Biden Pandemic Plan Highlights R&D Support

Applied Clinical Trials, Applied Clinical Trials-02-01-2021, Volume 30, Issue 1/2

President unveils lengthy program for combatting COVID-19 immediately following inauguration.

One day after his inauguration, President Joe Biden unveiled a lengthy program for combatting COVID-19 by ramping up distribution and inoculation of millions of Americans over the next three months. This comprehensive pandemic response began with the President signing a packet of executive orders that expand COVID-19 testing and required mask-wearing on federal property and in public transportation and makes wider use of the Defense Production Act (DPA) to reduce shortages of supplies such as protective equipment, lab equipment and vaccine production and delivery materials.

One of the initial executive orders signed by Biden calls for issuing a high-level plan for developing and testing promising COVID-19 treatments. The President calls for the secretary of Health and Human Services (HHS) and the director of the National Institutes of Health (NIH) to devise a plan supporting large-scale randomized trials and other studies able to identify promising treatments that can be “easily manufactured, distributed, and administered, both domestically and internationally.” In emphasizing the need for randomized trials, the provision highlights the administration’s emphasis on relying on science in medical decisions, as opposed to the promotion of untested products by the Trump administration.

To limit contamination from COVID-19, Goal 3 of the National Strategy, which seeks to mitigate spread through expanded masking and testing and an increased medical workforce, also supports accelerated research and clinical development of new treatments. Starting with a comprehensive preclinical drug discovery and development program of treatments that can be readily scaled and administered, it also calls for diverse clinical trials to ensure that new therapies address the needs of communities of color, children, pregnant women, and high-risk populations. And it aims to improve access to more affordable, high-quality treatments by preventing shortages through investment in advanced biopharmaceutical manufacturing, advanced purchase agreements, and strengthened surveillance systems.

The comprehensive vaccination campaign also supports ongoing vaccine R&D as a way to bolster vaccine access. Important goals are for the government to fund research and testing of vaccines for adolescents and children and the development of formulations that may be easier to deliver and administer. To assess whether current vaccines remain effective against new viral strains, NIH, FDA and BARDA will evaluate the need to alter current vaccines. FDA is cited as key to authorizing effective vaccines for rapid delivery, for assessing emerging viral mutations, and for establishing recommendations for dosing and expanding vaccine supply.

Jill Wechsler is Applied Clinical Trials' Washington Correspondent