Drugs

Moderna Covid Vaccine 95% Efficacy: Interim Analysis

Moderna says its investigational Covid-19 vaccine is showing a 94.5% efficacy rate based on a NIH-appointed data safety monitoring board interim analysis. The COVE study, which enrolled more than 30,000 participants to evaluate the company’s messenger RNA vaccine (mRNA-1273) has reached 95 Covid-19 cases — 90 observed in the placebo group versus five in the vaccine group, according to Moderna. The analysis also examined the study’s secondary endpoint of severe Covid-19 cases and found 11 such cases, all within the placebo group. The analysis did not show any significant safety concerns. Moderna says preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.

The company plans to submit to FDA an Emergency Use Authorization (EUA) and seek similar authorizations from other global regulatory agencies. “By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S,” it says. “The company remains on track to manufacture 500 million to 1 billion doses globally in 2021.”

Moderna joins Pfizer as the only companies to report interim results from Covid-19 vaccine trials thus far. Last week, Pfizer and BioNTech’s vaccine is more than 90% effective in preventing the virus based on the evaluation of 94 Covid cases in participants, according to their interim analysis (see earlier story). Pfizer says an emergency use authorization submission could be completed later this month, which will then trigger an FDA an advisory committee meeting to review data and make recommendations on the vaccine’s availability.

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