FDA poised to announce tougher standards for a Covid-19 vaccine that make it unlikely one will be cleared by Election Day

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The FDA stated it would communicate additional guidance as per the criteria to obtain an emergency clearance. It is in an effort to enhance public confidence in the agency. Supporters of the FDA would also wish to highlight agency career scientists, in particular the one responsible for the vaccine-approval process. He has threatened to resign if he is pressured to approve a vaccine before he believes it to be safe and effective.

The White House contradicts the agency and their scientists often. Moreover, there are critics who believe no emergency authorization should be given to a vaccine.

“Things are so revved up right now that there is quite a possibility that the American public won’t accept a vaccine because of all the things that are going on,” said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. “U.S. history is littered with good vaccines that get voted off the island because of bad public perceptions.”

Just last week Alex Azar, the secretary of health and human services , sought to revoke the FDA authority and other agencies. Here is a comment from HHS: the change “minimizes litigation risk … prevents potential future abuse of authority, and is consistent with congressional intent.” They mentioned that this action will not impact the FDA’s work on vaccines and covid-19 treatments.

Nevertheless, FDA experts criticized the timing as pressure mounts on the vaccine-approval decision. “Why take this health decision-making away from public health agencies like FDA at this particular moment?” said Patricia Zettler, an Ohio State University law professor and former associate chief counsel at the FDA.

The FDA, will require data for an emergency authorization that is more proximate to a full approval. Officials indicated that a higher standard is necessary because the vaccine is given to healthy people and should be both safe and effective with more certainty of said outcome.

The FDA recognized that any emergency authorization would be decided with less safety data than would be expected for a typical approval. They will require a study to follow up with participants in their clinical trial for a significant duration to determine whether or not problems occur for the patient after the dosage.

Many officials have made criticisms about the FDA decision of emergency authorizations for hydroxychloroquine and convalescent plasma.

The FDA would benefit with more health leaders and scientists giving their voice from inside and outside the government for the public to accept a given vaccine, said Daniel Carpenter, a Harvard University professor of government. Experts such as Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, could strongly influence public opinion with his endorsement, he said.

A group of high caliber individuals are ready to articulate their backing of FDA career officials, via webinars and podcasts. Advocacy groups, pharma officials, bioethicists and a bipartisan group of former commissioners. Mark McClellan, FDA chief during the George W. Bush administration; Obama administration commissioners Margaret Hamburg and Robert Califf; and Scott Gottlieb, Trump’s first FDA commissioner encompass this support group.

“The four of us feel this is the time for us to step forward,” Califf said. “We don’t speak jointly often, but when we do, it signals an important issue that deserves attention.”

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