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.” 

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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

 

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