Foster Urges HHS and FDA to Speed Up Approval Process for COVID-19 Vaccine
Washington, DC – Yesterday, Congressman Bill Foster (D-IL) and Congresswoman Donna Shalala (D-FL) led a letter to the Secretary of Health and Human Services and the Commissioner of the Food and Drug Administration urging them to speed up the evaluation and approval process for a COVID-19 vaccine, and to prepare for a more rapid deployment to the public. The letter was signed by 35 Members of Congress.
Under current processes, the approval timeline for vaccines range from 18 months to several years. The letter argues that because of the enormous human costs of the COVID-19 pandemic, a more rapid process is necessary. Specifically, it requests the FDA to consider testing vaccines using “Challenge Trials” that many experts believe can reduce the time required to test a COVID-19 vaccine to 2-3 months while minimizing the health risk to test subjects.
The Members wrote, “Every week of delay in the deployment of a vaccine to the seven billion humans on Earth will cost thousands of lives. Human misery also results from the economic damage caused by COVID-19 pandemic, and by the tragic psychological impact of social isolation on humans of all ages. Therefore, in addition to proceeding along the normal route for developing an approved vaccine for COVID-19, we urge you to consider adopting, in parallel, expedited procedures for testing, approval and use of COVID-19 vaccines.
“Congress understands that a more risk-tolerant development process is likely appropriate in the case of a COVID-19 vaccine. In the case of accelerated human trials, justifiable risks may be taken by parallel testing of multiple dose levels, advancing more rapidly from phase to phase and potentially by challenge trials that involve deliberately infecting volunteers who have received candidate vaccines or placebos to confirm the efficacy of those vaccines and are at very low risk of serious disease from the infection. This could accelerate the emergency use and eventual licensure of vaccines that have also shown safety in larger groups by many months. We urge you to consider these and other options, provided they proceed with the principle of informed consent of truly voluntary subjects and are backed by the best available science.”
A copy of the letter is available here.