The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) discussed vaccinations for COVID-19, influenza, respiratory syncytial virus (RSV), pneumococcal infections, and other infectious diseases and made some related recommendations during their first 2024 meeting, held February 28 to 29.
The updated recommendations for vaccination against meningococcal disease, polio, chikungunya, and Hemophilus influenzae disease are available here.
COVID-19 Vaccine Recommendations
The ACIP now recommends that persons 65 years of age and older should receive an additional dose of the updated (2023-2024) COVID-19 vaccine.1 The additional dose must be administered at least 4 months following the previous dose of the updated vaccine.
Adults aged 65 years and older have expressed a high level of concern about COVID-19, with 68.4% of individuals indicating they would definitely receive another vaccine dose should it become available.2 The effectiveness of an additional dose of COVID-19 vaccine is demonstrated by past recommendations.
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The need for the recommended 4-month COVID-19 booster vaccine for those age 65 and older is supported by both hospitalization data and scientific reasoning.
The need for the recommended 4-month COVID-19 booster vaccine for those age 65 and older is supported by both hospitalization data and scientific reasoning. An estimated 67% of COVID-19 hospitalizations were among patients age 65 years and older between October 2023 and January 2024, according to ACIP current respiratory season calculations made using data from COVID-NET, a population-based hospitalization surveillance program.3 Moreover, hospitalizations were 5 times higher for those age 65 years and older vs those aged 50 to 64 years.
The need for booster protection is also indicated by data showing that older adults may not be able to generate robust, long-lasting neutralizing antibody responses or good memory cytotoxic T-cells as there are fewer naive T-cells that respond to new pathogens.2
Vaccine formulations for the next COVID-19 season are already underway.2
Notably, members of the ACIP expressed concern that offering booster vaccinations for those age 65 and older at 4-month intervals could create vaccine fatigue as well as confusion for providers, given that immunocompromised patients may receive a booster dose following a 2-month interval.
In their June 2024 meeting, the ACIP plans to propose revised time frames for COVID-19 vaccine development and vaccination that will allow health care providers ample time to prepare for the COVID-19 viral season.
RSV Vaccine Developments
An ACIP work group on RSV vaccination in older adults presented its recommendation that providers and patients “consider timing of the RSV vaccination as part of shared clinical decision-making discussions,” noting that for most older adults, RSV vaccination is most beneficial when received in late summer or early fall, before the start of RSV season.4
Although shared decision-making between patient and provider is currently recommended for determining whether or not an adult patient should receive the RSV vaccine, this recommendation may be replaced by a universal recommendation that adults above a certain age receive the RSV vaccine, and a risk-based recommendation that adults over age 50 years receive the vaccine, according to the work group report, “RSV Vaccination in Older Adults: Work Group Interpretations.”4
The ACIP also expressed its intention to discuss the potential approval of the GSK RSV vaccine, AREXVY, for those aged 50 to 59 at “increased risk of RSV disease” at their June meeting. AREXVY is currently approved for use in adults aged 60 and above.4
In anticipation of RSV-related actions set for June, the ACIP reviewed RSV vaccine data related to the Moderna mRNA vaccine.4,5 The committee also discussed concerns over the potential connection between currently approved RSV vaccines and an increased incidence of Guillain-Barré Syndrome (GBS).
Moderna mRNA RSV Vaccine
Moderna has been conducting a clinical trial for their mRNA-based RSV vaccine for adults age 60 years and older (ClinicalTrials.gov Identifier: NCT05127434), which works by encoding the RSV fusion (F) glycoprotein.5 According to an ACIP report on trial findings that was presented at the February meeting, the vaccine has been generally well tolerated, efficacious through a median 8.6 months of follow-up, and presented no safety concerns (including no concern over GBS).
The trial enrolled a total of 26,550 healthy adults age 60 years and older, including those with chronic, stable health conditions. The primary endpoint was vaccine efficacy in preventing the first episode of RSV lower respiratory tract disease (LRTD) between 14 days and 12 months post-vaccination. The secondary endpoint was vaccine efficacy in preventing the first episode of RSV acute respiratory disease (ARD) and first hospitalization between 14 days and 12 months.
Trial investigators found that vaccine efficacy for RSV-LRTD with 2 or more symptoms reached 83.7%, whereas efficacy for RSV-LRTD with 3 or more symptoms was calculated as 82.4%.5 The efficacy threshold for RSV-ARD was set at 68.4%. Vaccine efficacy met lower bounds of confidence interval criteria to exceed 20%.
RSV Vaccines and GBS
For the February ACIP meeting, CDC’s Immunization Safety Office and the US Food and Drug Administration (FDA) shared preliminary data from multiple surveillance systems on the risk for GBS after RSV vaccination.4
An elevated but rare risk for GBS was observed following administration of the GSK’s AREXY and Pfizer’s ABRYSVO vaccines for RSV. According to the work group report on RSV Vaccination in Older Adults, current surveillance data “support a potential increased risk for GBS after RSV vaccination among adults aged ≥60 years.”4
The report went on to note that “there is currently insufficient evidence to confirm whether RSV vaccination is associated with increased risk for GBS in older adults, or to estimate the magnitude of any increase in GBS risk after RSV vaccination.”4
Currently, clinical trials are underway evaluating the safety of these vaccines, examining the association between RSV vaccines and the incidence of GBS. More conclusive evidence of potential risks following RSV vaccination will be available following RSV monitoring using self-controlled case series designs.
Influenza Immunization in Children With Asthma
The ACIP also assessed evidence evaluating the safety of the live attenuated influenza vaccine (LAIV4) in children with asthma.6 The evidence indicated that LAIV4 may be a suitable option for children age 5 years and older with asthma.
Evidence presented included a study assessing whether LAIV4 is noninferior to IIV4. The study included 151 patients between the ages of 5 and 7 years with persistent asthma who were randomly assigned to 2 groups: one receiving LAIV4 FluMist and the other receiving IIV4 Fluzone. On days 15 and 43, the 2 groups were evaluated for symptoms following vaccination. The study investigators compared the proportion of patients using LAIV4 vs IIV4 who experienced an asthma exacerbation during the 42 days following vaccination.
Study findings showed that in the 14 days following vaccination, 3 exacerbations were reported among those receiving LAIV4 vs 4 exacerbations among those receiving IIV4 (3.9% vs. 5.7%, P =.74). In the 42-day symptom assessment, 8 asthma exacerbations were documented among those receiving LAIV4 and 10 among those receiving IIV4 (10.8% vs. 14.7%, p = 0.74). The upper bound for noninferiority was set at 10% with a difference in proportion of 3.9 (CI: 90%: -0.15, 0.07).6 Researchers rejected the null hypothesis and proved LAIV4 noninferiority to IIV4.
Limitations of the study include the enrollment of fewer participants than intended, setting the power at 79% and the enrollment of patients within 2 separate influenza seasons, which may have led to slightly different products.
Further discussion of the suitability of LAIV4 for children age 5 years and older with asthma is anticipated at future ACIP meetings.
Pneumococcal Vaccination: PCV21 Considerations
The ACIP also discussed incorporating a recently developed pneumococcal vaccine, V116, a 21-valent pneumococcal conjugate vaccine (PCV21), into its roster of recommended pneumococcal vaccines. Toward that end, the committee reviewed phase 3 clinical trial results for V116 (ClinicalTrials.gov Identifier: NCT05425732).
The ACIP reported that the following policy questions are being actively considered by its work group:7
Should PCV21 be recommended for US adults aged 19 and older who currently have a recommendation to receive a PCV?
Should PCV21 be recommended for US adults aged 50 to 64 years who do not have risk-based indication for the pneumococcal vaccine?
Should PCV21 be recommended for US adults aged 19 to 49 years who do not have risk-based indication for the pneumococcal vaccine?
About 30% to 40% of adult invasive pneumococcal disease (IPD) cases are caused by serotypes that are not contained in currently available pneumococcal vaccines.8 The PCV21 vaccine contains most of these serotypes and provides broader coverage. In a phase 3, randomized, double-blind, active comparator-controlled clinical study of the V116 PCV21 vaccine, V116 was concluded to be superior to PCV20 for 10 out of the 11 of its unique strains.
The work group concluded that pneumococcal disease is of public health importance to adults currently recommended for PCV vaccination. While it may be appropriate to expand vaccination to patients between the ages of 50 to 64, committee members concluded that epidemiology does not support expanding vaccination to younger adults without indication.
At its June meeting, the ACIP plans to consider official draft policies on PCV21 use in US adults.7
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.
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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.
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