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Pfizer (PFE) RSV Vaccine Found Effective in Older Adults
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Pfizer (PFE - Free Report) has announced that its bivalent respiratory syncytial virus (RSV) vaccine candidate, or RSVpreF, was found to be effective in a phase III study on the candidate to prevent lower respiratory tract illness caused by RSV in individuals aged 60 years and above.
The study's primary objective was to assess the safety and efficacy of the vaccine for the prevention of moderate to severe lower respiratory tract illness (LRTI-RSV) during the first RSV season.
Data from the interim analysis of the RENOIR study demonstrated vaccine efficacy of 66.7% in participants with two or more RSV-associated symptoms. However, the vaccine efficacy was 85.7% in participants with more severe disease having three or more symptoms. The LRTI-RSV disease causes a high rate of morbidity and mortality in older adults and young kids.
The interim analysis was conducted by an independent, external Data Monitoring Committee (DMC). In the study, the vaccine was well-tolerated, with no safety concerns. Based on the positive data, Pfizer plans to file a biologics license application (BLA) seeking approval from the FDA in fall 2022.
Pfizer is also conducting a phase III study on RSVpreF in healthy pregnant women to help protect their babies from RSV after birth.
Pfizer’s stock is down 18.9% this year so far against a decrease of 0.5% for the industry.
Image Source: Zacks Investment Research
Currently, there are no FDA-approved vaccines against RSV infections — a serious respiratory disease that leads to 177,000 hospitalizations and more than 14,000 deaths in the United States each year.
GSK plc (GSK - Free Report) is also developing an RSV vaccine for older adults. The company is planning to file regulatory applications seeking approval of its RSV vaccine candidate for older adults in the second half of 2022.
In June, GSK announced positive headline data from a pre-specified efficacy interim analysis of a phase III study on its RSV vaccine candidate in older adults. Data from the interim analysis showed that the vaccine candidate achieved statistically significant and clinically meaningful efficacy.
AstraZeneca (AZN - Free Report) and Sanofi (SNY - Free Report) are developing an RSV vaccine, called nirsevimab for protection against LRTI in infants.
A phase III study conducted jointly by AstraZeneca and Sanofi, MELODY, met its primary endpoint of reducing the incidence of medically- LRTI. A single dose of AstraZeneca and Sanofi’s nirsevimab reduced LRTI, like bronchiolitis or pneumonia caused by RSV, 74.5% compared to placebo in infants born at term or late preterm.
AstraZeneca and Sanofi have already filed a marketing authorization application (MAA) for the nirsevimab vaccine under an accelerated assessment procedure in Europe. The regulatory decision in Europe is expected to come in the second half of 2022.
Image: Bigstock
Pfizer (PFE) RSV Vaccine Found Effective in Older Adults
Pfizer (PFE - Free Report) has announced that its bivalent respiratory syncytial virus (RSV) vaccine candidate, or RSVpreF, was found to be effective in a phase III study on the candidate to prevent lower respiratory tract illness caused by RSV in individuals aged 60 years and above.
The study's primary objective was to assess the safety and efficacy of the vaccine for the prevention of moderate to severe lower respiratory tract illness (LRTI-RSV) during the first RSV season.
Data from the interim analysis of the RENOIR study demonstrated vaccine efficacy of 66.7% in participants with two or more RSV-associated symptoms. However, the vaccine efficacy was 85.7% in participants with more severe disease having three or more symptoms. The LRTI-RSV disease causes a high rate of morbidity and mortality in older adults and young kids.
The interim analysis was conducted by an independent, external Data Monitoring Committee (DMC). In the study, the vaccine was well-tolerated, with no safety concerns. Based on the positive data, Pfizer plans to file a biologics license application (BLA) seeking approval from the FDA in fall 2022.
Pfizer is also conducting a phase III study on RSVpreF in healthy pregnant women to help protect their babies from RSV after birth.
Pfizer’s stock is down 18.9% this year so far against a decrease of 0.5% for the industry.
Image Source: Zacks Investment Research
Currently, there are no FDA-approved vaccines against RSV infections — a serious respiratory disease that leads to 177,000 hospitalizations and more than 14,000 deaths in the United States each year.
GSK plc (GSK - Free Report) is also developing an RSV vaccine for older adults. The company is planning to file regulatory applications seeking approval of its RSV vaccine candidate for older adults in the second half of 2022.
In June, GSK announced positive headline data from a pre-specified efficacy interim analysis of a phase III study on its RSV vaccine candidate in older adults. Data from the interim analysis showed that the vaccine candidate achieved statistically significant and clinically meaningful efficacy.
AstraZeneca (AZN - Free Report) and Sanofi (SNY - Free Report) are developing an RSV vaccine, called nirsevimab for protection against LRTI in infants.
A phase III study conducted jointly by AstraZeneca and Sanofi, MELODY, met its primary endpoint of reducing the incidence of medically- LRTI. A single dose of AstraZeneca and Sanofi’s nirsevimab reduced LRTI, like bronchiolitis or pneumonia caused by RSV, 74.5% compared to placebo in infants born at term or late preterm.
AstraZeneca and Sanofi have already filed a marketing authorization application (MAA) for the nirsevimab vaccine under an accelerated assessment procedure in Europe. The regulatory decision in Europe is expected to come in the second half of 2022.
Pfizer currently hasa Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.