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Pfizer's (PFE) RSV Vaccine Gets FDA Nod for Pregnant Women
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Pfizer (PFE - Free Report) announced that the FDA has granted approval to its new vaccine Abrysvo for the prevention of respiratory syncytial virus (RSV) in infants through maternal immunization.
Abrysvo, Pfizer’s bivalent RSV prefusion F (RSVpreF) vaccine, is now approved 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 of pregnant individuals at 32 through 36 weeks gestational age.
Abrysvo was approved for older adults in the United States in May. In June, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices also recommended Abrysvo for use in older adults aged 60 and older.
With the latest approval, Pfizer’s vaccine has become 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.
The FDA approval was based on primary analysis results from the pivotal phase III study called MATISSE on the candidate.
The approval was expected, as, in May, the Vaccines and Related Biological Products Advisory Committee voted in favor of approving Abrysvo for the prevention of RSV in infants through maternal immunization.
Abrysvo is under review for older adults as well as for infants through maternal immunization in Europe, with a decision expected in the second half of 2023
Older adults, young infants and people with some chronic medical conditions are at maximum risk of getting LRTI-RSV disease. RSV is a contagious disease and a common cause of respiratory illness globally. In the United States, every year, approximately 500,000 to 600,000 infants experience LRTD due to RSV, which is a leading cause of infant hospitalization. The RSV vaccines are expected to reduce these infant hospitalizations this year. Pfizer is the only company now which has an RSV vaccine to help protect older adults, as well as infants through maternal immunization.
Pfizer’s stock has declined 27.8% so far this year against an increase of 7.8% for the industry.
Image Source: Zacks Investment Research
In May, the FDA approved GSK’s (GSK - Free Report) RSV vaccine, Arexvy, for the prevention of LRTD caused by RSV in older adults aged 60+ years. 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.
AstraZeneca (AZN - Free Report) and Sanofi’s (SNY - Free Report) RSV antibody called Beyfortus/nirsevimab was approved in the United States for protection against LRTI caused by RSV in newborns and infants in July. Beyfortus was approved in Europe in November 2022. The approval for Beyfortus was based on data from the MELODY phase III and other phase IIb studies conducted jointly by AstraZeneca and Sanofi.
Moderna has also developed 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 has filed for regulatory approvals of the RSV vaccine for older adults in several countries.
Image: Bigstock
Pfizer's (PFE) RSV Vaccine Gets FDA Nod for Pregnant Women
Pfizer (PFE - Free Report) announced that the FDA has granted approval to its new vaccine Abrysvo for the prevention of respiratory syncytial virus (RSV) in infants through maternal immunization.
Abrysvo, Pfizer’s bivalent RSV prefusion F (RSVpreF) vaccine, is now approved 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 of pregnant individuals at 32 through 36 weeks gestational age.
Abrysvo was approved for older adults in the United States in May. In June, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices also recommended Abrysvo for use in older adults aged 60 and older.
With the latest approval, Pfizer’s vaccine has become 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.
The FDA approval was based on primary analysis results from the pivotal phase III study called MATISSE on the candidate.
The approval was expected, as, in May, the Vaccines and Related Biological Products Advisory Committee voted in favor of approving Abrysvo for the prevention of RSV in infants through maternal immunization.
Abrysvo is under review for older adults as well as for infants through maternal immunization in Europe, with a decision expected in the second half of 2023
Older adults, young infants and people with some chronic medical conditions are at maximum risk of getting LRTI-RSV disease. RSV is a contagious disease and a common cause of respiratory illness globally. In the United States, every year, approximately 500,000 to 600,000 infants experience LRTD due to RSV, which is a leading cause of infant hospitalization. The RSV vaccines are expected to reduce these infant hospitalizations this year. Pfizer is the only company now which has an RSV vaccine to help protect older adults, as well as infants through maternal immunization.
Pfizer’s stock has declined 27.8% so far this year against an increase of 7.8% for the industry.
Image Source: Zacks Investment Research
In May, the FDA approved GSK’s (GSK - Free Report) RSV vaccine, Arexvy, for the prevention of LRTD caused by RSV in older adults aged 60+ years. 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.
AstraZeneca (AZN - Free Report) and Sanofi’s (SNY - Free Report) RSV antibody called Beyfortus/nirsevimab was approved in the United States for protection against LRTI caused by RSV in newborns and infants in July. Beyfortus was approved in Europe in November 2022. The approval for Beyfortus was based on data from the MELODY phase III and other phase IIb studies conducted jointly by AstraZeneca and Sanofi.
Moderna has also developed 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 has filed for regulatory approvals of the RSV vaccine for older adults in several countries.
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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