Biologics

FDA Authorizes Pfizer Bivalent Vaccine for Young Children

FDA has amended the emergency use authorization (EUA) for the Pfizer-BioNTech Covid-19 bivalent vaccine and its use as a single booster dose to include children aged six months through four years at least two months after completing their primary vaccination with three doses of the monovalent vaccine. Previously this vaccine’s EUA was limited to use as a booster in children aged five years and older.

“Today’s authorization provides parents and caregivers of children 6 months through 4 years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech Covid-19 Vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech Covid-19 Vaccine, Bivalent,” CBER director Peter Marks is quoted in a release as saying. “Currently available data show that vaccination remains the best defense against severe disease, hospitalization and death caused by Covid-19 across all age groups, and we encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent Covid-19 vaccine.”

Approval was based on immune response data from 60 children in this age group who had completed primary vaccination with three doses of the monovalent vaccine and received a booster dose of the bivalent vaccine. “One month after receiving the Pfizer-BioNTech Covid-19 Vaccine, Bivalent, the study participants demonstrated an immune response to both the original SARS-CoV-2 virus strain and to omicron BA.4/BA.5,” the agency says.

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