The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and olderThe KP.2 adaptation is based on FDA guidance, which stated that KP.2 is the preferred strain for COVID-19 vaccines for the US 2024-2025 fall and winter season, if feasibleShipping will begin immediately to ensure robust supply and rapid access of this season’s vaccine in pharmacies, hospitals, and clinics across the country NEW YORK and MAINZ, GERMANY ...

The Food and Drug Administration on Thursday approved updated Covid vaccines from Pfizer and Moderna, putting the new shots on track to reach most Americans in the coming days amid a summer surge of the virus. The jabs target a strain called KP.2, a descendant of the highly contagious omicron subvariant JN.1 that began circulating widely in the U.S. earlier this year. KP.2 was the dominant Covid strain in May, but now only accounts for roughly 3% of all U.S. cases as of Saturday, according to the latest Cen ...

Last week, Pfizer (PFE) and partner BioNTech (BNTX) 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 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 comparabl ...

Pfizer (PFE) and partner BioNTech (BNTX) 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 demo ...

A clinical-trial failure for Pfizer and BioNTech means Moderna is leading the race to develop a combo shot for the flu and COVID-19.Pfizer (PFE -1.43%) and BioNTech (BNTX -2.36%) recently fell behind in their race with Moderna (MRNA 0.25%) to develop new combination shots that could be worth billions in annual sales. Top-line results from an experimental vaccination to protect against influenza and COVID-19 weren't a complete disaster, but there isn't much room for error when it comes to vaccine development ...

Core Insights - Pfizer's stock has declined by 46% since early 2022, primarily due to a significant drop in revenue and earnings as the pandemic-related results faded [1] - Recent second-quarter results indicate a potential recovery for Pfizer, with sales reaching $13.3 billion, marking a 2% year-over-year increase [2] Revenue Performance - In 2022, Pfizer achieved $100 billion in sales, a milestone in the biopharmaceutical industry, largely driven by its COVID-19 products [2] - Excluding the COVID-19 portfolio, Pfizer's revenue would have increased by 14% in the second quarter of 2024, indicating strong underlying performance [3] Guidance and Projections - Pfizer raised its full-year revenue guidance from a range of $58.5 billion to $61.5 billion to a new range of $59.5 billion to $62.5 billion, reflecting a $1 billion increase [4] - The adjusted earnings-per-share guidance was also upgraded from $2.15-$2.35 to $2.45-$2.65 [4] Product Development and Market Position - Pfizer has received seven new approvals in the past year, with ongoing development of new products, including a GLP-1 candidate for weight loss [5] - The acquisition of Seagen for $43 billion is expected to enhance Pfizer's oncology portfolio, providing future growth catalysts [5] Valuation and Dividend Appeal - Pfizer's forward price-to-earnings ratio stands at 10.8, significantly lower than the healthcare industry average of 18.3, suggesting the stock is undervalued [6] - The company offers a dividend yield of 5.88%, having increased its payouts by nearly 17% over the past five years, appealing to value and dividend investors [6]

Investors were cautiously pessimistic about the latest news coming out of the company's lab.In the thick of the coronavirus pandemic several years ago, any positive news from a developer of COVID-19 vaccines or drugs would have been met with a surge of buying in its stock. We're not in 2021 anymore, though, and an encouraging development from Pfizer (PFE -1.43%) on a combination COVID/influenza jab was met with a collective shrug by the market. In fact, investors traded out of the stock to the point that it ...

Key TakeawaysThe experimental COVID-19/flu vaccine from Pfizer and BioNTech missed one of two key endpoints in a Phase 3 study.The companies reported that while the shot worked against COVID-19 and influenza A, it fell short versus influenza B.Pfizer and BioNTech said they are evaluating adjustments to the vaccine. Shares of Pfizer (PFE) and American depositary receipts (ADRs) of BioNTech (BNTX) dropped in intraday trading Friday following disappointing results from a late-stage study of the drugmakers' co ...

Pfizer logo is seen on Pfizer World Headquarters in Manhattan, New York, United States of America, ... [+] on July 6th, 2024. (Photo by Beata Zawrzel/NurPhoto via Getty Images)NurPhoto via Getty ImagesWith Pfizer’s sales rising in Q2, despite falling sales of Covid-19 products, we think that it may well be the turning point for Pfizer stock. It has seen a decline of 15% from levels of $35 in early January 2021 to around $30 now, vs. an increase of about 65% for its peer, Merck stock (NYSE: MRK), over this p ...

Core Insights - Pfizer and BioNTech's Phase 3 trial for a combination vaccine against influenza and COVID-19 met one of its two primary immunogenicity objectives, specifically achieving robust responses against influenza A and comparable responses against COVID-19, but did not meet the non-inferiority objective for the influenza B strain [1][2][3] - The companies are considering adjustments to the combination vaccine candidate and will engage with health authorities regarding next steps [1][2] - Pfizer's separate Phase 2 trial for a second-generation trivalent influenza mRNA vaccine showed promising results, demonstrating strong immunogenicity against all strains compared to standard influenza vaccines [1][5] Phase 3 Trial Details - The Phase 3 trial enrolled over 8,000 adults aged 18-64 to assess the safety, tolerability, and immunogenicity of a single-dose combination vaccine [2] - The trial compared the combination vaccine to a licensed influenza vaccine and the companies' licensed COVID-19 vaccine, focusing on antibody responses to both influenza and SARS-CoV-2 [2] - The combination vaccine elicited robust responses for influenza A but lower geometric mean titers for influenza B, while showing comparable responses against SARS-CoV-2 [2] Company Statements - Pfizer expressed optimism about the results, highlighting the robust immunogenicity against influenza A and the commitment to developing vaccines that address respiratory diseases [3] - BioNTech emphasized the importance of the insights gained from the trial for future development of combination vaccines [3] Phase 2 Trial Insights - Pfizer's Phase 2 trial for second-generation influenza vaccines involved 450 participants and aimed to improve immunogenicity and breadth of protection [5] - The new trivalent formulations showed strong responses against influenza A and B, with no safety signals reported [5] Industry Context - Influenza causes significant health burdens in the U.S., with annual hospitalizations ranging from 140,000 to 710,000 and deaths between 12,000 and 52,000, leading to economic losses of approximately $25 billion [7] - Current influenza vaccines typically provide 40% to 60% protection, with lower efficacy in years of poor strain matching, highlighting the need for improved vaccine technologies like mRNA [7]