The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) addressed new initiatives and voted on several vaccine recommendations in their first 2024 meeting, held from February 28 to 29.
The ACIP discussed several vaccines during the 2-day meeting, including those for protection against COVID-19, Chikungunya, diphtheria and tetanus (DT), Hemophilus influenzae type b (Hib), polio, respiratory syncytial virus (RSV), meningococcal disease, and pneumococcal disease. The updated recommendations for vaccination against COVID-19, RSV, and pneumococcal disease are available here.
DT Vaccine
The DT vaccine, which was previously recommended for children younger than 7 years with a contraindication to pertussis-containing vaccines, has been discontinued in the United States. The ACIP now recommends the tetanus and diphtheria (Td) vaccine for this group, particularly in those who develop encephalopathy within 7 days of DT vaccination.1 Current guidelines indicate the diphtheria, tetanus, and pertussis (DTaP) vaccine as the first dose in the vaccination series. Children aged 7 years and older with contraindications may now receive Td for all remaining doses. Although it remains a viable option, the Td vaccine contains a lower dose of diphtheria toxoid, suggesting a decrease in its efficacy.
The ACIP approved the vaccines for children resolution for coverage of the Td vaccine in children younger than 7 years who have contraindications to pertussis-containing vaccines.2 This update is anticipated to be included in the recommended immunization schedule. Guidelines regarding the administration of a single booster dose of the Tdap vaccine among children aged between 11 and 12 years remain unchanged.
"
Revisions to the schedule should optimize protection against meningitis.
Meningococcal Vaccination
The meningococcal conjugate vaccine (MenABCWY), a pentavalent formulation from Pfizer®, was approved by the Food and Drug Administration (FDA) in October 2023. The ACIP now recommends the MenABCWY vaccine among children and adolescents for whom both the MenACWY and MenB vaccines are indicated at a single visit. The approval of the MenABCWY vaccine provides multiple options for revising the meningococcal vaccine schedule, including the elimination of a MenACWY vaccine dose in children aged 11 to 12 years and a change in the recommended age group for MenB vaccination to increase protection at the time of college entry.
Evidence suggests that college-aged students have a 3.5-fold higher risk for serogroup B disease than noncollege-aged students, with disease incidence peaking at 19 years of age and declining after 20 years of age.3 According to the ACIP, "Revisions to the schedule should optimize protection against meningitis." They also noted that the approval of a pentavalent formulation will serve to lower the number of injections needed for protection against meningococcal disease.
The ACIP proposed several options to consider for revising the recommended meningococcal vaccine schedule, as shown in the table:3
Option
ACWY Dose #1
ACWY Dose #2
B Dose #1
B Dose #2
Current Recommendation
11-12 years
16 years
16-23 years (preferred 16-18 years) *SCDM
16-23 years (preferred 16-18 years) *SCDM
1
11-12 years
16 years
16 years
17-18 years
2
11-12 years
16 years
16 years risk-based
17-18 years risk-based
3
No dose
16 years
16 years risk-based
17-18 years risk-based
4
15 years
17-18 years
17-18 years
17-18 years
*SCDM = shared clinical decision making
There is ongoing discussion regarding these 4 options as the ACIP noted that the existing vaccination platform took years to implement and any revisions to the schedule may affect school requirements.
Chikungunya Vaccination
Chikungunya is a viral disease transmitted to humans by infected mosquitoes. The Chikungunya vaccine (IXCHIQ) was licensed in the US by the FDA in November 2023 for use among individuals at risk for exposure to the virus, including travelers, laboratory workers, and those residing in areas with increased transmission risk. The vaccine is available as a single-dose primary schedule for individuals aged 18 years and older.4
The ACIP recommends the vaccine for adults traveling to a country or territory where there has been an outbreak of Chikungunya.2
However, the vaccine may be considered for the following individuals in the event of planned travel to a country or territory where there is no outbreak but where substantial evidence of transmission has occurred within the past 5 years:2
Individuals aged 65 years and older with underlying health conditions likely to have mosquito exposure
Individuals scheduled to remain abroad an extended period (≥6 months)
In regard to laboratory workers, the ACIP recommends Chikungunya vaccination for those whose research or diagnostic work involves the use of live viruses. The ACIP noted that the virus is primarily transmitted through aerosol, as well as percutaneous and possibly mucosal routes.2
Individuals who are pregnant should avoid exposure to Chikungunya.6 The ACIP noted that Chikungunya vaccination should be deferred until after delivery but may be considered for individuals at increased risk for exposure. However, they recommend against vaccination during the first trimester as well as after 36 weeks’ gestation.
Polio Vaccination
The ACIP considered modifying the polio vaccine schedule for US children who have been vaccinated against polio in other countries. Six countries (Bangladesh, Cuba, Ecuador, India, Nepal, and Sri Lanka) include fractional inactivated polio virus (fIPV) vaccination in recommended routine childhood immunization schedules.8
According to the ACIP, 2 fIPV doses are considered valid and counted as one full intramuscular dose of IPV with respect to the US schedule. However, 1 fIPV dose is not considered a viable alternative to 1 IPV dose.8
Guidelines regarding children who have been vaccinated against polio in the US remain unchanged.
Hib Vaccination
There are ongoing discussions regarding the expansion of Hib vaccine recommendations for American Indian and Alaska Native (AI/AN) infants. Guidelines suggest the use of PedvaxHIB® (Hemophilus b conjugate vaccine) for AI/AN infants. However, the emergence of combination vaccines, such as Vaxelis®, may expand options for this population.
Vaxelis, initially licensed by the FDA in December 2018, is a hexavalent vaccine comprising DTaP, inactivated polio, Hemophilus influenzae type B conjugate, and hepatitis B virus vaccine formulations. Similar to PedvaxHIB, Vaxelis contains Hib conjugate at a lower dose.7 Combination vaccines provide an opportunity for fewer shots, reduce the risk for missed doses, and lower the burden of vaccine administration. Results of a phase 4 trial conducted among AI/AN infants (N=333) showed that Vaxelis was noninferior to PedvaxHIB with respect to Hib antibody levels 30 days following receipt of the first vaccine dose.8
Members of the ACIP will vote on additional vaccine recommendations at their next scheduled meeting in June of 2024.
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The Conversation — Tuberculosis (TB) is the world’s deadliest bacterial infection. It afflicted over 10 million people and took 1.3 million lives in 2022. These numbers are predicted to increase dramatically because of the spread of multidrug-resistant TB.
Why does 1 patient with TB recover from the infection while another succumbs? And why does 1 drug work in 1 patient but not another, even if they have the same disease?
People have been battling TB for millennia. For example, researchers have found Egyptian mummies from 2400 BCE that show signs of TB. While TB infections occur worldwide, the countries with the highest number of multidrug-resistant TB cases are Ukraine, Moldova, Belarus and Russia.
Researchers predict that the ongoing war in Ukraine will result in an increase in multidrug-resistant TB cases because of health care disruptions. Additionally, the COVID-19 pandemic reduced access to TB diagnosis and treatment, reversing decades of progress worldwide.
Rapidly and holistically analyzing available medical data can help optimize treatments for each patient and reduce drug resistance. In our recently published research, my teamand I describe a new artificial intelligence (AI) tool we developed that uses worldwide patient data to guide more personalized and effective treatment of TB.
Predicting Success or Failure
My team and I wanted to identify what variables can predict how a patient responds to TB treatment. So we analyzed more than 200 types of clinical test results, medical imaging and drug prescriptions from over 5000 patients with TB in 10 countries. We examined demographic information such as age and gender, prior treatment history and whether patients had other conditions. Finally, we also analyzed data on various TB strains, such as what drugs the pathogen is resistant to and what genetic mutations the pathogen had.
Looking at enormous datasets like these can be overwhelming. Even most existing AI tools have had difficulty analyzing large datasets. Prior studies using AI have focused on a single data type — such as imaging or age alone — and had limited success predicting TB treatment outcomes.
We used an approach to AI that allowed us to analyze a large and diverse number of variables simultaneously and identify their relationship to TB outcomes. Our AI model was transparent, meaning we can see through its inner workings to identify the most meaningful clinical features. It was also multimodal, meaning it could interpret different types of data at the same time.
Once we trained our AI model on the dataset, we found that it could predict treatment prognosis with 83% accuracy on newer, unseen patient data and outperform existing AI models. In other words, we could feed a new patient’s information into the model and the AI would determine whether a specific type of treatment will either succeed or fail.
We also found that certain drug combinations worked better in patients with certain types of drug-resistant infections but not others, leading to treatment failure. Combining drugs that are synergistic, meaning they enhance each other’s potency in the lab, could result in better outcomes. Given the complex environment in the body compared with conditions in the lab, it has so far been unclear whether synergistic relationships between drugs in the lab hold up in the clinic. Our results suggest that using AI to weed out antagonistic drugs, or drugs that inhibit or counteract each other, early in the drug discovery process can avoid treatment failures down the line.
Ending TB With the Help of AI
Our findings may help researchers and clinicians meet the World Health Organization’s goal to end TB by 2035, by highlighting the relative importance of different types of clinical data. This can help prioritize public health efforts to mitigate TB.
While the performance of our AI tool is promising, it isn’t perfect in every case, and more training is needed before it can be used in the clinic. Demographic diversity can be high within a country and may even vary between hospitals. We are working to make this tool more generalizable across regions.
Our goal is to eventually tailor our AI model to identify drug regimens suitable for individuals with certain conditions. Instead of a one-size-fits-all treatment approach, we hope that studying multiple types of data can help physicians personalize treatments for each patient to provide the best outcomes.
Originally published on The Conversation through a Creative Commons License.
The Pediatric Infectious Diseases Society (PIDS) Pediatric COVID-19 Therapies Taskforce has released updated guidance on COVID-19 management in adolescents and children. The new guidance was published in the Journal of the Pediatric Infectious Diseases Society.
Although most children with COVID-19 infection experience mild to moderate illness, some are at increased risk for severe or critical illness, as well as long-term complications.
A panel of experts in pediatric infectious diseases, pharmacotherapy, and intensive care medicine met to update interim guidance statements on COVID-19 prevention and management in children and adolescents that were issued by the PIDS in 2022. The panel assessed evidence on risk factors for severe disease in pediatric patients with COVID-19, as well as the safety and efficacy of preventive and therapeutic interventions. They also evaluated similar evidence captured from adult patients and determined whether it could be applied to pediatric populations.
Following review of the evidence, the panel issued new guidance in 4 domains of pediatric COVID-19 management:
Risk stratification;
Early treatment for patients who do not require hospitalization;
Treatment to prevent disease progression in hospitalized patients; and
Pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).
"
Understanding the risk factors for severe illness and the evidence for safety, efficacy, and effectiveness of therapies for COVID-19 in children is necessary to optimize therapy.
Risk Stratification
When stratifying children and adolescents with COVID-19 infection into risk groups, the panel advises clinicians to consider age, medical complexity, prior immunity, immunocompromised status, and chronic conditions, such as hematologic, metabolic, cardiac, pulmonary, gastrointestinal, kidney, neurodevelopmental, and psychiatric conditions.
The risk for critical COVID-19 differs on the basis of age and demonstrates a U-shaped distribution in which the risk is highest in younger infants and older adolescents and lowest in primary school-aged children. Medical complexity also serves as a predictor for critical disease, with prior research indicating a 10-fold greater risk for critical COVID-19 in children with at least 2 underlying conditions than in those without comorbidities. Moreover, available evidence suggests that the risk for poor outcomes increases with each additional preexisting condition. The conditions associated with the greatest increase in risk include seizure disorders, cardiovascular disease, neurologic disease, prematurity, diabetes, obesity, chronic lung disease, and immunocompromised conditions.
The panel recommends clinicians to consider the role of prior immunity in assessing the risk for disease progression in pediatric patients. Data captured during Omicron waves show that monovalent and bivalent COVID-19 vaccines were more than 75% effective at preventing severe disease among children. In addition, prior infection combined with booster vaccination confers even greater protection against severe disease, though this hybrid immunity wanes over time.
Early Treatment in Nonhospitalized Pediatric Patients
For nonhospitalized children at reduced risk for severe disease who test positive for SARS-CoV-2, the panel suggests symptomatic care and recommends against the administration of specific treatments. However, specific treatments may be considered appropriate for patients at moderate or high risk for severe disease.
Treatment should be administered within 7 days of COVID-19 symptom onset, and both patient age and time since presentation should inform the choice of therapy. Available treatment options include remdesivir, nirmatrelvir-ritonavir, monoclonal antibodies, and molnupiravir. In addition, pediatric patients who are immunocompromised and at risk for severe disease may be candidates for COVID-19 convalescent plasma.
Treatment for Hospitalized Pediatric Patients
According to the panel, children infected with COVID-19 who are hospitalized for non-COVID-19-related conditions should be cared for in the same manner as nonhospitalized children with COVID-19 if ventilation is not required. For children who require hospitalization for COVID-19, clinicians should consider age, illness severity, vaccination and prior infection status, symptom duration, and other risk factors for disease progression in decisions regarding treatment and management.
The panel defined several goals for clinicians to aim for in the management of children and adolescents hospitalized with COVID-19 infection. These include prioritizing prevention of severe disease progression and mortality, minimizing the duration of hospitalization, avoiding treatment-related adverse effects, and providing cost-effective, equitable care.
In regard to available treatment options, the panel recommends remdesivir for pediatric patients aged 12 years and older who require supplemental oxygen or noninvasive ventilation. The panel also suggests the use of dexamethasone for patients who require high-flow oxygen therapy, noninvasive ventilation, or mechanical ventilation. In addition, tocilizumab or baricitinib may be considered for patients who require respiratory support and experience worsening symptoms with evidence of significant inflammation.
The panel recommends against the use of monoclonal antibodies and convalescent plasma in most pediatric patients, with the exception of those with severe immunocompromised conditions or contraindications to other available therapies.
PrEP and PEP
There are no PrEP or PEP agents authorized for use in pediatric patients in the United States. In other regions where these agents have been authorized, the panel suggests the use of PrEP and COVID-19 vaccination as a complementary strategy for severe disease prevention. High-risk pediatric patients with immunocompromised conditions or contraindications to vaccination may be eligible for PrEP with tixagevimab-cilgavimab.
The use of PEP in children and adolescents should be considered on an individual basis. For high-risk pediatric patients outside the US, the panel suggests PEP with bamlanivimab or casirivimab-imdevimab. The panel advises clinicians to consider patients’ immunocompromised status, vaccination history, and other identifiable risk factors in the administration of PrEP or PEP, as well as the efficacy of these agents against circulating COVID-19 variants.
According to the panel, “Understanding the risk factors for severe illness and the evidence for safety, efficacy, and effectiveness of therapies for COVID-19 in children is necessary to optimize therapy.”
Disclosures: Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Kaiser Health News — Gayle Borne has fostered more than 300 children in Springfield, Tennessee. She’s cared for kids who have rarely seen a doctor — kids so neglected that they cannot speak. Such children are now even more vulnerable because of a law Tennessee passed last year that requires the direct consent of birth parents or legal guardians for every routine childhood vaccination. Foster parents, social workers, and other caregivers cannot provide permission.
In January, Borne took a foster baby, born extremely premature at just over 2 pounds, to her first doctor’s appointment. The health providers said that without the consent of the child’s mother, they couldn’t vaccinate her against diseases like pneumonia, hepatitis B, and polio. The mother hasn’t been located, so a social worker is now seeking a court order to permit immunizations. “We are just waiting,” Borne said. “Our hands are tied.”
Tennessee’s law has also stymied grandmothers and other caregivers who accompany children to routine appointments when parents are at work, in drug and alcohol rehabilitation clinics, or otherwise unavailable. The law claims to “give parents back the right to make medical decisions for their children.”
Framed in the rhetoric of choice and consent, it is one of more than a dozen recent and pending pieces of legislation nationwide that pit parental freedom against community and children’s health. In actuality, they create obstacles to vaccination, the foundation of pediatric care.
"
You should have the right to protect your family from preventable diseases.
Such policies have another effect. They seed doubt about vaccine safety in a climate rife with medical misinformation. The trend has exploded as politicians and social media influencers make false claims about risks, despite studies showing otherwise.
Doctors traditionally give caregivers vaccine information and get their permission before delivering more than a dozen childhood immunizations that defend against measles, polio, and other debilitating diseases.
But now, Tennessee’s law demands that birth parents attend routine appointments and sign consent forms for every vaccine given over 2 or more years. “The forms could have a chilling effect,” said Jason Yaun, a Memphis pediatrician and past president of the Tennessee chapter of the American Academy of Pediatrics.
“People who promote parental rights on vaccines tend to downplay the rights of children,” said Dorit Reiss, a vaccine policy researcher at the University of California Law-San Francisco.
Drop in Routine Vaccination Rates
Misinformation coupled with a parental rights movement that shifts decision-making away from public health expertise has contributed to the lowest childhood vaccine rates in a decade.
This year, legislators in Arizona, Iowa, and West Virginia have introduced related consent bills. A “Parents’ Bill of Rights” amendment in Oklahoma seeks to ensure that parents know they can exempt their children from school vaccine mandates along with lessons on sex education and AIDS. In Florida, the medical skeptic leading the state’s health department recently defied guidance from the Centers for Disease Control and Prevention (CDC) by telling parents they could send unvaccinated children to a school during a measles outbreak.
Last year, Mississippi began allowing exemptions from school vaccine requirements for religious reasons because of a lawsuit funded by the Informed Consent Action Network, which is listed as a leading source of anti-vaccine disinformation by the Center for Countering Digital Hate. A post on ICAN’s website said it “could not be more proud” in Mississippi to “restore the right of every parent in this country to have his or her convictions respected and not trampled by the government.”
Even if some bills fail, Reiss fears, the revived parental rights movement may eventually abolish policies that require routine immunizations to attend school. At a recent campaign rally, Republican presidential candidate Donald Trump said, “I will not give one penny to any school that has a vaccine mandate.”
The movement dates to the wake of the 1918 influenza pandemic, when some parents pushed back against progressive reforms that required school attendance and prohibited child labor. Since then, tensions between state measures and parental freedom have occasionally flared over a variety of issues. Vaccines became a prominent one in 2021, as the movement found common ground with people skeptical of COVID-19 vaccines.
“The parental rights movement didn’t start with vaccines,” Reiss said, “but the anti-vaccine movement has allied themselves with it and has expanded their reach by riding on its coattails.”
When Lawmakers Silence Health Experts
In Tennessee, anti-vaccine activists and libertarian-leaning organizations railed against the state’s health department in 2021 when it recommended COVID-19 vaccines to minors, following CDC guidance. Gary Humble, executive director of the conservative group Tennessee Stands, asked legislators to blast the health department for advising masks and vaccination, suggesting the department “could be dissolved and reconstituted at your pleasure.”
Backlash also followed a notice sent to doctors from Michelle Fiscus, then the state’s immunization director. She reminded them that they didn’t need parental permission to vaccinate consenting adolescents 14 years or older, according to a decades-old state rule called the Mature Minor Doctrine.
In the weeks that followed, state legislators threatened to defund the health department and pressured it into scaling back COVID-19 vaccine promotion, as revealed by The Tennessean. Fiscus was abruptly fired. “Today I became the 25th of 64 state and territorial immunization program directors to leave their position during this pandemic,” she wrote in a statement. “That’s nearly 40% of us.” Tennessee’s COVID-19 death rate climbed to one of the nation’s highest by mid-2022.
By the time two state legislators introduced a bill to reverse the Mature Minor Doctrine, the health department was silent on the proposal. Despite obstacles for foster children who would require a court order for routine immunizations, Tennessee’s Department of Children’s Services was silent, too.
Notably, the legislator who introduced the bill, Republican Rep. John Ragan, was among those simultaneously overseeing a review of the agency that would determine its leadership and budget for the coming years. “Children belong to their families, not the state,” said Ragan as he presented the bill at a state hearing in April 2023.
Democratic Rep. Justin Pearson spoke out against the bill. It “doesn’t take into account people and children who are neglected,” he told Ragan. “We are legislating from a point of privilege and not recognizing the people who are not privileged in this way.”
Rather than address such concerns, Ragan referenced a Supreme Court ruling in favor of parental rights in 2000. Specifically, judges determined that a mother had legal authority to decide who could visit her daughters. Yet the Supreme Court has also done the opposite. For instance, it sided against a legal guardian who removed her child from school to proselytize for the Jehovah’s Witnesses.
Still, Ragan swiftly won the majority vote. Tennessee Gov. Bill Lee, a Republican, signed the bill in May, making it effective immediately. Deborah Lowen, then the deputy commissioner of child health at the Department of Children’s Services, was flooded with calls from doctors who now face jailtime and fines for vaccinating minors without adequate consent. “I was and remain very disheartened,” she said.
A Right to Health
Yaun, the Memphis pediatrician, said he was shaken as he declined to administer a first series of vaccines to an infant accompanied by a social worker. “That child is going into a situation where they are around other children and adults,” he said, “where they could be exposed to something we failed to protect them from.”
“We have had numerous angry grandparents in our waiting room who take kids to appointments because the parents are at work or down on their luck,” said Hunter Butler, a pediatrician in Springfield, Tennessee. “I once called a rehabilitation facility to find a mom and get her on the phone to get verbal consent to vaccinate her baby,” he said. “And it’s unclear if that was OK.”
Childhood immunization rates have dropped for 3 consecutive years in Tennessee. Nationwide, downward trends in measles vaccination led the CDC to estimate that a quarter million kindergartners are at risk of the highly contagious disease.
Communities with low vaccination rates are vulnerable as measles surges internationally. Confirmed measles cases in 2023 were almost double those in 2022 — a year in which the World Health Organization estimates that more than 136,000 people died from the disease globally. When travelers infected abroad land in communities with low childhood vaccination rates, the highly contagious virus can spread swiftly among unvaccinated people, as well as babies too young to be vaccinated and people with weakened immune systems.
“There’s a freedom piece on the other side of this argument,” said Caitlin Gilmet, communications director at the vaccine advocacy group SAFE Communities Coalition and Action Fund. “You should have the right to protect your family from preventable diseases.”
In late January, Gilmet and other child health advocates gathered in a room at the Tennessee Statehouse in Nashville, offering a free breakfast of fried chicken biscuits. They handed out flyers as legislators and their aides drifted in to eat. One pamphlet described the toll of a 2018-19 measles outbreak in Washington state that sickened 72 people, most of whom were unvaccinated, costing $76,000 in medical care, $2.3 million for the public health response, and an estimated $1 million in economic losses due to illness, quarantine, and caregiving.
Barb Dentz, an advocate with the grassroots group Tennessee Families for Vaccines, repeated that most of the state’s constituents support strong policies in favor of immunizations. Indeed, 7 in 10 US adults maintained that public schools should require vaccination against measles, mumps, and rubella, in a Pew Research Center poll last year. But numbers have been dropping.
“Protecting kids should be such a no-brainer,” Dentz told Republican Rep. Sam Whitson, later that morning in his office. Whitson agreed and reflected on an explosion of anti-vaccine misinformation. “Dr. Google and Facebook have been such a challenge,” he said. “Fighting ignorance has become a full-time job.”
Whitson was among a minority of Republicans who voted against Tennessee’s vaccine amendment last year. “The parental rights thing has really taken hold,” he said, “and it can be used for and against us.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
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