September 23, 2020, 12:56 pm News Staff -- The AAFP joined two broad coalitions to once again urge policymakers to center crucial decisions about COVID-19 vaccine development on science alone.
Only when a prospective vaccine meets the FDA's "existing high standards of safety and efficacy," followed by scrupulous clinical trials, should it be authorized or licensed, said a Sept. 17 letter to FDA Commissioner Stephen M. Hahn, M.D.; and Peter Marks, M.D, Ph.D.; director of the agency's Center for Biologics Evaluation and Research.
"Thorough and transparent FDA review of data supporting a vaccine's approval is the essential foundation upon which we can strengthen public confidence in a COVID-19 vaccine," the letter said. "Now more than ever, Americans must maintain trust in the independent decision-making authority and scientific rigor of the FDA."
To ensure that trust, the Academy and 90 co-signatories asked Hahn to stand by an Aug. 5 Washington Post column in which he wrote, "I have repeatedly said that all FDA decisions have been, and will continue to be, based solely on good science and data. The public can count on that commitment."
In the weeks since Hahn made that pledge, public skepticism about partisan forces in play behind the scenes at the CDC and other federal agencies has sharply increased as the administration has sounded differing messages about the timing and availability of possible COVID-19 vaccines and states have expressed worry about delivering doses. A change in testing guidance that drew loud criticism -- including from the AAFP -- was quietly reversed on Sept. 18. And disagreements about oversight and process are spilling into public view.
With these shifts in mind, the Academy also added its voice to a Sept. 22 statement from 80 national organizations -- ahead of a Sept. 23 Senate committee hearing on the federal response to COVID-19 -- making a similar plea to health officials across the administration.
"To promote public health and economic recovery, government decisions must be based on evidence -- not politics or individual interests," said the statement, which appeared the same day as an advertisement in The Wall Street Journal's Washington, D.C., edition.
"Already, 78% of Americans worry the COVID-19 vaccine approval process is being driven by politics rather than science," it added, citing a Pew study published Sept. 17.
"The leaders of our federal agencies -- even if they serve as political appointees -- must be independent voices that are guided by evidence and the integrity of their agencies' employees."
The statement, like the Sept. 17 letter to Hahn and Marks, emphasized that existing FDA standards must remain the benchmark for developing and administering any COVID-19 vaccine. It also called for "routine, rapid, accurate and easy-to-access COVID-19 testing -- followed by timely and efficient contact tracing."
In more promising news, a Sept. 22 Washington Post story suggested that updated FDA vaccine guidelines, intended to "boost transparency and public trust," were imminent.
Among the groups signing both calls to action were the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American College of Physicians.