The American College of Radiology and more than 90 other healthcare and scientific organizations are urging the U.S. FDA to proceed carefully in approving a vaccine for COVID-19.
ACR and numerous others voiced their concerns in a letter sent to the Food and Drug Administration commissioner Thursday. They want the agency to stick with its “existing high standards of safety and efficacy” when greenlighting any coronavirus antidote.
“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,” ACR, and others including the American College of Physicians and patient advocacy groups, wrote Sept. 17. “While we are encouraged by the rapid development of the COVID-19 vaccine, the process must be fully transparent and not circumvent regulatory standards.”
The letter writers also want the FDA to test any new drug out in populations disproportionately affected by the pandemic, such as Blacks, Latinos, seniors and healthcare workers. Pregnant women, children and other groups in which the vaccine may act differently “should be a priority,” too, the group added.
ACR’s advocacy arrived the same day as a new poll out of the Pew Research Center, which found that 49% of Americans likely would not get vaccinated at this time. That’s in contrast to the 72% who said they planned to receive the drug back in May, Pew reported Thursday. The CDC and White House have sparred in recent weeks over the readiness of a COVID-19 vaccine. Robert Redfield, head of the agency, said the American public may not have widespread access to a vaccine until mid- to late 2021, a statement that drew rebuke from President Donald Trump and others, STAT reported.
The signatories asked the agency to separate the science from other outside factors influencing its decision-making.
“Now more than ever, Americans must maintain trust in the independent decision-making authority and scientific rigor of FDA,” concluded the letter writers, who also included the Infectious Diseases Society of America, the Council of Medical Specialty Societies, and the National Black Nurses Association.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.