ACIP Meeting: COVID-19 Vaccines to be Administered Through Shared Clinical Decision-Making
The Advisory Committee on Immunization Practices (ACIP) voted to recommend that COVID-19 vaccines be administered through individual-based decision making.
The Advisory Committee on Immunization Practices (ACIP) has voted 12-0 to recommend COVID-19 vaccines be administered based on individual-based decision-making, also known as shared clinical decision making, for adults aged 65 and older, rather than a universal recommendation.
They voted to recommend the same language for individuals aged 6 months through 64 years, with an emphasis that risk-benefit for vaccination is most favorable for individuals at increased risk and lowest for individuals not at increased risk.1
Another vote on the belief that state and local jurisdictions should require a prescription for the administration of a COVID-19 vaccine failed 6-6, with the chair, Martin Kulldorff, PhD, breaking a tie to ensure the vote's failure.
A series of other statements were voted on. The committee voted 11-1 on language affirming that the CDC will engage in an effort to make informed consent processes more consistent for COVID-19 vaccines and 12-0 on the recommendation that health care providers should discuss the risks and benefits of COVID=19 vaccination for individual patients, with a focus on risk factors of COVID-19, the benefits and risks of vaccination, and related uncertainties.1
Spirited Discussion of COVID Vaccines Dominated Committee and Public Comments
The votes occurred during day 2 of a meeting that took place at the CDC headquarters in Atlanta, GA. They followed an hours-long discussion marked by a series of presentations and discussions on the efficacy—and purported safety concerns—of the vaccines.1
The recommendation that a prescription be required for COVID-19 vaccination would have likely added an unnecessary layer of complexity for individuals seeking the vaccine. Hillary Blackburn, PharmD, the first pharmacist to be a member of the ACIP, noted that this would have impacted access and act as a barrier for people to have access to the vaccine.1
Historically, ACIP recommendations have determined which vaccines insurance companies will cover. The new recommendations could have a major impact on access to and insurance coverage for vaccines in the upcoming respiratory season and beyond.
Though there is momentum among insurers to cover vaccines recommended prior to the current ACIP meeting through 2026—bolstered by a recent statement from AHIP affirming coverage for updated COVID-19 vaccines—the new recommendations may alter the future environment for health plans and reduce access for patients.2
Some liaisons from public health societies noted that the recommendation was voted on based on theoretical and rare concerns rather than a vast trough of reliable data indicating such worries.1
"I would encourage the committee to make decisions based on the data, not on theoretical concerns that were raised,” Grant C. Paulsen, MD, pediatric infectious disease doctor at Cincinnati Children’s Hospital, noted in during his public comment.1
COVID-19 Vaccines Remain Effective, Though Disease Burden Has Reduced
The meeting began with a presentation from the National Center for Immunization and Respiratory Diseases highlighting the current vaccine effectiveness (VE) of the COVID-19 vaccines. Although the vaccine is proven effective as a stand-alone intervention, VE measures the real-world benefit of current vaccination in a population that already has existing protection. Data indicates that the 2024-2025 COVID-19 vaccines provided VE of 44% to 46% in immunocompromised adults aged 65 years against hospitalization, with more significant VE against critical illness.3
Additionally, in children aged 9 months through 17 years, the 2023-2024 vaccine dose provided VE ranging from 53% to 64% shortly following administration. Vaccination was also associated with a reduced likelihood of developing symptoms of long COVID in both children and adults, along with 45% reduced transmission in 6 months after vaccination.3
An economic analysis of COVID-19 vaccination compiled by the University of Michigan COVID-19 Vaccination Modeling Team was also presented. Key results included determinations that the vaccines are expected to prevent illness and death for all groups, but that the overall economic value of vaccination has declined compared with earlier seasons because overall COVID-19 burden is currently very low. This was a sentiment echoed by many, including Retsef Levi, PhD, professor of operations management at MIT Sloan School of Management, lead expert on the ACIP’s COVID-19 immunizations workgroup, and vocal critic of mRNA vaccines.4,5
Levi, during his presentation of the work group’s findings, echoed past concerns of purported vaccine injuries, including myocarditis. Cases of myocarditis and pericarditis have been rarely observed following COVID-19 vaccination, though the clinical course is generally mild. Investigators have found that, in all age groups, the overall risks of COVID-19 infection-related hospitalization and death are significantly greater than the risk of post-vaccine myocarditis.1,6
Contrastingly, in a presentation given by workgroup member Henry Bernstein, DO, MHCM, FAAP et al, the positive benefits of simple, stable vaccine recommendations were highlighted. Bernstein argued against the provision of shared clinical decision-making, explaining that it acts as a barrier to vaccination. Furthermore, Bernstein argued that the need for provider prescription as part of the process creates an unnecessary step to receiving a vaccine and does not optimally target high-risk individuals.7
In their messages for ACIP considerations, Bernstein et al highlighted the importance of COVID-19 vaccination for pregnant women, pediatric patients—noting that they remain at high risk for severe COVID-19—and anyone who feels they want protection for themselves or their family.7
“COVID-19 vaccines are safe and effective,” Bernstein noted emphatically. “And if we don’t want to say they are safe and effective, they work.”1
Purported Immunologic Effects and Correlates of Protection Spark Debate
A major topic of discussion was alleged biological concerns related to how mRNA vaccines affect the body over time. A presentation from Wafik El-Deiry, MD, PhD, FACP and Charlotte Kuperwasser, PhD highlighted concerns, including possible lasting immune system changes, biodistribution of vaccine components beyond the injection cite, unintended frameshifting, and DNA contamination.1,8
There was debate regarding the final point, as some members of the committee voiced concern regarding supposed impurities in COVID-19 mRNA vaccines and possible link to cancers. Kirk Milhoan, MD, PhD, a pediatric cardiologist, expressed concern regarding the pharmacokinetics of the product and requested explanation from FDA representatives.1
“I am really confused about the pharmacologic rigor for this product before it was released, and now with evidence of contamination, why is this not pulled off, like any other biologic or medicine that has contamination?" Milhoan explained. It is critical to note that these studies have often used very small sample numbers and utilized selective reporting and validation methods, and WHO, FDA, and other regulatory agencies have affirmed that residual DNA is minimal and poses no risk to human health.1,9,10
A brief discussion broke out between Robert Malone, MD and Cody Meissner, MD regarding the correlates of vaccine-induced protection used for COVID-19 vaccines. These are immune functions that correlate and may be responsible for vaccine-induced efficacy. Malone contended that there were no established correlates of protection for COVID-19 vaccines, to which Meissner referenced research from The New England Journal of Medicine indicating that serum anti-spike IgG concentration and anti-SARS-CoV-2 neutralizing antibody titers are applicable correlates.1,11
"There is no established correlate of protection for COVID. Period. Full stop. Don't say otherwise,” Malone exclaimed in response to a commenter.1
“There is a reasonable measurement of neutralizing or binding antibodies that correlate with protection against symptomatic infection in the first few months,” Meissner explained in response.1
“Where is the study, Cody?” Malone asked.
REFERENCES
1. Meeting of the Advisory Committee on Immunization Practices (ACIP) – September 19, 2025 – Day 2 of 2. Streamed on YouTube on September 19, 2025. Accessible: https://www.youtube.com/live/_9ChY9SpPlY
2. AHIP. AHIP statement on vaccine coverage. News Release. Released September 16, 2025. Accessed September 19, 2025. https://www.ahip.org/news/press-releases/ahip-statement-on-vaccine-coverage
3. National Center for Immunization and Respiratory Diseases. Updates to COVID-19 vaccine effectiveness. Presented: September 19, 2025, in Atlanta, Georgia. Accessible: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cdc.gov/acip/downloads/slides-2025-09-18-19/04-Srinivasan-covid-508.pdf
4. University of Michigan. Economic analysis of COVID-19 vaccination. Presented: September 19, 2025, in Atlanta, Georgia. Accessible: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cdc.gov/acip/downloads/slides-2025-09-18-19/08-Srinivasan-covid-508.pdf
5. Manalac T. CDC Names Vaccine Critic Retsef Levi as Head of COVID-19 Workgroup. BioSpace. Published August 26, 2025. Accessed September 19, 2025. https://www.biospace.com/policy/cdc-names-vaccine-critic-retsef-levi-as-head-of-covid-19-workgroup
6. Heidecker B, Dagan N, Balicer R, et al. Myocarditis following COVID‐19 vaccine: incidence, presentation, diagnosis, pathophysiology, therapy, and outcomes put into perspective. A clinical consensus document supported by the Heart Failure Association of the European Society of Cardiology (ESC) and the ESC Working Group on Myocardial and Pericardial Diseases. Eur J Heart Fail. 2022. doi: 10.1002/ejhf.2669. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cdc.gov/acip/downloads/slides-2025-09-18-19/11-perlman-bernstein-miglis-covid-508.pdf
7. Bernstein H. Additional Workgroup Considerations in COVID-19 Vaccination Policy and Practice. Presented: September 19, 2025, in Atlanta, Georgia. Accessible: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cdc.gov/acip/downloads/slides-2025-09-18-19/11-perlman-bernstein-miglis-covid-508.pdf
8. El-Diery W, Kuperwasser C. Workgroup Safety Uncertainties of mRNA COVID Vaccines. Presented: September 19, 2025, in Atlanta, Georgia. Accessible: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cdc.gov/acip/downloads/slides-2025-09-18-19/06-el-deiry-kuperwasser-covid-508.pdf
9. Therapeutic Goods Administration—Australian Department of Health, Disability, and Ageing. Addressing misinformation about excessive DNA in the mRNA vaccines. News Release. Released October 18, 2024. Accessed September 19, 2025. https://www.tga.gov.au/news/media-releases/addressing-misinformation-about-excessive-dna-mrna-vaccines
10. Petousis-Harris H. Plasmid-gate: Debunking the DNA contamination claims in mRNA vaccines. Global Vaccine Data Network. Published October 17, 2024. Accessed September 19, 2025. https://www.globalvaccinedatanetwork.org/news/plasmid-gate_debunking_the_DNA_contamination_claims_in_mRNA_vaccines
11. Gilbert PB, Donnis RO, Koup RA, et al. A Covid-19 Milestone Attained — A Correlate of Protection for Vaccines. N Engl J Med. 2022;387(24):2203-2206. doi:10.1056/NEJMp2211314
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