ACIP Evidence to Recommendations (EtR) for Use of 2024-2025 COVID-19 Vaccines in Persons ≥6 Months of Age

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Question: Should 2024-2025 COVID-19 vaccines be recommended for use in persons ≥6 months of age?

Population: People ≥6 months of age

Intervention:

  • 2024-2025 COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) for people ≥6 months of age

The emergence of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), in late 2019 has led to a global pandemic with substantial societal and economic impact on individual persons and communities. As of July 2024, millions of COVID-19-associated hospitalizations and more than one million deaths due to COVID-19 have occurred in the United States.  Persons of all ages are at risk for infection and severe disease. However, the risk for severe illness from COVID-19 is higher in people aged ≥65 years. Additionally, there is a disproportionate burden of COVID-19 infections and deaths among racial and ethnic minority communities.1

As of June 27, 2024, three COVID-19 vaccines were approved under a Biologics License Application or authorized under an Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices (ACIP): 1) 2023-2024 Formula Pfizer-BioNTech/Comirnaty COVID-19 vaccine; 2) 2023-2024 Formula Moderna/Spikevax COVID-19 vaccine, and 3) 2023-2024 Formula Novavax COVID-19 vaccine.

On June 13, 2024, FDA recommended JN.1 lineage vaccines with the KP.2 strain, if feasible, for the 2024-2025 COVID-19 vaccines. On June 27, 2024, ACIP recommended the 2024-2025 COVID-19 vaccination with an FDA authorized or approved vaccine for all persons aged ≥6 months. On August 22, 2024, FDA approved the 2024-2025 COVID-19 vaccines by Moderna (Spikevax) and Pfizer-BioNTech (Comirnaty) for use in persons aged ≥12 years and authorized the Moderna and Pfizer-BioNTech 2024-2025 Formula vaccines for use in children aged 6 months−11 years under Emergency Use Authorization (EUA). On August 30, 2024, FDA authorized 2024-2025 COVID-19 vaccine by Novavax for use in persons aged ≥12 years under EUA. The 2024-2025 COVID-19 vaccines are meant to broaden vaccine-induced immunity and provide protection against the currently circulating SARS-CoV-2 JN.1 sublineage variants, including against severe COVID-19-associated illness and death.

Additional background information supporting the ACIP recommendation on the use of the 2024-2025 COVID-19 vaccine for persons ages ≥6 months can be found in the relevant publication of the recommendation referenced on the ACIP website.

1 Centers for Disease Control and Prevention. COVID Data Tracker. Atlanta, GA: U.S. Department of Health and Human Services, CDC. https://covid.cdc.gov/covid-data-tracker. Accessed July 29, 2024

Public Health Problem

Problem
Criteria Work Group Judgements Evidence Additional Information
Is the problem of public health importance? Yes During May 2023-May 2024, COVID-19-associated hospitalization rates were substantially higher in those ages 75 years and older compared with other age groups. The next highest rates were in adults ages 65-74 years and infants less than 6 months of age.1
In relation to monthly rates of COVID-19-associated deaths by age group from May 2023-April 2024, the highest death rates were seen in adults ages 75 years and older, followed by those ages 65-74 years.2 Looking at COVID-19-assoicated deaths by week during June 2023-June 2024 in the United States, there was a peak in January 2024; and while weekly COVID-19-associated death rates decreased from January 2024 to June 2024, it is important to note that COVID-19-associated deaths occur all year.3 Regarding the total number of COVID-19-associated deaths in each age group during 2023, there were over 44,000 deaths in adults ages 65 years and older. When looking at the youngest age groups, there were 58 deaths in infants ages less than a year, 44 deaths in children ages 1-4 years and 81 deaths in children ages 5-19 years.4 When comparing pediatric COVID-19-associated deaths to those associated with influenza in 2023, the number of deaths is comparable in all of the age groups.5
The incidence of Multisystem Inflammatory Syndrome in Children (MIS-C) in the United States has varied with COVID-19 variant predominant periods. While rates of MIS-C have overall decreased in the US, cases of MIS-C continue to be reported with 117 cases reported in 2023 and an incidence of 0.11 per 1,000,000 person-months.6
Children without underlying medical conditions continue to be hospitalized with COVID-19 and have severe outcomes. Out of all children with a COVID-19-associated hospitalization between July 2023 and March 2024, 50% had no underlying medical conditions; and, of those, 18% were admitted to the intensive care unit. When comparing annual hospitalizations due to COVID-19 in the US pediatric population compared to other vaccine preventable diseases prior to their respective vaccine recommendations, there were higher rates of COVID-19 hospitalizations during 2022-2023 and 2023-2024.7,8,9,10 Similarly, when comparing pediatric deaths per year in the United States due to COVID-19 compared to other vaccine preventable diseases prior to their respective vaccine recommendations, there were a higher number of deaths due to COVID-19 in 2023.11,12,13,14,15,16

Benefits and Harms

Benefits and Harms
Criteria Work Group Judgements Evidence Additional Information
How substantial are the desirable anticipated effects? Moderate / Large Published assessments of previous vaccine formulations, vaccine effectiveness (VE) and safety were evaluated using GRADE. The pooled VE estimates from the observational studies demonstrated that updated (i.e., 2023-2024 and bivalent) COVID-19 vaccine reduced medically-attended emergency department/urgent care (ED/UC) COVID-19 in adolescents and adults (pooled VE: 43%, 95% CI 30–54%; based on 5 studies).1,2,3,4,5 The pooled VE against hospitalization due to COVID-19 in adolescents and adults was 44% (95% CI 34–52%), based on 8 studies.2,3,4,5,6,7,8,9 The pooled VE for prevention of death due to COVID-19 in adolescents and adults was 23% (95% CI 8–36%), based on 3 studies.2,8,9 For infants and children, COVID-19 vaccine reduced medically-attended ED/UC visits (VE 80%, 95% CI 42%–96%) based on one study.10 For infants and children, benefits of protection against hospitalization and death were indirectly inferred from adolescents and adults.
Recent VE data were also reviewed. 2023-2024 COVID-19 vaccination provided increased protection against symptomatic SARS-CoV-2 infection and COVID-19−associated ED/UC visits and hospitalizations compared to no 2023-2024 vaccine dose. The waning patterns appeared similar to previous COVID-19 vaccine formulations, with the most durable protection against critical illness, noting that statistical power was lacking in the longest time periods since vaccination. As with previous COVID-19 vaccine formulations, effectiveness was similar across age groups. Receipt of 2023-2024 vaccine did provide protection against JN.1 and other circulating variants, though this may be lower than protection provided against XBB sub-lineage variants. However, waning of immunity is expected.
The ACIP reviewed modeling data on the potential impact of different 2024-2025 COVID-19 vaccine recommendations. Modeling projected more hospitalizations averted when 2024-2025 COVID-19 vaccines are universally recommended compared to no recommendation or recommended only for those at high risk.11
Data on post-COVID conditions (PCC) were also reviewed. Three study cohorts have shown that COVID-19 mRNA vaccination is associated with a reduced recurrence of post-COVID conditions, or PCC, following SARS-COV-2. Among children ages 5-17 years, completion of the original formula primary vaccine series prior to infection resulted in a decrease in symptoms ranging from 34%-48%. Among adults, 3 doses of original formula vaccines prior to infection were associated with a decrease in symptoms ranging from 24%-42%.12
ACIP reviewed data on COVID-19 vaccine effectiveness in preventing multi-system inflammatory syndrome in children (MIS-C) in US children ages 5-18 years old. A multi-center case-control investigation from July 2021-April 2022 compared the odds of receiving 2 doses of BNT162b2 (original formula) vaccine between MIS-C case patients and hospital-based controls who tested negative for SARS-CoV-2 and found 92% of MIS-C cases were unvaccinated compared to 69% of hospital-based controls.13
How substantial are the undesirable anticipated effects? Small
ACIP also reviewed additional CDC data on 2023-2024 COVID-19 vaccine safety. Vaccine Safety Datalink (VSD) surveillance for prespecified outcomes of special interest identified two statistical signals for mRNA COVID-19 vaccines during the 2023-2024 season.14 The first was for Guillain-Barré Syndrome (GBS) following Pfizer-BioNTech COVID-19 vaccine among people aged ≥65 years. An association between GBS and mRNA COVID-19 vaccines had not been identified prior to 2023-2024 in VSD or other systems. This 2023-2024 signal for GBS may or may not represent a true risk; if there is a true risk, the estimated excess number of GBS cases after mRNA COVID-19 vaccine is similar to estimates with other adult vaccines. Additionally, VSD identified a statistical signal for ischemic stroke among adults aged ≥50 years: following Moderna among adults aged ≥65 years and following Pfizer-BioNTech vaccine among adults aged 50-64 years. A similar signal had previously been observed for the bivalent Pfizer-BioNTech COVID-19 vaccine formulation during 2022-2023 and reviewed by ACIP in October 2023. The cumulative evidence to date does not provide clear and consistent evidence of a safety problem for ischemic stroke, and a follow-up VSD study is in progress to further assess the risk of ischemic stroke following mRNA vaccines. No other new or unexpected safety concerns were identified for the 2023-2024 COVID-19 vaccines. Any real or theoretical risks of vaccine adverse events need to be placed in the context of benefits of COVID-19 vaccines in preventing COVID-19 and its potentially serious complications, including stroke.
Do the desirable effects outweigh the undesirable effects Favors Intervention The Work Group decided that the desirable effects of the 2024-2025 COVID-19 vaccine among people ≥6 months of age outweigh the undesirable effects.

Values

Values
Criteria Work Group Judgements Evidence Additional Information
Does the target population feel that the desirable effects are large relative to undesirable effects? Varies Key attitudes and experiences among parents of children ages 6 months-17 years responding to the National Immunization Survey-Child COVID-19 Module (NIS-CCM) during December 2023 found that parents of older children generally reported more confidence in vaccine safety and confidence in the importance of COVID-19 vaccines to protect their child.1
Key attitudes and experiences among adults ages 18 years and older responding to the National Immunization Survey-Adult COVID Module (NIS-ACM) in April 2024 found that confidence in vaccine safety and the importance of COVID-19 vaccines all increased with increasing age.2
Is there important uncertainty about or variability in how much people value the main outcomes? Probably important uncertainty or variability Approximately 1 in 5 Americans in February 2024 considered COVID-19 a major threat to public health, which is down from its peak of 66% in March 2020.3
In relation to concerns about the risk of COVID-19 by age, in February 2024 adults ages 65 years and older were more concerned about getting COVID-19 and requiring hospitalization, and younger adults ages 18-29 years are more concerned about unknowingly spreading the virus to others.3
Results from the National Immunization Survey-Child COVID-19 Module (NIS-CCM) in December 2023 showed that approximately 30% of parents of children ages 6 months-17 years reported being concerned about their children getting COVID-19 disease.1
When looking at key attitudes and experiences among adults ages 18 years and older from the National Immunization Survey-Adult COVID Module in April 2024, concern about COVID-19 disease increased with increasing age.2

Acceptability

Acceptability
Criteria Work Group Judgements Evidence Additional Information
Is the intervention acceptable to key stakeholders? Varies Over time, the percentage of US adults who report they are up to date with COVID-19 vaccines has decreased from 69% in August 2021 to 28% in February 2024.1

According to the National Immunization Survey-Adult COVID Module (NIS-ACM) and -Child COVID Module (NIS-CCM), vaccination rates for the 2023-2024 COVID-19 vaccine increased with age. By April 30, 2024, over 40% of adults ages 65 years and older received the 2023-2024 COVID-19 vaccine and just over 10% of adults ages 18-29 years received the 2023-2024 COVID-19 vaccine. By April 2024, among children 6 months-17 years, overall coverage of the 2023-2024 COVID-19 vaccine was approximately 14%, with the lowest coverage among children ages 6 months-4 years.2

During May 2-26, 2024, Omnibus survey results focusing on the intent to get the 2024-2025 COVID-19 vaccine among adults ages 18 years and older shows higher intent with increasing age. Intent is also higher for those living in urban areas than rural areas, and higher for insured adults compared to uninsured adults. In relation to intent to get an annual COVID-19 vaccine among adults ages 18 years and older, 34.5% of adults reported that they would get a COVID-19 vaccine every year if recommended.3

Further results from the National Immunization Survey-Child COVID Module (NIS-CCM) from December 2023 among parents of children ages 6 month-17 years reported concern about side effects (88%), COVID-19 vaccine is ineffective (58%) and child unlikely to get sick from COVID-19 (56%) as the primary reasons for not getting their child vaccinated.4 Furthermore, less than 29% of parents of children ages 6 months-17 years reported a healthcare provider recommend their child get a 2023-2024 COVID-19 vaccine.5 Results from the National Immunization Survey-Adult COVID Module (NIS-ACM) from April 2024 showed that among adults ages 18 years and older, 17% of adults ages 18-49 years reported a healthcare provider recommendation for the 2023-2024 COVID-19 vaccine, whereas 24% of adults ages 50-64 years and 27% of adults ages 65 years and older received a healthcare provider recommendation.6

Results from the Omnibus Surveys from January 5-29, 2024, showed that among those that reported they received the 2023-2024 COVID-19 vaccine or definitely would receive it, the majority had no concerns or issues with COVID-19 vaccination: 67% of adults ages 18-59 years and 83% of adults ages ≥60 years. Among those that reported they probably would receive the 2023-2024 vaccine or were unsure, unknown serious side effects and too busy or kept forgetting were the most commonly reported issues for adults ages 18-59 years and effectiveness and unknown serious side effects were the most commonly reported issues among those ages ≥60 years. Among those who reported that they probably or definitely would not get the 2023-2024 vaccine, unknown serious side effects, not enough studies, and distrust of the government and pharma were the most frequently reported concerns.7

Feasibility

Feasibility
Criteria Work Group Judgements Evidence Additional Information
Is the intervention feasible to implement? Probably yes / Varies In relation to feasibility of vaccine implementation, no substantial clinical consideration changes are expected. Therefore, supporting tools and documents from the 2023-2024 vaccine will not need to be significantly revised or reprogrammed. There will continue to be single dose presentations and minimum order quantities as indicated by vaccine manufacturer and age group:
  • Moderna
    • ≥6 months: manufacturer-prefilled syringes (10-pack)
  • Novavax
    • ≥12 years: manufacturer-prefilled syringes (10-pack)
  • Pfizer-BioNTech
    • ≥12 years: manufacturer-prefilled syringes (10-pack)
    • 5-11 years: single dose vial (10-pack)
    • 6 months – 4 years: 3-dose multi-dose vial (10-pack)
Preparation is also not expected to change. Moderna and Novavax vaccines require no dilution; and Pfizer-BioNTech vaccine requires for the 6 month – 4-year formulation.
Storage and handling requirements will consist of the following:
Moderna: Frozen until expiration; 30 days at refrigerator storage
Novavax: Refrigerator storage (stable at 2-8°C)
Pfizer-BioNTech:
  • Prefilled syringes (≥12 years): Refrigerator storage (2-8°C), never frozen
  • Vials (6 months – 11 years): Ultra-cold storage until expiration; 10 weeks at refrigerator storage; use within 12 hours of dilution

Ultra-cold storage continues to be a challenge, as most provider offices do not have an ultra-cold storage unit, but the smaller minimum order quantities (10) will help with this challenge.

There continues to be barriers to implementing COVID-19 vaccines, including an increasingly complex routine vaccination schedule that includes immunization products for three viral respiratory diseases (i.e., COVID-19 vaccine, influenza vaccine, RSV vaccine and Nirsevimab, a long-acting monoclonal antibody for RSV prevention in infants). This requires a need for more storage space to store all recommended immunization products, an increased need for education across vaccination providers, and can lead to more opportunities for vaccine administration errors.1 In addition, there is a financial burden for healthcare practices to store the vaccine, which is costly and for which there is low demand. There will soon be a financial burden for uninsured and underinsured people with the end of the Bridge Access Program.2 Conclusively, with fewer primary care practices carrying COVID-19 vaccines, there are barriers to access, particularly for those with difficulty traveling to another location for vaccination.1

Resource Use

Resource Use
Criteria Work Group Judgements Evidence Additional Information
Is the intervention a reasonable and efficient allocation of resources? Probably yes The incremental cost-effectiveness ratios (ICERs) demonstrated a cost per quality-adjusted life year (QALY) of about $23,000 in those ages 65 years and older, about $113,000 in those ages 50-64 years and around $200,000 for those ages 50 years and younger. The estimates in younger age groups were very sensitive to changes in parameter inputs. ICERs were more favorable for higher vaccine impact, higher risk of hospitalization, higher quality of life impact for symptomatic illness and lower vaccine dose cost.1 ICERs would be more favorable in younger age groups if the cost of vaccination was lower.

Health Equity Questions and Evidence Reviewed

CDC is committed to COVID-19 vaccine equity, which is when everyone has fair and just access to COVID-19 vaccination.1 The Evidence to Recommendations Framework (EtR), through which ACIP considers all evidence regarding the potential use of a vaccine to guide its recommendations, includes an Equity Domain. However, the impact of the intervention on health equity was not clear through the current EtRs to date. Therefore, processes were put in place to restructure the Equity domain of the Evidence to Recommendations Framework for COVID-19 vaccines.

In April – August 2022, a subset of the COVID-19 ACIP Work Group engaged in a critical review of the Equity Domain and gathered extensive input and feedback on strategies to adjust the domain through the following mechanisms: a thorough review of use of the Equity domain (April 2022), a one-time consultation with health equity experts (May 2022), an iterative review of possible adjustment strategies with experts (June – August 2022), presentation to leadership and membership of the National Medical Association and presentation to the Structural & Social Determinants of Health Workgroup of the Office of Minority Health and Health Equity (August 2022). Through this process, it became clear that consideration of equity is integral to every aspect of production, study, authorization, and recommendation of COVID-19 vaccines.

The need for a systematic, reliable, and action-oriented review of evidence toward enhanced equity was also made clear: structural problems require structural solutions. Adjustment of structure is required for meaningful change; and adjustment of the EtR Framework to enable systematic and reliable review of evidence toward actionable recommendations to enhance equity may facilitate meaningful change. Therefore, we proposed a change to restructure the Equity Domain as a consideration across each EtR Domain for COVID-19 vaccines. We recommended the systematic, reliable inclusion of data to speak to the Equity considerations in each domain, both to demonstrate the data and encourage actions needed to enhance equity as relevant to each domain. Therefore, we removed the voting question on Equity and enhance attention to equity across all domains. We did not recommend voting on these Equity questions, but rather using them to ensure consideration of equity through every step of the process of production, study, authorization, and recommendation of COVID-19 vaccines. For that reason, while the Work Group reviewed data to support the recommendation, they did not determine their judgement for any of the Equity Domain Questions. This structure is used in this Evidence to Recommendations (EtR) Framework.

1 www.cdc.gov/coronavirus/2019-ncov/community/health-equity/vaccine-equity.html

Evidence

Evidence
Evidence to Recommendations (EtR) Domain Domain Equity Question Evidence Reviewed
Public Health Problem Does the problem impact all populations equally? Inequities in COVID-19 hospitalizations by race and ethnicity continue. The cumulative age-adjusted hospitalization rates from October 2023-May 2024 demonstrate disparities in hospitalizations by race and ethnicity, with the highest rates in American Indian and Alaska Native persons, followed by Black, non-Hispanic persons, Hispanic persons, and White, non-Hispanic persons.17
Benefits and Harms Are the desirable and undesirable anticipated effects demonstrated across all populations equally? There is no evidence to suggest that COVID-19 vaccine effectiveness varies substantially by race/ethnicity. Differences in vaccine hesitancy/uptake, crowding, access to care, and prior infection could impact vaccine effectiveness and these factors may also differ by race and ethnicity. There is also no evidence to suggest that COVID-19 vaccine safety profiles vary by race and ethnicity; however, risk has been shown to differ by age and sex, as risk for myocarditis is highest in adolescent and young adult males. Benefits and harms for the U.S. population are best assessed when clinical trial and study populations are optimally representative of the U.S. population.
Values Is there important variability in how patients or populations value the outcome? Key attitudes and experiences among parents of children ages 6 months – 17 years responding to the National Immunization Survey-Child COVID Module (NIS-CCM) in December 2023 by race and ethnicity showed that Black, non-Hispanic parents were more concerned about their child getting COVID-19 disease and had the lowest confidence in vaccine safety for their child. White, non-Hispanic parents had the lowest confidence in COVID-19 vaccine importance.1
Among adults ages ≥18 years responding to the National Immunization Survey-Adult COVID Module (NIS-ACM) in April 2024, Black, non-Hispanic persons reported the highest rate of concern about COVID-19 disease followed by American Indian and Alaska Native persons. American Indian and Alaska Native persons also had the lowest confidence in COVID-19 vaccine safety and vaccine importance.2
In relation to concerns about risk of COVID-19 by race and ethnicity, data from the Pew Research Center in February 2024 show that Black persons (43%) are more likely to be concerned about getting a serious case of COVID-19. Whereas, Asians (54%) are more concerned about unknowingly spreading COVID-19 to others, followed closely by Black person (51%).3 In February 2024, lower income Americans (38%) continued to be particularly concerned about getting a serious case of COVID-19. Lower income Americans were also more likely than middle- and upper-income Americans to worry about unknowingly spreading COVID-19, but the differences are modest.3
Acceptability Is the intervention equally acceptable across all populations? Among children ages 6 months-17 years included in the NIS-CCM during April 1-27, 2024, vaccination coverage differed by race and ethnicity. Coverage was highest among White, non-Hispanic children and lowest among Black, non-Hispanic children. Vaccination coverage was higher in urban/suburban areas compared with rural areas. Children covered by private health insurance had higher vaccination coverage than children who were uninsured or covered by Medicaid. Furthermore, vaccination coverage increased with increasing household income.8
Among adults ages ≥18 years responding to the NIS-ACM during April 1 – 27, 2024, vaccination coverage also differed by race and ethnicity. Coverage was highest among White, non-Hispanic adults and lowest among American Indian/Alaska Native and Native Hawaiian/Other Pacific Islander adults. Vaccination coverage was also higher in urban/suburban areas compared with rural areas; and adults with health insurance had significantly higher vaccination coverage than adults without insurance. Vaccination coverage also increased with increasing household income.9
Feasibility Is the intervention equally feasible to implement across all populations? Free updated COVID-19 vaccines are available to most people living in the U.S. through their private health insurance, Medicare, and Medicaid plans. Eligible children are able to receive COVID-19 vaccines through the existing Vaccines for Children (VFC) program. However, there are 25-30 million adults without health insurance and additional adults whose insurance does not cover all COVID-19 vaccination costs. The Bridge Access Program, which provided free updated COVID-19 vaccines to adults without health insurance and adults whose health insurance does not cover all COVID-19 vaccine costs, ended in August 2024, which will result in inequities in vaccine access.2
Resource Use Is the intervention a reasonable and efficient allocation of resources across all populations? The incremental cost-effectiveness ratios (ICERs) become more favorable as the probability of hospitalization increases, suggesting that COVID-19 vaccination is more cost effective in those at increased risk of hospitalization, such as those with underlying conditions.1

Work Group Interpretation Summary

As of June 2024, COVID-19 burden was lower than at previous points in the pandemic; however, there are still thousands of hospitalizations and hundreds of deaths each week. Although, people ages 5-49 years had the lowest hospitalization rates compared to other age groups, severe outcomes occur in the youngest ages, including children with no underlying medical conditions. Additional studies are needed to understand the Vaccine Safety Datalink (VSD) statistical signals seen for the 2023-2024 COVID-19 vaccine. The increased rate of Guillain-Barre Syndrome (GBS) following Pfizer COVID-19 vaccine among people aged ≥65 years may or may not represent a true risk. If it is a true risk, the burden of disease in this age group is such that the benefit of vaccination still outweighs the risk. The VSD statistical signals for ischemic stroke after mRNA COVID-19 vaccines during the 2023-2024 season do not provide sufficient evidence to conclude that there is a safety concern, and a follow up VSD study is in progress.

Coverage of the 2023-2024 COVID-19 vaccine was low, particularly in children. Provider recommendation may encourage greater COVID-19 vaccine uptake. It would be important to understand why providers are not recommending the vaccine, in addition to continuing to address inequities in vaccine access. High vaccine cost and decreased disease burden has resulted in less favorable incremental cost-effectiveness ratios (ICERs) for younger age groups. The Work Group expressed concern about current ICERs for those ages less than 50 years. The Work Group noted that while the burden of disease in pediatric age groups supported recommending COVID-19 vaccine in these age groups, the high cost of the vaccine was a concern. ICERs in pediatric age groups were sensitive to changes in parameter inputs (i.e., uncertain) and were still considered preliminary.

The Work Group began deliberations considering both universal and non-universal policy options, but non-universal options had significant implementation challenges. Risk based recommendations would not allow access to COVID-19 vaccines for those not in a defined risk group. The current list of conditions that increase risk of severe illness due to COVID-191 is extensive and includes the majority of the US adult population.2 There are no groups without a risk of severe illness. Shared clinical decision making (SCDM) would create barriers to vaccination, may not effectively target those at highest risk, and would likely increase inequities in vaccine access. COVID-19 epidemiology remains uncertain and universal recommendations would need to be considered if there was an unexpected increase in burden following a risk-based or SCDM decision. COVID-19 disease burden remains substantial, and consistent recommendations may increase coverage over time.

Benefits of COVID-19 vaccination vary by age and risk status. Under a universal recommendation, 2024-2025 COVID-19 vaccines will be available to all persons ages ≥6 months. Additional implementation efforts should be targeted toward those that will receive the most benefit from COVID-19 vaccination, including people ages ≥65 years, people with underlying medical conditions1 including immunocompromise, and pregnant people to protect themselves and their infants. The Work Group will continue to evaluate COVID-19 vaccine policy, including the need for a universal recommendation, particularly as COVID-19 epidemiology continues to change.

1 https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html

2 Overweight and obesity are considered conditions with conclusive or suggestive evidence of increasing risk and have a combined prevalence >70%. National Health Statistics Reports; https://stacks.cdc.gov/view/cdc/106273

Balance of consequences

The majority of the Work Group felt that the desirable consequences probably outweigh undesirable consequences in most settings, and a minority felt that the desirable consequences clearly outweigh undesirable consequences in most settings

Is there sufficient information to move forward with a recommendation? Yes

Policy options for ACIP consideration

ACIP recommends the intervention

Draft recommendation

ACIP recommends 2024-2025 COVID-19 vaccines as authorized or approved by FDA in persons ≥6 months of age

Final deliberation and decision by ACIP

On June 27, 2024, ACIP voted (11-0, 1 recused) in favor of recommending:

2024-2025 COVID-19 vaccines authorized or approved by FDA in persons ≥6 months of age

Final ACIP recommendation

ACIP recommends the intervention

ACIP recommends 2024-2025 COVID-19 vaccines as authorized or approved by FDA in persons ≥6 months of age

References

Public Health Problem:

  1.  CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalization-network. Accessed June 17, 2024
  2. Provisional data from the CDC’s National Center for Health Statistics (NCHS) National Vital Statistic System (NVSS);  CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#demographicsovertime. Accessed June 16, 2024
  3. CDC COVID Data Tracker. National Center for Health Statistics (NCHS) National Vital Statistics System (NVSS). https://covid.cdc.gov/covid-data-tracker/#trends_weeklydeaths_select_00. Accessed June 17, 2024
  4. Centers for Disease Control and Prevention, National Center for Health Statistics. National Vital Statistics System, Provisional Mortality on CDC WONDER Online Database. Data are from the final Multiple Cause of Death Files, 2018-2022, and from provisional data for years 2023-2024, as compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. Number of deaths includes COVID-19 code (U07.1) as the underlying cause of death. Accessed at http://wonder.cdc.gov/mcd-icd10-provisional.html on June 5, 2024
  5. Centers for Disease Control and Prevention, National Center for Health Statistics. National Vital Statistics System, Provisional Mortality on CDC WONDER Online Database. Data are from the final Multiple Cause of Death Files, 2018-2022, and from provisional data for years 2023-2024, as compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. Number of deaths includes influenza codes (J09-J11) or COVID-19 code (U07.1) as the underlying cause of death. Accessed at http://wonder.cdc.gov/mcd-icd10-provisional.html on June 5, 2024
  6. Yousaf AR, Lindsey KN, Wu MJ, et al. Notes from the Field: Surveillance for Multisystem Inflammatory Syndrome in Children — United States, 2023. MMWR Morb Mortal Wkly Rep 2024;73:225–228. DOI: http://dx.doi.org/10.15585/mmwr.mm7310a2
  7. https://www.cdc.gov/mmwr/preview/mmwrhtml/ss5603a1.htm
  8. Davis MM, Patel MS, Gebremariam A. Decline in varicella-related hospitalizations and expenditures for children and adults after introduction of varicella vaccine in the United States. Pediatrics. 2004;114(3):786-792. doi:10.1542/peds.2004-0012
  9. Centers for Disease Control and Prevention (CDC). Direct and indirect effects of routine vaccination of children with 7-valent pneumococcal conjugate vaccine on incidence of invasive pneumococcal disease–United States, 1998-2003. MMWR Morb Mortal Wkly Rep. 2005 Sep 16;54(36):893-7. PMID: 16163262.
  10. COVID-NET data October 2022 – September 2023 and October 2023 – May 2024. COVID-19 rates have not been adjusted for reason for admission. COVID vaccine first introduced in 12-17 years in May 2021; in 5-11 years in November 2021 and in 6 months – 4 years in June 2022
  11. Vogt TM , Wise ME, Bell BP, Finelli L. Declining hepatitis A mortality in the United States during the era of hepatitis A vaccination. J Infect Dis2008; 197:1282–8.
  12. National Notifiable Diseases Surveillance System with additional serogroup and outcome data from Enhanced Meningococcal Disease Surveillance for 2015-2019.
  13. Meyer PA, Seward JF, Jumaan AO, Wharton M. Varicella mortality: trends before vaccine licensure in the United States, 1970-1994. J Infect Dis. 2000;182(2):383-390. doi:10.1086/315714
  14. Roush SW , Murphy TV; Historical comparisons of morbidity and mortality for vaccine-preventable diseases in the United States. JAMA 2007; 298:2155–63.
  15. Glass RI, Kilgore PE, Holman RC, et al. The epidemiology of rotavirus diarrhea in the United States: surveillance and estimates of disease burden. J Infect Dis. 1996 Sep;174 Suppl 1:S5-11
  16. http://wonder.cdc.gov/mcd-icd10-provisional.html on May 14 2024 . COVID vaccine first introduced in 12-17 years in May 2021; in 5-11 years in November 2021 and in 6 months – 4 years in June 2022
  17. CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalization-network. Accessed June 20, 2024

Benefits and Harms:

  1. Tenforde MW, Weber ZA, Natarajan K, et al. Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19–Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults — VISION Network, Nine States, September–November 2022. MMWR Morb Mortal Wkly Rep 2023;71:1637–1646. DOI: http://dx.doi.org/10.15585/mmwr.mm7153a1
  2. Ackerson, B. K., et al. (2024). Effectiveness and durability of mRNA-1273 BA.4/BA.5 bivalent vaccine (mRNA-1273.222) against SARS-CoV-2 BA.4/BA.5 and XBB sublineages. Human Vaccines & Immunotherapeutics 20(1): 2335052. https://doi.org/10.1080/21645515.2024.2335052
  3. DeCuir J, Payne AB, Self WH, et al. Interim Effectiveness of Updated 2023–2024 (Monovalent XBB.1.5) COVID-19 Vaccines Against COVID-19–Associated Emergency Department and Urgent Care Encounters and Hospitalization Among Immunocompetent Adults Aged ≥18 Years — VISION and IVY Networks, September 2023–January 2024. MMWR Morb Mortal Wkly Rep 2024;73:180–188. DOI: http://dx.doi.org/10.15585/mmwr.mm7308a5
  4. Caffrey, A. R., et al. (2024). “Effectiveness of BNT162b2 XBB vaccine in the US Veterans Affairs Healthcare System.” medRxiv: 2024.2004.2005.24305063. https://doi.org/10.1101/2024.04.05.24305063
  5. Tartof, S. Y., et al. (2023). Effectiveness of BNT162b2 BA.4/5 bivalent mRNA vaccine against a range of COVID-19 outcomes in a large health system in the USA: a test-negative case–control study. The Lancet Respiratory Medicine 11(12): 1089-1100. https://doi.org/10.1016/S2213-2600(23)00306-5
  6. Link-Gelles R, Weber ZA, Reese SE, et al. Estimates of Bivalent mRNA Vaccine Durability in Preventing COVID-19–Associated Hospitalization and Critical Illness Among Adults with and Without Immunocompromising Conditions — VISION Network, September 2022–April 2023. MMWR Morb Mortal Wkly Rep 2023;72:579–588. DOI: http://dx.doi.org/10.15585/mmwr.mm7221a3
  7. DeCuir, J., et al. (2024). “Durability of protection from original monovalent and bivalent COVID-19 vaccines against COVID-19-associated hospitalization and severe in-hospital outcomes among adults in the United States — September 2022–August 2023.” medRxiv: 2024.2001.2007.24300910. https://doi.org/10.1101/2024.01.07.24300910
  8. Lin, D.-Y., et al. (2023). Durability of Bivalent Boosters against Omicron Subvariants. New England Journal of Medicine 388(19): 1818-1820. https://www.nejm.org/doi/full/10.1056/NEJMc2302462
  9. Paritala, S., et al. (2023). Effectiveness of Bivalent Boosters Over Nine and Half Months in Nebraska. medRxiv: 2023.2012.2003.23299338. https://doi.org/10.1101/2023.12.03.23299338
  10. Link-Gelles, R., et al. (2023). “Effectiveness of Monovalent and Bivalent mRNA Vaccines in Preventing COVID-19-Associated Emergency Department and Urgent Care Encounters Among Children Aged 6 Months-5 Years – VISION Network, United States, July 2022-June 2023.” MMWR Morb Mortal Wkly Rep 72(33): 886-892. https://pubmed.ncbi.nlm.nih.gov/37590187/
  11. Home – COVID 19 scenario model hub (covid19scenariomodelinghub.org)
  12. Unpublished data from the HEROES/RECOVER, PROTECT cohorts. HEROES Protocol; RECOVER Protocol; PROTECT Protocol
  13. Zambrano LD, et al. Clin Infect Dis. 2022 Aug 4:ciac63
  14. Duffy J. COVID-19 vaccine safety surveillance for the 2023-2024 season. Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, Georgia, June 27, 2024. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-06-26-28/04-COVID-Duffy-508.pdf

Values:

  1. CDC. COVID-19 Vaccination Coverage and Vaccine Confidence Among Children. https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/children.html Accessed April 30, 2024
  2. CDC. COVID-19 Vaccination Coverage and Vaccine Confidence Among Adults. https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adults.html Accessed May 30, 2024
  3. Pew Research Center. March 7, 2024. How Americans View the Coronavirus, COVID-19 Vaccines Amid Declining Levels of Concern. https://www.pewresearch.org/science/2024/03/07/how-americans-view-the-coronavirus-covid-19-vaccines-amid-declining-levels-of-concern/ Accessed April 23, 2024

Acceptability:

  1. Pew Research Center. March 7, 2024. How Americans View the Coronavirus, COVID-19 Vaccines Amid Declining Levels of Concern. https://www.pewresearch.org/science/2024/03/07/how-americans-view-the-coronavirus-covid-19-vaccines-amid-declining-levels-of-concern/ Accessed April 23, 2024
  2. https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/index.html
  3. CDC Unpublished Data. Omnibus Surveys. May 2-26, 2024
  4. CDC. COVID-19 Vaccination Coverage and Vaccine Confidence Among Children. https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/children.html  Accessed April 30, 2024
  5. CDC. COVID-19 Vaccination Coverage and Vaccine Confidence Among Children. https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/children.html  Accessed May 30, 2024
  6. CDC. COVID-19 Vaccination Coverage and Vaccine Confidence Among Adults. https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adults.html  Accessed May 30, 2024
  7. CDC. Unpublished Data. Omnibus Surveys. January 5-29, 2024
  8. CDC. COVID-19 Vaccination Coverage and Vaccine Confidence Among Children. https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/children.html  Accessed May 24, 2024
  9. CDC. COVID-19 Vaccination Coverage and Vaccine Confidence Among Adults. https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adults.html  Accessed May 24, 2024

Feasibility:

  1. CDC, Immunization Services Division, internal planning documents
  2. https://www.cdc.gov/vaccines/programs/bridge/index.html

Resource Use:

  1. Prosser L. Economic analysis of COVID-19 vaccination. Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, GA; June 27, 2024. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-06-26-28/05-COVID-Prosser-508.pdf
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