Biologics

Pfizer, Moderna Vaccines Safe & Effective in Children: FDA

FDA briefing documents for its advisory committee review on 6/14-15 of the Pfizer-BioNTech and Moderna Covid-19 vaccines show that they are both safe and effective in children aged six years and younger.

In the Pfizer vaccine, vaccine efficacy was observed at 75.6% in trial participants aged six months to 23 months, and 82.4% effective in children aged two to four years. Meanwhile, the Moderna vaccine showed a 36.8% vaccine efficacy in trial participants aged two to five years, and 50.6% effective in children aged six to 23 months.

On the safety side, FDA briefing documents said there were no cases of myocarditis or pericarditis seen in either vaccine. They said that for the Pfizer vaccine the adverse reactions reported among participants six months through four years of age were lower than those reported among older age groups. And for the Moderna vaccine, FDA said that in children six months through 11 years of age adverse reactions were “generally lower compared to those observed in adolescents and in previous clinical trials with young adults, with the exception of fever which was reported more frequently in the younger age groups compared to adolescents and adults.”

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