FDA panel recommends Pfizer RSV vaccine for older adults

Happy March—and Women’s History Month. Today, we have news on Pfizer’s RSV vaccine for older adults and Acceligen’s gene-edited pigs that are resistant to a deadly disease. (650 words, 3 minutes, 15 seconds)

FDA panel recommends Pfizer RSV vaccine for older adults

A Food and Drug Administration (FDA) advisory panel yesterday recommended Pfizer’s RSV vaccine candidate for older adults, making approval of the first RSV vaccine in the U.S. likely by spring.

The news: By a 7-4 vote, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended approval of Pfizer’s RSVpreF vaccine for respiratory syncytial virus (RSV) for adults over 60.

Why it matters: RSV is particularly dangerous for older adults, says the Centers for Disease Control and Prevention (CDC). BIO member Pfizer’s single-dose vaccine was as much as 86% effective at reducing the risk of illness from RSV in a phase 3 clinical trial.

Up next: The vaccine candidate by BIO member GSK, which the advisory committee will consider today. Additional BIO members—Bavarian Nordic, Johnson & Johnson, and Moderna—will likely seek approval of their candidates before the fall RSV season, too.

Pediatrics could get a long-awaited immunization for infants—another cohort at serious risk, as Sanofi, Merck and Pfizer present to the FDA for approval, as Bio.News recently reported. 

What happens next: The FDA will decide by May whether to approve Pfizer’s RSVpreF for adults over 60. FDA usually follows VRBPAC’s recommendations. The CDC, which generally aligns with FDA decisions, would then need to approve it.

More Health News:

Bio.News (Opinion): Will gene therapies for ultra-rare diseases become a cautionary tale – or life-saving products?
Two treatments “represent first-ever gene therapies for these patients whose inherited genetic diseases are usually diagnosed soon after birth and can be deadly. However, at present we have no way to provide these treatments to all patients,” writes Frederic Revah, Ph.D., CEO of Genethon. 

JMCP: Drugs likely subject to Medicare negotiation, 2026-2028
“For 2026, the top [10] drugs projected for negotiation include anticoagulants Eliquis (apixaban) and Xarelto (rivaroxaban), oral antidiabetics Januvia (sitagliptin) and Jardiance (empagliflozin), the tumor necrosis factor inhibitor Enbrel (etanercept), and the inhalers Symbicort (budenoside/formoterol) and Breo Ellipta (fluticasone/vilanterol) (Table 1). Three cancer therapies are projected to be eligible for negotiation in 2026 as well, including the kinase inhibitors Imbruvica (ibrutinib) and Ibrance (Palbociclib) and the antiandrogen Xtandi (enzalutamide).”

These gene-edited pigs are resistant to a deadly disease

Acceligen has developed a new breed of pigs resistant to the devastating disease Porcine Reproductive and Respiratory Syndrome (PRRS), the BIO member company announced Monday.

What’s PRRS? A viral disease that impairs reproduction and attacks the respiratory system in pigs, PRRS costs the pork industry $644 million a year. Vaccines provide limited protection as the virus mutates rapidly, and there are no effective treatments.

Enter gene editing: Researchers at Kansas State University discovered that pigs born without the coding for the CD163 protein in their DNA are resistant to PRRS. Acceligen is gene editing for protein modification to make pigs naturally resistant.

Along with preventing economic loss, “breeding of pigs naturally resistant to PRRS may reduce the environmental impact of pork production by improving efficiency,” says Acceligen.

This isn’t Acceligen’s first rodeo: The company developed gene-edited cattle with a “slick coat” that makes them more tolerant of higher temperatures caused by climate change. As the first gene-edited food animals to receive a Food and Drug Administration (FDA) “low-risk” determination, these cattle can be marketed without prior FDA approval.

What they’re saying: “Gene-editing is one of the most powerful breeding tools that allows us to address some of the biggest challenges facing the pork industry and to create a more sustainable and ethical food system,” says Acceligen CEO Tad Sonstegard.

President Biden’s Wednesday: Giving remarks on his nomination of Julie Su to serve as the Secretary of Labor. “If confirmed by the Senate, she would be the first Asian American to serve as a Cabinet secretary under Biden,” NBC notes.

What’s Happening on Capitol Hill: The Senate Agriculture Committee will hold a hearing on the Farm Bill, focusing on conservation and forestry, with witnesses from the USDA and U.S. Forest Service, followed by a business meeting to discuss the nomination of Margo Schlanger to be Assistant Secretary of Agriculture for Civil Rights.