Biologics

Pfizer Seeking Vaccine EUA for Tots: Reports

Pfizer/BioNTech reportedly have started submitting data to FDA to support an emergency use authorization for their Covid-19 vaccine for use in children aged six months to four years old. Bloomberg News reports it learned of the rolling submission of data from sources familiar with the situation.

The news service reports that parents and the Biden administration have been pushing the companies to move faster to get vaccines cleared for younger kids, especially when the omicron variant caused pediatric infections to jump.

Meanwhile, FDA late Tuesday (2/1) announced a 2/15 virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the Pfizer-BioNTech EUA request. “The need for a safe and effective vaccine for our youngest children is significant, particularly given the rapid spread of the omicron variant, the notable rise in the number of hospitalizations in young children with severe disease, and the possibility that future variants could cause severe disease in those who are unvaccinated,” CBER director Peter Marks is quoted in a release as saying. “As we have done for other COVID-19 vaccine authorizations, this meeting will help ensure that the public has a clear understanding of the data and information the FDA will evaluate as it considers whether to authorize the vaccine. We are committed to a transparent process, which will include input from our external advisors.”

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