A Comment to Meeting of the Advisory Committee on Immunization Practices – September 2025 (Docket CDC-2025-0454)

FDA Commissioner Dr. Marty Makary recently acknowledged that “…there have been children who have died from the covid vaccine…,” requiring “intense investigation.” I had implored the FDA to “call for a halt to the deployment of the vaccine until further safety data is available” in December of 2020. The benefit-risk profile of these products is evolving, but not at a fast enough pace for me. First, it was acknowledged by HHS that risks outweighed benefit for healthy children and pregnant women, then, for the rest of the “low-risk,” “general public.” In writing to the ACIP today, I hope to prevent the fossilization of the benefit-risk profile for those deemed “high-risk,” those with comorbidities or “older adults.” I hope to demonstrate that there is, at best, insufficient evidence to make a “favorable benefit-risk” profile for the “high risk” “[o]n the basis of immunogenicity.” For any ACIP members who may already be in agreement with this stance, I hope to offer additional support.

Dear ACIP members,

Since my posting of An Evolving Understanding of Benefit-Risk Assessment of the Covid “Vaccines”: Protecting Our Most Vulnerable, where I asked:

Has “a material change in the risk/benefit assessment based on evolving understanding of the disease or condition [COVID-19]…”:

1. “ma[d]e an EUA unnecessary” for children?”

EUAs for COVID-19 “vaccines” have since been rescinded.

In that article, I also question the recommendation: “The COVID-19 vaccine will only be recommended for children and pregnant women who are immunocompromised…”:

1. ““Has the safety and efficacy of the covid ‘vaccines’ in immunocompromised children and pregnant women been established with well-controlled studies measuring severe clinical outcomes such as severe illness, hospitalization, or death?
2. Are surrogate measures of vaccine-induced antibody titers being used as evidence supporting continued vaccination in immunocompromised children and pregnant women?
3. If so, have covid vaccine-induced antibody titers been “validated” as a surrogate endpoint?

Note: “Biomarkers and surrogate endpoints alone do not give us the total picture of benefit and risk of a therapy… These limitations underscore the importance of continued evaluation in the post-market phase when products are approved based upon surrogate endpoints that have not been validated, as well as the need to rigorously evaluate and sometimes re-evaluate surrogate endpoints clinically.””

To my understanding, the answers are no (#1), yes (#2), and no (#3). As per the July 9, 2025 Center Director Decisional Memo – SPIKEVAX, “[v]accine doses can increase antibodies, but fail to further improve clinical outcomes” and “[m]ake no mistake—antibody titers are a surrogate endpoint.” The memo goes on to say: “The proper interpretation of surrogate endpoints is key to understanding this application. CBER has shown flexibility and will accept these surrogate endpoints for children at high risk of severe COVID-19 outcomes, but will not for healthy children.” Also, “[i]n the meantime, CBER OCD will exercise regulatory flexibility in making products available to kids at high risk of severe disease of COVID-19.”

“Surrogate endpoints that have undergone this testing are called validated surrogate endpoints and these are accepted by the FDA as evidence of benefit.” Based on this statement, unvalidated surrogate endpoints such as antibodies would not be sufficient evidence of efficacy (benefit) for the immunocompromised, nor for those 65 years of age and older. As per the same memo, “[a]ntibodies are not gold standard science.”

Moreover, questions of benefit answer only half of the benefit-risk equation that must be performed for every vaccine approval, then recommendation by risk group.

Recently, HHS’s assessment of COVID-19 vaccine benefit-risk seems to have evolved, not only for healthy children and pregnant women, but also for the “general public”/non “higher risk” population. The same July 9^th memo notes: “Due to this decrease in [COVID-19] disease severity, any vaccination-related harms have a greater potential of outweighing potential benefits in low-risk populations.” Yet could not many of the vaccination-related harms be even greater in “high risk” groups such as those with comorbidities and the elderly? Are the risks of COVID-19 vaccines in “high-risk” individuals assumed to be comparable to those in “healthy” individuals?

Per then Secretary Becerra’s 12th Amendment to Declaration under the PREP Act, he “determined there is a credible risk that COVID–19 may in the future constitute such an emergency and am thus amending this Declaration to prepare for and mitigate that risk.” Yet is it still true today that “…there is a credible risk that COVID–19 may in the future constitute such an emergency…”? For example, per a May 16, 2025, Center Director Decisional Memo, there is “…diminishing risk of severe outcomes from COVID-19 in the American population…,” “…infection with the SARS-CoV-2 virus has been shown to provide durable protection against future severe disease and death…,” and “…the risk of severe outcomes from COVID-19 has decreased dramatically over the last four years…”

Most recently, on August 5, 2025, HHS Secretary Robert Kennedy Jr. stated: “…HHS has determined that mRNA technology poses more risk than benefits for these respiratory viruses [COVID-19 and flu].”

Based on the above alone, in my opinion, the final ACIP recommendation should be “ACIP does not recommend the Intervention” for any population, as per the ACIP Evidence to Recommendations Framework. In my assessment of all public data stemming from the COVID-19 vaccines since December 2020, I would choose this option under “Balance of Consequences”:  “Undesirable consequences clearly outweigh desirable consequences in most settings.” Still, some may choose “There is insufficient evidence to determine the balance of consequences” based alone on the lack of valid surrogate endpoints and absence of well-controlled studies measuring severe clinical outcomes and safety in the heterogeneous “high-risk.”

Thank you for considering my input.

Respectfully,

Carol Taccetta, MD, FCAP

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Dr. Carol Taccetta is a U.S.-licensed physician, board-certified in pathology, with a career in drug development spanning 25 years. Key agency interactions include Dr. Taccetta’s co-drafting of a chapter in the 1989 U.S. Surgeon General’s Report (CDC), as well as serving as Sponsor’s Responsible Medical Officer for a successful New Drug Application (NDA) to the FDA.

Please note: The views expressed are Dr. Taccetta’s personal opinions and do not reflect the views of former or current employers or any professional organizations to which she belongs.

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