Biologics

FDA, Expert Debate Bivalent Covid Vaccine Deployment

FDA commissioner Robert Califf and CBER director Peter Marks are airing their disagreement with Children’s Hospital of Philadelphia Vaccine Education Center director Paul Offit over Covid-19 vaccine strategy in a series of letters in the New England Journal of Medicine. In a 2/9 Perspective, Offit cited preliminary immunogenicity results and one effectiveness study to argue that the Covid-19 bivalent boosters should not be deployed throughout the entire U.S. population.

In a letter in the 3/1 issue, Califf and Marks cite another study that found the bivalent boosters had better immunogenicity against emerging variants than the monovalent boosters. “Given the excellent safety profile of the vaccines … the totality of the available evidence supports the vaccination of all currently eligible persons with updated Covid-19 vaccines as an important public health intervention,” Califf and Marks write.

In response, Offit says the study cited by Califf and Marks did not have statistically significant efficacy results. He says Califf and Marks were correct that the bivalent boosters have enhanced protection against symptomatic disease in 18-to-49-year-olds, at least in the short term. “However,” he continues, “the protection against hospitalization that was afforded by bivalent boosters, which is the goal of this vaccine, was limited to people over 65 years of age, and those with a median age of 76. Booster administration should be targeted to the groups most likely to be hospitalized — specifically, persons who are elderly or immunocompromised, have multiple coexisting conditions, or are pregnant.”

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

Read more

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