CDC formally accepts ACIP's shared decision‑making guidance — clinician consultation required before COVID shots; VFC shipments to begin
The CDC has formally accepted ACIP's new guidance making COVID‑19 vaccination an individualized, shared clinical decision (with a universal recommendation only for adults 65+), requiring clinician consultation and enabling the agency to begin shipping COVID vaccines through the Vaccines for Children program. At the same meeting ACIP voted to recommend separate MMR and varicella doses for the first dose in children under 4 (with VFC coverage for the combined MMRV curtailed), tabled a proposed change to the newborn hepatitis B dose, added language on risks and uncertainties to patient information, and provoked criticism over process and potential impacts on coverage and uptake after a recent reshuffle of panel members; acting CDC director Jim O’Neill said, “Informed consent is back.”
📌 Key Facts
- The CDC has formally accepted the Advisory Committee on Immunization Practices (ACIP) recommendations from the Sept. 18–19, 2025 meeting — a step the agency said is the final one needed to begin shipping COVID-19 vaccines to providers through the Vaccines for Children (VFC) program (which covers roughly 40% of U.S. children); reporters noted an unexplained two‑week delay between the ACIP vote and CDC acceptance.
- ACIP met Sept. 18–19 in Atlanta after a substantial reshuffle of the panel by HHS Secretary Robert F. Kennedy Jr. (including five newly appointed members that week); multiple outlets described the meeting as unusual and at times chaotic, with process concerns and criticisms about selective data use.
- The panel voted to change guidance on the combined MMRV shot for young children: ACIP recommended that the first measles–mumps–rubella and varicella doses be given separately for children under 4 because CDC staff data showed a small increased risk of febrile seizures when MMRV is used as the first dose in toddlers (risk window cited around 12–23 months/14–18 months); ACIP also decided the VFC program should not cover the combined MMRV for under‑4s.
- On hepatitis B, ACIP voted (11–1) to postpone indefinitely any change to the universal newborn birth‑dose policy (effectively maintaining the long‑standing birth dose for now) and, separately, unanimously recommended hepatitis B testing for all pregnant women.
- On COVID‑19 vaccines ACIP recommended a universal recommendation for adults 65+ but moved to an "individual‑based/shared clinical decision‑making" approach for younger adults and children (the committee also approved adding language on "risks and uncertainties" to CDC materials); a proposal to require prescriptions for COVID shots failed in a tied vote.
- CDC and ACIP leaders framed the change as restoring informed consent — acting CDC Director Jim O'Neill said, "Informed consent is back" — and some reporting says the guidance requires clinician consultation before receiving a COVID shot; public‑health and medical experts (including AAP, IDSA, independent researchers and state/regional public‑health coalitions) warned the new approach could reduce uptake, create confusion and have downstream effects on coverage and who may administer vaccines.
- Major medical societies, independent experts and public‑health authorities publicly criticized aspects of the meeting and recommendations, warning about impacts on vaccine confidence and access; former CDC director Susan Monarez and others testified about internal pressure and agency upheaval, and several outlets highlighted the broader political context and controversy around administration statements about vaccines and autism.
- ACIP also approved updating adult and pediatric immunization schedules to reflect individualized/shared decision‑making for COVID vaccines and strengthened informed‑consent materials; the agencies noted these changes could affect copayment and insurance mechanics even as some reporting emphasized that shared decision‑making, as adopted, keeps COVID shots accessible through Medicaid, Medicare, CHIP and private insurers.
📰 Sources (18)
- Acting CDC Director Jim O'Neill publicly framed the move: "Informed consent is back."
- The agency cited the change as the final step allowing CDC to start shipping COVID vaccines to providers through the Vaccines for Children Program (covers ~40% of U.S. children).
- Report notes an unexplained two‑week delay between the ACIP vote and CDC's formal acceptance of the recommendations.
- Includes on‑the‑record reactions from independent experts (Dorit Reiss) and medical‑society leadership (Dr. Tina Tan) criticizing the change and warning about uptake and public confidence.
- Describes that the guidance will affect who can give and receive the COVID shot and could change copayment/insurance coverage mechanics.
- CDC has officially updated its adult and child immunization schedules to apply 'individual‑based decision‑making' (shared clinical decision‑making) for COVID‑19 vaccination.
- CDC now recommends that children under age 4 receive a standalone varicella (chickenpox) vaccine rather than the combined MMRV as the first dose, citing a slightly higher febrile‑seizure risk with MMRV in toddlers.
- Jim O'Neill, acting CDC director and deputy HHS secretary, is quoted saying: 'Informed consent is back.'
- Article reiterates ACIP membership was appointed by HHS Secretary Robert F. Kennedy Jr. and notes major medical organizations (American Academy of Pediatrics, Infectious Diseases Society of America) publicly disagree with the guidance.
- MAHA movement allies explicitly tell strategists they believe RFK Jr.'s autism/acetaminophen claims will help mobilize voters for Republican candidates in the 2026 midterms.
- Direct quotes from Republican lobbyist Marty Irby saying the autism/medical‑mistrust messaging will be 'an important part of the midterm election.'
- Reporting that the MAHA Institute hosted a recent Washington, D.C. event featuring dissident doctors and holistic consultants to promote autism theories and push policy ideas (including adding autism to the VICP).
- HHS internally and publicly has walked back a specific suggestion linking acetaminophen (Tylenol) use in pregnancy to autism, and the article documents advocacy and pushback from autism advocates and families.
- Kennedy purged more than a dozen ACIP experts in June 2025 and installed a new advisory panel that met in September 2025 to discuss vaccine recommendations.
- The administration repeated, days after the September meetings, the claim (presented without evidence) that vaccines contributed to autism, a thoroughly debunked theory.
- Former CDC director Susan Monarez testified she was ousted and warned that Kennedy’s actions could lead to more deaths from vaccine-preventable diseases; the article includes her warning and context about protests after her firing.
- Direct quotes from Michael Osterholm expressing concern that administration misinformation will reduce vaccination uptake.
- Specific medical societies and state coalitions publicly urging broader pediatric COVID vaccination: AAP 'strongly recommending' shots for ages 6 months–2 years and advising shots for older children at parents' discretion.
- Infectious Diseases Society of America (IDSA) recommends COVID vaccines for everyone ages 6 months and older (explicit professional-society endorsement).
- A four‑governor West Coast Health Alliance (CA, OR, WA, HI) and a Northeast Public Health Collaborative (including New York and neighbors) have issued state-level guidance urging vaccination for specific age groups, diverging from CDC's 'may receive' language.
- PBS reports ACIP chair Martin Kulldorff opened the meeting challenging claims the panel is anti‑vaccine and invited former CDC directors to a public debate on vaccine science.
- Adds on-record defense from ACIP member Dr. Joseph Hibbeln stating the committee did not enter with pre‑determined attitudes and is "not... anti‑vaxxers."
- Notes some ACIP members were appointed as recently as this week, underscoring the extent and recency of the panel’s reshuffle by HHS Secretary Robert F. Kennedy Jr.
- Includes outside expert reactions: APHA’s Dr. Georges Benjamin described the committee’s performance as "sloppy," and Brown University’s Jennifer Nuzzo criticized reliance on anecdotes over epidemiologic evidence.
- States a planned vote on the hepatitis B vaccine was tabled during the meeting (process context to the final outcome).
- ACIP voted 11–1 to strengthen informed-consent materials by adding language on 'risks and uncertainties' for COVID vaccines.
- ACIP voted 12–0 to update adult and pediatric immunization schedules to reflect individualized (shared) decision-making for COVID vaccines.
- Article specifies that shared decision-making keeps COVID shots accessible through Medicaid, Medicare, CHIP and private insurance.
- CDC stated risk–benefit is most favorable under age 65 for those at higher risk and lowest for those not at increased risk.
- Direct on‑record quotes from Dr. Retsef Levi (arguing for prescriptions), Dr. Cody Meissner (opposing Rx requirement), and Dr. Henry Bernstein (warning access limits would undermine trust).
- CBS reports ACIP framed COVID-19 vaccination as shared clinical decision-making for adults 65+ and for ages 6 months–64, declining a universal recommendation and emphasizing higher benefit for those at increased risk.
- ACIP unanimously voted to recommend hepatitis B testing for all pregnant women (new detail not in prior summaries).
- Members approved updating CDC language on potential COVID-19 vaccine risks and recommended clinicians communicate risks on an individual basis.
- Reiterates the close prescription requirement vote: a 6–6 split with the chair voting no (tie-breaking detail).
- Adds clinical rationale for the MMRV change: elevated febrile seizure risk window (14–18 months) for first dose in young toddlers; no elevated risk when used as the second dose at ages 4–6.
- ACIP voted to recommend COVID-19 vaccination for adults 65+ and to use shared decision-making for adults under 65 rather than a universal recommendation.
- A proposal to require a prescription for COVID-19 vaccination failed on a tie vote after ACIP chair Martin Kulldorff voted no to break the tie.
- ACIP recommended adding language about possible risks and uncertainties regarding COVID-19 vaccine effectiveness to CDC information sheets.
- NPR details a chaotic meeting with process concerns raised by clinicians, including an AMA statement criticizing selective use of data.
- Recommendations are not final until acting CDC Director Jim O’Neill signs them.
- ACIP voted 11–1 to postpone indefinitely any change to the recommendation for a hepatitis B vaccine at birth; Chair Martin Kulldorff dissented.
- ACIP reversed its prior-day vote and decided the Vaccines for Children program should not cover the combined MMRV shot for children under 4.
- Chair Martin Kulldorff acknowledged members are largely new and said a redo was needed due to confusing wording; RFK Jr. recently replaced the panel and added five members this week.
- ACIP member Robert Malone moved to postpone the hepatitis B question, calling a vote 'premature.'
- Any ACIP votes still require approval by acting CDC director Jim O'Neill.
- American Academy of Pediatrics opposes the change, arguing seizure risks are rare and accusing the panel of spreading misinformation.
- Supporters frame the change as reducing the risk of fever-related (febrile) seizures.
- NPR notes the change could affect coverage, with the MMRV combo potentially no longer covered by Medicaid/CHIP for under‑4s.
- Reports the meeting has been unusual, with the 12 new members closely re‑examining legacy data seeking evidence of harm.
- Confirms the votes still require final approval from the CDC director and that Hepatitis B and COVID recommendations are slated for votes today.
- ACIP voted to shift guidance for children under 4 away from the combined MMRV vaccine.
- The panel now recommends administering MMR and varicella as separate vaccines for this age group.
- This is a formal recommendation change emerging from the Sept. 18–19 ACIP meeting.
- ACIP opened with a debate on the MMRV (measles, mumps, rubella, varicella) combo shot for children under 4, focusing on CDC staff data showing a slight increase in febrile seizure risk in 12–23‑month‑olds versus separate MMR and varicella shots.
- ACIP member Retsef Levi favored the safer option given the seizure risk, while member/pediatrician Cody Meissner argued febrile seizures are generally benign and warned removing the option could reduce vaccination uptake.
- American College of Physicians president and ACIP liaison Dr. Jason Goldman urged against changing recommendations to preserve parental choice and avoid confusion and coverage issues.
- ACIP chair Martin Kulldorff publicly rebuked critics (including former CDC directors), denied the panel is anti‑vaccine, and challenged them to an open public debate.
- Report notes five new ACIP members were added this week by HHS Secretary Robert F. Kennedy Jr., and this is the second ACIP meeting since he replaced the prior panel.
- CBS reports the precise voting language for ACIP items has not been shared with CDC staff or made public ahead of the meeting.
- Agenda framing: ACIP is expected to vote on the combined MMRV vaccine, the universal newborn hepatitis B dose, and COVID-19 vaccine eligibility.
- Internal perspective: A longtime CDC staffer says the meeting feels like 'putting science on trial' and 'about criticizing the data.'
- Jim O’Neill’s internal email to CDC staff (obtained by CBS) emphasizes 'rigorous science,' 'transparency,' and that 'not every health decision is the government’s business,' aiming to rebuild public trust.
- CBS highlights potential downstream impacts on vaccine access via Medicaid and Medicare depending on how ACIP recommendations are set.
- AP-sourced prepared testimony details Monarez’s claim that RFK Jr. sought preapproval of ACIP recommendations and ordered firings.
- Hearing timing (Sept. 17, 10 a.m. EDT) and additional witness (Debra Houry) specified.
- Confirms ACIP will discuss COVID‑19, hepatitis B and varicella, with some members questioning the newborn hepatitis B dose.
- Confirms ACIP meets Thursday–Friday and will consider multiple vaccine recommendations (Hep B, RSV, MMRV).
- Introduces Monarez’s warning to the Senate that proceeding with the meeting poses a 'real risk' of limiting vaccines for children.
- Details Monarez’s claim that she was pressured by RFK Jr. to pre-approve ACIP recommendations and fire career scientists, which she refused.
- Meeting: ACIP convenes Sept. 18–19, 2025 at a CDC office in Atlanta.
- Proposal: Sources say the panel is expected to vote on delaying hepatitis B vaccination until age 4, replacing the birth dose in place for 30+ years.
- Context: Childhood hepatitis B cases fell 99% (1990–2022) under the birth‑dose policy; pediatricians and former CDC officials flag lack of usual work‑group process ahead of the meeting.
- Officials: Demetre Daskalakis describes effort to 'dislodge' the birth dose; HHS spokesman Andrew Nixon says recommendations will be guided by 'gold standard science.'
- Additional items: ACIP will also discuss MMRV and COVID vaccine recommendations; draft agenda was released Sunday.