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Pfizer (PFE) Posts Positive Data on Bivalent BA.4/5 COVID Jab
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Pfizer, Inc. (PFE - Free Report) and its partner BioNTech (BNTX - Free Report) announced positive preliminary data from a phase II/III study. The study is evaluating the safety, tolerability and immunogenicity of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.
Data from the study showed that following seven days of dose administration in adults, a 30-µg dose of Pfizer/BioNTech’s Omicron BA.4/BA.5-adapted bivalent vaccine showed a substantial increase in antibody responses which were above pre-booster levels in adults aged 18 years and older. Comparatively, Pfizer/BioNTech’s monovalent vaccine generated more limited increases in antibody responses against the BA.4/BA.5 subvariants in older adults aged 55 years and above.
The approved/authorized monovalent COVID-19 vaccines were not very effective against the BA.4/BA.5 subvariants. Though administering a primary vaccination regimen has reduced severe outcomes caused by COVID-19 variants, clinical studies have shown the antibody levels to wane over time. While booster doses of monovalent vaccines have restored these antibodies to their previous levels, this protection also weakens over time.
The bivalent vaccine contains an mRNA encoding the spike protein in the original/monovalent vaccine and an mRNA encoding the spike protein common in the Omicron BA.4 and BA.5 variants.
Based on the above data, management suggests that the bivalent vaccine provides better protection against the BA.4/BA.5 subvariants than the monovalent vaccine in adults. The safety profile of the bivalent vaccine was also consistent with the monovalent vaccine.
Shares of Pfizer have lost 27.2% in the year so far compared with the industry’s 5.1% decline.
Image Source: Zacks Investment Research
This August, the FDA granted EUA to Pfizer/BioNTech and Moderna’s (MRNA - Free Report) Omicron BA.4/BA.5-adapted bivalent vaccines for a single booster dose. The Pfizer/BioNTech and Moderna booster vaccines can be given at least two months following primary or booster vaccination.While Moderna’s Omicron booster is authorized for adults aged 18 years and older, Pfizer/BioNTech’s version is approved for people 12 and older.
The EUA was expanded earlier this week to include children as young as five years. Following the EUA expansion, a 10-µg dose of Pfizer/BioNTech’s bivalent vaccine is authorized for individuals aged between five and 11 years. A 25-µg and 50-µg dose of Moderna’s bivalent vaccine is authorized for children aged six to 11 years and adolescents aged 12 to 17 years, respectively.
The above authorizations granted to Pfizer and Moderna are based on clinical studies on their bivalent Omicron BA.1-adapted vaccines and pre-clinical data from studies on their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines. Unlike all previously-approved COVID-19 vaccines, the authorization granted to these booster shots is not supported by data from any human clinical studies demonstrating the vaccine’s effectiveness.
Pfizer/BioNTech plans to present additional data from the phase II/III study in the coming weeks. Once this additional data is available, the same will be used by the companies to support its regulatory filings for the bivalent vaccine across different countries. Pfizer/BioNTech are also evaluating their bivalent vaccine in phase I/II/III study in young children aged between six months through 11 years.
In the past 60 days, estimates for Morphic’s 2023 loss per share have narrowed from $3.77 to $3.61. Shares of Morphic have lost 41.4% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.
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Pfizer (PFE) Posts Positive Data on Bivalent BA.4/5 COVID Jab
Pfizer, Inc. (PFE - Free Report) and its partner BioNTech (BNTX - Free Report) announced positive preliminary data from a phase II/III study. The study is evaluating the safety, tolerability and immunogenicity of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.
Data from the study showed that following seven days of dose administration in adults, a 30-µg dose of Pfizer/BioNTech’s Omicron BA.4/BA.5-adapted bivalent vaccine showed a substantial increase in antibody responses which were above pre-booster levels in adults aged 18 years and older. Comparatively, Pfizer/BioNTech’s monovalent vaccine generated more limited increases in antibody responses against the BA.4/BA.5 subvariants in older adults aged 55 years and above.
The approved/authorized monovalent COVID-19 vaccines were not very effective against the BA.4/BA.5 subvariants. Though administering a primary vaccination regimen has reduced severe outcomes caused by COVID-19 variants, clinical studies have shown the antibody levels to wane over time. While booster doses of monovalent vaccines have restored these antibodies to their previous levels, this protection also weakens over time.
The bivalent vaccine contains an mRNA encoding the spike protein in the original/monovalent vaccine and an mRNA encoding the spike protein common in the Omicron BA.4 and BA.5 variants.
Based on the above data, management suggests that the bivalent vaccine provides better protection against the BA.4/BA.5 subvariants than the monovalent vaccine in adults. The safety profile of the bivalent vaccine was also consistent with the monovalent vaccine.
Shares of Pfizer have lost 27.2% in the year so far compared with the industry’s 5.1% decline.
Image Source: Zacks Investment Research
This August, the FDA granted EUA to Pfizer/BioNTech and Moderna’s (MRNA - Free Report) Omicron BA.4/BA.5-adapted bivalent vaccines for a single booster dose. The Pfizer/BioNTech and Moderna booster vaccines can be given at least two months following primary or booster vaccination.While Moderna’s Omicron booster is authorized for adults aged 18 years and older, Pfizer/BioNTech’s version is approved for people 12 and older.
The EUA was expanded earlier this week to include children as young as five years. Following the EUA expansion, a 10-µg dose of Pfizer/BioNTech’s bivalent vaccine is authorized for individuals aged between five and 11 years. A 25-µg and 50-µg dose of Moderna’s bivalent vaccine is authorized for children aged six to 11 years and adolescents aged 12 to 17 years, respectively.
The above authorizations granted to Pfizer and Moderna are based on clinical studies on their bivalent Omicron BA.1-adapted vaccines and pre-clinical data from studies on their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines. Unlike all previously-approved COVID-19 vaccines, the authorization granted to these booster shots is not supported by data from any human clinical studies demonstrating the vaccine’s effectiveness.
Pfizer/BioNTech plans to present additional data from the phase II/III study in the coming weeks. Once this additional data is available, the same will be used by the companies to support its regulatory filings for the bivalent vaccine across different countries. Pfizer/BioNTech are also evaluating their bivalent vaccine in phase I/II/III study in young children aged between six months through 11 years.
Pfizer Inc. Price
Pfizer Inc. price | Pfizer Inc. Quote
Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold).A better-ranked stock in the overall healthcare sector is Morphic (MORF - Free Report) , which sports a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Morphic’s 2023 loss per share have narrowed from $3.77 to $3.61. Shares of Morphic have lost 41.4% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.