One of President-elect Joe Biden’s COVID-19 task force advisers expressed confidence in the vaccine approval process in the U.S., despite months of worry over undue political pressure on the Food and Drug Administration (FDA).
Dr. Céline Gounder, a professor and infectious disease doctor at NYU Langone Health, told Yahoo Finance Wednesday that while having two vaccines “should be seen as light at the end of the tunnel. The fact is that ... we still have a ways to go.”
While many worry about the speed at which the vaccines have been developed and tested, Gounder said she believes the vaccine authorizations will be based on proper regulatory reviews.
“What you’re seeing is a return to business as usual,” she said.
An emergency use authorization “will be an indication of safety and efficacy,” but the incoming administration will continue to monitor the vaccine through “a full approval process,” Gounder added.
But without the transition team being allowed access to the regulatory body, as well as being given any insight into the contracts with vaccine makers through Operation Warp Speed, it is impossible for the team to prepare accordingly — or know if the operation needs to continue.
“We’re not being allowed to have those conversations with career officials who have access to that data that we do not have access to now,” Gounder said. Little else is known about what efforts and policies the Biden administration can pursue or implement.
But Gounder anticipates a similar timeline for vaccines as that of National Institute of Allergy and Infectious Diseases director Dr. Anthony Fauci.
“The vaccines will not be available to the general public until April or May,” she said.
In the interim, masking, social distancing and attention to testing and contact tracing is crucial.
“If you do each of those things, the mask-wearing and so on, we are very concretely saving lives during that time,” Gounder said, adding, “We still have a little ways to go.”
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