Biologics

Vaccine Decisions ‘Based on Good Science, Data’: Hahn

FDA commissioner Stephen Hahn has written a Washington Post opinion column to reassure Americans that “all FDA decisions (on Covid-19 vaccines) have been, and will continue to be, based solely on good science and data. The public can count on that commitment.” In the column, Hahn says that while testing of vaccine candidates is underway and manufacturing capacity is rapidly expanding, “the development effort must adhere to standards that will ensure any Covid-19 vaccine’s safety and effectiveness.”

He notes that FDA already has stated that any authorized or approved Covid-19 vaccine would have to show that it prevents the disease or decreases its severity in at least 50% of people who are vaccinated. “This is a reasonable standard given the nature and impact of the pandemic,” he adds.

Hahn also stresses that a key element in FDA’s testing requirements is assuring diversity among the test subjects. He says that “all phases of vaccine clinical development should include the people most affected thus far by Covid-19, specifically racial and ethnic minorities, elderly individuals, and people with other medical conditions. Only by gathering data on these populations can we gain a full understanding of a vaccine candidate’s safety and effectiveness.”

Hahn concludes with a definitive statement that every FDA resource has been and will continue to be at the ready to facilitate clinical testing programs and to review clinical data and manufacturing facilities. “I can provide further assurances that any vaccine authorized for widespread use will meet the appropriate standards for quality, safety, and efficacy,” he says.

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

Read more

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