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Pfizer (PFE), BioNTech COVID-Flu Combo Shot Study Falters
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Pfizer (PFE - Free Report) and partner BioNTech (BNTX - Free Report) announced that a phase III study evaluating an mRNA-based combination vaccine candidate against influenza and COVID-19 missed one of its two primary immunogenicity objectives. The vaccine combines Pfizer’s investigational mRNA-based influenza vaccine candidate with it and BioNTech’s popular marketed COVID-19 vaccine called Comirnaty. The study was conducted in more than 8000 healthy individuals aged 18-64.
The study’s two primary immunogenicity objectives were to demonstrate that the antibody responses elicited by the combination vaccine against the SARS-CoV-2 strain and influenza A and B strain were non-inferior to standard of care (“SOC”). The combination vaccine demonstrated comparable responses against the SARS-CoV-2 strain versus Comirnaty. The vaccine also demonstrated a continued trend of higher responses against influenza A. However, the combination vaccine failed to show non-inferiority against the influenza B strain in geometric mean titers and seroconversion. No new safety signals were found in the phase III study.
The companies are evaluating adjustments to their combination vaccine program to improve immune responses against influenza B and will discuss the next steps with health authorities.
BioNTech’s shares were down 2.4% on Friday in response to this news, while Pfizer’s shares were down 1.4%.
So far this year, Pfizer’s stock has declined 1.7% against an increase of 24.1% for the industry.
Image Source: Zacks Investment Research
Pfizer and BioNTech successfully paired up to give the world the most successful mRNA-based COVID-19 vaccine in 2021. Moderna (MRNA - Free Report) also launched an mRNA-based COVID-19 vaccine, which was equally successful. Moderna is also evaluating a mRNA-based COVID/flu combination vaccine in a phase III study. In June, Moderna announced that a phase III study on its COVID/flu combination vaccine met its primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the study in adults 50 years and older.
Pfizer also announced data from a separate phase II study evaluating a second-generation trivalent influenza mRNA vaccine. In the study, the vaccine demonstrated robust immunogenicity against all strains compared to a SOC influenza vaccine in individuals 18-64 years of age.
Last year, Pfizer announced data from a phase III study on a first-generation quadrivalent (“qIRV”) vaccine candidate. While the mRNA vaccine demonstrated efficacy in participants 18-64 years of age, the primary endpoints for this qIRV first-generation candidate were not met in adults aged 65 and older. In order to improve immunogenicity, Pfizer developed the second-generation mRNA-based candidates. The trivalent influenza mRNA vaccine elicited robust responses against influenza A and B, including a continued trend of higher influenza A responses versus a licensed influenza vaccine.
A large drugmaker worth considering is Eli Lilly (LLY - Free Report) , carrying a Zacks Rank of 2 (Buy). Year to date, Lilly’s stock has risen 58.2%. Earnings estimates for 2024 have risen from $13.71 to $15.77 per share over the past 30 days. For 2025, earnings estimates have risen from $19.42 to $22.79 per share over the same timeframe.
The healthcare bellwether’s performance has been solid, with the company exceeding earnings expectations in each of the trailing four quarters. It delivered a four-quarter earnings surprise of 69.07%, on average. In the last reported quarter, the company delivered an earnings surprise of 48.48%
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Pfizer (PFE), BioNTech COVID-Flu Combo Shot Study Falters
Pfizer (PFE - Free Report) and partner BioNTech (BNTX - Free Report) announced that a phase III study evaluating an mRNA-based combination vaccine candidate against influenza and COVID-19 missed one of its two primary immunogenicity objectives. The vaccine combines Pfizer’s investigational mRNA-based influenza vaccine candidate with it and BioNTech’s popular marketed COVID-19 vaccine called Comirnaty. The study was conducted in more than 8000 healthy individuals aged 18-64.
The study’s two primary immunogenicity objectives were to demonstrate that the antibody responses elicited by the combination vaccine against the SARS-CoV-2 strain and influenza A and B strain were non-inferior to standard of care (“SOC”). The combination vaccine demonstrated comparable responses against the SARS-CoV-2 strain versus Comirnaty. The vaccine also demonstrated a continued trend of higher responses against influenza A. However, the combination vaccine failed to show non-inferiority against the influenza B strain in geometric mean titers and seroconversion. No new safety signals were found in the phase III study.
The companies are evaluating adjustments to their combination vaccine program to improve immune responses against influenza B and will discuss the next steps with health authorities.
BioNTech’s shares were down 2.4% on Friday in response to this news, while Pfizer’s shares were down 1.4%.
So far this year, Pfizer’s stock has declined 1.7% against an increase of 24.1% for the industry.
Image Source: Zacks Investment Research
Pfizer and BioNTech successfully paired up to give the world the most successful mRNA-based COVID-19 vaccine in 2021. Moderna (MRNA - Free Report) also launched an mRNA-based COVID-19 vaccine, which was equally successful. Moderna is also evaluating a mRNA-based COVID/flu combination vaccine in a phase III study. In June, Moderna announced that a phase III study on its COVID/flu combination vaccine met its primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the study in adults 50 years and older.
Pfizer also announced data from a separate phase II study evaluating a second-generation trivalent influenza mRNA vaccine. In the study, the vaccine demonstrated robust immunogenicity against all strains compared to a SOC influenza vaccine in individuals 18-64 years of age.
Last year, Pfizer announced data from a phase III study on a first-generation quadrivalent (“qIRV”) vaccine candidate. While the mRNA vaccine demonstrated efficacy in participants 18-64 years of age, the primary endpoints for this qIRV first-generation candidate were not met in adults aged 65 and older. In order to improve immunogenicity, Pfizer developed the second-generation mRNA-based candidates. The trivalent influenza mRNA vaccine elicited robust responses against influenza A and B, including a continued trend of higher influenza A responses versus a licensed influenza vaccine.
Zacks Rank & Stock to Consider
Pfizer has a Zacks Rank #3 (Hold) currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Pfizer Inc. Price and Consensus
Pfizer Inc. price-consensus-chart | Pfizer Inc. Quote
A large drugmaker worth considering is Eli Lilly (LLY - Free Report) , carrying a Zacks Rank of 2 (Buy). Year to date, Lilly’s stock has risen 58.2%. Earnings estimates for 2024 have risen from $13.71 to $15.77 per share over the past 30 days. For 2025, earnings estimates have risen from $19.42 to $22.79 per share over the same timeframe.
The healthcare bellwether’s performance has been solid, with the company exceeding earnings expectations in each of the trailing four quarters. It delivered a four-quarter earnings surprise of 69.07%, on average. In the last reported quarter, the company delivered an earnings surprise of 48.48%