Kennedy's First Pass at US Vaccine Policy: ACIP Guidance Reversed, Clinical Trials Amended, WHO Abandoned
Kennedy over 2 weeks has introduced changes in vaccination recommendations and research policy that undermine already tenuous public trust and understanding.
In a sweeping policy reversal, US Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced on May 27 that the CDC will no longer recommend COVID-19 vaccination for healthy children and pregnant women, marking one of the most significant changes to federal vaccination guidance since the pandemic began.1
©Rafael Henrique/stock.adobe.com
Kennedy, a longtime vaccine skeptic appointed by President Donald Trump to "Make America Healthy Again," made the announcement in a video posted to X (formerly Twitter), flanked by National Institutes of Health (NIH) Director Jay Bhattacharya, MD, PhD, and FDA Commissioner Marty Makary, MD, MPH.
"I couldn't be more pleased to announce that, as of today, the COVID-19 vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule," Kennedy said.¹
The announcement represents a dramatic departure from previous Biden administration guidance. "Last year, the Biden administration urged healthy children to get yet another COVID shot, despite the lack of any clinical data to support the repeat booster strategy in children," Kennedy stated.¹
"That ends today," added Bhattacharya. "It's common sense, and it's good science."¹
FDA Commissioner Makary reinforced the position, stating: "There's no evidence that healthy kids need it today, and most countries have stopped recommending it for children."¹
New FDA Framework Demands Rigorous Clinical Trials
The policy changes extend beyond simple recommendation removals. In a landmark article published in the New England Journal of Medicine, FDA Commissioner Makary and Vinay Prasad, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research (CBER), outlined a new evidence-based approach that fundamentally alters how COVID-19 vaccines will be evaluated and approved.²
Under the new framework, the FDA will require different levels of evidence for 3 distinct populations:
"On the basis of immunogenicity — proof that a vaccine can generate antibody titers in people — the FDA anticipates that it will be able to make favorable benefit-risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe COVID-19 outcomes, as described by the CDC," the authors wrote.3
"For all healthy persons — those with no risk factors for severe COVID-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted," they continued.3
Medical Community Pushback
The policy changes have drawn sharp criticism from infectious disease specialists and public health organizations. Tina Tan, MD, president of the Infectious Diseases Society of America (IDSA), expressed strong opposition to the changes.
"The craziness never ends and the recent change to the CDC immunization schedule regarding the COVID-19 vaccine and use in pregnant women and healthy children is complete madness," Tan told Contemporary Pediatrics. "Also not vaccinating healthy children is completely inappropriate given that some healthy children can have severe COVID infections with long-lasting consequences; children can get Long COVID."4
Regarding pregnant women, Tan highlighted significant risks: "COVID-19 infection can have extremely serious consequences in pregnant women resulting in hospitalization, pre-term labor, pre-eclampsia, heart injury, blood clots, hypertension, kidney damage, so not vaccinating them is sheer madness and will contribute to a significant increase in possible morbidity and mortality."4
Georges Benjamin, MD, executive director of the American Public Health Association, called for Kennedy's removal in April, stating: "As a physician, I pledged to first do no harm and to speak up when I see harm being done by others. I ask my colleagues to join me and speak up. Secretary Robert Kennedy is a danger to the public's health and should resign or be fired."1
Broader Administrative Changes
Kennedy's tenure has extended beyond vaccination policy to encompass wide-ranging health agency reforms. Since taking office, he has:
- Canceled and rescheduled vaccine panel meetings
- Forced out or accepted resignations from senior CDC and FDA officials involved with vaccines
- Terminated NIH grants studying vaccine hesitancy
- Mandated placebo-controlled studies for certain vaccines
- Implemented massive workforce reductions and organizational restructuring across health agencies
US Withdrawal from WHO
In a related development, Kennedy announced Tuesday that both the United States and Argentina were withdrawing from the World Health Organization over its handling of the COVID-19 pandemic.
"The WHO's handling of the COVID-19 pandemic revealed serious structural and operational shortcomings that undermined global trust and highlighted the urgent need for independent, science-based leadership in global health," the joint statement read.5
FDA Advisory Panel Maintains JN.1 Recommendation
Despite the broader policy shifts, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted May 22 to recommend that COVID-19 vaccines for the 2025-2026 respiratory virus season continue to target the monovalent JN.1 lineage.6
“[Last year] we were trying to make a very similar decision about JN.1 where there were other variants appearing at that time and we decided to stay with it," said Archana Chatterjee, MD, PhD, VRBPAC voting member and vice president for medical affairs at Rosalind Franklin University of Medicine and Science. "Even though we've heard from the CDC and some others that perhaps this may not be the variant that we end up with in the fall, this is the closest to it that we can probably get."6
Global COVID-19 Surveillance Data
Current WHO surveillance shows mixed global trends. The organization reports that global COVID-19 activity has been increasing, with test positivity rates reaching 11% primarily in the Western Pacific, Southeast Asia, and Eastern Mediterranean regions—levels not seen since July 2024.7
Conversely, countries in the African Region, European Region, and the Americas are reporting low SARS-CoV-2 activity with positivity rates ranging from 2% to 3%.7
In the United States, CDC data shows a declining trend, with test positivity dropping from 3.2% four weeks ago to 2% in the most recent week. Emergency department visits for COVID-19 decreased 6.5% week-over-week to 0.3%, while weekly COVID-19 deaths fell 20% to 0.4%.⁶
WHO tracking indicates shifting viral evolution patterns. The previously predominant LP.8.1 variant has been declining while the NB.1.8.1 variant, classified as a Variant Under Monitoring, is increasing and now represents 10.7% of global sequences as of mid-May.7
The New Balance
The new policies represent what Makary and Prasad describe as "a balance of regulatory flexibility and a commitment to gold-standard science."3
"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk," they wrote in the NEJM editorial.
They argue this approach addresses declining public trust in vaccines, noting that "less than 25% of Americans received boosters each year, ranging from less than 10% of children younger than 12 years of age in the 2024–2025 season to 50% of adults over 75 years old."²"These clinical trials will inform future directions for the FDA, but more important, they will provide information that is desperately craved by health care providers and the American people."3
