Biologics

Pfizer/BioNTech Submit EUA for Covid-19 Vaccine

Pfizer and BioNTech have submitted an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 based on Phase 3 data showing a vaccine efficacy rate of 95%. The latest analysis is based on 170 Covid cases, of which 162 were observed in the placebo group versus eight in the vaccine group. The companies say the data demonstrate that the vaccine was well tolerated across all populations in the 43,000-participant trial. Additionally, there were no serious safety concerns observed, with the only Grade 3 adverse events greater than 2% in frequency being fatigue (3.8%) and headache (2.0%). Pfizer also says that based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.

In response, FDA has scheduled a 12/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss the EUA request. “I want to assure the American people that the FDA’s process and evaluation of the data for a potential Covid-19 vaccine will be as open and transparent as possible,” said FDA commissioner Stephen Hahn. “While we cannot predict how long the FDA's review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible.”

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