FDA Approves Pfizer’s RSV Vaccine for Adults 18-59

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FDA approved the first vaccine for adults ages 18-59 for respiratory syncytial virus (RSV). Pfizer announced in a press release that Abrysvo was approved after positive results from its Phase 3 trials. Abrysvo offers protection against lower respiratory tract disease (LRTD), which can be caused by RSV.

The vaccine had previously been approved for individuals over 60 years and older. It is also the only RSV vaccine approved for pregnant individuals at 32-36 weeks.

In a press release, Pfizer’s chief US commercial officer and executive vice president Aamir Malik said, “RSV represents a significant threat to younger adults with certain chronic conditions. After decades of vaccine research by the scientific community and Pfizer, we now have the opportunity to help alleviate the burden of RSV in this high-risk adult population. With this approval, we are proud that Abrysvo is now the only RSV vaccine indicated for adults aged 18 to 49 at increased risk for the disease, expanding on its existing indications for older adults and pregnant women.”

This is the latest FDA approval for Pfizer. The company recently announced that FDA approved Hympavzi for the treatment of hemophilia A or B without inhibitors for adults and adolescents.² This drug is the first drug of its kind to be administered via a pre-filled pen or syringe and also the first once-weekly subcutaneous prophulactic hemophilia A or B treatment.

In a press release issued at the time, Suchitra S. Acharya, M.D., director at the Hemostasis and Thrombosis Center Northwell Health and program head of the bleeding disorders and thrombosis program at Cohen Children’s Medical Center, said, “The approval of Hympavzi is a meaningful advancement for people living with hemophilia A or B without inhibitors for bleed prevention, with a generally manageable safety profile and a straightforward once-weekly subcutaneous administration. Hympavzi aims to reduce the current treatment burden by meeting an important need for these patients, including many who have required frequent, time-consuming intravenous treatment infusion regimens.”

“Hympavzi is Pfizer’s second hemophilia treatment to receive FDA approval this year and is the latest meaningful scientific advancement in our more than 40-year commitment to improve care for people living with hemophilia,” said Malik. “We look forward to launching this latest medical breakthrough and to now offer three distinct classes of hemophilia medicines–an anti-TFPI, gene therapy, and recombinant factor treatments–that can meet the unique treatment needs of a wide range of patients.”

In other recent news for Pfizer, the board of directors elected Tim Buckley to join its ranks.³ In a press release, Pfizer CEO and chairman of the board Albert Bourla said, “We are pleased to welcome Tim Buckley to Pfizer’s Board of Directors. Tim is a widely respected business leader with deep expertise in global investment management, financial markets, and operations and someone who values a shared sense of purpose, all of which will be an asset to Pfizer and our shareholders.”

In the same press release, Buckley said, “I'm honored to join Pfizer’s Board of Directors, a group of leaders with distinguished careers in science, government, academia, technology and business. I'm impressed with Pfizer’s dedication to patients and focus on innovation to improve health. I look forward to working with the Board and management to support the breakthroughs that change patients' lives while concurrently driving long-term shareholder value.”

Sources

1. U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults Aged 18 to 59 at Increased Risk for Disease. Pfizer. October 22, 2024. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-rsv-vaccine-abrysvor-adults-aged-18
2. U.S. FDA Approves Pfizer’s HYMPAVZI™ (marstacimab-hncq) for the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors. Pfizer. October 11, 2024. Accessed October 23, 2024. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-hympavzitm-marstacimab-hncq
3. Tim Buckley Elected to Pfizer’s Board of Directors. Pfizer. October 15, 2024. Accessed October 23, 2024. https://www.pfizer.com/news/press-release/press-release-detail/tim-buckley-elected-pfizers-board-directors