Biologics

FDA Questions J&J Covid Vaccine Booster Data

Although not taking a position on whether FDA should approve a booster shot for the Johnson & Johnson Covid-19 vaccine, agency reviewers are raising questions about the company’s evidence for such boosters. In a briefing document released in advance of a 10/15 meeting of the Vaccine and Related Biological Products Advisory Committee to consider the company’s request for booster shot authorization, agency reviewers say a test used by the company was likely not sensitive enough to accurately determine the benefit of a booster shot. They also said they didn’t have enough time to independently review much of the trial data submitted by J&J in support of its application to expand the vaccine’s emergency use authorization to include a booster shot six months after the primary shot.

Members of the advisory committee are being asked to discuss:

whether the J&J data support the safety and effectiveness of its Covid-19 vaccine for a booster dose at least two months after a single-dose primary vaccination; and
whether the data support that an interval of at least six months between the primary vaccination and booster dose may result in a more robust booster response.

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