Biologics

Limited Covid Vaccines OK’d for Upcoming Season

FDA has approved supplemental BLAs from Moderna and Pfizer/BioNTech for their mRNA Covid-19 vaccines with 2025-2026 formulations that target the LP.8.1 variant of SARS-CoV-2, which is the dominant circulating strain of the disease. The agency also approved Novavax’s Nuvaxovid Covid vaccine for 2025-2026 season.

The approval for Moderna covers Spikevax and its use in individuals six months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from Covid-19, and all adults 65 years of age and older. mNexspike, Moderna's new Covid-19 vaccine, was also approved for individuals 12 through 64 years of age with at least one underlying condition, and all adults 65 years of age and older.

The Pfizer approval of vaccine Comirnaty is intended for use in adults aged 65 years and older, as well as in individuals aged 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes. And Novavax’s Covid vaccine is approved for use in adults 65 years and older or individuals 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes.

The approval actions were first announced by HHS secretary and vaccine skeptic Robert F. Kennedy Jr. in a X post. He said previous emergency use authorizations for Covid vaccines “once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” by the approvals. He said the Covid-19 vaccines “are available for all patients who choose them after consulting with their doctors. The American people demanded science, safety, and common sense. This framework delivers all three.”

The vaccines will next need authorization from the CDC's Advisory Committee on Immunization Practices (ACIP). Kennedy recently replaced all of the panel members, and it now includes some opposed to Covid vaccines.

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

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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