Letter to FDA from Carol Taccetta, MD, FCAP

July 5, 2021

Dr. Janet Woodcock, Acting Commissioner of Food and Drugs. Janet.Woodcock@fda.hhs.gov

Dr. Peter Marks, Center for Biologics Evaluation and Research Food and Drug Administration. Dept. of Health and Human Services (HHS)Peter.Marks@fda.hhs.gov

RE: The repeated misuse and misinformation of “safe and effective” in the context of investigational COVID-19 “vaccines”:

Dear Drs. Woodcock and Marks,

I was not surprised to find the FDA’s co-signature absent from the recent June 23^rd statement made by the HHS, Centers for Disease Control and Prevention (CDC), and multiple other non-government organizations: “The vaccines are safe and effective.”¹ I was not surprised as I know you have not yet determined safety and efficacy for these Investigational New Drug (IND) products.^2,3,4 Even the Fact Sheets state, “The significant known and potential risks and benefits of [manufacturer] COVID-19 Vaccine, and the extent to which such risks and benefits are unknown.”^5,6,7

Indeed, your “primary objectives in reviewing an IND are, in all phases of the investigation, to assure the safety and rights of subjects, and, in Phase 2 and 3, to help assure that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of the drug's effectiveness and safety.”⁸

But I also know you’re aware that “any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.” ⁹ So, I am surprised, that, as the FDA falls under the umbrella of the HHS, and as your organization is the only one authorized to deem a new drug or vaccine as “safe and effective,” that you have not instructed your leadership and colleagues to immediately correct this misinformation of “vaccines are safe and effective.”

In addition to the HHS website, the CDC’s website also states “COVID-19 vaccines are safe and effective.”¹⁰ Their website additionally states: “The FDA and CDC have confidence that this [Janssen] vaccine is safe and effective in preventing COVID-19.”¹¹ Were you aware of this?

Would not the onus fall on you to rapidly take action regarding the misuse of “safe and effective” in the context of investigational COVID-19 “vaccines” within all HHS websites and communications?¹

Or, are you actually in agreement with the HHS and CDC statements and website content in that the COVID-19 “vaccines” are established as “safe and effective”? Please clarify immediately, as if you are in agreement, this would raise even further questions and concerns.

Sincerely,

Carol Taccetta, MD, FCAP

1 https://www.hhs.gov/about/news/2021/06/23/statement-following-cdc-acip-meeting-nations-leading-doctors-nurses-public-health-leaders-benefits-vaccination.html

2 https://www.fda.gov/media/144412/download

3 https://www.fda.gov/media/144636/download

4 https://www.fda.gov/media/146303/download

5 https://labeling.pfizer.com/ShowLabeling.aspx?id=14471

6 https://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-providers.pdf

7 https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-HCP-fact-sheet.pdf

8 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.22

9https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.7

10 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html