Biologics

FDA Panel Backs Trivalent Influenza Vaccine for 2027 Season

FDA’s Vaccines and Related Biological Products Advisory Committee has voted to recommend that seasonal influenza vaccines for the 2026–2027 U.S. season use a trivalent formulation, targeting two influenza A strains and one influenza B strain. Panel members voted 7–0 in favor of recommended strains for both egg-based and newer manufacturing platforms, including cell-culture, recombinant protein, and nucleic-acid–based vaccines.

For egg-based vaccines, the panel recommended inclusion of the following viruses:

A/Missouri/11/2025 (H1N1)pdm09-like virus
A/Darwin/1454/2025 (H3N2)-like virus
B/Tokyo/EIS13-175/2025 (B/Victoria lineage)-like virus

For cell-culture, recombinant protein, and nucleic-acid–based vaccines, the recommended strains were:

A/Missouri/11/2025 (H1N1)pdm09-like virus
A/Darwin/1415/2025 (H3N2)-like virus
B/Pennsylvania/14/2025 (B/Victoria lineage)-like virus

The panel recommendations mirrored the globally recommended vaccine composition that FDA suggested in its briefing document.

CDC data presented at the meeting showed the 2025–2026 influenza season has already produced an estimated 24 million to 47 million cases, 310,000 to 710,000 hospitalizations, and 21,000 to 72,000 deaths since 10/1/2025. The season peaked in late December but has recently seen a relative rise in influenza B infections and a decline in influenza A cases.

Hospitalizations also peaked in late December, mirroring the previous season, the CDC said. Among adults, hospitalization rates reached 76 per 100,000 people, the third-highest level recorded since the 2010–2011 flu season. Pediatric hospitalizations ranked second highest during the same timeframe, and the CDC reported 90 pediatric deaths during the current season. Among cases where vaccination status was known, 85% of children who died were not fully vaccinated, according to the agency.

Despite the ongoing burden of seasonal influenza, vaccine uptake continues to fall. CDC data show the number of influenza vaccine doses distributed each season has dropped by about 23% since the 2019–2020 season.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome