Pfizer PFE announced that the U.S. Centers for Disease Control and Prevention (CDC) has recommended the use of its recently approved respiratory syncytial virus (RSV) vaccine Abrysvo (RSVpreF) to immunize infants, through maternal immunization, during this fall season.
The CDC recommendation comes after its Advisory Committee on Immunization Practices voted 11 to 1 for use of Abrysvo in pregnant individuals during 32-36 weeks gestational age, using seasonal administration.
A bivalent RSV prefusion F vaccine, Abrysvo, was approved by the FDA last month for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization.
The vaccine is the first maternal immunization vaccine to be approved to help protect infants (from first breath through their first six months of life from RSV disease) in the United States.Top of Form
Earlier this May, Abrysvo was approved for older adults in the United States. The vaccine has already been recommended for use by the CDC.
Last month, Abrysvo was granted marketing authorization in the European Union for prevention of RSV in both older adults and newborns.
Pfizer’s shares have lost 36.2% year to date against the industry’s 5.7% growth.
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RSV is a contagious disease and a common cause of respiratory illness globally. Older adults, young infants and people with some chronic medical conditions are at maximum risk of getting LRTD-RSV disease. Management estimates that every year nearly 500,000-600,000 infants experience LRTD caused by RSV in the United States alone, which is a leading cause of infant hospitalization. The RSV vaccines are expected to reduce these infant hospitalizations this year.
Pfizer’s Abrysvo is one of the two recently approved FDA medications available for immunizing newborns. Last month, the CDC recommended AstraZeneca AZN and Sanofi’s SNY RSV antibody nirsevimab to prevent LRTD caused by RSV in newborns and infants. Sanofi/AstraZeneca markets the vaccine under the trade name Beyfortus. Beyfortus was approved in the European Union last year in October.
The approval for Beyfortus was based on data from the MELODY phase III and other phase IIb studies conducted jointly by AstraZeneca and Sanofi. Unlike vaccines that stimulate the immune system to produce antibodies, therapies like Beyfortus contain antibodies that are directly delivered into the bloodstream.
In May, the FDA approved GSK’s GSK RSV vaccine, Arexvy, for the prevention of LRTD caused by RSV in older adults aged 60 and above. This was the first RSV vaccine for older adults to be approved anywhere in the world. GSK’s Arexvy was approved in Europe in June 2023.
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