Biologics

Makary Suggests Raising Bar on Covid Boosters

FDA commissioner Marty Makary continues to suggest that the bar is moving for Covid-19 vaccine boosters, telling CBS News in a 4/29 interview that the last study Novavax had conducted to demonstrate clinical benefit was from 2021 “and it excluded people with prior Covid infection. Now, essentially everyone has natural immunity. So it’s my general feeling, not with this particular product, which I can’t discuss in depth, but with drugs in general, that we need to know if they work today in order to be able to recommend them.

“So,” he continued, “we are asking some companies, in general, to do clinical studies, a basic clinical study, so we can educate the population and have information to work with.” Makary questioned whether a 12-year-old, thin, healthy girl should get a seventh Covid-19 shot this year? “I don't know the answer to that, because we don’t have good clinical data.”

CBS correspondent Major Garrett asked Makary about political appointee Tracy Beth Høeg who was asked to evaluate the Novavax vaccine data. "Dr. Høeg is an amazing MD-PhD who has joined my staff as a special assistant to the commissioner. And she is involved in reviewing data sets at the agency. And I'm really excited to have her in the process," Makary said.

As for Covid shots for next winter, Garrett asked if FDA is still planning to approve booster updates to current vaccines. “We’re taking a look,” Makary said. “I can't comment on any particular application. As you know, we have a bunch of applications for those booster shots. Remember, Major, 85% of American health care workers said no to the last Covid booster, so we have a bit of a public trust problem. I think there’s a void of data, and I think rather than allow that void to be filled with opinions, I'd like to see some good data.”

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