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Pfizer's (PFE) RSV Vaccine for Infants Gets FDA Panel Vote

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Pfizer (PFE - Free Report) announced the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted in favor of its bivalent vaccine candidate PF-06928316 or RSVpreF to help prevent respiratory syncytial virus (RSV) in infants through maternal immunization. The committee believes the available data supports the efficacy and safety of the RSV vaccine. The committee voted 10 to 4 on safety and 14 to 0 on effectiveness.

The vaccine candidate is under FDA review for preventing medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals. Adecision from the FDA is expected in August.

The VRBPAC’s positive vote was based on primary analysis results from the pivotal phase III study called MATISSE on the candidate.

Pfizer’s BLA seeking approval of the RSV vaccine for older adults (aged 60 and above) is also under priority review, with the FDA decision expected later this month. The VRBPAC also voted in favor of the RSV vaccine for older adults in February 2023. The vaccine candidate is also under review for both older adults and maternal immunization in Europe.

Pfizer’s stock has declined 30.5% in the past year against an increase of 9.3% for the industry.

Until a year back there were no FDA-approved vaccines against RSV infections anywhere in the world. Early this month, the FDA approved GSK’s (GSK - Free Report) RSV vaccine, Arexvy forthe prevention of LRTD caused by RSV in older adults. This was the first RSV vaccine for older adults to be approved anywhere in the world. Older adults, young infants and people with some chronic medical conditions are at maximum risk to get LRTI-RSV disease.

GSK’s RSV vaccine is under review in Japan and Europe as well. In April, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of the vaccine. A final European regulatory decision is expected soon.

AstraZeneca (AZN - Free Report) and Sanofi’s (SNY - Free Report) RSV vaccine called Beyfortus/nirsevimab was approved in Europe for protection against LRTI caused by RSV in newborns and infants in November 2022. A similar application is under review in the United States, with an FDA decision expected in the third quarter of this year.  The approval for Beyfortus was based on data from the MELODY phase III and other phase IIb studies conducted jointly by AstraZeneca and Sanofi.

If approved, Pfizer’s vaccine will be the first maternal immunization vaccine to be approved to help protect infants at first breath through their first six months of life from RSV disease in the United States.

Moderna is also developing an mRNA vaccine, mRNA-1345, targeting RSV in a phase III study, ConquerRSV, in older adults. The study met the primary efficacy endpoints, per top-line data announced in January. Based on these results, Moderna expects to file for regulatory approval. The company is also evaluating mRNA-1345 in an early-stage study in pediatric populations.

Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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