Will FDA Speed Up Full Approval Process For Covid Vaccines?
Some public health officials and politicians are calling on the Food and Drug Administration to step up their review, arguing that it would help some hesitant Americans to get vaccinated.
Calls Rise For FDA To Fully Approve COVID-19 Vaccines
Calls are rising from some experts for the Food and Drug Administration (FDA) to move faster to fully approve the COVID-19 vaccines, in what could be a key step to address vaccine hesitancy. As the vaccination rate lags, with the country on pace to miss President Biden’s goal of vaccinating 70 percent of adults by July 4, polling indicates full approval could help convince some of the remaining unvaccinated people to get the shots. (Sullivan, 6/27)
Arkansas Governor Says Final FDA Approval Of COVID-19 Vaccine Would Help Fight Hesitancy
Arkansas Governor Asa Hutchinson said Sunday he believes final, non-emergency use approval from the Food and Drug Administration (FDA) of coronavirus vaccines would help combat hesitancy among Arkansas residents to get their shots. "Whenever they see emergency use authorization, then they say, well, they haven't made a final approval, they haven't got all the research completed that is needed on there. They want to do more study. And so it was approved as emergency use," Hutchinson, a Republican, said in an interview on "Face the Nation." "And so for that reason, you can't mandate it. We don't mandate it in Arkansas. We have to rely upon the education." (Quinn, 6/27)
How Full FDA Approval Could Pave The Way For COVID-19 Vaccine Mandates
In reality, vaccines that have been given an EUA have gone through a rigorous examination by the FDA that is very similar to its full approval process. In the case of the authorized COVID-19 vaccines, the FDA evaluated data from clinical trials that included tens of thousands of study participants, as well as the companies’ manufacturing plans to ensure the quality and consistency of the vaccines. An EUA is only given after the FDA’s Vaccines and Related Biological Products Advisory Committee—15 scientists with expertise in immunology, epidemiology, vaccine safety, and more—determines the “known and potential benefits outweigh the known and potential risks of the vaccine,” according to the FDA. (Kramer, 6/11)