Safety, Not Politics, Must Drive COVID-19 Vaccine Timeline

September 03, 2020

ARLINGTON, VA—Rachel Levine, MD, president of the Association of State and Territorial Health Officials (ASTHO) and secretary of health at the Pennsylvania Department of Health, issued the following statement in response to comments from federal leadership implying a COVID-19 vaccine could be distributed to the public prior to the completion of phase 3 clinical trials.

“Our nation’s health officials are concerned by recent statements from FDA Commissioner Hahn and NIAID Director Fauci indicating they would consider authorizing the use of a COVID-19 vaccine prior to the completion of phase 3 clinical trials. The safety and efficacy of vaccines is paramount to protecting the health of the American public and to building confidence in our state and territorial immunization programs.

“The nation’s health officials strongly encourage FDA to require the completion of phase 3 trials—or an equally rigorous evaluation—prior to approving a COVID-19 vaccine. Leadership must use the best available science to guide vaccine distribution decisions and timelines.

“We agree with the urgent need to mobilize and prepare for a massive vaccination campaign that may be necessary this fall. CDC’s announcement that states should be ready to distribute a vaccine by Nov. 1 indicates that urgency, but federal policy makers must also acknowledge and support the herculean effort involved in standing up a safe and effective nationwide program of this magnitude. States and territories are doing all they can in the middle of the pandemic to plan and prepare for a COVID-19 vaccination campaign. We look forward to collaborating with CDC to advance a timeline that is timely, feasible, and above all, safe for the public.

“In these unprecedented times, the federal government must uphold a key principle of medical practice to ‘do no harm.’ We look forward to partnering with FDA, NIH, CDC, and other federal agencies to provide insight and guidance, utilize state and local experience with previous mass vaccination campaigns, and support a timeline that is grounded in ethical decision-making.

“We must also address concerning racial and ethnic inequities in vaccination rates and speak to the mistrust that many Americans have of governmental immunization efforts. Vaccinations are a monumental public health accomplishment built on decades of research and transparency by the world’s scientists. We must work together to ensure the COVID-19 vaccine builds upon this legacy.”


ASTHO is the national nonprofit organization representing the public health agencies of the United States, the U.S. territories and freely associated states, and Washington, D.C., as well as the more than 100,000 public health professionals these agencies employ. ASTHO members, the chief health officials of these jurisdictions, are dedicated to formulating and influencing sound public health policy and to ensuring excellence in public health practice.