Biologics

FDA Issues EUA for Moderna Covid-19 Vaccine

FDA 12/18 issued an Emergency Use Authorization (EUA) for Moderna’s Covid-19 vaccine for use in individuals 18 years of age and older. The EUA follows a 20 to 0 advisory committee vote the day before recommending its issuance. Shipments of almost six million vaccine doses could begin early next week.

An FDA release says the vaccine was 94.1% effective in preventing Covid-19 disease among clinical trial participants with 11 cases of Covid-19 in the vaccine group and 185 in the placebo group. “At the time of the analysis of these 196 Covid-19 cases, none in the vaccine group and 30 in the placebo group were classified as severe,” it says. “After the analysis of these 196 cases was completed, one severe case in the vaccine group was identified and is awaiting confirmation. At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.”

The most common adverse reactions associated with the vaccine reported by clinical trial participants were injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%).” FDA says that the EUA requires mandatory reporting from Moderna and vaccination providers on the following to the agency’s Vaccine Adverse Event Reporting System: all vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of Covid-19 that result in hospitalization or death.

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