08/10/2020 | Press release | Distributed by Public on 08/10/2020 15:59
SCHAUMBURG, IL - Congressman Raja Krishnamoorthi issued the statement below in response to an article in the Journal of the American Medical Association authored by FDA's leadership stating specifically, 'Given the widespread potential use of a COVID-19 vaccine, transparent discussion at FDA's Vaccines and Related Biological Products Advisory Committee [VRBPAC] will be needed prior to vaccine authorization or licensure to ensure clear public understanding of the evidence supporting vaccine safety and efficacy.' The article was authored by FDA Commissioner Stephen Hahn, M.D., FDA Deputy Commissioner for Medical and Scientific Affairs Ananda Shah, M.D., and Center for Biologics Evaluation and Research Director Peter Marks, M.D., PhD.:
'I'm glad to see that the FDA appears to agree with me and others that a review of any COVID-19 vaccine by the Vaccines and Related Biological Products Advisory Committee is necessary to ensure public confidence in such a vaccine's safety and efficacy,' said Congressman Raja Krishnamoorthi. 'This growing consensus only reaffirms the importance of VRBPAC review as a required component of any vaccine's approval and that's precisely what I introduced the EVALUATE Act to do.'
The EVALUATE Act would require the FDA to first solicit and consider advice from VRBPAC before licensing or authorizing any potential COVID-19 vaccine. Such advice would have to pertain to the safety and efficacy of the vaccine and whether there should be additional studies to evaluate the vaccine. This advice would be received at a meeting open to the public, and all materials presented for or by the Advisory Committee would have to be promptly made available to the public.
The text of the bill can be found here.