Ex-Obama FDA chief trusts agency’s approval process

Dr. Margaret Hamburg, former Food and Drug Administration commissioner in the Obama administration, told CNBC on Wednesday that she trusts the regulatory agency will adhere to strict scientific principles as it evaluates coronavirus vaccines.”It’s an agency that is so committed to strong science, the integrity of the people who work there,” Hamburg said on “Closing Bell.” “And I really feel confident that everyone there has been working 24/7 to help accelerate the process of vaccine development and review as much as possible but that no corners will be cut in terms of assuring the soundness of the scientific data on which decisions will be made.”Earlier Wednesday, U.S. pharmaceutical giant Pfizer and its German partner BioNtech said they would be applying for emergency use authorization with the FDA “within days,” after final data showed their vaccine was 95% effective in preventing Covid-19. The top official at the Department of Health and Human Services, which oversees the FDA, has said it will move “as quickly as possible” to approve the vaccines for limited use.Once a vaccine is approved, it is critical that a large portion of the American public receive it, said Hamburg, who led the FDA from 2009 to 2015. However, there is significant hesitancy toward a coronavirus vaccine among Americans, public opinion polling shows. According to an October Gallup poll, 58% of people said they would receive a vaccine. That is an improvement from September, when 50% of Americans indicated they would.”Trust is a huge issue,” Hamburg said. “We can have the world’s most safe and effective vaccine, and if people don’t trust it and have confidence in it, they won’t use it, and it won’t be, in fact, of any use in actually curbing the epidemic and really quashing this global pandemic.”Some Americans, particularly Democratic-leaning voters, were concerned the vaccine had become politicized in the runup to the Nov. 3 election. President Donald Trump, for example, had repeatedly said a vaccine could be ready by the election, a timeline faster than health officials were giving, leading some to believe scientific principles may be sacrificed for the sake of electoral politics.In addition to Pfizer releasing its data, Moderna announced on Monday its Covid-19 vaccine was almost 95% effective in preventing the disease, based on preliminary results. The Massachusetts-based biotech firm said it would apply for emergency use authorization with the FDA in the coming weeks.A group of advisors has been asked by the FDA to set aside three days early next month for possible meetings, a critical component to the agency’s authorization process for a Covid-19 vaccine, CNBC reported earlier Wednesday. People familiar with the plans told CNBC’s Meg Tirrell the advisory group could be asked to evaluate the vaccines from both Moderna and Pfizer.While vaccine development has been sped up in response to the pandemic, which has killed more than 1.3 million people globally, Hamburg said the process has been carried out with integrity. “There have been rigorous scientific standards applied to the development process,” she said.Along with FDA officials, an outside group of “distinguished, experienced” scientists will help evaluate the vaccine candidate, Hamburg added. “I think that should also help reassure people if they make a strong recommendation for this authorization to go forward.”

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