Biologics

Advisors to Consider Moderna Vaccine Booster

The FDA Vaccines and Related Biological Products Advisory Committee meets 10/14 to consider Moderna’s request for an emergency use authorization (EUA) for a booster dose of its mRNA Covid-19 vaccine. An agency briefing document released in advance of the meeting contains effectiveness and safety data on the proposed booster shot from 171 adults age 18 and older in an ongoing Phase 2 study who received a booster shot six months after completing a two-dose primary series.

FDA says Moderna is requesting an EUA for a booster dose at least six months after the primary series for:

individuals age 65 and older;
individuals age 18 through 64 at high risk of severe Covid-19; and
individuals age 18 through 64 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19, including severe Covid-19.

The advisory committee is being asked to discuss whether the data Moderna is presenting support the safety and effectiveness of its vaccine for EUA use as a booster dose at least six months after completing the primary series in the specified populations.

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