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Pfizer (PFE) Gets Breakthrough Therapy Status for RSV Vaccine
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Pfizer (PFE - Free Report) announced that the FDA granted Breakthrough Therapy designation to its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF. The designation was granted by the FDA for active immunization of pregnant women to prevent RSV-associated lower respiratory tract illness in infants from birth up to six months of age.
A Breakthrough Therapy status is granted to medicines being evaluated for serious conditions where early clinical evidence indicates said medicines’ potential for substantial improvement over available therapies.
The above designation was based on data from the phase IIb proof-of-concept study, evaluating the safety and immunogenicity of RSVpreF in healthy pregnant women. The study evaluated the administration of the maternal RSV vaccine candidate in pregnant women aged 18 to 49 years between 28 and 36 weeks gestation or in their infants.
The company is currently evaluating RSVpreF in a phase III study for vaccination against RSV infection in infants.
Pfizer believes that RSVpreF has the potential to become the first RSV vaccine that will help protect infants in their vulnerable first months of life from the disease caused by the highly-contagious RSV virus. The company stated that RSV affects approximately 2.1 million children younger than five years old every year and causes 58,000 hospitalizations in the same age group in the United States. Currently, there are no FDA-approved RSV vaccines, implying an attractive opportunity.
Pfizer is also developing the RSV vaccine candidate, RSVpreF, for the immunization of older adults aged 60 years and above in a phase III model.
Shares of Pfizer have rallied 38.7% in the past year compared with the industry’s rise of 18.4%.
Image Source: Zacks Investment Research
RSV is a common and pervasive cause of acute respiratory illness, which usually starts in the fall months. The highly contagious virus affects the lungs and airways.
Some other companies are also developing their respective vaccines for treating RSV.
British pharma giant Glaxo (GSK - Free Report) is evaluating its maternal RSV vaccine candidate in the phase III GRACE study. The study is evaluating the efficacy of a single dose of the unadjuvanted candidate in pregnant women.
Glaxo is also developing RSV vaccines for pediatric patients as well as for older adults, using different novel technologies.
J&J (JNJ - Free Report) is evaluating its RSV vaccine candidate in older adults aged 60 years and above. J&J initiated a phase III study on the candidate in September last year.
We remind investors that J&J’s RSV vaccine also enjoys Breakthrough Therapy Designation from the FDA for the prevention of RSV-associated lower respiratory tract disease.
Small biotech firm Novavax (NVAX - Free Report) is also developing ResVax, its RSV vaccine candidate, in a phase III study for protecting infants by immunizing their mothers against the disease. ResVax is also being investigated in phase II and phase I studies for addressing older adults and the pediatric patient population, respectively, for the given indication.
Image: Bigstock
Pfizer (PFE) Gets Breakthrough Therapy Status for RSV Vaccine
Pfizer (PFE - Free Report) announced that the FDA granted Breakthrough Therapy designation to its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF. The designation was granted by the FDA for active immunization of pregnant women to prevent RSV-associated lower respiratory tract illness in infants from birth up to six months of age.
A Breakthrough Therapy status is granted to medicines being evaluated for serious conditions where early clinical evidence indicates said medicines’ potential for substantial improvement over available therapies.
The above designation was based on data from the phase IIb proof-of-concept study, evaluating the safety and immunogenicity of RSVpreF in healthy pregnant women. The study evaluated the administration of the maternal RSV vaccine candidate in pregnant women aged 18 to 49 years between 28 and 36 weeks gestation or in their infants.
The company is currently evaluating RSVpreF in a phase III study for vaccination against RSV infection in infants.
Pfizer believes that RSVpreF has the potential to become the first RSV vaccine that will help protect infants in their vulnerable first months of life from the disease caused by the highly-contagious RSV virus. The company stated that RSV affects approximately 2.1 million children younger than five years old every year and causes 58,000 hospitalizations in the same age group in the United States. Currently, there are no FDA-approved RSV vaccines, implying an attractive opportunity.
Pfizer is also developing the RSV vaccine candidate, RSVpreF, for the immunization of older adults aged 60 years and above in a phase III model.
Shares of Pfizer have rallied 38.7% in the past year compared with the industry’s rise of 18.4%.
Image Source: Zacks Investment Research
RSV is a common and pervasive cause of acute respiratory illness, which usually starts in the fall months. The highly contagious virus affects the lungs and airways.
Some other companies are also developing their respective vaccines for treating RSV.
British pharma giant Glaxo (GSK - Free Report) is evaluating its maternal RSV vaccine candidate in the phase III GRACE study. The study is evaluating the efficacy of a single dose of the unadjuvanted candidate in pregnant women.
Glaxo is also developing RSV vaccines for pediatric patients as well as for older adults, using different novel technologies.
J&J (JNJ - Free Report) is evaluating its RSV vaccine candidate in older adults aged 60 years and above. J&J initiated a phase III study on the candidate in September last year.
We remind investors that J&J’s RSV vaccine also enjoys Breakthrough Therapy Designation from the FDA for the prevention of RSV-associated lower respiratory tract disease.
Small biotech firm Novavax (NVAX - Free Report) is also developing ResVax, its RSV vaccine candidate, in a phase III study for protecting infants by immunizing their mothers against the disease. ResVax is also being investigated in phase II and phase I studies for addressing older adults and the pediatric patient population, respectively, for the given indication.
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Pfizer currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.