Biologics

Vaccines Panel Mulls Omicron Boosters

FDA’s Vaccines and Related Biological Products Advisory Committee is meeting 6/28 to discuss whether and how the SARS-CoV-2 strain composition of Covid-19 vaccine boosters should be modified for use this fall and winter. This is a follow-up meeting to a 4/6 panel deliberation that discussed how the primary Covid-19 vaccinations and booster shots have decreased effectiveness against the Omicron variants and waning effectiveness over time. Some health experts predict another late-year Covid infection wave as people remain indoors again during the colder months, and the agency has said a decision must be made this summer for the vaccines to be available in November.

Both Pfizer-BioNTech and Moderna have studied newer vaccines that are based on the current Omicron variant that the panel members will be reviewing. “The current epidemiology of SARS-CoV-2, the evidence of waning immunity elicited by current Covid-19 vaccines, and the available immunogenicity data generated from a limited number of variant-specific vaccine candidates suggest that an updated vaccine composition may provide added benefit against currently circulating virus variants,” a just-released FDA briefing document says.

FDA says the only voting question panel members have is: “Does the committee recommend inclusion of a SARS-CoV-2 Omicron component for Covid-19 booster vaccines in the U.S.?”

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