HHS and American Academy of Pediatrics Differ on COVID-19 Vaccine Recommendation

As the 2025-2026 respiratory season approaches, the guideline recommendations for COVID-19 immunization still cause confusion for patients and health care providers alike.

As the 2025-2026 respiratory season approaches, the CDC’s Advisory Committee on Immunization Practices has not met and voted on guidelines for COVID-19 vaccines. | Image Credit: myskin

Although the CDC’s Advisory Committee on Immunization Practices (ACIP) has not met and voted on guidelines for COVID-19 vaccines, Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr, FDA Commissioner Marty Makary, MD, MPH, and National Institutes of Health Director Jay Bhattacharya, MD, PhD, announced on X that the COVID-19 recommendations for healthy children and healthy pregnant women have been removed from the CDC’s recommended immunization schedule.¹

In August 2025, the American Academy of Pediatrics (AAP) released its annual respiratory immunization schedule, including guidance for influenza, respiratory syncytial virus, and COVID-19 vaccines for children and adolescents from birth to age 18 years. AAP has been creating guidance for pediatricians since 1930, and although the immunization schedule follows tradition, it is the first time the organization diverged heavily from the ACIP guidance.²

“The AAP will continue to provide recommendations for immunizations that are rooted in science and are in the best interest of the health of infants, children, and adolescents,” Susan J. Kressly, MD, FAAP, president of AAP, said in a news release.² “Pediatricians know how important routine childhood immunizations are in keeping children, families, and their communities healthy and thriving.”

COVID-19 Recommendations From AAP

Infants and children from 6 through 23 months are at the highest risk for developing severe COVID-19, according to AAP, which is why the organization is recommending the vaccine for all children in this age group regardless of risk factors. Further, the organization states that children younger than 2 years old should be prioritized for vaccination.²

In addition to children younger than 2, the AAP recommends a single dose for all children and adolescents 2 through 18 years who are at high risk for severe COVID-19, residents of long-term care facilities, those who have not been vaccinated against COVID-19, and patients whose household contacts are at high risk for severe COVID-19. AAP also stated that the vaccine should be available to children who do not fall into the risk group but whose parents or guardians wish to have them receive the vaccine.²

“We extensively reviewed the most recently available data about COVID-19 risks in kids, as well as the safety and effectiveness of available COVID-19 vaccines. It's clear they are very safe for all populations,” Sean O’Leary, MD, FAAP, chair of the AAP Committee on Infectious Diseases, said in a news release.² “Among the reasons we decided to move to a risk-based recommendation for healthy older children is the fact that the hospitalization rate for young children and children with underlying medical conditions remains high, in line with rates for many of the other vaccine-preventable diseases for which we vaccinate.”

COVID-19 Recommendations From HHS, ACIP, and CDC

Besides the video released on X, there has not been an official statement or vote on the COVID-19 recommendations from ACIP or the CDC. However, in late August and early September, the FDA began to approve COVID-19 vaccines for the upcoming respiratory season, which include³:

• Nuvaxovid: for patients aged 12 through 64 years with at high risk of severe disease with least 1 underlying condition
• Spikevax: for patients 6 months through 64 years at high risk of severe disease with at least 1 underlying condition
• mNexspike: for patients aged 12 through 64 years at high risk of severe disease with at least 1 underlying condition
• Comirnaty: for patients aged 5 through 64 years at high risk for severe disease with at least 1 underlying condition

All the vaccines have also been approved for adults 65 years and older to prevent COVID-19.

“The American people deserve confidence that medical recommendations are based solely on science and public health,” Andrew Nixon, director of communications at HHS, said in a statement to Drug Topics^®. “We call on the AAP to strengthen conflict-of-interest safeguards and keep its publications free from financial influence, ensuring every recommendation reflects only the best interests of America’s children. Instead, the AAP is undermining national immunization policymaking with baseless political attacks. Secretary Kennedy has stood firm in his commitment to science, transparency, and restoring public trust. By bypassing the CDC’s advisory process and freelancing its own recommendations, while smearing those who demand accountability, the AAP is putting commercial interests ahead of public health and politics above America’s children.”

Kennedy also posted a screenshot of AAP’s corporate donors, which include Moderna, Pfizer, and Sanofi, who are all manufacturers of COVID-19 vaccines (Spikevax and mNexspike, Comirnaty, and Nuvaxovid, respectively).⁴

Kennedy posted: “AAP is angry that CDC has eliminated corporate influence in decisions over vaccine recommendations and returned CDC to gold-standard science and evidence-based medicine laser-focused on children’s health . . . AAP should also be candid with doctors and hospitals that recommendations that diverge from the CDC’s official list are not shielded from liability under the 1986 Vaccine Injury Act.”⁴

The National Childhood Vaccine Injury Act of 1986 created the National Vaccine Injury Compensation Program, which provides compensation to patients who are injured by certain vaccines, which includes vaccines covering diphtheria, haemophilus, hepatitis A, hepatitis B, human papillomavirus, seasonal flu, measles, mumps, meningococcal disease, pertussis, pneumococcal disease, polio, rotavirus, rubella, tetanus, and varicella.⁵

Pharmacist Response to Mixed Recommendations

“[Patients are] understandably confused. The space around vaccines is changing so rapidly,” Laura Knockel, PharmD, BCACP, clinical associate professor at the University of Iowa College of Pharmacy, said.⁶ “There's so much misinformation and disinformation out there, so I really think the first step is to acknowledge that concern, and again, coming from the point of they want to do what's best for their child.”

She explained that pharmacists play a large role in navigating the confusion around COVID-19 vaccines and avoid repeating recommendations without evidence. Pharmacists can also provide reputable sites to patients, which can include healthychildren.org or immunize.org's public website, vaccineinformation.org.⁶

“Staying up to date is really important and staying up to date on what the evidence tells us that the COVID-19 vaccine is safe and effective for everyone, including children,” Knockel said.⁷ “In fact, infants and children younger than 2 years old are at the highest risk for severe COVID-19, and so we need to make sure they're protected. Even if your pharmacy doesn't administer immunizations for children, you still play a part in recommending that that child receive the appropriate vaccine wherever they are able to receive it.”

She added that the process to receive an immunization at a pharmacy could now include extra steps. In many states, the pharmacy’s vaccine authority is contingent on ACIP recommendations, so if a vaccine is not listed on the immunization schedule, pharmacists and pharmacy technicians cannot administer it. However, like other FDA-approved medications, vaccines can be prescribed for off-label use, but it relies on prescriptions from health care providers and is dependent on the state a pharmacist practices in.⁶

“Big thing is this takes time. It adds to the workload of both pharmacies and provider offices, and then, as pharmacists, I think we need to ensure we're explaining why we're unable to provide a vaccine in the same way that we were last year and making sure we give the patient other suggestions on how to receive that vaccine,” Knockel said.⁶ “We want to make sure that they understand that we're not the ones refusing it. It's just our hands are tied. We're unable to provide it, and then, give them those suggestions on where to go and what to do next.”

REFERENCES

1. Gallagher A. New COVID-19 vaccine recommendations cause confusion among public, health care providers. Drug Topics. June 10, 2025. Accessed September 8, 2025. https://www.drugtopics.com/view/new-covid-19-vaccine-recommendations-cause-confusion-among-public-health-care-providers

2. The American Academy of Pediatrics releases its own evidence-based immunization schedule. News release. American Academy of Pediatrics. August 19, 2025. Accessed September 8, 2025. https://www.aap.org/en/news-room/news-releases/aap/2025/the-american-academy-of-pediatrics-releases-its-own-evidence-based-immunization-schedule/

3. Gallagher A. CVS, Walgreens will limit COVID-19 vaccine offerings in 16 states. Drug Topics. September 2, 2025. Accessed September 8, 2025. https://www.drugtopics.com/view/cvs-walgreens-will-limit-covid-19-vaccine-offerings-in-16-states

4. Kennedy S [@seckennedy]. This is a screenshot from American Academy of Pediatrics’ webpage, thanking the organization’s top corporate donors. These four companies make virtually every vaccine on the CDC recommended childhood vaccine schedule. AAP is angry that CDC has eliminated corporate influence in decisions over vaccine recommendations and returned CDC to gold-standard science and evidence-based medicine laser-focused on children’s health. AAP today released its own list of corporate-friendly vaccine recommendations. The Trump Administration believes in free speech and AAP has a right to make its case to the American people. But AAP should follow the lead of HHS and disclose conflicts of interest, including its corporate entanglements and those of its journal—Pediatrics—so that Americans may ask whether the AAP’s recommendations reflect public health interest, or are, perhaps, just a pay-to-play scheme to promote commercial ambitions of AAP’s Big Pharma benefactors. AAP should also be candid with doctors and hospitals that recommendations that diverge from the CDC’s official list are not shielded from liability under the 1986 Vaccine Injury Act. X; August 19, 2025. https://x.com/seckennedy/status/1957914911415153107?s=46&t=9AHxthXdGRIl37bvHR6MCg. Accessed September 8, 2025.

5. About the national vaccine injury compensation program. Health Resources and Services Administration. Updated September 2025. Accessed September 8, 2025. https://www.hrsa.gov/vaccine-compensation/about

6. Gallagher A. Q&A: pharmacists advocate for evidence-based immunization guidelines for COVID-19 vaccines. Drug Topics. September 1, 2025. Accessed September 8, 2025. https://www.drugtopics.com/view/q-a-pharmacist-advocates-for-evidence-based-immunization-guidelines-for-covid-19-vaccines

7. Gallagher A. Q&A: CDC alters COVID-19 recommendations, leading to confusion on pediatric vaccine schedules. Drug Topics. August 30, 2025. Accessed September 8, 2025. https://www.drugtopics.com/view/q-a-cdc-alters-covid-19-recommendations-leading-to-confusion-on-pediatric-vaccine-schedules