Pfizer COVID-19/Flu Combo Vaccine Underperforms in Late-Stage Trial
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Pfizer COVID-19/Flu Combo Vaccine Underperforms in Late-Stage Trial, Lagging Behind Competitors
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Pfizer COVID-19/Flu Combo Vaccine Underperforms in Late-Stage Trial, Lagging Behind Competitors
On August 16, Pfizer revealed disappointing results from the latest phase of its COVID-19 and flu combination vaccine project.
The vaccine failed to meet its primary endpoints in the Phase 3 clinical trial, causing concern among investors.
Pre-market trading saw Pfizer’s stock dip by 0.3%, while BioNTech’s shares dropped by more than 4%.
Pfizer and German biotech company BioNTech, who first partnered on a flu vaccine in 2018 and later developed a blockbuster COVID-19 vaccine during the pandemic, are now working on a combined vaccine aimed at protecting against both the flu and COVID-19. However, their combined vaccine has encountered setbacks in late-stage trials, falling short of a critical goal, which could jeopardize its future in the post-pandemic vaccine market.
In a statement released on Friday, Pfizer disclosed that the Phase 3 trial demonstrated a strong immune response against influenza A when compared to the standard flu vaccine. However, the combination vaccine did not provide effective protection against influenza B.
The combo vaccine, based on BioNTech’s proprietary mRNA platform, includes mRNA sequences encoding the wild-type SARS-CoV-2 spike protein, the Omicron BA.4/BA.5 spike proteins, and the hemagglutinin proteins from four different flu strains.
During the Phase 3 clinical trial, Pfizer enrolled over 8,000 adults aged 18 to 64 to assess the vaccine’s safety, tolerability, and efficacy, with no safety concerns reported.
Despite the setback, Pfizer’s head of vaccine research and development, Annaliesa Anderson, stated, “We remain optimistic about our flu/COVID-19 combo vaccine program and are evaluating the next steps.” The companies are reportedly in discussions with health authorities about the trial results and are considering adjustments to the vaccine candidate to improve its effectiveness against influenza B.
Dr. Ugur Sahin, CEO and co-founder of BioNTech, emphasized the importance of these insights, saying, “We are committed to developing combination vaccines that offer broader protection against multiple respiratory diseases. The learnings from this trial will play a crucial role in guiding the development of our combination vaccine program. We are confident that, together with Pfizer, we can successfully accomplish this task.”
Analysts have commented that the underperformance of Pfizer’s combo vaccine in the late-stage trial may put the company at a disadvantage in its competition with Moderna. A redesigned vaccine could delay Pfizer’s product launch by at least two years.
In June of this year, Moderna announced that its COVID-19/flu combination vaccine showed comparable efficacy to standalone vaccines, positioning the mRNA vaccine manufacturer to seek approval for its third product. Moderna’s Phase 3 clinical trial, which evaluated the antibody response in over 8,000 adults aged 50 and older, found that the combo vaccine was as effective as the company’s standalone COVID-19 vaccine and two commonly used seasonal flu vaccines, Fluzone and Fluarix, across different age groups.
Pfizer COVID-19/Flu Combo Vaccine Underperforms in Late-Stage Trial, Lagging Behind Competitors
(source:internet, reference only)
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