Biologics

CDC Backs Most of FDA EUA for Covid Booster

(Update 9/24): Less than 24 hours after FDA amended the emergency use authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine to allow a booster dose for certain adults, the Centers for Disease Control and Prevention (CDC) 9/23 narrowed the recommended shots to exclude front-line and other workers who might be at a greater risk for getting serious Covid disease. The CDC did, however, recommend the remaining FDA booster indications — people 65 and older and certain people with underlying conditions. Updated: Overnight, the CDC clarified that other groups (frontline and healthcare workers) may receive a booster shot based on their individual risk and benefit. This group did not get a recommendation that they should get a booster shot.

FDA late 9/22 amended the EUA, following a 9/17 unanimous recommendation (see earlier story) to permit the booster in a limited population. Panel members had earlier rejected a proposal to recommended broader booster shots — for those aged 16 years and older.

During the meeting, panel members were not overwhelmingly convinced that current data supported widespread booster shots among those already fully vaccinated. In a briefing document, FDA noted that “overall data indicate that currently U.S.-licensed or authorized Covid-19 vaccines still afford protection against severe Covid-19 disease and death in the United States.”

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