Ex-Obama FDA chief trusts the agency’s approval process



Dr Margaret Hamburg, a former commissioner of the Food and Drug Administration in the Obama administration, told CNBC on Wednesday that she is confident that the regulatory agency will adhere to strict scientific principles when evaluating coronavirus vaccines.

“It’s an agency so committed to strong science, the integrity of the people who work there,” Hamburg said on “Closing Bell”. “And I have real confidence that everyone there has been working 24/7 to help speed up the process of vaccine development and revision as much as possible, but that there will be no cuts in ensuring the soundness of the scientific data that will be decided on. be taken. “

Earlier Wednesday, US pharmaceutical giant Pfizer and its German partner BioNtech said they would apply for emergency use authorization from the FDA “within days” after final data showed their vaccine was 95% effective in preventing Covid-19. . The top official from the Department of Health and Human Services, who oversees the FDA, has said it will be “as soon as possible” to approve the restricted-use vaccines.

Once a vaccine is approved, it’s critical that much of the American public gets it, said Hamburg, who led the FDA from 2009 to 2015. However, there is significant hesitation among Americans regarding a coronavirus vaccine, according to opinion polls. According to an October Gallup poll, 58% of people said they would receive a vaccine. That’s an improvement from September, when 50% of Americans said they would.

“Trust is a huge problem,” said Hamburg. “We can have the world’s most safe and effective vaccine, and if people don’t trust it and don’t trust it, they won’t use it, and in fact it won’t be of any use to the epidemic and destroying this global one. pandemic. “

Some Americans, particularly Democratic voters, were concerned that the vaccine had become politicized in the run-up to the November 3 election. For example, President Donald Trump had said repeatedly that a vaccine could be ready for election, a timeline faster than health officials gave, leading some to believe scientific principles could be sacrificed for electoral politics.

In addition to releasing data from Pfizer, Moderna announced on Monday that its Covid-19 vaccine is nearly 95% effective at preventing the disease, based on preliminary results. The Massachusetts-based biotech company said it would apply for an emergency use permit from the FDA in the coming weeks.

A group of advisers have been asked by the FDA to set aside three days early next month for potential meetings, a critical part of the agency’s authorization process for a Covid-19 vaccine, CNBC reported earlier Wednesday. People familiar with the plans told CNBC’s Meg Tirrell that the advisory group could be asked to evaluate both Moderna and Pfizer’s vaccines.

Although vaccine development has accelerated in response to the pandemic, which killed more than 1.3 million people worldwide, Hamburg said the process was conducted with integrity. “There are strict scientific standards applied to the development process,” she said.

Along with FDA officials, an outside group of “prominent, experienced” scientists will assist in evaluating the vaccine candidate, Hamburg added. “I think that should also help reassure people if they make a strong recommendation to allow this authorization to go ahead.”


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