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A group of nearly 100 healthcare and scientific professional organizations urged the FDA to proceed with caution, only approving a vaccine that meets safety and efficacy standards.
The American College of Radiology (ACR) joined nearly 100 other professional organizations in a call to the U.S. Food & Drug Administration, asking the agency to forego approving a COVID-19 vaccine unless it reaches “existing high standards of safety and efficacy.”
In a letter published Sept. 17, the ACR and its colleagues expressed appreciation for the FDA’s leadership in Operation Warp Speed, the initiative that aims to deliver 300 million doses of a safe, effective vaccine by January 2021. But, the letter writers also urged caution.
“Approving a vaccine that has not been shown through clinical trials to be safe and effective could cause more harm by significantly undermining COVID-19 vaccination efforts and seriously eroding public confidence in all vaccines,” they wrote. “While we are encouraged by the rapid development of the COVID-19 vaccine, the process must be fully transparent and not circumvent regulatory standards.”
Any potential vaccine candidate must be studied in all populations, they added, including black, Hispanic, Latino, Asian American, Native Hawaiian, Pacific Islanders, Native Americans, and all other populations who routinely face healthcare disparities or who have been disproportionately impacted by the pandemic. Additionally, they said, the agency should place priority on children, pregnant women, and any other population in whom vaccines typically perform differently.
These good faith efforts are critical, the group said, because a recent poll from the Pew Center revealed that 49 percent of Americans have indicated they will not get a COVID-19 vaccine, including may communities that have been most heavily impacted. That’s a significant 21-percent plummet from May when 72 percent indicated they would do so. The decline is a result of growing doubts surrounding the vaccine development process, as well as disagreements within the federal government, including the nation’s healthcare agencies and the Administration, over when a vaccine can potentially be delivered.
“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,” they wrote as they encouraged the agency to maintain its autonomy and dedication to long-standing scientific principles.
“Now more than ever, Americans must maintain trust in the independent decision-making authority and scientific rigor of FDA,” the group concluded. “We...thank you for repeatedly pledging that ‘all FDA decisions have been, and will continue to be, based solely on good science and data.’”