WASHINGTON, DC – Congressman Andy Kim today expressed concerns about the potential of an Emergency Use Declaration for a coronavirus vaccine and called for a clear articulation of all steps being taken to ensure a safe and effective vaccine is approved through evidence-based measures alone.
In a letter to Dr. Stephen Hahn, Commissioner of the Food and Drug Administration (FDA), Rep. Kim wrote, "As trials advance from Phase III into a potential Emergency Use Authorization (EUA) approval process during this time, we have a responsibility to ensure that safety and efficacy are not compromised. Furthermore, we have a responsibility to the public to provide clarity and confidence in any upcoming vaccine.”
"The rapid turnaround time expected by President Trump, who has indicated that a vaccine may be available before the November 3 election, further hastens testing time for these new vaccines and stands in direct contrast to the guidance provided by public health experts," continued Rep. Kim. "Here, I want to emphasize how important it will be to determine approval based on evidence alone.”
In the letter, Congressman Kim asked the following questions of Commissioner Hahn, requesting answers by September 1, 2020.
- Does the FDA plan to utilize an EUA for one or more coronavirus vaccines? If so, how many vaccines is the FDA expecting to receive EUA authorization?
- How does the FDA plan to demonstrate to the American people that the vaccines will be approved on the basis of evidence and not influenced by politics?
- If an EUA is used, how exactly does the FDA plan to shorten a typical approval time of one to two years into one to two months without sacrificing quality and safety?
- What parameters is the FDA using to assess the vaccine candidates? How do these parameters differ from those adhered to during assessments of traditional candidates?
- How does the FDA plan to assess vaccine approaches which have never been developed and scaled before, such as the mRNA candidates, in a one to two month time period?
- What process will the Data Safety Monitoring Board follow in order to assess and/or audit all vaccine candidates equally and effectively?
- What monitoring measures will be put in place at the national and subnational levels to ensure there are no adverse side effects from any COVID-19 vaccine?
- How will the FDA be working with other agencies like DoD to ensure proper production and deployment and distribution of a vaccine?
The letter in its entirety can be found HERE.