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During coronavirus vaccine development, medical groups urge FDA to ‘maintain transparency’

Medical groups and health organizations have urged the U.S. Food and Drug Administration (FDA) to remain transparent and maintain independent authority when giving approval to COVID-19 vaccine candidates, which they say will play a key role in earning the public’s trust.

“We really want to make sure that all of the appropriate safety and efficacy standards are followed so when the vaccine is ready to be administered to the public it has gone through the proper procedures”, Dr. Thomas File, president of the Infectious Diseases Society of America(IDSA), told Fox News.

The IDSA recently spearheaded a letter involving over 90 organizations representing scientists, physicians and other health providers, as well as patients and medical advocates to the FDA. The letter urged FDA leaders to assure that all COVID-19 vaccine candidates meet all standard regulations before being given authorization or licensure, File told Fox News.

“We want to stress how important that there be complete transparency and complete compliance with the existing high standards of safety and efficacy that are required to ensure that we have a safe and effective vaccine,” File said.

The letter said that when the process is not transparent, it loses public confidence and could undermine efforts for vaccination.

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A letter involving over 90 organizations representing scientists, physicians and other health providers, as well as patients and medical advocates was sent to the FDA urging the federal agency to assure all COVID-19 vaccine candidates meet all standard regulations before being given authorization or licensure.

A letter involving over 90 organizations representing scientists, physicians and other health providers, as well as patients and medical advocates was sent to the FDA urging the federal agency to assure all COVID-19 vaccine candidates meet all standard regulations before being given authorization or licensure.
(iStock)

File stressed to Fox News that transparency builds trust.

“We need a safe and effective vaccine – but we also have to have public confidence” File said. “Public confidence is important so they feel safe and confident in using the vaccine.”

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Vaccination is the way to curtail this pandemic, Files said. He also discussed that the recent halt of the Astra Zeneca COVID-19 vaccine trial after one participant developed a neurological condition during the study should show the public that there is transparency in the vaccine development process.

“When Astra Zeneca paused the trial because of the neurologic disease,” File explained to Fox News, “it gives us assurance that vaccine development is being closely watched for safety,” File said. Since then, the trials have been restarted in the UK, File explained.

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The letter also addressed the need for vaccine studies to include Black, Latinx and other populations including the elderly and those with underlying health conditions, according to a press release provided to Fox News. File also noted that when the vaccine becomes available, it needs to be accessible to hard-hit communities that had high rates of the coronavirus and experienced poor outcomes.

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“It’s important that clinical trials include populations for which there are health disparities – people of color, the underserved and those with significant underlying health risks,” File said in the interview. “It’s important to include those populations in the trials so patients will have confidence in the vaccines,” he added.

Some of the organizations involved with the letter included Infectious Diseases Society of America, the Council of Medical Specialty Societies, the American College of Physicians, the National Black Nurses Association, Vaccinate Your Family and Trust for America’s Health.

The FDA did not immediately respond to Fox News’ request for comment. 

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