe have accepted marketing applications for its RSVpreF vaccine candidate for respiratory syncytial virus (RSV), with decisions expected later this year.

The FDA has accepted for priority review a submission seeking clearance of RSVpreF for the prevention of medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals.

The vaccine works by vaccinating a pregnant person, who then passes on some protective antibodies to the infant.

Data from preliminary studies show the vaccine is 82% effective at protecting newborns within the first three months of life, dropping to 69% within six months. The vaccine has also shown promising data in adults 65 and older.

In December of last year, the FDA accepted an application for priority review aimed at preventing lower respiratory tract disease caused by RSV in individuals aged 60 years and older, with a target action date set for May.

Meanwhile, the European Medicines Agency (EMA) accepted a marketing application under accelerated assessment for RSVpreF for both older adults and maternal immunization to help protect infants.

A decision is expected in the second half of 2023. If approved, RSVpreF will help protect infants from the devastating effects of this infectious disease.

RSV can cause serious illness, especially in infants and older adults, and is the most common cause of bronchiolitis and pneumonia in kids under the age of 1 in the U.S.

If the FDA approves the vaccine in August, it will then go to the CDC for final approval.

Last year, the EU granted approval for AstraZeneca and Sanofi’s Beyfortus (nirsevimab) for the prevention of RSV lower respiratory tract disease in newborns and infants during their first RSV season.

Nirsevimab, a drug that is not a vaccine but a monoclonal antibody designed to protect infants from RSV complications is administered to infants as a one-time injection after birth.

Nirsevimab is already approved in Europe and the United Kingdom, according to Sanofi, and was accepted for FDA review in January.

Nirsevimab would become the first preventative option for the infant population, including those born healthy, preterm, or with specific health conditions upon approval.

The FDA has pledged to expedite the review, with the target action date set for the third quarter of 2023 under the Prescription Drug User Fee Act.

Meanwhile, pediatric hospitals across the US are reporting a surge in RSV-related admissions, with infections up by 69% last fall, and pediatric bed occupancy reaching its highest in two years.

In most cases, infants and toddlers with RSV can recover at home unless they experience difficulty breathing, irritability, or fatigue.

Parents can protect their children from RSV by following the three Ws of the coronavirus pandemic: Wear a mask, wash your hands and watch your distance, while those with premature births or chronic lung disease should discuss medication options with their pediatrician.

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