Biologics

FDA Confirms Moderna Vaccine Efficacy Ahead of Panel Vote

FDA briefing information released in advance of a 12/17 advisory committee meeting confirms that Moderna’s investigational Covid-19 vaccine (mRNA-1273) efficacy in preventing Covid-19 was 94.5%. There were five Covid-19 cases in the vaccine group and 90 cases in the placebo group, the agency says, adding that “subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe Covid-19.”

The briefing document said secondary efficacy analyses show a vaccine benefit in preventing severe Covid-19 (11 protocol-defined severe Covid-19 cases in the placebo group vs. 0 cases in the vaccine group). Data also showed vaccine benefit in preventing Covid-19 following the first dose, and in preventing Covid-19 in individuals with prior SARS-CoV-2 infection.

FDA says that the data “supported a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an emergency use authorization...The most common solicited adverse reactions associated with mRNA-1273 were injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%).” It says severe adverse reactions occurred in 0.2% to 9.7% of participants, and were more frequent after the second dose and were generally less frequent in participants over age 65 compared to younger participants.

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