Advisory Committee on Immunization Practices (ACIP) Evidence to Recommendations (EtR) for Use of Additional Doses of 2024-2025 COVID-19 Vaccines in Older Adults and People who are Moderately or Severely Immunocompromised

About

The Evidence to Recommendations (EtR) framework describes information considered in moving from evidence to ACIP vaccine recommendations.

Summary

Question:

Should a second dose* of 2024-2025 COVID-19 vaccine be recommended for adults ages 65 years and older?

Should a second dose** of 2024-2025 COVID-19 vaccine be recommended for people ages 6 months-64 years who are moderately or severely immunocompromised?

Should additional doses (i.e., 3 or more) of 2024-2025 COVID-19 vaccine be recommended for people ages 6 months and older who are moderately or severely immunocompromised under shared clinical decision-making?

Populations:

  • People ages 65 years and older
  • People ages 6 months and older who are moderately or severely immunocompromised

Intervention:

  • Additional doses of 2024-2025 COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech)

The emergence of SARS-CoV-2, the virus that causes COVID-19 has led to a global pandemic with substantial societal and economic impact on individual persons and communities. As of October 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 and people who are moderately or severely immunocompromised.1

On June 27, 2024, the Advisory Committee on Immunization Practices (ACIP) voted to recommend 2024-2025 COVID-19 vaccines for everyone ages 6 months and older as approved and authorized by the Food and Drug Administration (FDA). 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.

ACIP most recently recommended a second dose of 2023–2024 COVID-19 vaccine for adults ages ≥65 years in February 2024. Since April 2023, people aged ≥6 months who are moderately or severely immunocompromised have had the option to receive ≥1 additional doses of COVID-19 vaccine at least 2 months after receipt of the most recent dose and additional doses, as indicated, based on individual circumstances and clinical judgment of a healthcare provider (shared clinical decision-making).

On October 23, 2024, ACIP voted that, in addition to previously recommended 2024–2025 vaccination, all adults aged ≥65 years and people aged 6 months–64 years who are moderately or severely immunocompromised are recommended to receive a second dose of 2024-2025 COVID-19 vaccine (recommended interval 6 months; minimum interval 2 months). ACIP also recommended additional doses (i.e., three or more doses) of 2024-2025 COVID-19 vaccine for people aged ≥6 months who are moderately or severely immunocompromised under shared clinical decision-making (minimum interval 2 months).

Further background information supporting the ACIP recommendation on the use of additional doses of the 2024-2025 COVID-19 vaccine in older adults and people who are moderately or severely immunocompromised can be found in the relevant publication of the recommendation referenced on the ACIP website.

*If previously unvaccinated and receiving Novavax, 2 doses are recommended as initial vaccination series followed by a third dose of any age-appropriate 2024-2025 COVID-19 vaccine 6 months (minimum interval 2 months) after second dose.

**If previously unvaccinated or receiving initial vaccination series, at least 2 doses of 2024-2025 vaccine are recommended, and depending on vaccination history more may be needed. The additional 2024-2025 vaccine dose is recommended 6 months (minimum interval 2 months) after completion of initial vaccination series.

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 October 29, 2024

Public Health Problem

Criteria Work Group Judgements Evidence
Is the problem of public health importance? Adults ages ≥65 years: Yes
People ages ≥6 months who are moderately or severely immunocompromised: Yes
 Data from the National Respiratory and Enteric Virus Surveillance System (NREVSS) in the United States from August 27, 2022-October 12, 2024 showed that influenza and RSV have clear increases in percent positivity during the typical respiratory virus months in addition to periods of low percent positivity, whereas SARS-CoV-2 circulates year-round. Since 2020, SARS-CoV-2 percent positivity has consistently peaked in the winter and late-summer.1 COVID-19-associated hospitalizations observed in the COVID-NET surveillance system have also peaked in the winter and late-summer.2 The factors impacting COVID-19 periodicity are likely multifactorial with host, viral, environmental, and behavioral factors all playing a role. Potential contributors include natural infection (and reinfection), timing of vaccination, waning immunity, variant emergence and characteristics, temperature, relative humidity, ultraviolet radiation, travel, school/daycare schedules, time spent indoors, as well as holidays and large gatherings.
Older adults
Hospitalization data from COVID-NET during October 2023-August 2024 showed that about 70% of COVID-19-associated hospitalizations among adults are in people ages 65 years and older; and about 50% of hospitalizations are in those ages 75 years and older.3 Data from CDC’s National Center for Health Statistics (NCHS) from January 1, 2023-September 30, 2024, showed that the monthly rates of COVID-19-associated deaths were highest in those ages 75 years and older, and rates in adults ages 65 to 74 years were the second highest.4 The weighted U.S. SARS-CoV-2 antibody seroprevalence by vaccine and infection history based on blood donations from October 1-December 31, 2023 showed that seroprevalence of SARS-CoV-2 antibodies was at 99% or higher in adults aged ≥ 30 years. However, those ages 65 years and older have a higher proportion with vaccine-only seroprevalence at 24% compared to younger age groups (14% for those aged 50-64 years and 9% for those aged 30-49 years).5 Immunosenescence, or the age-associated immune decline that may result in an inefficient immune response to novel antigens and an inability to develop proper immunity against infections and upon vaccination, is also important when considering the older adult population. 6, 7 
People who are moderately or severely immunocompromised
Based on data from COVID-NET from July 2023-May 2024, across all age groups, about 1 in 6 (15.6%) persons hospitalized with COVID-19 have an immunocompromising condition.3 The three most common immunocompromising conditions among persons hospitalized with COVID-19 in COVID-NET were immunosuppressive therapy (within the 12 months before admission), solid organ malignancy (current/in treatment or diagnosed in the 12 months before admission) and systemic steroid therapy (within 2 weeks before admission). The risk for severe outcomes during COVID-19-associated hospitalization among adults varied by immunocompromising condition status, with a higher proportion being admitted to the ICU, receiving invasive mechanical ventilation, and experiencing in-hospital death.3

Benefits and Harms

Criteria Work Group Judgements Evidence
How substantial are the desirable anticipated effects? Adults ages ≥65 years: Moderate/Large
People ages ≥6 months who are moderately or severely immunocompromised: Moderate
People ages ≥6 months who are moderately or severely immunocompromised under shared clinical decision-making: Moderate
 Older adults
2023-2024 COVID-19 vaccination provided increased protection against COVID-19-associated emergency department/urgent care visits and hospitalizations compared to no 2023-2024 vaccine dose.1 Protection waned to 0 against COVID-19-associated emergency department/urgent care visits and hospitalization by approximately 4-6 months. Waning patterns of the 2023-2024 COVID-19 vaccine appeared similar to previous COVID-19 vaccine formulations with the most durable protection against critical illness.2 Vaccine effectiveness (VE) against critical illness (i.e., defined as admission to the intensive care unit or death) remained above 40% at 5 months after vaccination among those ages 65 years and older. As with previous COVID-19 vaccine formulations, effectiveness was similar across age groups.3,4,5 Data from prior seasons showed that an additional dose of the same formulation appeared to provide additional protection. Updated COVID-19 vaccination helped provide protection against COVID-19-related thromboembolic events, such as ischemic stroke, venous thromboembolism, and myocardial infarction in adults ages 65 years and older.6 Based on modeling data, annual and semiannual COVID-19 vaccine doses are likely to have the largest benefit in people ages 65 years and older and people who are moderately or severely immunocompromised.7
People who are moderately or severely immunocompromised
COVID-19 vaccines have been shown to provide protection for persons with and without immunocompromise.1 Patterns of COVID-19 vaccine effectiveness in people with immunocompromise were different season-to-season, with generally lower vaccine effectiveness compared to non-immunocompromised people, and with inconsistent waning patterns.2,8 During 2023-2024, vaccine effectiveness against hospitalization in people with immunocompromising conditions waned to 0 by approximately 4-6 months.1 The inconsistency in waning patterns is likely multifactorial, including heterogeneity among those classified as immunocompromised, variation in underlying immunity and response to prior infection, differing health behaviors (e.g., masking, social distancing) over time and by immunocompromise status.1 Based on modeling data, annual and semiannual COVID-19 vaccine doses are likely to have the largest benefit in people ages 65 years and older and people who are moderately or severely immunocompromised.7
How substantial are the undesirable anticipated effects? Adults ages ≥65 years: Minimal/Small
People ages ≥6 months who are moderately or severely immunocompromise: Minimal/Small
People ages ≥6 months who are moderately or severely immunocompromised under shared clinical decision-making: Minimal/Small
 No new safety data was presented as part of this evidence to recommendations framework, but previously presented information was summarized including Vaccine Safety Datalink (VSD) statistical signals identified for ischemic stroke following 2023–2024 COVID-19 vaccination for Moderna (aged ≥65 years) and Pfizer (aged 50-64 years) and for Guillain-Barré syndrome (GBS) following 2023–2024 Pfizer COVID-19 vaccine.9,10 It is currently unclear if the VSD signal for ischemic stroke in 2023–2024 represented a true increased risk following COVID-19 vaccination. VSD had not identified any signals for GBS with previous mRNA COVID-19 vaccine formulations (i.e., original primary series, original booster, or 2022–2023 bivalent), and the increased rate ratio observed for GBS following the Pfizer COVID-19 vaccine during the 2023–2024 season may or may not represent a true risk. These outcomes continue to be monitored.
Robust safety surveillance from over 3 years of COVID-19 vaccine use demonstrated that serious adverse events have been rare. Anaphylactic reactions have been rarely reported following receipt of COVID-19 vaccines.11 There has also been a rare risk of myocarditis and pericarditis; however, this is predominately in males ages 12-39 years.12 There has been no increased risk observed in adults ages 65 years and older. Whether the risk might be different in immunocompromised people is unknown.
COVID-19 vaccine doses continue to be reactogenic. The rate of local and systemic reactions reported to V-safe was lower with additional doses than after the initial series.13,14 Most vaccine recipients have mild reactions, but during 2023-2024, at least 10% reported health impact events during the 7 days post-vaccination, such as being unable to complete daily activities.15 Overall, symptoms were less frequent and severe among older adults compared with adolescents and younger adults.
Do the desirable effects outweigh the undesirable effects Adults ages ≥65 years: Favors intervention
People ages ≥6 months who are moderately or severely immunocompromised: Favors intervention
People ages ≥6 months who are moderately or severely immunocompromised under shared clinical decision-making: Favors intervention/Unclear
 The Work Group decided that the desirable effects of a second dose of 2024-2025 COVID-19 vaccine in adults ages ≥65 years and people who are moderately or severely immunocompromised outweigh the undesirable effects. The Work Group felt that additional doses (i.e., 3 or more) of 2024-2025 COVID-19 vaccine in people who are moderately or severely immunocompromised either outweigh the undesirable effects or the balance was unclear.

Values

Criteria Work Group Judgements Evidence
Does the target population feel that the desirable effects are large relative to undesirable effects? Adults ages ≥65 years: Moderate
People ages ≥6 months who are moderately or severely immunocompromised: Moderate/Large
People ages ≥6 months who are moderately or severely immunocompromised under shared clinical decision-making: Moderate/Large
 Data from the National Immunization Survey-Adult COVID Module (NIS-ACM) from July 2024 showed that generally, adults ages 65 years and older were more concerned about COVID-19 disease and had higher confidence in vaccine safety and vaccine importance than younger adults.1
Omnibus survey results from August 2024 on intent to receive 2024-2025 COVID-19 vaccination showed that among all adults, 24.7% of adults 18 years and older reported they “definitely will” get a first dose of the 2024-2025 COVID-19 vaccination. Among adults ages 65 years and older and 18 years and older with health conditions including cancer, solid organ or blood stem cell transplant, HIV, and immunocompromised state, 32.6% indicated they “definitely will” get a second dose of COVID-19 vaccination and 25.9% of adults 18 years and older with health conditions “definitely will” get three or more doses.2
Is there important uncertainty about or variability in how much people value the main outcomes? Adults ages ≥65 years: Probably important uncertainty or variability/Probably not important uncertainty or variability
People ages ≥6 months who are moderately or severely immunocompromised: Probably important uncertainty or variability/Probably not important uncertainty or variability
People ages ≥6 months who are moderately or severely immunocompromised under shared clinical decision-making: Probably important uncertainty or variability/Probably not important uncertainty or variability
 Data from NIS-ACM in July 2024 indicated that adults ages 18-49 years and 50-64 years were less concerned about COVID-19 disease and less confident in vaccine safety and vaccine importance than adults 65 years and older.1
Limited data exists on concern about COVID-19 disease specifically in people who are moderately or severely immunocompromised.

Acceptability

Criteria Work Group Judgements Evidence
Is the intervention acceptable to key stakeholders? Adults ages ≥65 years: Probably yes/Yes
People ages ≥6 months who are moderately or severely immunocompromised: Probably yes/Yes
People ages ≥6 months who are moderately or severely immunocompromised under shared clinical decision-making: Probably yes/Yes
 Based on data from the National Immunization Survey-Adult COVID Module (NIS-ACM), about 40% of those ages 65-74 years and 75 years and older were vaccinated with 2023-2024 COVID-19 vaccine by the week ending May 3, which is notably higher than other age groups.1 NIS-ACM data on COVID-19 vaccination coverage among adults ages 65 years and older with the addition of those who received at least a second dose of the 2023-2024 COVID-19 vaccine showed that through the end of June 2024, 8.9% of adults ages 65 years and older received at least a second dose of the 2023-2024 COVID-19 vaccine.2 COVID-19 vaccination coverage of at least 2 doses of the 2023-2024 COVID-19 vaccine in adults ages 18 years and older who are immunocompromised indicated that 5.4% of immunocompromised adults received at least 2 doses of the 2023-2024 COVID-19 vaccine by June 2024.2
A healthcare provider recommendation is a key driver of vaccine uptake. Looking at provider recommendations by age, among participants in NIS-ACM in July 2024 reports of a healthcare provider recommendation for COVID-19 vaccine was highest among adults ages 65 years and older compared to younger age groups.3 Furthermore, a healthcare provider recommendation was higher among adults ages 65 years and older who received at least 2 doses of the 2023-2024 COVID-19 vaccine by end of June 2024.2
An October 2024 survey of physicians, advanced practice providers, pharmacists, and nurses who spent at least 50% of time providing outpatient care and have vaccines administered at the work site showed that 70% of respondents reported recommending a second COVID-19 vaccination to eligible patients ages 65 years and older most of the time or always. These recommendation results were similar by provider type. Furthermore, 68% of respondents reported recommending a second COVID-19 vaccination to eligible patients who were immunocompromised most of the time or always; and the recommendations were also similar across provider type.4
The Work Group obtained feedback via Work Group liaisons from organizations that focus on older adults, people with immunocompromise, healthcare providers and pharmacists. This feedback noted that age-based recommendations or universal recommendations were preferred over risk-based or shared clinical decision-making, as there are implementation challenges for both risk-based and shared clinical decision-making on top of an already complicated vaccination schedule, and shared clinical decision-making recommendations can appear to have lower confidence and are difficult to communicate. Additionally, frequent changes in vaccine recommendations create confusion. Most respondents preferred one to two total recommended doses of COVID-19 vaccine per year and reiterated that self-attestation of immunocompromise status is permissible.

Feasibility

Criteria Work Group Judgements Evidence
Is the intervention feasible to implement? Adults ages ≥65 years: Probably yes/Yes
People ages ≥6 months who are moderately or severely immunocompromised: Probably yes/Yes
People ages ≥6 months who are moderately or severely immunocompromised under shared clinical decision-making: Probably yes/Yes
 Based on survey data from general internal medicine physicians regarding pneumococcal and HPV shared clinical decision-making, most physicians strongly agreed that shared clinical decision-making required more time than routine recommendations. Most respondents also thought that it creates confusion; and just over 40% either strongly or somewhat strongly agreed that shared clinical decision-making was hard to explain to patients and that they did not know how to implement this type of recommendation as ACIP intended.1
While these data are not COVID-19 vaccine specific, they can inform understanding of acceptability of shared clinical decision-making for providers.

Resource Use

Criteria Work Group Judgements Evidence
Is the intervention a reasonable and efficient allocation of resources? Adults ages ≥65 years: Probably yes/Yes
People ages ≥6 months who are moderately or severely immunocompromised: Probably yes/Yes
People ages ≥6 months who are moderately or severely immunocompromised under shared clinical decision-making: Varies
 The base case incremental cost effectiveness ratio (ICER) was $356,534 per quality adjusted life year for a second dose of the 2024-2025 COVID-19 vaccine in adults ages 65 years and older. When increasing the probability of hospitalization, the ICERs were more favorable across all age groups.1
There was no data specific to the cost effectiveness of additional doses in people who are moderately or severely immunocompromised.
For all COVID-19 vaccines, if list prices were reduced, vaccination would be more cost-effective.

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 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 EtR frameworks 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.

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

Evidence

 

Evidence to Recommendations Domain Domain Equity Question Evidence Reviewed
Public Health Problem Does the problem impact all populations equally? Age-adjusted cumulative COVID-19 hospitalizations per 100,000 population by race and ethnicity in the United States from COVID-NET during October 2023-September 2024 showed that there are still notable disparities in COVID-19 hospitalization rates particularly for American Indian and Alaska Native, non-Hispanic persons and Black, non-Hispanic persons.7 The percent of people with multiple chronic conditions by age among Asian, Black, Latino/Hispanic, and White adults in the National Health Interview Survey from 1999 to 2018 indicated that there are differences by race and ethnicity in the percent that have multiple comorbidities at younger ages. This may be contributing to some of the inequity seen in the burden of COVID-19 by race and ethnicity. Therefore, it is important context to keep in mind when considering age-based recommendations. Differences in prevalence of multiple chronic conditions by age and race/ethnicity in the National Health Interview Survey from 1999 to 2018 showed that starting at the 35-39 years age group, the presence of multiple chronic conditions diverges between Black and White persons, and this difference continues to increase through age 60-64 years before converging to a similar prevalence at ages 80 years and older. This convergence at later ages is likely related to survival bias. As related to the policy, age related recommendations can address some of the racial and ethnic disparities in risk factors for COVID-19 and lead to higher uptake in populations that need it most.
Data from the 2021 National Health Interview Survey (NHIS) showed that overall, the prevalence of self-reported status of immunosuppression across US adults was 7% and varied by race and ethnicity with American Indian and Alaska Native persons having the highest rates. Also, from NHIS, prevalence of self-reported status of immunosuppression varied by sex with females having the highest prevalence; and a higher proportion of people with self-reported immunosuppression were insured compared to uninsured.9
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 and ethnicity.16,17 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? Data from National Immunization Survey-Adult COVID Module (NIS-ACM) in July 2024 on COVID-19 vaccination key attitudes and experiences by race and ethnicity among adults ages 65 years and older showed that Black, non-Hispanic adults were more concerned about COVID-19 disease than people of other racial and ethnic groups. In relation to confidence in COVID-19 vaccine safety and importance, there was variability by race and ethnicity.1
Acceptability Is the intervention equally acceptable across all populations? Among adults ages 65 years and older responding to the NIS-ACM through June 2024, vaccination coverage differed by race and ethnicity. Coverage of at least two doses of the 2023-2024 COVID-19 vaccine was statistically higher in Black, non-Hispanic adults compared to White, non-Hispanic adults. Furthermore, vaccination coverage was higher in urban areas compared to rural areas.2
Among adults with immunocompromising conditions responding to the NIS-ACM, vaccination coverage differed by race and ethnicity. Coverage of at least two doses of the 2023-2024 COVID-19 vaccine was statistically lower in Asian adults compared to White, non-Hispanic adults. Moreover, vaccination coverage was higher in suburban areas compared to rural areas. Vaccination coverage was also higher in those with health insurance compared to those without; and vaccination coverage was higher among those with a healthcare provider recommendation.2
Feasibility Is the intervention equally feasible to implement across all populations? Social determinants of health drive differences in vaccine access creating disparities in uptake. Additional dose recommendations may further increase these disparities. For example, decreased access with the end of the Bridge Access Program, increased prevalence with age creating potential challenges getting to vaccination sites and decreased access in settings with existing challenges (e.g., long-term care). Furthermore, in the absence of an ACIP recommendation, access may decrease if required to pay out of-pocket.
Resource Use Is the intervention a reasonable and efficient allocation of resources across all populations? A second dose of COVID-19 vaccine is most cost-effective in older adults in whom disease burden is highest. A second dose of COVID-19 vaccine is likely more cost-effective in populations with a higher prevalence of risk factors, such as underlying conditions, which increase their probability of hospitalization due to COVID-19. There is no information specific to cost-effectiveness of additional doses in people who are moderately or severely immunocompromised.

Work Group Interpretation Summary

A harmonized recommendation for older adults and immunocompromised persons would ease implementation and help simplify an already complicated immunization schedule. Some Work Group members were not in favor of a harmonized recommendation but rather supported having differing recommendations in the two populations under consideration. Relative absence of data makes selecting the correct number of recommended doses challenging for immunocompromised persons, especially given the heterogeneity of this population. Despite hesitations about a shared clinical decision-making recommendation, many Work Group members acknowledged the benefit for people who are moderately or severely immunocompromised, which allows for flexibility in additional doses and may allow these patients to time vaccine receipt around travel, life events, chemotherapy, etc.

There was low uptake of more than one dose of the 2023-2024 vaccine, as complexity of an already existing schedule has led to reduced adherence by clinicians. Provider recommendations directly impact uptake, and as part of this recommendation, provider education and ensuring providers are on board is critical to improving adherence. While simpler vaccine recommendations are not perfect, there may be benefits in increasing vaccine uptake, and enhancing protection at the population level. Focusing on number of doses of the 2024-2025 vaccine rather than additional doses in recommendations could help reduce complexity and improve uptake.

Balance of consequences

A second dose of 2024-2025 COVID-19 vaccine in adults ≥65 years:

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

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

A second dose in people ages 6 months - 64 years who are moderately or severely immunocompromised:

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

Additional doses (i.e., 3 or more) in people ages ≥6 months who are moderately or severely immunocompromised:

The Work Group felt that the desirable consequences probably outweigh undesirable consequences in most settings.

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

Type of recommendation, a second dose of 2024-2025 COVID-19 vaccine in adults ≥65 years:

Adults ages 65 years and older are recommended to receive a second dose of 2024-2025 COVID-19 vaccine.

Type of recommendation, a second dose in people ages 6 months – 64 years who are moderately or severely immunocompromised:

People ages 6 months – 64 years who are moderately or severely immunocompromised are recommended to receive a second dose of 2024-2025 COVID-19 vaccine.

Type of recommendation, additional doses (i.e., 3 or more) in people ages ≥6 months who are moderately or severely immunocompromised:

People ages 6 months and older who are moderately or severely immunocompromised are recommended to receive additional doses (i.e., 3 or more) based on shared clinical decision-making.

Draft recommendation

ACIP recommends 2024-2025 COVID-19 vaccines as authorized or approved by FDA in adults ages 65 years and older and persons ≥6 months of age who are moderately or severely immunocompromised.

Final deliberation and decision by ACIP

On October 23, 2024, ACIP voted (15-0) in favor of recommending:

A second dose* of 2024-2025 COVID-19 vaccine for adults ages 65 years and older

A second dose** of 2024-2025 COVID-19 vaccine for people ages 6 months-64 years who are moderately or severely immunocompromised

Additional doses (i.e., 3 or more doses) of 2024-2025 COVID-19 vaccine for people ages 6 months and older who are moderately or severely immunocompromised under shared clinical decision-making

*If previously unvaccinated and receiving Novavax, 2 doses are recommended as initial vaccination series followed by a third dose of any age-appropriate 2024-2025 COVID-19 vaccine 6 months (minimum interval 2 months) after second dose.

**If previously unvaccinated or receiving initial vaccination series, at least 2 doses of 2024-2025 vaccine are recommended, and depending on vaccination history more may be needed. The additional 2024-2025 vaccine dose is recommended 6 months (minimum interval 2 months) after completion of initial vaccination series.

Final ACIP recommendation

ACIP recommends the intervention

ACIP recommends a second dose of 2024-2025 COVID-19 vaccine for adults ages 65 years and older, a second dose of 2024-2025 COVID-19 vaccine for people ages 6 months-64 years who are moderately or severely immunocompromised, and additional doses (i.e., 3 or more doses) of 2024-2025 COVID-19 vaccine for people ages 6 months and older who are moderately or severely immunocompromised under shared clinical decision-making.

References

Public Health Problem

  1. CDC. National Respiratory and Enteric Virus Surveillance System (NREVSS). https://www.cdc.gov/nrevss/php/dashboard/index.html
  2. CDC. COVID-NET COVID-19 Hospitalization surveillance network. https://www.cdc.gov/covid/php/covid-net/index.html
  3. CDC. Unpublished data from COVID-NET
  4. Provisional death data from CDC's National Center for Health Statistics (NCHS), National Vital Statistics System (NVSS); CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#demographicsovertime Accessed October 22, 2024
  5. Unpublished update from Jones JM, Manrique IM, Stone MS, et al. Estimates of SARS-CoV-2 Seroprevalence and Incidence of Primary SARS-CoV-2 Infections Among Blood Donors, by COVID-19 Vaccination Status — United States, April 2021–September 2022. MMWR Morb Mortal Wkly Rep 2023;72:601–605. DOI: http://dx.doi.org/10.15585/mmwr.mm7222a3
  6. de Candia P, Prattichizzo F, Garavelli S, Matarese G. T Cells: Warriors of SARS-CoV-2 Infection. Trends Immunol. 2021 Jan;42(1):18-30. doi: 10.1016/j.it.2020.11.002. Epub 2020 Nov 13. PMID: 33277181; PMCID: PMC7664351
  7. Rey, Gertrud. T Cell Responses to Coronavirus Infection are Complicated. https://www.virology.ws/2020/11/05/t-cell-responses-to-coronavirus-infection-are-complicated/
  8. CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalization-network. Accessed October 15, 2024
  9. Caraballo C, Herrin J, Mahajan S, et al. Temporal Trends in Racial and Ethnic Disparities in Multimorbidity Prevalence in the United States, 1999-2018. Am J Med. 2022;135(9):1083-1092.e14. doi:10.1016/j.amjmed.2022.04.010
  10. Martinson ML, Lapham J. Prevalence of Immunosuppression Among US Adults. JAMA. 2024;331(10):880–882. doi:10.1001/jama.2023.28019. https://jamanetwork.com/journals/jama/fullarticle/2815274

Benefits and Harms

  1. Link-Gelles R. Effectiveness of COVID-19 Vaccines. Presented at the Advisory Committee of Immunization Practices Meeting, Atlanta, GA; October 23, 2024. https://www.cdc.gov/acip/downloads/slides-2024-10-23-24/04-COVID-Link-Gelles-508.pdf
  2. Link-Gelles R. Effectiveness of COVID-19 (2023-2024 Formula) vaccines. Presented at the Advisory Committee on Immunization Practices Meeting, Atlanta, GA; June 27. 2024. https://www.cdc.gov/acip/downloads/slides-2024-06-26-28/03-COVID-Link-Gelles-508.pdf
  3. DeCuir J, Surie D, Zhu Y, et al. Effectiveness of Monovalent mRNA COVID-19 Vaccination in Preventing COVID-19–Associated Invasive Mechanical Ventilation and Death Among Immunocompetent Adults During the Omicron Variant Period — IVY Network, 19 U.S. States, February 1, 2022–January 31, 2023. MMWR Morb Mortal Wkly Rep 2023;72:463–468. DOI: http://dx.doi.org/10.15585/mmwr.mm7217a3
  4. Link-Gelles R. COVID-19 Vaccine Effectiveness during Omicron. Presented at the Advisory Committee on Immunization Practices Meeting, Atlanta, GA; April 20, 2022. https://stacks.cdc.gov/view/cdc/116527
  5. Link-Gelles R. COVID-19 vaccine effectiveness updates. Presented at the Advisory Committee on Immunization Practices Meeting, Atlanta, GA; June 23, 2023. https://www.cdc.gov/acip/downloads/slides-2023-06-21-23/02-COVID-Havers-Galang-Link-Gelles-508.pdf
  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. Park, H.J., Gonsalves, G.S., Tan, S.T. et al. Comparing frequency of booster vaccination to prevent severe COVID-19 by risk group in the United States. Nat Commun 15, 1883 (2024). https://doi.org/10.1038/s41467-024-45549-9
  8. Britton A, Embi PJ, Levy ME, et al. Effectiveness of COVID-19 mRNA Vaccines Against COVID-19–Associated Hospitalizations Among Immunocompromised Adults During SARS-CoV-2 Omicron Predominance — VISION Network, 10 States, December 2021—August 2022. MMWR Morb Mortal Wkly Rep 2022;71:1335–1342. DOI: http://dx.doi.org/10.15585/mmwr.mm7142a4.
  9. FDA. CDC and FDA Identify Preliminary COVID-19 Vaccine Safety Signal for Persons Aged 65 Years and Older. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cdc-and-fda-identify-preliminary-covid-19-vaccine-safety-signal-persons-aged-65-years-and-older
  10. Duffy J. COVID-19 vaccine safety surveillance for the 2023-2024 season. Presented at the Advisory Committee on Immunization Practices Meeting, Atlanta, GA; June 27, 2024. https://www.cdc.gov/acip/downloads/slides-2024-06-26-28/04-COVID-Duffy-508.pdf
  11. Klein NP, Lewis N, Goddard K, et al. Surveillance for adverse events after COVID-19 mRNA vaccination. JAMA 2021;326:1390–9. https://doi.org/10.1001/jama.2021.15072 PMID:34477808
  12. Markowitz LE, Hopkins RH Jr, Broder KR, et al. COVID-19 Vaccine Safety Technical (VaST) Work Group: enhancing vaccine safety monitoring during the pandemic. Vaccine 2024. Epub February 9, 2024. https://doi.org/10.1016/j.vaccine.2023.12.059 PMID:38341293
  13. Hause AM, Baggs J, Marquez P, et al. Safety Monitoring of COVID-19 mRNA Vaccine Second Booster Doses Among Adults Aged ≥50 Years — United States, March 29, 2022–July 10, 2022. MMWR Morb Mortal Wkly Rep 2022;71:971–976. DOI: http://dx.doi.org/10.15585/mmwr.mm7130a4
  14. Hause AM, Baggs J, Marquez P, et al. Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses Among Persons Aged ≥12 Years with Presumed Immunocompromise Status — United States, January 12, 2022–March 28, 2022. MMWR Morb Mortal Wkly Rep 2022;71:899–903. DOI: http://dx.doi.org/10.15585/mmwr.mm7128a3
  15. Shimabukuro T. COVID-19 mRNA bivalent booster vaccine safety. Presented at the Advisory Committee on Immunization Practices Meeting, Atlanta, GA; February 24, 2023. https://www.cdc.gov/acip/downloads/slides-2023-02-22-24/COVID-02-Shimabukuro-508.pdf
  16. Florea A, Sy LS, Qian L, et al. Effectiveness of Messenger RNA-1273 Vaccine Booster Against Coronavirus Disease 2019 in Immunocompetent Adults. Clin Infect Dis. 2023 Jan 13;76(2):252-262. doi: 10.1093/cid/ciac785. PMID: 36134518; PMCID: PMC9619452.
  17. Rane MS, Robertson MM, Kulkarni SG, et al. Effectiveness of Covid-19 vaccines against symptomatic and asymptomatic SARS-CoV-2 infections in an urgent care setting. Vaccine. 2023 Jan 23;41(4):989-998. doi: 10.1016/j.vaccine.2022.12.039. Epub 2022 Dec 20. PMID: 36588007; PMCID: PMC9763212.

Values

  1. CDC. COVID-19 Vaccination Coverage and Vaccine Confidence Among Adults. https://www.cdc.gov/covidvaxview/interactive/adults.html?CDC_AAref_Val=https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adults.html Accessed October 3, 2024
  2. CDC Unpublished Data. Omnibus Surveys. August 8-26, 2024

Acceptability

  1. CDC. Adult Vaccination Coverage and Intent. https://www.cdc.gov/covidvaxview/weekly-dashboard/adult-vaccination-coverage.html Accessed October 4, 2024
  2. National Immunization Survey-Adult COVID Module (NIS-ACM) Unpublished Data by end of June 2024
  3. CDC. COVID-19 Vaccination Coverage and Vaccine Confidence Among Adults. https://www.cdc.gov/covidvaxview/interactive/adults.html?CDC_AAref_Val=https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adults.html Accessed October 4, 2024
  4. University of Iowa/Rand, Unpublished Survey of Physicians, Advanced Practice Providers, Pharmacists and Nurses. October 9-16, 2024

Feasibility

  1. Kempe A, Lindley MC, O'Leary ST, et al. Shared Clinical Decision-Making Recommendations for Adult Immunization: What Do Physicians Think? J Gen Intern Med. 2021;36(8):2283-2291. https://pubmed.ncbi.nlm.nih.gov/33528783/.

Resource Use

  1. Prosser L. Economic analysis of an additional dose of the 2024-2025 COVID-19 vaccination. Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, GA; October 23, 2024. https://www.cdc.gov/acip/downloads/slides-2024-10-23-24/05-COVID-Prosser-508.pdf
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Content Source:
National Center for Immunization and Respiratory Diseases (NCIRD)