The Vaccine Intelligence Report: February 11-18

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: 

  • After initially rejecting Moderna’s application for its mRNA flu vaccine, the FDA reversed course after the company proposed a revised approval strategy   
  • The AMA and VIP will conduct an independent vaccine review ahead of the 2026–27 respiratory season in a departure from the CDC 
  • NIH Director Dr. Jay Bhattacharya has been named Acting CDC Director after HHS Deputy Secretary Jim O’Neill was ousted, but questions about long-term agency authority remain 
  • Medical organizations are urging the court to restore the prior childhood schedule and pause ACIP actions; a ruling is expected before ACIP’s scheduled February 25-27 meeting 
  • New Hampshire and Florida advanced measures to weaken vaccine requirements, while California, Maine, and Oregon moved to bolster vaccine access and legal protections 
  • The U.S. has reported nearly 1,000 measles cases in 2026, with ongoing outbreaks continuing to drive spread across several states 
  • Flu activity remains elevated across the country, and children are experiencing severe outcomes: 66 pediatric deaths have been recorded this year 
  • On February 24, medical societies and Vaccinate Your Family will hold a congressional briefing on the childhood immunization schedule to explain differences between CDC and AAP recommendations 

NEED TO KNOW 

FDA Reverses Course, Accepts Moderna’s mRNA Flu Vaccine for Review After Initial Rejection 

  • After rejecting Moderna’s application for its mRNA-based seasonal influenza (flu) vaccine earlier this month (February 10), the Food and Drug Administration (FDA) reversed course this week (February 18), accepting Moderna’s amended application for review following a “Type A” meeting between the agency and the company.  
    • A Type A meeting is a formal mechanism companies can use after an application is rejected. During the meeting, Moderna proposed a revised approval strategy that separates age groups and commits to additional post-marketing research. 
  • Moderna’s updated filing now seeks full approval for adults ages 50-64 and accelerated approval for adults 65 and older, with a post-marketing study requirement to generate additional evidence in older adults.  
    • This means there is now a pathway by which the FDA could grant standard approval for the younger age group based on existing data, while allowing the vaccine to be used in older adults sooner under an accelerated pathway. 
  • For context, the vaccine, mRNA-1010, is designed to protect against the four flu strains included in each year’s seasonal flu shot and uses messenger RNA (mRNA) technology, which researchers say could allow faster updates and better strain matching when circulating strains shift—addressing a longstanding challenge in flu prevention.   
    • Moderna’s application was supported by a phase III trial that enrolled more than 40,000 adults age 50 and older, and according to the company, the study showed that the mRNA-1010 vaccine generated stronger immune responses than the currently licensed standard-dose flu shot.  
  • The FDA said its initial refusal-to-file decision was made based on how Moderna designed its large phase III trial, rather than on any newly identified safety concerns.  
    • The key issue raised centered on participants 65 years and older. While it is typically recommended in the U.S. that adults 65+ years old receive a high-dose flu vaccine because they are at greater risk of severe illness, Moderna tested its vaccine in adults 65+ years old against a standard-dose flu shot.   
    • Following the rejection, Moderna maintained that it developed the trial in consultation with the FDA and that the refusal came as a surprise, arguing that the company believed it followed prior agency feedback and that no new safety issues were raised during the filing.  
    • Additionally, according to agency officials close to the matter, the decision to reject the application was made by senior FDA leadership who overruled career reviewers who were prepared to move Moderna’s application forward—a historically uncommon dynamic in the vaccine review process.   
  • While the agency’s acceptance of the amended application has helped remedy the immediate issue, the handling of the application continues to raise broader questions about leadership’s potential politicization of vaccine reviews, clarity around regulatory expectations, and the stability of vaccine approval pathways—particularly for mRNA products.   
    • Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has publicly criticized vaccines, including those that use mRNA, and experts warn that regulatory decisions that lack sound scientific evidence could undermine confidence and jeopardize U.S. leadership in biomedical innovation.  

 

AMA, Vaccine Integrity Project Launch Independent Vaccine Review, Departing from CDC 

  • The American Medical Association (AMA) and the University of Minnesota’s Vaccine Integrity Project (VIP) announced last week (February 10) that they will launch an independent, evidence-based review of vaccines ahead of the 2026-27 respiratory virus season.  
    • The effort will initially focus on influenza, Covid, and respiratory syncytial virus (RSV) vaccines. 
  • The initiative will be designed to systematically evaluate available data on safety, efficacy, and clinical impact, and will be supported by expert panels, structured evidence assessments, and publicly available summaries.   
    • The process will identify key policy questions, review clinical trial data and real-world evidence, and produce concise evidence briefs intended to support transparent and scientifically consistent decision-making.  
  • Organizers say findings will be released in advance of the next respiratory season so that clinicians, health officials, policymakers, and the public have clear, science-based evidence available prior to making immunization recommendations.  
    • The goal of the effort is not to issue recommendations but to ensure physicians and the American public have “a transparent, evidence-based process by which vaccine recommendations are made,” according to AMA Trustee, Dr. Sandra Adamson Fryhofer. 
  • The initiative comes amid criticism and uncertainty surrounding changes to the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) over the past year, which has led to eroded trust in federal vaccine guidance and created confusion about how evidence is being evaluated to inform recommendations.  
  • The move represents a notable shift in the vaccine policy landscape, as ACIP has served for decades as the leading body for reviewing vaccine evidence, and the committee’s recommendations have generally guided and been aligned with medical societies nationwide. The AMA’s decision to establish a parallel review process represents an unprecedented departure from this longstanding structure. 

 

NIH Director Named Acting CDC Director Amid Broader HHS Turnover 

  • HHS leadership saw significant changes this week, capped by Wednesday’s announcement that National Institutes of Health (NIH) Director Dr. Jay Bhattacharya will serve as Acting CDC Director following the departure of Deputy Secretary Jim O’Neill. 
    • O’Neill—who had also been serving as Acting CDC Director since August 28—left the agency on Friday (February 13). He originally assumed the CDC post after Senate-confirmed Director Dr. Susan Monarez was dismissed after just one month amid contentious policy changes at the agency. 
    • As Acting Director, Bhattacharya now holds authority—alongside the HHS Secretary—to formally adopt or reject ACIP recommendations, a particularly consequential role as the panel weighs potential changes to federal vaccine policy. 
  • Bhattacharya’s new responsibilities come in addition to leading the National Institutes of Health, where more than half of the agency’s 27 institutes and centers currently lack permanent directors.  
    • Bhattacharya recently notified NIH staff of another institute director departure, bringing the total number of vacancies to 16.  
  • The CDC transition is part of broader turnover across HHS. General Counsel Mike Stuart is also leaving the department, while four senior aides were elevated as part of a reported effort to sharpen the department’s focus on drug pricing and food safety initiatives. 
  • The longer-term leadership picture at CDC remains uncertain. Under the Federal Vacancies Reform Act, an acting official may serve for 210 days following a vacancy—in this case, until March 25. 
    • If the administration submits a nominee, an Acting Director may continue serving during Senate consideration. If a nomination is rejected or withdrawn, a new 210-day period may begin. This process may only occur twice, but it would bring us well into President Trump’s term. 
    • Former CDC officials have expressed skepticism that a new nominee for CDC Director could be confirmed by the Senate in the current environment.  
  • In the interim, Bhattacharya will be balancing oversight of both NIH and CDC at a moment when vaccine policy, agency authority, and public trust in federal health institutions remain central points of debate. 

 

Medical Groups Urge Court to Reverse CDC Vaccine Policy Changes 

  • During a Friday (February 13) hearing, major medical organizations led by the American Academy of Pediatrics (AAP) urged a federal judge to reverse changes to the CDC recommended childhood immunization schedule and halt the scheduled February ACIP meeting. 
    • AAP is joined by several co-plaintiffs, including the American Public Health Association (APHA), American College of Physicians (ACP), Infectious Diseases Society of America (IDSA), Society for Maternal-Fetal Medicine (SMFM), and others, including three women who allege they were harmed by the changes. 
  • The lawsuit has drawn broad support across the medical and public health community. More than 70 organizations published a letter Friday urging the court to affirm the need for an independent ACIP. 
    • More than 100 experts and organizations filed an amicus brief in support of the plaintiffs, warning the changes could reduce vaccination rates and increase preventable outbreaks. Defend Public Health also filed an amicus brief in support of the medical organizations. 
    • Dr. Richard Besser—President and CEO of the Robert Wood Johnson Foundation (which joined the group amicus brief) and former CDC Acting Director—published an op-ed last week, emphasizing the importance of this court case. “The decision will affect physicians’ ability to properly practice medicine, parents’ ability to care for their children and children’s ability to grow up healthy.” 
  • As of February 16, Massachusetts federal judge Brian E. Murphy has not yet ruled. With ACIP scheduled to meet February 25, he noted he must decide the case on an “uncomfortably tight timeline” and requested additional responses from the government by end of day Wednesday (February 18).  

As Federal Policy Shifts, States Split on Vaccine Requirements and Infrastructure 

  • As Kennedy works to reshape federal vaccine policy, allied groups are advancing parallel efforts in the states. 
    • A newly formed Medical Freedom Act Coalition—comprised of at least 15 organizations including Children’s Health Defense (CHD) and the MAHA Institute—aims to repeal state laws codifying vaccine requirements.  
    • CHD’s General Counsel recently said the “ultimate goal is to remove mandates.” School and daycare immunizations requirements, however, are not compulsory medical procedures, and all states allow medical exemptions under law.  
  • Several states have recently advanced legislation that would weaken vaccine requirements or alter vaccine infrastructure: 
    • Florida held a hearing last week on HB 399, which would allow individuals to sue vaccine manufacturers if the company advertised a vaccine in the state—mirroring a Texas law enacted last year. Legal experts warn the measure could conflict with federal law.  
      • Vaccine injury claims are already addressed through the federal Vaccine Injury Compensation Program (VICP), with claimants retaining the right to pursue additional legal action. 
  • New Hampshire advanced HB 1811, which would eliminate all school vaccine requirements except polio. Lawmakers are also considering HB 1719, which would align state policy with the CDC’s revised childhood schedule (removing the universal hepatitis B birth dose), and HB 1584, which would broaden religious exemptions. 
    • The full House is set to vote on these bills within the coming weeks, with the first votes scheduled today (February 19). 
  • At the same time, some states are moving in the opposite direction: 
    • On Tuesday, California’s Attorney General announced plans to sue the Trump administration over changes to the recommended childhood immunization schedule. 
    • Maine lawmakers introduced bills (LD 2071 and 2146) last week to expand pharmacist vaccination authority, strengthen liability protections, and require insurance coverage without cost-sharing. 
    • Oregon is considering legislation (SB 1598) that would allow the state health authority to issue a standing vaccination order, following similar policies permitted in California and Washington. The Senate committee was scheduled to vote on the bill yesterday (February 18).   
  • As federal vaccine guidance shifts, state legislatures are emerging as the next major policy arena—pursuing sharply divergent approaches to immunization requirements and access. 

 

Scientists Identify Cause of Rare Clotting Events Linked to Adenovirus Covid Vaccines 

  • Researchers have identified the biological mechanism behind the rare but serious blood clotting condition linked to certain Covid vaccines, helping explain a safety signal that first emerged in 2021. 
    • These vaccines—manufactured by Johnson & Johnson in the U.S. and AstraZeneca in Europe and Australia—used an adenovirus to ferry a gene for the Covid virus’s spike protein to the recipient. 
    • Adenoviruses are a common virus that can cause mild or moderate diseases such as the common cold or bronchitis. 
  • The vaccines were associated in very rare cases with vaccine-induced immune thrombotic thrombocytopenia (VITT)—a syndrome involving unusual blood clots and low platelet counts. 
    • In the U.S., safety monitoring systems detected this rare risk associated with the J&J vaccine, leading to a pause in use, updated warnings, and ultimately the removal of the vaccine from the U.S. market. Many European countries similarly limited use of the AstraZeneca vaccine or dropped it entirely. 
    • In a new study, researchers identified a mutation in a person’s cells that can lead the adenovirus protein in the vaccine to trigger an immune response that activates platelets and leads to clotting. They also noted that VITT patients had likely been previously infected with an adenovirus, priming their immune system for the reaction. 
  • Experts say the findings help explain what happened biologically and may inform the design of future viral vector vaccines—while also underscoring how rare adverse events can be detected and investigated through post-authorization safety surveillance.

OUTBREAK OUTLOOK 

Measles Continues to Spread as More HHS Officials Urge Vaccination  

  • As of February 13, the U.S. has recorded 997 measles cases so far in 2026. Several states remain key areas to watch:   
    • South Carolina‘s ongoing upstate outbreak added 29 cases from February 10 to February 17, bringing total case numbers to 962 since last October.  
      • Providers who have treated measles patients in recent months say the outbreak is taking a toll.  
      • One clinic in Spartanburg treats patients in their cars to prevent measles from spreading inside the waiting room, especially to infants who are too young to be vaccinated.  
      • The clinic’s medical director fears infections may be undercounted, saying that some families who come to the clinic with “telltale signs” of measles refuse to be tested. 
    • Arizona and Utah have recorded 49 and 104 cases in 2026, respectively. Utah’s case count includes two new cases in Tooele County—the first reported cases in this county since the outbreak began. 
    • New York has reported its first case this year, in an infant who had recently traveled overseas. 
    • North Carolina has confirmed 21 cases in 2026, many of which have occurred in counties bordering South Carolina. 
    • Vermont also confirmed its first measles case of 2026, in an adult who had recently traveled internationally.   
  • FDA Commissioner Dr. Marty Makary and NIH Director Dr. Jay Bhattacharya have signaled support for the measles, mumps, and rubella (MMR) vaccine, underscoring its efficacy in preventing infection. 

 

Influenza B Circulation Increases 

  • CDC data for the week ending February 7 show that flu activity remains elevated. Positive test rates and outpatient provider visits have increased compared to the previous week, but hospitalizations are decreasing.  
    • Six pediatric flu deaths were reported in the past week, increasing this season’s total to 66. Recent flu-related deaths were reported in several states including Massachusetts (the state’s seventh pediatric flu death this season) and Tennessee (the state’s first this season). 
    • While influenza A remains the most commonly circulating strain this season, cases of influenza B have increased nationwide in recent weeks, accounting for nearly one-third of positive tests for the week ending February 7. 
      • While both influenza A and B share similar symptoms, the latter tends to circulate later in the season and is more likely to cause severe outcomes in children than adults. 
  • More broadly, national respiratory illness activity remains moderate as of February 13. 
    • RSV activity is elevated and growing in parts of the Midwest and Western U.S., and hospitalizations remain elevated.   
    • Covid activity is elevated in and rising in some areas of the U.S., though hospitalizations continue to decline.  

REALITY CHECK 

CLAIM: mRNA vaccines—like the Covid vaccine—are experimental, not adequately understood, and their safety should be questioned. 

  • REALITY: mRNA vaccine technology is built on decades of foundational scientific research and has undergone large-scale clinical testing and extensive real-world safety monitoring that has demonstrated that serious adverse events are rare and that the benefits of these vaccines far outweigh the risks.  
  • While the first widespread use of mRNA vaccines occurred during the Covid pandemic, scientists—including those at the NIH and other leading institutions—have been studying mRNA’s use as a treatment since the 1990s. 
  • Before authorization and approval, mRNA Covid vaccines were evaluated in large randomized clinical trials involving tens of thousands of participants—approximately 30,000 to 43,000 individuals per pivotal trial—and following authorization were administered to millions of people in the U.S. and billions globally, providing an unprecedented volume of real-world safety data.   
  • Additionally, safety monitoring has continued after approval through multiple overlapping safety systems in the U.S. including The Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD), and V-Safe—all of which are designed to efficiently detect even rare adverse events and trigger further investigation when needed.  
  • Like any medical intervention, mRNA vaccines can cause side effects, but they are typically mild and temporary (e.g. soreness at the injection site, fatigue, or headache) as the immune system responds. 
    • In rare cases, where a more serious or unexpected side effect is identified—like when safety monitoring identified a small risk of myocarditis in some vaccine recipients—the adverse event is rigorously studied, warning labels are updated, and appropriate language is incorporated into clinical guidance, demonstrating the efficacy of the safety monitoring systems we have in place.
  • Overall, a substantial body of clinical trial data, post-authorization surveillance, and evidence-based, peer-reviewed research consistently shows that the benefits of mRNA vaccines in protecting against severe disease, hospitalization, and death far outweigh any risks associated with the vaccine, and there is no credible scientific evidence demonstrating widespread or unrecognized major safety issues associated with their use. 

CLAIM: Even if polio vaccination rates drop below the level needed to maintain herd immunity, the disease isn’t that dangerous, given how rare it is. 

  • REALITY: This claim is misleading. Polio is rare today because vaccination has kept transmission low. When vaccination rates fall, the virus can spread silently—leading to preventable paralysis and death.  
    • About 72% of infections are asymptomatic, meaning people can spread the virus without knowing it. 
  • While most polio infections cause no symptoms, the disease can be devastating for those who develop severe illness: 
    • About 1 in 25 infections lead to viral meningitis—inflammation of the lining of the brain and spinal cord that can cause severe headache and pain. 
    • Up to 1 in 200 infections with polio virus type 1 result in paralytic polio, which can cause permanent paralysis. 
  • Among people who develop paralytic polio, 5–10% die when the virus paralyzes the muscles used for breathing. Survivors may experience lifelong disability, muscle atrophy, chronic pain, or post-polio syndrome decades later. 
  • Polio is also highly contagious. Before vaccines became available in 1955, the U.S. recorded an average of 16,000 cases of paralytic polio annually, with outbreaks overwhelming hospitals and leaving thousands of children with lifelong paralysis.  
  • Following widespread vaccination, polio cases have declined by more than 99% globally, preventing an estimated 20 million cases of paralysis. The U.S. reported no paralytic cases in 2023. 

WHAT TO WATCH 

Senate Hearing Scheduled for Surgeon General Nominee Casey Means (Feb. 25) 

  • The Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on the nomination of Dr. Casey Means for Surgeon General on February 25. 
    • Trump nominated Means after withdrawing his first choice for the role: Dr. Janette Nesheiwat, a former Fox News contributor. The President has said he selected Means based on Kennedy’s recommendation. 
    • Her hearing was originally scheduled for October but was postponed after Means went into labor. 
  • Means is a wellness entrepreneur and influencer. She earned a medical degree from Stanford but is not a practicing doctor, as she withdrew early from her residency program and her medical license lapsed in 2024.   
  • She has criticized vaccines, alleging that childhood vaccination is linked to “health declines in vulnerable children” and promoting sources that incorrectly suggest vaccines cause autism. 

Democrats Call for Removal of ACIP Members Ahead of Scheduled Meeting (Feb. 25-27)  

  • In advance of the scheduled ACIP meeting (February 25-27), House Democrats are calling on Kennedy to remove two newly appointed OB-GYNs, Dr. Adam Urato and Dr. Kimberly Biss, from ACIP, citing concerns over anti-vaccine ideology. 
    • Lawmakers argue their records and public comments could jeopardize evidence-based vaccine guidance, particularly for women and infants. 
    • The group also urged Kennedy to reinstate previous ACIP members who were fired, arguing the panel has shifted away from scientific integrity. 
  • As of Wednesday (February 18), HHS missed both deadlines to upload the required Federal Register notice ahead of the meeting, indicating that the meeting may be postponed. A CDC officer reportedly told staff Tuesday that the meeting likely wouldn’t take place as scheduled.   

U.S. to Participate in WHO Flu Vaccine Composition Convening (Feb. 26) 

  • The U.S. will participate in the World Health Organization’s (WHO) February 26 meeting in Turkey to discuss the composition of the 2026-2027 flu vaccine for the northern hemisphere, despite officially withdrawing from the organization last month.  
  • The group will then issue recommendations on the composition of the influenza vaccines for the following flu season. These recommendations are used by national vaccine regulatory agencies and pharmaceutical companies to develop, produce, and license the vaccines.  

 

FDA Vaccine Advisory Committee to Decide on Next Season’s Flu Vaccines (Mar. 12) 

  • Following the WHO meeting, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRPBAC) will meet on March 12 to publicly make recommendations on the strains to include in U.S. flu vaccines for the 2026-2027 season.  
  • This would mark VRPBAC’s first flu strain selection meeting since March 2024 after the Committee’s 2025 meeting was abruptly canceled.  
    • Strains for the 2025-2026 flu vaccine were selected following a closed-door meeting with FDA, CDC, and Department of Defense (DoD) officials, bypassing the usual input from independent vaccine advisors.  

WHO Criticizes Planned CDC-Funded Hepatitis B Vaccine Study, Which Remains Paused 

  • Last week, WHO denounced a planned CDC-funded study of hepatitis B vaccination in newborns in Guinea-Bissau, which Director-General Dr. Tedros Adhanom Ghebreyesus called “unethical.” 
    • The organization also released a formal statement underscoring the importance of the hepatitis B birth dose and explaining why withholding the vaccine is wrong.  
  • The study is currently suspended pending further review, according to country officials who said it had not received proper ethical approval. 
    • Researchers have declined to answer questions about the trial’s status, but confirmed it would be registered on clinicaltrials.gov “prior to initiation as per standard procedure.” As of February 18, it is not listed on the site.   

REMINDER: Medical Societies to Brief Congress on Vaccine Recommendations (Feb. 24) 

  • To address these discrepancies, AAP will join the American College of Obstetricians and Gynecologists (ACOG), the Infectious Diseases Society of America (IDSA), and Vaccinate Your Family (VYF) for a congressional briefing to explain differences in recommendations. 

### 

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 

If additional members of your team would benefit from receiving this newsletter, please reply to this email with their information so they can be added to the newsletter distribution list.