Biologics

Panel Backs Pfizer’s RSV Vaccine

FDA’s Vaccines and Related Biological Products Advisory Committee 5/18 voted 14-0 that a Pfizer BLA demonstrated effectiveness for its Abrysvo (RSVpreF) vaccine for preventing respiratory syncytial virus (RSV) in infants from birth through six months by active immunization of pregnant individuals. A separate vote of 10-4 found that the data supported the safety of the vaccine.

In a briefing document released in advance of the committee meeting, agency reviewers said that vaccine efficacy for preventing severe RSV within 90 days after birth was 81.8%, with six cases in the vaccine group and 33 cases in the placebo group. Vaccine efficacy within 180 days after birth was 69.4%, with 19 cases in the vaccine group and 62 cases in the placebo group. Regarding safety, premature births were reported in 5.7% of infants in the vaccine group compared with 4.7% in the placebo group. Agency reviewers said this was a numerical imbalance and “not statistically significant.”

In voting no on the safety question, Children’s Hospital of Philadelphia professor Paul Offit said there were not enough safety data on premature births. “If you’re, in any sense, risking premature births with this vaccine, then I think there will be a big price to pay, and so I guess I just don’t feel we have enough data to be reassured, so that’s why I voted no,” he said after voting.

Scientific advisor and respiratory diseases consultant Daniel Feikin said he was concerned about the preterm birth imbalance but he voted yes because he was not convinced that there’s a clear causal relationship. “I’m still struck by the fact that this study was done in the setting of a pandemic … when so many things were different, and that this signal was not seen in high income countries,” he said. “And the key will be doing really good post marketing surveillance.”

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