Did Christine Grady Personally Approve the Pfizer Vaccine?

The wife of Dr. Anthony Fauci is also the chief of bioethics at the National Institutes of Health.

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Claim

Dr. Christine Grady, who is married to Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, is also the chief of bioethics for the National Institutes of Health and personally gave final approval of the Pfizer vaccine to fight COVID-19.

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Context

Dr. Christine Grady is indeed married to Dr. Anthony Fauci, and she is chief of bioethics at the National Institutes of Health (NIH) Clinical Center and a member of the NIH research community. However, the authority to issue emergency use authorizations and approvals (EUA) of vaccines lies with the U.S. Food and Drug Administration, not the NIH. In a statement to Snopes, the NIH said that Grady does not approve the conduct of any research protocol, and she has no input into the FDA process for issuing EUAs.

Origin

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Following the U.S. full approval of the Pfizer BioNTech COVID-19 vaccine in late August 2021, some social media users suggested that nefarious actions of health experts were at play. In particular, posts claimed that National Institutes of Health (NIH) Chief of Bioethics Dr. Christine Grady, who is married to Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, was personally involved in the final approval of the Pfizer COVID-19 vaccine. 

Such posts alleged that the bioethicist and her husband presented a conflict of interest in approving the vaccine — and that the mainstream media failed to properly investigate and report such concerns. 

“This will blow your mind!” read memes readers sent to Snopes. 

“DID YOU KNOW: FDA doesn’t do testing for drug approval… NIH does and provides its findings for FDA approval… who is Christine Grady, head of NIH Bio Ethics…Who is her spouse? Move along, nothing to see here…”  

Grady has been married to Fauci since 1985, and she is chief of bioethics at the NIH Clinical Center and a member of the institution’s research community. But in a statement sent to Snopes, the NIH said that Grady does not approve the conduct of any research protocol, and she has no input into the U.S. Food and Drug Administration (FDA) process for issuing emergency use authorizations.

“The authority to issue emergency use authorizations and approvals lies with the U.S. Food and Drug Administration, not the NIH,” wrote the health agency. “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. Bioethics Department staff are available for bioethics consultation within the research programs of the NIH.” 

Fauci was appointed director of the NIAID in 1984 and oversees research on infectious diseases. He came to the forefront in 2020 when he led the COVID-19 response team. Grady, on the other hand, is a nurse-bioethicist and senior investigator at NIH and serves as the chief of the Department of Bioethics in one of the world’s largest research hospitals. 

The Department of Bioethics is described as “a center for research, training, and service related to bioethical issues” that conducts conceptual, empirical, and policy-related research into bioethical issues. Grady’s research focuses primarily on the ethics of clinical research as well as ethical issues faced by nurses and other health care providers — not in approving COVID-19 vaccines.

The Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty, was approved on Aug. 23, 2021, following its EUA on Dec. 11, 2020. And all vaccines approved by the FDA undergo agency standard processes for reviewing quality, safety, and effectiveness:

For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. 

For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.

A look through official documents issued by the FDA in August 2021 related to the approval of Comirnaty revealed no mention of Grady, including the approval letter, letter of authorization, a concurrence letter, and a decision memorandum.  

Sources

A Candid Conversation with Dr. Anthony Fauci and Dr. Christine Grady. www.youtube.com, https://www.youtube.com/watch?v=2TzxTZ6r4tE. Accessed 9 Sept. 2021.

About Us | Bioethics. https://www.bioethics.nih.gov/about. Accessed 9 Sept. 2021.

https://www.bioethics.nih.gov/about. Accessed 9 Sept. 2021.

Anthony S. Fauci, M.D., NIAID Director | NIH: National Institute of Allergy and Infectious Diseases. https://www.niaid.nih.gov/about/director. Accessed 9 Sept. 2021.

Christine Grady, MSN, PhD | Clinical Center. https://clinicalcenter.nih.gov/meet-our-doctors/cgrady.html. Accessed 9 Sept. 2021.\

https://clinicalcenter.nih.gov/meet-our-doctors/cgrady.html. Accessed 9 Sept. 2021.

Commissioner, Office of the. “Comirnaty and Pfizer-BioNTech COVID-19 Vaccine.” FDA, Aug. 2021. www.fda.gov, https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine.

“FDA Approves First COVID-19 Vaccine.” FDA, 23 Aug. 2021, https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.

“FDA Approves First COVID-19 Vaccine.” FDA, 23 Aug. 2021, https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.

“Principal Investigators.” NIH Intramural Research Program, https://irp.nih.gov/pi/christine-grady. Accessed 9 Sept. 2021.

“US Regulators Give Full Approval to Pfizer COVID-19 Vaccine.” Snopes.Com, https://www.snopes.com/ap/2021/08/23/us-regulators-give-full-approval-to-pfizer-covid-19-vaccine/. Accessed 9 Sept. 2021.