Biologics

Califf Says No Panel Will Review Covid Boosters

FDA commissioner Robert Califf says there will not be any advisory committee meeting to review recent submissions from Pfizer/BioNTech and Moderna that seek emergency use authorizations for new Covid-19 booster vaccines. In an 8/25 Twitter post, Califf said an “extensive discussion” was held in June by the agency’s vaccines advisory committee, which “voted overwhelmingly to include an omicron component in Covid-19 boosters. FDA has no new questions that warrant committee input.”

Califf said FDA will rely on the totality of the available evidence in making a decision on the EUAs, including: Clinical trial data from other bivalent mRNA COVID-19 boosters; real-world evidence from current Covid-19 vaccines administered to millions of people; and Non-clinical data for the bivalent BA.4/5 booster vaccines.

“Bivalent and multivalent vaccines are very common and modifying a vaccine to include different virus strains often does not require a change in other ingredients,” he said. “FDA has extensive experience with reviewing strain changes in vaccines, as is done with the annual flu vaccine.”

It appears the CDC is expecting a positive agency decision on the boosters as early as next week. CDC’s Advisory Committee on Immunization Practices is already scheduled to convene meetings on 9/1-2 to review the boosters, after which CDC director Rochelle Walensky must sign off on the updated boosters before they can be administered to the public

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