Biologics

‘Vaccine Experts’ Fear Trump Pressure on Covid Tests: CNN

CNN reports that vaccine experts it contacted are concerned that President Trump will exert political pressure to get a Covid-19 vaccine on the market before it has been fully studied and approved. The report says the experts are asking FDA for assurance that it will not authorize a vaccine unless it has first been studied on at least 30,000 people.

“Each vaccine needs to be tested on at least 30,000 volunteers,” National Institutes of Health director Francis Collins told the news network. “We don’t believe that we have enough power in the analysis to be able to document the vaccine works unless you get to roughly that number.”

New York University bioethicist Art Caplan, who has been a consultant with the federal government and the World Health Organization on vaccines, said he would like to see FDA make such a commitment to encourage trust in the vaccine. “Collins understands that this is necessary to convince a somewhat skeptical public,” Caplan said. The article says a CNN poll last month found that one-third of Americans said they would not try to get vaccinated against the coronavirus, even if the vaccine was low-cost and widely available.

The report says that Oxford University and AstraZeneca have started a Phase 3 trial on their vaccine candidate that is expected to involve 42,000 people. Moderna expects to start a Phase 3 trial in July using 30,000 participants.

However, some of the experts who spoke with CNN expressed concern that even if companies intend to enroll sufficient participants, the administration will prematurely approve the vaccines before the end of the trials. “I worry that a desperate White House could bring pressure on FDA to approve something way before it’s ready, just to be able to say ‘We promised you a vaccine and we got you one,’” Caplan said.

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