The Vaccine Intelligence Report: January 14-21

The Vaccine Intelligence Report—brought to you by Vaccinate Your Family—provides clear, fact-based updates on vaccine policy, research, and public health each week. This report is part of Viral Truths, a resource designed to cut through the noise, offering concise information to help navigate the evolving immunization landscape.

THIS WEEK AT A GLANCE

  • Kennedy removed four members of the federal advisory panel that oversees the Vaccine Injury Compensation Program in what is seen as an early step to remake the program
  • The FDA has requested that flu vaccine manufacturers update their labels to include a warning on febrile seizures
  • Major health systems and pediatric hospitals have rejected the CDC’s new childhood vaccine schedule, as have more than 20 states, highlighting divisions in vaccine policy
  • Research shows rising vaccine exemption rates and declining vaccination rates across the U.S., as well as a loss of U.S. voter confidence in federal vaccine policy
  • The future of a controversial grant to study hepatitis B vaccination in Guinea-Bissau is unclear, while experts raise serious concerns about the science, underlying agenda, and ethics
  • The South Carolina measles outbreak continues to surge, approaching the size of the 2025 Texas outbreak, and the U.S. may lose its measles elimination status
  • Flu activity has slowed in some states but continues to take a toll, with 15 new pediatric flu deaths reported in the latest week on record

NEED TO KNOW

Kennedy Removes ACCV Members, Casting Uncertainty Over Vaccine Injury Compensation Program

  • ACCV plays a central role in overseeing VICP, advising on program implementation and recommending changes, including to the Vaccine Injury Table. The table determines which vaccines and injuries qualify for compensation and the timeframes in which symptoms must appear. When an injury is listed, claimants do not need to prove fault or causation—eligibility is automatic if criteria are met.
    • Because of this structure, changes to the table carry significant implications. Adding or removing vaccines or injuries can expand or restrict access to compensation and influence public confidence in the vaccine safety system.
    • Experts warn that expanding injury listings without new evidence or scientific consensus could strain or destabilize the VICP fund and discourage manufacturers from remaining in the market.
  • Kennedy’s decision to remove sitting members mid-term has raised concerns that he may seek to replace established experts with individuals aligned with his vaccine-skeptical views, mirroring last year’s overhaul of the Advisory Committee on Immunization Practices (ACIP).
    • The move is particularly notable given Kennedy’s background as a vaccine injury attorney and long-standing critic of U.S. vaccine policy, prompting questions about whether future recommendations could be driven more by ideology than scientific consensus.
  • In short, while still early, the removals mark another consequential step toward reshaping the nation’s vaccine safety and compensation framework—and signal heightened uncertainty around the future direction of VICP.
    • That said, experts emphasize that any changes to VICP cannot be made unilaterally. Federal law requires formal rulemaking, and efforts to bypass established procedures would likely face legal challenges and delays.

FDA Requests Flu Vaccine Manufacturers Update Labels With Febrile Seizure Warning

  • The Food and Drug Administration (FDA) sentsafety-labeling letters to manufacturers of six influenza (flu) vaccines sold in the U.S., requesting updated label language warning of a small increased risk of febrile seizures in young children shortly after vaccination.
    • The affected vaccines are produced by AstraZeneca (FluMist), CSL Seqirus (Afluria, Flucelvax), GSK (Fluarix, FluLaval), and Sanofi (Fluzone). All have been on the U.S. market for at least 13 years; Sanofi’s Fluzone has been in use since 1980.
  • Febrile seizures are fever-related convulsions that can happen in young children—while these convulsions can be alarming, they are usually brief, generally harmless, and nearly all children recover fully.
    • It is important to note that febrile seizures can occur in childhood with or without vaccination, and vaccines can actually help prevent febrile seizures by preventing infections that cause high fevers.
  • According to the FDA, the label change was prompted by two postmarketing observational studies that found an increased risk of febrile seizures on day 0–1 after vaccination in children ages 6 months through 4 years.
    • The FDA said the findings come from retrospective analyses conducted through the agency’s Biologics Effectiveness and Safety System (BEST) system, which analyzed three commercial insurance claims databases and compared seizure diagnoses shortly after vaccination with a later “control” window.
    • The FDA letters did not include full datasets but cited one data partner’s estimate that roughly 21 febrile seizures occurred per 1 million quadrivalent doses administered and roughly 44 occurred per 1 million trivalent doses.
  • Manufacturers acknowledged the request and emphasized the long-standing safety profiles of their products and robust safety monitoring that is already in place.
    • Sanofi noted that, despite billions of doses administered globally, febrile seizures have occurred in a “limited subset of patients” and that existing data continue to support the vaccine’s safety and efficacy. GSK similarly underscored that patient safety remains its top priority and reaffirmed confidence in its seasonal influenza vaccines.
  • Manufacturers have 30 days to accept the changes, propose revisions, or formally contest the request.

U.S. Vaccine Policy Further Splinters as Doctors and States Reject Federal Guidance

  • Following the unilateral overhaul of the CDC’s recommended childhood immunization schedule, divisions between federal guidance and that of the medical community and states have grown significantly more pronounced.
  • This week, seven major medical organizations (including AAP) have taken another step to push back on the new vaccine schedule, filing a lawsuitthat requests the courts restore the vaccine schedule to its April 2025 version—before any changes were made under Kennedy.
    • The suit alleges that HHS “failed to consider…whether the changes to the Childhood Schedule would lead to increases in serious illness and death due to vaccine-preventable illnesses, or increased burden on the American healthcare system, or increased financial burden on American families.”
  • The new childhood schedule has also been rejected at the state level. Kansas is now the 21st state to confirm that it will not follow federal guidance—and localities are following suit even in states that have not taken this step, such as St. Louis County in Missouri.
    • The states and municipalities have instead said that they will follow AAP guidance or make their own vaccine recommendations based on scientific evidence.
  • See last week’s Vaccine Intelligence Report for more on the widening divide between federal vaccine guidance and that of medical organizations and states.

U.S. Voters Express Lack of Confidence in Federal Guidance as Vaccination Rates Decline

  • A new poll found that half of U.S. voters disapprove of the Trump administration’s handling of vaccine policy, which has left them less confident in federal guidance.
  • Relatedly, exemption rates for childhood vaccines typically required to attend school have increasedacross the U.S. since the start of the Covid pandemic.
    • From 2021 to 2024, over half of U.S. counties saw nonmedical exemptions—which may be described as religious, philosophical, or personal belief exemptions—increase by at least 1%, and 1 of every 20 counties rose at least 5%.
  • Additionally, a survey of measles, mumps, and rubella (MMR) vaccination found “substantial gaps in coverage” with overall uptake (1 or more MMR dose) among children under 5 at just 64%.
    • This is particularly concerning, as the community immunity threshold is 92%-94%.
    • The research identified clusters of under-vaccination across the South and Southwest, including areas that have experienced significant measles outbreaks.
    • Researchers attribute the decline in coverage to “multifaceted vaccine hesitancy and pandemic-related disruption,” and they underscore the need for better surveillance to enable targeted, timely public health interventions.
  • Lower childhood vaccination rates are associated with increased risk of disease outbreaks. The vast majority of measles cases in 2025 and 2026 (93% and 95%, respectively) have been among children who are unvaccinated or have an unknown vaccination status.

Experts Raise Ethical and Scientific Concerns Over CDC-Funded Hepatitis B Study

  • A $1.6 million grant awarded from the CDC to Danish researchers for a hepatitis B vaccine study in newborns in Guinea-Bissau has drawn widespread criticism over the award process, the researchers’ credibility, the study’s scientific rigor, and its ethical implications.
    • The randomized controlled trial would enroll 14,500 infants, administering a hepatitis B vaccine at birth to half while withholding it from the control group. Researchers would then track early-life mortality, illness, and developmental outcomes.
  • The award was announced in December—just two days after the CDC adopted ACIP’s recommendation to end the long-standing U.S. recommendation for universal hepatitis B vaccination at birth.
    • The grant was issued as a no-bid contract, did not undergo a customary ethics review, and originated from an unsolicited proposal submitted by Danish researchers Peter Aaby and Christine Stabell Benn. Notably, Stabell Benn also serves as an advisor to ACIP.
    • According to leaked emails, the researchers worked closely with two Kennedy appointees with a history of anti-vaccine advocacy—Lyn Redwood and Stuart Burns—to secure funding.
  • The researchers’ work has frequently been cited by anti-vaccine activists and by Kennedy himself, while being challenged by numerous experts. A systematic analysis of their prior studies found “indications that the researchers systematically selected and highlighted results that supported their theories.”
    • The pair are best known for promoting the controversial idea that vaccines may have broad “non-specific effects” on the immune system beyond protection against targeted diseases.
  • Experts warn the grant appears to be designed to generate post hoc justification for policy changes that officials planned to make—or, in the case of the hepatitis B birth dose, have already implemented. Dr. Daniel Jernigan, former Director of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, characterized the effort as “trolling to find evidence,” rather than objective science.
  • Scientists have also raised substantive concerns about the study’s design and relevance.
    • Hepatitis B infections acquired in infancy typically lead to chronic liver disease decadeslater, meaning a five-year follow-up would not meaningfully capture long-term outcomes of delayed vaccination.
    • Guinea-Bissau’s population, disease burden, and healthcare system also differ substantially from those of the U.S., limiting applicability.
    • In addition, none of the vaccines used in the trial are FDA-approved or available on the U.S. market.
  • Most importantly, experts say the study raises profound ethical concerns. Researchers plan to withhold the hepatitis B birth dose from more than 7,000 newborns in a country where the virus is highly prevalent—nearly one in five people lives with chronic hepatitis B.
    • Infants infected in their first year of life have a 90% chance of developing chronic hepatitis B, and 25% of those individuals will ultimately die from the disease.
    • Given strong evidence that birth-dose vaccination is protective, withholding it is considered unethical—particularly in a low-income country with limited healthcare resources.
  • Last week, an official from the Africa Centres for Disease Control and Prevention said the controversial trial had been cancelled. However, HHS officials have since said the study is proceeding as planned.

OUTBREAK OUTLOOK

South Carolina Measles Outbreak Dominates U.S. Case Increases, New Resource Highlights Vaccination Rates by County

  • As of January 16, the U.S. has recorded 2,540measles cases since January 1, 2025.
    • Officials in South Carolina reported 212 new measles cases in the week between January 13and 20. The state’s ongoing outbreak now totals 646 cases, including students at dozens of schools, as well as Clemson University.
      • South Carolina’s outbreak now approaches the size of Texas’ outbreak last year, which infected over 760 people between January and August.
      • The South Carolina outbreak has been linked to new cases in North Carolina and Washington this week.
    • Additional measles cases have been confirmed in Arizona, Kentucky, and Utah.
  • The U.S. Vaccination Map is a new interactive resource that displays county-by-county data on measles vaccination rates for children under 5 years of age and projected measles risk level, as well as total state measles cases in 2025.
    • The map was developed as part of a study that found hotspots of MMR under-vaccination closely overlap with recent measles outbreaks.
      • For example, New Mexico, South Carolina, and Texas—states with some of the lowest county-level MMR vaccination rates among children under 5—have experienced significant measles activity in the past year, underscoring the importance of vaccination in preventing outbreaks.
    • While county-level vaccination rates can indicate areas more susceptible to measles outbreaks, measles is a highly contagiousdisease that spreads rapidly and unpredictably. The best way to avoid measles infection and spread is to get the MMR vaccine, which is up to 97% effective at preventing measles.

Flu Activity Slows; Officials Warn of Severity for Children

  • Flu activity has decreased or remained stable for two consecutive weeks, but remains elevated along with flu-related hospitalizations across the country.
    • For the week ending January 10, 34 states + D.C. were experiencing high or very high flu activity, down from 41 states + D.C. the week prior.
    • CDC estimates that there have been over 18 million illnesses, 230,000 hospitalizations, and 9,300 deaths from flu so far this season.
    • Officials warn that flu activity could surge againin the coming weeks. Last year, a second wave of flu occurred in February after a lull around this time.
  • The CDC has reported 32 pediatric deathsassociated with flu this season, including 15 reported during the week ending January 10. Recent pediatric deaths occurred in Colorado, Massachusetts, Ohio, and Virginia.
    • Experts warn that flu can progress rapidly in children—many pediatric flu-related deaths occur before a child sees a physician, or while in the emergency room.
    • Although children with underlying conditions are at a greater risk for complications and death, about half of hospitalizations and deaths occur among healthy children.
    • Even children who recover from flu can experience serious ongoing complications, including rare neurological effects.
  • The latest CDC reporting as of January 16 shows moderate respiratory illness activity across much of the U.S., with Delaware, Maryland, New Hampshire, and Ohio currently experiencing high levels.

New Research Affirms Safety and Efficacy of Maternal RSV, Flu, Tdap Vaccination

  • A Harvard Medical School analysis of safety data for Pfizer’s Abrysvo RSV vaccine confirmed the vaccine’s safety during pregnancy, finding that administration after 32 weeks’ gestation does not increase the risk of adverse pregnancy outcomes including preterm birth.
    • RSV is the leading cause of infant hospitalization in the U.S., and the American College of Obstetricians and Gynecologists (ACOG) recommends pregnant women between 32 through 36 weeks of gestation receive the maternal vaccine.
  • Another study found that infants born to mothers who received flu and tetanus, diphtheria, and pertussis (Tdap) vaccines are less likely to be hospitalized or visit the emergency room for flu- or pertussis-related illness.
    • Because infants under 6 months of age are too young to receive a flu vaccine and those under 2 months are ineligible for the Tdap vaccine, maternal vaccination during pregnancy is an effective way to mitigate the risk of infection and severe outcomes.

REALITY CHECK

These fact checks respond to several recent claims made by different groups and individuals.

CLAIM: A flu vaccine is dangerous to young children because it causes febrile seizures.

  • REALITY: It is true that a small, short-term increase in febrile seizures has been observed in some studies within 0-1 day after flu vaccination in young children, but, even when increased risk is observed, the absolute risk is very low (about 5 events per 100,000 vaccinated children).
  • Additionally, the vast majority of febrile seizures—a term referring to convulsions caused by fever in children—are harmless, self-limited events, that typically only last a couple of minutes and almost never lead to long-term health issues, brain damage, or epilepsy.
  • Febrile seizures can occur in children regardless of vaccination status—between 3-4% of all childrenwill have one at some point, and they tend to occur in those who are already susceptible due to family history or genetic makeup.
  • Any fever, whether caused by vaccination or an actual infection, can trigger a febrile seizure—flu infection itself commonly causes high fever in young children and is associated with a higher risk of febrile seizures, hospitalization, and serious complications than a flu vaccine.
  • This means that by protecting against the flu, the vaccine actually reduces the overall number and severity of fevers in children, therefore helping prevent febrile seizures that could otherwise occur during infection.

CLAIM: The need for vaccine booster doses shows that vaccines are ineffective—if they really worked, people wouldn’t need boosters.

  • REALITY: Needing a booster dose does not mean that vaccines “don’t work.” Booster doses are a well-established part of immunization science and help reinforce naturally waning immunity over time. There are many reasons why booster doses may be recommended, for example:
    • After receiving the first dose of a vaccine, the body creates antibodies and immune cells to protect against a given disease. Naturally, this immunity slowly decreases over time—booster doses remind the immune system to renew this protection.
    • Some viruses like flu mutate over time. New flu vaccines are developed each year, specifically designed to match the predicted circulating strains. Yearly doses are recommended to maintain protection against these new mutations.
  • Many common vaccines require additional doses or boosters, which are proven to significantly increase immunity and extend effectiveness:
    • Hepatitis A and B: One dose of the hepatitis A vaccine is estimated to provide protectionagainst infection for more than 10 years—after the second dose, this increases to at least 25 years in adults and 14-20 years in children. The first dose of the hepatitis B vaccine provides up to 50% protection, which increases to 80% and up to 100% after the second and third doses, respectively, lasting for at least 30 years.
    • Haemophilus influenzae type B (Hib): The first dose of the Hib vaccine has been shown to be 59% effective against Hib disease—this increases to 92% and 93%, respectively, after the second and third doses.
    • Measles, mumps, rubella (MMR): More than 95% of individuals who receive a single dose of MMR will develop immunity to all three viruses (measles, mumps, and rubella). A second dose provides immunity to almost all individuals who did not respond to the first dose.
    • Varicella (chickenpox): One dose of the varicella vaccine is 82% effective against any form of varicella, while two doses are 92% effective at preventing all varicella.

WHAT TO WATCH

ACIP Schedules Next Meeting for February

  • The Advisory Committee on Immunization Practices is scheduled to meet February 25-26, marking its first meeting since recent federal actions altered several long-standing vaccine recommendations.
  • Leading medical societies are seeking a federal injunction to halt the meeting and block recent changes to the childhood immunization schedule.
    • AAP and other groups are asking a federal judge to restore the immunization schedule to its April 2025 form and to pause ACIP proceedings while litigation is ongoing.
    • A hearing on the request for preliminary injunctive relief is scheduled for February 13, which could determine whether the February ACIP meeting proceeds as planned.

PAHO to Review U.S., Mexico Measles Elimination Status in April

  • The Pan American Health Organization (PAHO) Regional Monitoring and Re-Commission for Measles, Rubella, and Congenital Rubella Syndrome (RVC) will meet virtually with the U.S. and Mexico on April 13 to review each country’s measles elimination status.
    • The RVC, an independent technical commission, will review comprehensive reports and epidemiological and laboratory evidence to assess the reestablishment of endemic transmission of measles.
    • Following its review, the RVC will submit its recommendations to the PAHO Director, who will formally determine the measles elimination status for each country.
  • Ralph Abraham, Principal Deputy CDC Director and a former Louisiana Surgeon General, downplayedthe U.S.’s potential loss of measles elimination status, saying he would view it as the “cost of doing business,” rather than a major event.

Vaccinate Your Family is a nonpartisan organization dedicated to protecting people of all ages from vaccine-preventable diseases. To learn more, visit us at: vaccinateyourfamily.org

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