DR. Margaret HamburgThe former commissioner of the Food and Drug Administration in the Obama administration told CNBC on Wednesday that she trusts the regulator will use strict scientific principles when making assessments Coronavirus Vaccinations.
“It is an agency that is so committed to strong science and the integrity of the people who work there,” said Hamburg “Close the bell.” “And I’m really confident that everyone there has worked around the clock to speed up the process of vaccine development and review as much as possible, but that no trade-offs are being made to ensure the accuracy of the scientific data on that Decisions are made. ” be made. “
Early Wednesday, US drug company Pfizer and his German partner BioNtech said they would apply for emergency approval from the FDA “within days” after the final data showed their vaccine was 95% effective in preventing Covid-19. The top official of the Department of Health and Human Services, which oversees the FDA, has announced that it will move “as quickly as possible” to approve the vaccines for limited use.
Once a vaccine is approved, it’s important that a large section of the American public get it, said Hamburg, who headed the FDA from 2009 to 2015. However, there is considerable reluctance among Americans to get a coronavirus vaccine, opinion polls show. According to a Gallup poll in October, 58% of people said they were receiving a vaccine. This is an improvement on September when 50% of Americans reported it.
“Trust is a big problem,” said Hamburg. “We can have the safest, most effective vaccine in the world, and if people don’t trust it and trust it, they won’t use it and, in fact, it will be of no use to actually contain the vaccine.” To really suppress epidemic and this global pandemic. “
Some Americans, especially Democratic voters, were concerned The vaccine had been politicized ahead of the November 3rd elections. President Donald Trump, for example, had repeatedly said a vaccine might be ready by choice, a timeline faster than that of the health authorities, which led some to believe in scientific principles can be sacrificed in the interests of electoral politics.
In addition to the publication of its data by Pfizer Moderna announced its Covid-19 vaccine on Monday Almost 95% effective in preventing the disease, based on preliminary results. The Massachusetts-based biotech company announced that it will apply for an emergency approval from the FDA in the coming weeks.
A group of advisors has been asked by the FDA to allow three days for potential meetings early next month, a key component of the agency’s approval process for a Covid-19 vaccine. CNBC reported earlier on Wednesday. People familiar with the plans told CNBC’s Meg Tirrell the advisory group could be asked to evaluate Moderna and Pfizer vaccines.
While vaccine development accelerated in response to the pandemic that killed more than 1.3 million people worldwideHamburg said the process was carried out with integrity. “Strict scientific standards were used in the development process,” she said.
Together with FDA officials, an outside group of “respected, experienced” scientists will help evaluate the vaccine candidate, Hamburg added. “I think that should also help reassure people when they make a strong recommendation for this permit.”