WASHINGTON, DC (TIP): On Aug 6, Indian American Rep. Raja Krishnamoorthi (D-IL), Chairman of the House Oversight Subcommittee on Economic and Consumer Policy, introduced the “Expeditious Vaccine Advice with Legitimate, Unbiased, Apolitical, and Technical Expertise Act,” or the “EVALUATE Act,” to require the Food and Drug Administration (FDA) to solicit and consider advice from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) before licensing or authorizing any COVID-19 vaccine. Rep. Krishnamoorthi introduced the bill with all of the Democratic Members of the Subcommittee: Representatives Mark DeSaulnier (D-CA), Ro Khanna (D-CA), Ayanna Pressley (D-MA), Rashida Tlaib (D-MI), Gerald Connolly (D-VA), and Katie Porter (D-CA).
“While it is essential that a COVID-19 vaccine become available to the public as quickly as possible, it is even more important that quality is not sacrificed for speed in testing and evaluating any such vaccine,” said Congressman Raja Krishnamoorthi. “Though the FDA has refused to commit to subjecting coronavirus vaccines to an independent advisory committee, we owe it to the American people to ensure a scientifically rigorous review. The EVALUATE Act would address this need by requiring the FDA to present its analysis of clinical trial data for independent examination in a public setting, so that the country can put their trust in COVID-19 vaccines.”
As the urgency of the coronavirus crisis has placed pressure on the FDA to approve a COVID-19 vaccine quickly, concerns have been raised in the scientific community that the FDA might approve a vaccine before its safety and efficacy is fully established. In lieu of the typical licensure process, the FDA could issue a more flexible Emergency Use Authorization. Meanwhile, any perception of hastiness or political meddling has the potential to erode public confidence in any vaccine that is approved and could lead to a substantial portion of the American population refusing to be inoculated. On July 15, the Subcommittee heard from an expert panel about the value of VRBPAC review to protect scientific integrity and increase public confidence.
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.