Overview
In late November 2025, Vinay Prasad, the Food and Drug Administration’s top vaccine regulator, emailed staff a sweeping memo claiming—without publicly disclosed evidence—that COVID-19 vaccines had caused the deaths of at least 10 children and announcing a fundamental rewrite of how the agency evaluates vaccines, including routine updates like the annual flu shot. On December 3, twelve former FDA commissioners spanning Republican and Democratic administrations responded with an extraordinary joint article in the New England Journal of Medicine, warning that Prasad’s plans would upend long‑standing, evidence‑based vaccine policy, delay access to life‑saving shots, and erode public trust in the agency.
This clash is the sharpest flashpoint yet in a broader reorientation of U.S. vaccine policy under President Donald Trump’s second administration and Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic who took office in February 2025 pledging to remake federal health agencies. Since then, Kennedy allies have narrowed COVID‑19 vaccine indications, purged CDC leadership, replaced the government’s main vaccine advisory panel, and supported controversial steps like ending universal hepatitis B vaccination at birth. The Prasad memo and the ex‑commissioners’ revolt crystallize a high‑stakes struggle over who sets the rules for vaccines in the United States—and whether scientific norms or political and ideological agendas will prevail.
Key Indicators
People Involved
Organizations Involved
The FDA is the primary U.S. regulator for drugs, vaccines, and biologics, historically regarded as a gold standard agency for evidence‑based evaluation of medical products.
The CDC is the lead U.S. public health agency responsible for disease surveillance and issuing vaccination recommendations that underpin clinical practice and insurance coverage.
HHS oversees the FDA, CDC, and other health agencies and is the key locus of political control over federal vaccine policy.
ACIP is the expert panel that advises CDC on vaccine schedules; its recommendations strongly shape clinical practice, insurance coverage, and public perception.
Timeline
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Experts warn Kennedy’s vaccine advisers have 'turned back the clock' on prevention
Expert ReactionA Reuters analysis quotes pediatricians and infectious disease specialists who say the Kennedy‑appointed vaccine panel’s rollback of hepatitis B and other changes could reverse decades of progress, while many medical groups vow to maintain broader vaccination practices regardless of federal guidance.
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Trump orders comprehensive review of childhood vaccine schedule
Executive DirectivePresident Trump directs Secretary Kennedy to conduct a sweeping review of the U.S. childhood vaccine schedule, with an eye toward aligning U.S. practices with countries that administer fewer vaccines, further raising concerns that longstanding protections could be weakened.
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CDC panel votes to end universal hepatitis B vaccination at birth
Policy RecommendationThe Kennedy‑appointed federal vaccine advisory committee votes 8–3 to stop recommending a hepatitis B shot for all newborns, limiting the birth dose to infants of infected or untested mothers and leaving others to parental–physician discretion; pediatric and infectious‑disease experts warn of preventable infections and deaths.
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Leaked memo sparks broader alarm among public health experts
Media RevelationNews outlets detail the contents of Prasad’s memo, including his directive that dissenting staff should resign and his skepticism of multiple simultaneous vaccines and established products like MMR, prompting strong criticism from vaccine specialists who warn of damage to public trust and immunization programs.
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Twelve former FDA commissioners publish NEJM article condemning vaccine overhaul
Public StatementA bipartisan group of 12 former FDA commissioners and acting commissioners publish an article in the New England Journal of Medicine decrying Prasad’s memo and proposed vaccine framework as a 'threat' to evidence‑based policy and public health, warning it would upend core vaccine development policies and raise a subjective approval bar.
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HHS appoints Kirk Milhoan to chair reconstituted vaccine advisory panel
AppointmentHHS names pediatric cardiologist Kirk Milhoan, who has backed controversial COVID‑19 treatments, as chair of the ACIP after Kennedy dismisses prior members, setting the stage for major shifts in U.S. vaccine recommendations.
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Prasad issues internal memo alleging 10 child deaths from COVID vaccines
Internal MemoVinay Prasad circulates a memo to FDA biologics staff claiming that a review of VAERS reports shows at least 10 children died due to COVID‑19 vaccination, and announces a new vaccine regulatory approach that would rely on large randomized trials instead of immune‑bridging for updating vaccines like flu shots and COVID boosters.
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Reports surface of plan to install Jim O’Neill as acting CDC director
Leadership PlanFollowing Monarez’s ouster, reporting indicates that HHS Deputy Secretary Jim O’Neill will serve as acting CDC director, deepening concerns about political control of vaccine guidance.
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CDC Director Susan Monarez fired after resisting vaccine directives
Leadership Shake-upThe White House announces that Susan Monarez is no longer CDC director after she refuses to support rescinding certain COVID‑19 vaccine approvals and firing senior vaccine staff. Her lawyers dispute the legality of the firing, and at least three top CDC officials resign in protest, accusing RFK Jr. of undermining vaccine science.
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FDA, under Prasad, restricts two COVID-19 vaccines to high-risk groups
Regulatory DecisionAgainst the advice of internal scientists, Vinay Prasad limits two updated COVID‑19 vaccines to seniors and people with underlying conditions, arguing the benefit‑risk calculus has shifted as severe COVID cases decline—an early sign of a more restrictive vaccine philosophy.
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RFK Jr. sworn in as HHS Secretary, launches 'Make America Healthy Again' agenda
AppointmentRobert F. Kennedy Jr. is sworn in as Secretary of Health and Human Services, and President Trump signs an executive order establishing the 'Make America Healthy Again' commission to probe chronic disease and health threats, signaling upcoming scrutiny of vaccines and environmental factors.
Scenarios
Prasad–Kennedy vaccine framework is implemented broadly, shrinking federal vaccine protections
Discussed by: Analysis and quotes in Reuters, Washington Post, STAT, AP, and medical society statements
In this scenario, political backing from President Trump and HHS leadership enables Vinay Prasad’s vaccine framework to be codified in formal FDA guidance and CDC recommendations. Vaccine updates—even for seasonal flu and COVID‑19 boosters—would require large randomized trials instead of immune‑bridging, slowing or halting updates and replacements for older vaccines. Combined with ACIP’s more restrictive recommendations, including narrower hepatitis B use and potentially other childhood shots, national vaccine coverage could fall, particularly among low‑income and marginalized groups. Former officials and professional societies would continue to protest, but Congress might not act decisively, leaving the new regime in place. This outcome risks outbreaks of vaccine‑preventable diseases and long‑term erosion of FDA and CDC credibility.
Institutional and political pushback forces moderation or reversal of key changes
Discussed by: Bipartisan criticism in Congress, ex‑officials’ op‑eds, and coverage in Washington Post, Guardian, STAT
Here, the unified stance of 12 former FDA commissioners, resignations by senior CDC leaders, and bipartisan concern in Congress lead to oversight hearings, litigation, and internal resistance that limit or overturn the most radical changes. Courts might scrutinize whether HHS and FDA followed proper administrative procedures and whether Prasad’s assertions about vaccine‑caused deaths are sufficiently grounded in evidence. Public and professional backlash to the hepatitis B decision could prompt the CDC director or future leadership to restore universal birth‑dose recommendations and resist further rollbacks. Under pressure, Kennedy or Prasad could be forced to adjust course, resign, or be reassigned, producing a more conventional, if bruised, vaccine governance structure.
Public health crises from resurgent diseases trigger emergency course correction
Discussed by: Implied in warnings by pediatric and infectious-disease experts quoted by AP, Reuters, and medical societies
If reduced vaccination coverage leads to major outbreaks—such as surges in hepatitis B, measles, or other preventable illnesses—hospitalizations and deaths could spur a rapid political and public backlash. Medical associations that already warn that Kennedy’s advisers are 'turning back the clock' might mobilize aggressively, while state and local health departments could chart their own paths, emphasizing traditional schedules. High‑visibility tragedies, such as clusters of severe pediatric disease, could force the administration or its successors to restore prior standards or adopt even stronger vaccine promotion policies, though trust damage could take years to undo.
Fragmented vaccine landscape emerges, with states and professional bodies diverging from federal guidance
Discussed by: Concerns raised in AP, Guardian, and Washington Post reporting about confusion, coverage, and legitimacy of recommendations
Professional societies and many state health departments are already signaling they may ignore Kennedy‑aligned federal recommendations that weaken vaccine protections. Over time, this could produce a patchwork of vaccine practices: some states, insurers, and hospital systems adhering to the traditional ACIP schedule or international norms, others embracing the more restrictive federal line. The federal‑state split would confuse patients and providers, complicate vaccine supply planning, and potentially widen health disparities, as communities aligned with mainstream medical guidance maintain higher coverage while others see preventable outbreaks.
Historical Context
UK MMR–Autism Scare and Measles Resurgence
1998–2010sWhat Happened
In 1998, a now‑discredited paper by Andrew Wakefield falsely linked the measles, mumps, and rubella (MMR) vaccine to autism, triggering a sharp drop in vaccination rates in parts of the UK and other countries. Subsequent investigations found serious methodological flaws and undisclosed conflicts of interest; the paper was retracted and Wakefield lost his medical license. Nonetheless, measles outbreaks surged in the 2000s and 2010s, with the UK temporarily losing its measles‑free status.
Outcome
Short term: Falling MMR uptake led to multiple measles outbreaks, hospitalizations, and deaths, forcing health authorities to mount catch‑up campaigns and public information efforts.
Long term: Although vaccine coverage gradually recovered, the episode entrenched organized anti‑vaccine movements and demonstrated how misinformation and perceived regulatory failures can cause durable distrust.
Why It's Relevant
The MMR scare illustrates how unsupported claims about vaccine harm—like Prasad’s unsubstantiated assertion of 10 child deaths—can lead to real disease resurgence even after being debunked, and how difficult it is for authorities to rebuild confidence once trust is lost.
1976 U.S. Swine Flu Vaccine Program and Guillain–Barré Concerns
1976–1979What Happened
Fearing a repeat of the 1918 pandemic, the Ford administration launched a national swine flu vaccination campaign in 1976. The pandemic never materialized at scale, and reports of increased Guillain–Barré syndrome (GBS) cases among vaccine recipients led to suspension of the program. Subsequent analyses suggested a small elevated GBS risk but also highlighted shortcomings in communication and decision‑making under political pressure.
Outcome
Short term: The program’s halt and intense media coverage damaged public confidence in flu vaccination and federal health agencies for years.
Long term: The episode prompted reforms in vaccine safety monitoring and risk‑benefit communication, but it remains a touchstone for critics who claim vaccines are rushed or unsafe.
Why It's Relevant
The swine flu case shows how politicized, poorly communicated vaccine decisions can backfire, setting back immunization efforts. The current fight over raising approval bars and revisiting COVID‑era decisions echoes long‑running debates about how agencies should balance speed, caution, and public trust.
Political Interference in U.S. COVID-19 Guidance (First Trump Administration)
2020–2021What Happened
During the initial COVID‑19 pandemic, political appointees in the Trump administration pressured the CDC and FDA on issues ranging from mask guidance to emergency authorizations of treatments like hydroxychloroquine, at times overruling or sidelining career scientists. Public messaging became inconsistent, and surveys showed declining trust in federal health agencies among segments of the population.
Outcome
Short term: Confused public guidance and politicized debates over masks, lockdowns, and vaccines contributed to polarization and uneven adherence to health measures.
Long term: The experience fueled calls for stronger firewalls between science agencies and political leadership, and set the stage for the current controversy as critics argue RFK Jr. is intensifying rather than resolving those governance problems.
Why It's Relevant
Today’s conflicts over the firing of CDC leaders, the reshaping of advisory panels, and Prasad’s unilateral memo reprise earlier concerns about political interference in health science—but now with a coherent ideological project to systematically rewrite vaccine norms, rather than ad hoc crisis decisions.