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Pfizer's (PFE) RSV Vaccine Study in Adults Under 60 Meets Goal
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Pfizer (PFE - Free Report) announced that a phase III study evaluating its new respiratory syncytial virus (RSV) Abrysvo in adults aged 18 to 59 met its primary endpoints.
Abrysvo was launched to help protect older adults as well as infants through maternal immunization in the United States as well as in the EU in 2023.
The study called MONeT evaluated the immunogenicity and safety of Abrysvo versus placebo in adults aged 18 to 59 who are at an increased risk of developing severe RSV-associated lower respiratory tract disease (LRTD). The study was conducted on adults aged 18 to 59 with certain underlying chronic conditions such as asthma, diabetes and chronic obstructive pulmonary disease and, therefore, at an increased risk of RSV disease.
The study met its co-primary immunogenicity endpoints and the primary safety endpoint. In the study, the immune response generated by Abrysvo was non-inferior to the responses seen in the study conducted in adults aged 60 or older, where vaccine efficacy is already demonstrated.
Pfizer plans to seek approval from the FDA for the expanded use of Abrysvo for adults 18 years and older by submitting these data. However, the company did not provide any timeline for the filing.
Abrysvo recorded sales of $890 million in 2023. If approved for expanded use in adults aged 18 to 59, sales of the vaccine will rise.
Pfizer’s stock has declined 35.9% in the past year against an increase of 20.0% for the industry.
Image Source: Zacks Investment Research
Pfizer is the only company with an RSV vaccine approved to help protect older adults as well as infants through maternal immunization in both the United States and the EU.
GSK’s (GSK - Free Report) RSV vaccine, Arexvy, is approved for the prevention of LRTD caused by RSV in older adults aged more than 60. This was the first RSV vaccine for older adults to be approved anywhere in the world. GSK’s Arexvy had an exceptional launch and generated £1.2 billion in sales in 2023. Over time, GSK expects Arexvy to generate more than £3 billion in annual sales.
GSK has submitted a regulatory filing seeking label expansion for Arexvy for adults aged 50-59 who are at increased risk of RSV disease. The FDA has granted priority review to the regulatory filing seeking expanded use of Arexvy for adults aged 50-59, with a decision expected on Jun 7.
AstraZeneca (AZN - Free Report) and Sanofi’s (SNY - Free Report) RSV antibody called Beyfortus was approved for protection against RSV in newborns and infants in 2023. Per the terms of the alliance, Sanofi is the commercial lead and AstraZeneca is the development and manufacturing lead.
Moderna has also developed an mRNA vaccine, mRNA-1345, targeting RSV. In July 2023, Moderna initiated regulatory submissions for using its RSV vaccine mRNA-1345 in older adults (60 years and older) in several markets, including the United States and Europe. The FDA’s final decision is expected before May 12, 2024.
Image: Bigstock
Pfizer's (PFE) RSV Vaccine Study in Adults Under 60 Meets Goal
Pfizer (PFE - Free Report) announced that a phase III study evaluating its new respiratory syncytial virus (RSV) Abrysvo in adults aged 18 to 59 met its primary endpoints.
Abrysvo was launched to help protect older adults as well as infants through maternal immunization in the United States as well as in the EU in 2023.
The study called MONeT evaluated the immunogenicity and safety of Abrysvo versus placebo in adults aged 18 to 59 who are at an increased risk of developing severe RSV-associated lower respiratory tract disease (LRTD). The study was conducted on adults aged 18 to 59 with certain underlying chronic conditions such as asthma, diabetes and chronic obstructive pulmonary disease and, therefore, at an increased risk of RSV disease.
The study met its co-primary immunogenicity endpoints and the primary safety endpoint. In the study, the immune response generated by Abrysvo was non-inferior to the responses seen in the study conducted in adults aged 60 or older, where vaccine efficacy is already demonstrated.
Pfizer plans to seek approval from the FDA for the expanded use of Abrysvo for adults 18 years and older by submitting these data. However, the company did not provide any timeline for the filing.
Abrysvo recorded sales of $890 million in 2023. If approved for expanded use in adults aged 18 to 59, sales of the vaccine will rise.
Pfizer’s stock has declined 35.9% in the past year against an increase of 20.0% for the industry.
Image Source: Zacks Investment Research
Pfizer is the only company with an RSV vaccine approved to help protect older adults as well as infants through maternal immunization in both the United States and the EU.
GSK’s (GSK - Free Report) RSV vaccine, Arexvy, is approved for the prevention of LRTD caused by RSV in older adults aged more than 60. This was the first RSV vaccine for older adults to be approved anywhere in the world. GSK’s Arexvy had an exceptional launch and generated £1.2 billion in sales in 2023. Over time, GSK expects Arexvy to generate more than £3 billion in annual sales.
GSK has submitted a regulatory filing seeking label expansion for Arexvy for adults aged 50-59 who are at increased risk of RSV disease. The FDA has granted priority review to the regulatory filing seeking expanded use of Arexvy for adults aged 50-59, with a decision expected on Jun 7.
AstraZeneca (AZN - Free Report) and Sanofi’s (SNY - Free Report) RSV antibody called Beyfortus was approved for protection against RSV in newborns and infants in 2023. Per the terms of the alliance, Sanofi is the commercial lead and AstraZeneca is the development and manufacturing lead.
Moderna has also developed an mRNA vaccine, mRNA-1345, targeting RSV. In July 2023, Moderna initiated regulatory submissions for using its RSV vaccine mRNA-1345 in older adults (60 years and older) in several markets, including the United States and Europe. The FDA’s final decision is expected before May 12, 2024.
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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