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- Christine Grady, Dr. Anthony Fauci’s wife, is chief of bioethics at the National Institutes of Health Clinical Center. She isn’t involved in issuing emergency use authorizations for unapproved medical products.
- Grady teaches medical ethics and researches ethical issues related to medicine and clinical research, according to the National Institutes of Health.
- She does not have authority to approve the conduct of any research protocol, “and she has no input into the FDA process for issuing EUAs,” the NIH said.
In December, the U.S. Food and Drug Administration issued its first emergency use authorization for a COVID-19 vaccine. An EUA is basically a greenlight for the agency to allow the use of unapproved medical products, such as a vaccine, during a public health emergency like the coronavirus pandemic.
Because all the evidence the FDA would usually require before approving a drug may not be available during a public health emergency, the FDA makes a judgment call based on the available information and a risk assessment. In this case, that means that three COVID-19 vaccines are now available to people in the United States even though clinical trials for these drugs are ongoing.
A claim spreading on social media wrongly claims that Dr. Anthony Fauci’s wife is responsible for making the decision about EUAs.
"Fauci’s wife is NIH chief of bioethics and human subjects research!" an Instagram post says. "That means she’s the one who rubber stamps exceptions to normal drug and vaccine testing."
This post was flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook.)
Fauci’s wife, Christine Grady, is chief of bioethics at the National Institutes of Health Clinical Center, but she isn’t involved in issuing emergency use authorizations, the NIH told PolitiFact in a statement.
"As part of her official duties, Dr. Grady and her staff teach medical ethics and perform research into complex ethical issues related to medicine and clinical research," the agency said in the statement. And while staff members in the bioethics department are available for bioethics consultation on NIH research programs, Grady does not have authority to approve the conduct of any research protocol, "and she has no input into the FDA process for issuing EUAs."
"She identifies, researches, and writes about ethical issues concerning COVID-19 vaccines, resource allocation, and the safety of healthcare workers during the pandemic," the story says. "Now she’s spearheading research into the ethics of America’s COVID-19 response."
Grady was also quoted in a later Science magazine story about the potential ethical problems with granting emergency use authorizations for some vaccines while other candidates are still in the planning or trial phase, because half of the participants in any ongoing studies would get a placebo at a time when a vaccine that has been shown to protect against COVID-19 is already available.
"It’s a very vexing issue," she said.
The first emergency use authorization for civilians was issued in 2009 and signed by Joshua Sharfstein, then acting commissioner of the U.S. Food and Drug Administration. It was during the H1N1 pandemic, and he gave some insight into the process in a Q&A that was published on Johns Hopkins University’s website in October.
"There was a question of using Tamiflu — which was a medication for flu which had dosing approved by the FDA — for very little babies. People were worried that H1N1 could affect them, but Tamiflu hadn’t been well studied for infants," he said. "So we brought together the best minds at the FDA to come up with a recommended dosing for young infants. We did an emergency use authorization to provide this official recommendation to clinicians."
We rate this Instagram post False.
Instagram post, May 20, 2021
U.S. Food and Drug Administration, Pfizer-BioNTech COVID-19 vaccine, visited May 21, 2021
U.S. Food and Drug Administration, Emergency use authorization for vaccines explained, Nov. 20, 2020
Johns Hopkins Bloomberg School of Public Health, What is emergency use authorization? Oct. 20, 2020
National Institutes of Health, Meet our doctors: Christine Grady, visited May 21, 2021
American Association of Critical-Care Nurses, COVID-19 vaccine: Ethical considerations, visited May 21, 2021
COVID Vaccines: Approaches to vaccine trial design, Nov. 4, 2020
Elle, Dr. Christine Grady is researching America’s ethical response to COVID-19, June 11, 2020
Science, Early approval of a COVID-19 vaccine could stymie the hunt for better ones, Oct. 14, 2020
Statement from the National Institutes of Health, May 20, 2021
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