ACIP Evidence to Recommendations (EtR) for Use of an Additional Dose of Updated (2023-2024 Formula) COVID-19 Vaccine in Older Adults

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Question: Should persons ages 65 years and older be recommended for an additional dose of 2023-2024 Formula COVID-19 vaccine?

Population: People ages 65 years and older

Intervention:

  • One additional dose of any updated (2023-2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) for people ages 65 years and older at least 4 months following the previous dose of updated (2023-2024 Formula) COVID-19 vaccine

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 dramatic societal and economic impact on individual persons and communities. As of February 3, 2024, more than 6.7 million COVID-19-associated hospitalizations and 1.1 million deaths due to COVID-19 have occurred in the United States.1 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.

Three COVID-19 vaccines are currently 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.

During September – October 2021, the FDA amended the COVID-19 vaccine EUAs to allow for booster doses of Pfizer-BioNTech and Moderna COVID-19 vaccines in persons who completed primary vaccination with these vaccines, as well as use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different COVID-19 vaccine. Previous data on the use of COVID-19 vaccine booster doses is linked here: EtR for Use of COVID-19 Vaccine Booster Doses | CDC.

On March 29, 2022, the FDA amended the original monovalent mRNA COVID-19 vaccine EUAs and on April 20, 2022, CDC recommended a second booster dose of either the original Pfizer-BioNTech or the original Moderna COVID-19 vaccine for individuals 50 years of age and older as well as certain immunocompromised individuals 12 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.

On August 31, 2022, the FDA amended the Emergency Use Authorization (EUA) of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. Following FDA’s regulatory action, CDC updated its COVID-19 vaccination guidance on September 1, 2022, for use of updated bivalent COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 years and older to better protect against the most recently circulating COVID-19 variant.2

In April 2023, FDA granted an EUA for additional bivalent mRNA COVID-19 vaccine doses for adults aged ≥65 years and for persons aged ≥6 months with immunocompromise. On April 20, 2023, CDC recommended that adults aged ≥65 years have the option to receive 1 additional bivalent vaccine dose ≥4 months after receipt of the most recent bivalent dose and persons aged ≥6 months who are moderately or severely immunocompromised have the option to receive ≥1 additional bivalent doses ≥2 months after receipt of the most recent bivalent dose and additional bivalent mRNA doses, as indicated, based on individual circumstances and clinical judgment.3

On September 11, 2023, FDA authorized the updated (2023–2024 Formula) COVID-19 mRNA vaccines by Moderna and Pfizer-BioNTech for use in persons aged 6 months–11 years under EUA and approved the updated Moderna and Pfizer-BioNTech COVID-19 vaccines for persons aged ≥12 years to more closely target circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. On September 12, 2023, ACIP recommended vaccination with the updated (2023-2024 Formula) COVID-19 vaccine as authorized under EUA or approved by BLA in persons aged ≥6 months. On October 3, 2023, FDA authorized the updated (2023-2024 Formula) Novavax COVID-19 vaccine for use in persons aged ≥12 years under EUA.4

On February 28, 2024, ACIP recommended that adults ages 65 years and older should receive an additional dose of any updated (2023-2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech). ACIP voted for the recommendation after reviewing data on the increased risk of severe disease from COVID-19 in older adults, along with currently available data on vaccine effectiveness. An additional dose of the updated COVID-19 vaccine is expected to restore vaccine effectiveness that may have waned and thereby increase protection against severe disease outcomes due to COVID-19, including death, among adults ages 65 years and older.

Additional background information supporting the interim ACIP recommendation on the use of an additional dose of (2023 – 2024 Formula) COVID-19 vaccine for persons ages 65 years and older 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; 2024, March 05. https://covid.cdc.gov/covid-data-tracker

2 Rosenblum HG, Wallace M, Godfrey M, et al. Interim Recommendations from the Advisory Committee on Immunization Practices for the Use of Bivalent Booster Doses of COVID-19 Vaccines — United States, October 2022. MMWR Morb Mortal Wkly Rep 2022;71:1436–1441. DOI: http://dx.doi.org/10.15585/mmwr.mm7145a2

3 Moulia DL, Wallace M, Roper LE, et al. Interim Recommendations for Use of Bivalent mRNA COVID-19 Vaccines for Persons Aged ≥6 Months — United States, April 2023. MMWR Morb Mortal Wkly Rep 2023;72:657–662. DOI: http://dx.doi.org/10.15585/mmwr.mm7224a3

4 Regan JJ, Moulia DL, Link-Gelles R, et al. Use of Updated COVID-19 Vaccines 2023–2024 Formula for Persons Aged ≥6 Months: Recommendations of the Advisory Committee on Immunization Practices — United States, September 2023. MMWR Morb Mortal Wkly Rep 2023;72:1140–1146. DOI: http://dx.doi.org/10.15585/mmwr.mm7242e1

Public Health Problem

Problem
Criteria Work Group Judgements Evidence Additional Information
Is the problem of public health importance? Yes The weekly number of COVID-19-associated hospitalizations in the United States for the 2023-2024 respiratory virus season peaked during the weeks ending December 30, 2023 and January 6, 2024 at about 35,000 hospitalizations a week. Throughout 2023, weekly hospitalizations were never less than 6,000 new admissions a week.1 Hospitalization rates are substantially higher in those ≥65 years compared with younger age groups. Since January 2023, hospitalization rates among those ≥65 years have tended to be around 5 times higher than hospitalization rates in those ages 50 – 64 years. Within the ≥65-year age group, hospitalization rates increase with increasing age.2
The weekly number of provisional COVID-19 deaths in the United States for the 2023-2024 respiratory virus season peaked the week ending January 13, 2024 at about 2,500 deaths. At the lowest point over the past year, weekly deaths were around 500 deaths per week.3 COVID-19 death rates are substantially higher in older adults compared to younger adults. Since January 2023, rates tend to be around 6 times higher in those 75 years and older than in those 65 – 74 years, who in turn have rates around 3 to 4 times higher than those 50 – 64 years.4
During July 1 – September 30, 2023, SARS-CoV-2 seroprevalence (i.e., the percentage of people with antibodies against SARS-CoV-2) in the United States was ≥95% across age groups, however 26% of those ages ≥65 years had vaccination-only seroprevalence compared with 14% in those 50 – 64 years and 9% in those 30 – 49 years.5
Despite peaks during the winter months, SARS-CoV-2 does not have clear seasonality that is seen with other respiratory viruses. During October 1, 2022 – February 17, 2023, >10% of tests for SARS CoV-2, influenza or RSV were positive during the winter months. During the summer months, influenza and RSV declined to <2% of positive tests, while SARS CoV-2 remained >4% of positive tests throughout the year.6 This lack of clear seasonality for SARS CoV-2/COVID-19 is also demonstrated with hospitalization rates, which peaked in the winter, but persisted throughout the year.7

Benefits and Harms

 

Benefits and Harms
Criteria Work Group Judgements Evidence Additional Information
How substantial are the desirable anticipated effects? Moderate Updated (2023-2024) COVID-19 vaccination provided increased protection against symptomatic SARS-CoV-2 infection and COVID-19-associated emergency department/urgent care visits and hospitalizations compared to no updated vaccine dose.1 Additionally, receipt of an updated (2023-2024) COVID-19 vaccine provides protection against JN.1 and other circulating variants.2 These early vaccine effectiveness estimates show no substantial waning; however, waning is expected. Among adults aged ≥18 years without immunocompromising conditions, bivalent booster vaccine effectiveness (VE) against COVID-19-associated hospitalization declined from 62% at 7–59 days postvaccination to 24% at 120–179 days compared with VE among unvaccinated adults.3 VE against critical illness was 69% during the 7–59 days after receipt of a bivalent dose and was more sustained (50% at 120–179 days after bivalent vaccination) than VE against hospitalization.3
There are no clinical trial data on an additional dose of updated (2023-2024 Formula) COVID-19 vaccine. The effectiveness of an additional dose in older adults has been demonstrated by past additional doses of original COVID-19 vaccine. Among adults aged 50 years and older eligible to receive a second original monovalent mRNA COVID-19 vaccine booster dose, VE for COVID-19-associated ED/UC encounters during the BA.2 period was 32% at 120 days or more after the third dose but increased to 66% 7 days or more after the fourth dose (median interval = 28 days). VE against COVID-19-associated hospitalization was 55% 120 days or more after the third dose but increased to 80% 7 days or more after the fourth dose (median interval = 27 days).4 Additionally, in a large cohort of nursing home residents, receipt of a second original monovalent mRNA COVID-19 booster dose during circulation of SARS-CoV-2 Omicron subvariants was 74% effective at 60 days against severe COVID-19-related outcomes (including hospitalization or death) and 90% against death alone compared with receipt of a single booster dose.5
How substantial are the undesirable anticipated effects? Small COVID-19 vaccines have a favorable safety profile as demonstrated by robust safety surveillance over 3 years of COVID-19 vaccine use.6 Anaphylactic reactions have been rarely reported following receipt of COVID-19 vaccines. There is a rare risk of myocarditis and pericarditis, however this is predominately in males ages 12-39 years.7  No new safety concerns have been identified for the updated (2023-2024 Formula) COVID-19 vaccine. 8 Reactogenicity symptoms have been reported following COVID-19 vaccines. Local reactions include pain at the injection site and less commonly, redness and swelling at the injection site. Systemic reactions include fever, fatigue, headache, chills, myalgia, and arthralgia. Overall, these symptoms are less frequent and severe among older adults compared with adolescents and younger adults.9
Do the desirable effects outweigh the undesirable effects? Favors intervention The Work Group decided that the desirable effects of an additional dose of updated (2023-2024 Formula) COVID-19 vaccine among older adults ages 65 years and older 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? Large Key attitudes and experiences among adults ages 18 years and older responding to the National Immunization Survey-Adult COVID Module (NIS-ACM) found that adults ages 65 years and older were more concerned about COVID-19 disease and had higher confidence in vaccine safety and vaccine importance compared to younger age groups.1
Additionally, half of adults report they plan to take precautions because of COVID-19 during the fall and winter months, with four in ten (41%) of adults ages 65 years and older planning to avoid large gatherings. Moreover, while younger adults were less likely to say they will avoid large gatherings, 21% of those under the age of 65 say they will take a test for COVID-19 before spending time with friends or family.2
Is there important uncertainty about or variability in how much people value the main outcomes? Probably important uncertainty or variability Results from the National Immunization Survey-Adult COVID Module (NIS-ACM) showed 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.1
In relation to precautions against COVID-19 during the fall and winter months, only a third (33%) of those under the age of 65 years, plan to avoid large gatherings and only 10% of those ages 65 years and older say they will take a test for COVID-19 before spending time with friends or family.2

Acceptability

Acceptability
Criteria Work Group Judgements Evidence Additional Information
Is the intervention acceptable to key stakehold-ers? Probably yes Results from the National Immunization Survey-Adult COVID Module (NIS-ACM) showed that as of February 2024, vaccination coverage with 2023-2024 COVID-19 vaccine among adults ages 18 years and older was highest among older adults ages 65-74 years and 75 years and older, compared to younger age groups.1
Furthermore, results from the nationally representative Omnibus Surveys from January 5-29, 2024, on the top COVID-19 vaccination concerns and issues among adults ages 65 years and older, by status/intent, showed that most COVID-19 vaccination concerns were reported by those who probably or definitely will not get vaccinated.2
Key attitudes and experiences among adults ages 18 years and older responding to the National Immunization Survey-Adult COVID Module (NIS-ACM) showed that adults who were vaccinated or definitely plan to get vaccinated were more likely to report that a healthcare provider recommended they get a COVID-19 vaccine. Additionally, adults ages 65 years and older were more likely to report a healthcare provider recommendation than younger adults.3
Among adults ages 65 years and older who already received an updated (2023-2024 Formula) COVID-19 vaccine dose, 68.4% reported they definitely will get an additional dose of updated (2023-2024 Formula) COVID-19 vaccine if it is recommended.4

Feasibility

Feasibility
Criteria Work Group Judgements Evidence Additional Information
Is the intervention feasible to implement? Probably yes COVID-19 vaccines are now available on the commercial market and are covered by private and public insurance and available through the Bridge Access Program and Vaccines for Children (VFC) Program for those that are uninsured or underinsured. However, an ACIP recommendation would be needed for insurance coverage of an additional dose of the 2023-2024 Formula COVID-19 vaccine, as insurance coverage is generally required under either a “should” or “may” recommendation.
Additional dose recommendation would be for the same formula (2023-2024) of COVID-19 vaccine that is currently available. Existing COVID-19 vaccine administration infrastructure and product can be used, as an age-based recommendation would not be overly burdensome to implement. However, an additional dose recommendation in those ages 65 years and older would add complexity to COVID-19 vaccine recommendations, which have been getting simpler. Frequent changes to vaccine recommendations can lead to vaccine fatigue. Systems are already planning for next season, and adding more recommendations for this year could add additional burden to an already fatigued system. Moreover, a minimal interval of 4 months used for additional dose recommendations may confuse providers accustomed to a 2-month interval between a person’s most recent COVID-19 vaccination and when the first  2023-24 COVID-19 vaccine was recommended. Providers would need to consider anticipated availability of updated vaccines next fall when considering providing vaccine doses during the summer months.

Resource Use

Resource Use
Criteria Work Group Judgements Evidence Additional Information
Is the intervention a reasonable and efficient allocation of resources? Probably yes An additional dose in adults ages 65 years and older had an incremental cost effectiveness ratio of $255,122 per quality-adjusted life year in the base case scenario. However, incremental cost effectiveness ratios became more favorable in scenarios that are approximate to vaccinating a higher risk group of people, which may be seen with underlying medical conditions or advanced age.1

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.

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. We recommend 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 will remove the voting question on Equity and enhance attention to equity across all domains. We do 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 newly proposed structure will be depicted in this Evidence to Recommendations (EtR) Framework.

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

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 demonstrate disparities in hospitalizations by race and ethnicity, particularly among American Indian and Alaska Native people and Black people.2
Regarding the number of chronic conditions by age among Asian, Black, Hispanic, and White adults in the National Health Interview Survey, the percentage with multiple underlying conditions increases with age and varies by race and ethnicity.8
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 adults ages 18 years and older responding to the National Immunization Survey-Adult COVID Module (NIS-ACM) by race and ethnicity showed that Black adults were more concerned about COVID-19 disease than people of other racial and ethnic groups, whereas confidence in COVID-19 vaccine safety and importance varied by racial and ethnic group with American Indian/Alaska Native adults the least confident in vaccine effectiveness and safety.1
In relation to precautions against COVID-19 during the fall and winter by race and ethnicity, larger proportions of Black adults (72%) and Hispanic adults (68%) report they plan to take precautions against COVID-19 than White adults (39%).2
Acceptability Is the intervention equally acceptable across all populations? Among adults ages 18 years and older responding to the National Immunization Survey-Adult COVID Module (NIS-ACM) during November 26, 2023 to December 30, 2023, vaccination coverage 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. Additionally, vaccination coverage was higher in urban and suburban areas compared with rural areas. Furthermore, adults with health insurance had significantly higher vaccination coverage than adults without insurance; and vaccination coverage increased with increasing age.5
Results from Omnibus surveys from November 30, 2023 – January 16, 2024, on intent to receive an additional COVID-19 vaccine dose among adults ages 18 years and older who received a dose since September 14, 2023 showed that disparities in COVID-19 vaccine coverage are observed across many demographic factors, including race and ethnicity, rurality, and insurance status.4
Feasibility Is the intervention equally feasible to implement across all populations? There have been past reports of sites being unaware of additional dose recommendations or requiring documentation to prove eligibility for an additional vaccine dose. Wide communication of any change in recommendations and that self-attestation is appropriate will be important to decrease barriers. The Bridge Access Program was designed to remove patient barriers to COVID-19 vaccines, however disparities in vaccine uptake by insured status continue. To the extent that existing disparities in vaccine uptake by characteristics such as race and ethnicity, urbanicity, and income are driven by differences in vaccine access, additional dose recommendations may further increase those disparities. Furthermore, access issues may be increased during a time when there are fewer off-site vaccination clinics, which are more common during fall vaccine rollouts. In the absence of an ACIP recommendation, additional doses might be an out-of-pocket cost, therefore those able to pay for an additional dose may have access while others do not.
Resource Use Is the intervention a reasonable and efficient allocation of resources across all populations? An additional dose of COVID-19 vaccine is most cost-effective in older adults in whom disease burden is highest compared to younger adults. An additional 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.

Work Group Interpretation Summary

The greatest benefit of a vaccine dose would be in those who have not yet received an updated (2023-2024 Formula) dose, particularly older adults, and those with underlying medical conditions. Data presented during the February 28, 2024 ACIP meeting emphasized the importance of any dose of updated (2023-2024 Formula) COVID-19 vaccine in older adults. Risk of severe illness due to COVID-19 continues throughout the year and is highest in those ≥65 years. Within the ≥65-year age group, risk increases with increasing age. Receipt of updated (2023-2024 Formula) COVID-19 vaccine provides protection against JN.1 and other circulating variants, however vaccine effectiveness is expected to wane with time from vaccination. In the past, we have seen greater durability in the protection against critical illness.

A “may” recommendation would provide flexibility for older adults to obtain an additional dose if they or their healthcare provider feel they would benefit. The most benefit would likely be in those with underlying medical conditions, advanced age, or circumstances that may increase risk (e.g., nursing home resident). An additional dose in adults ≥65 years may restore protection that has waned, which is a smaller, incremental benefit on top of the protection still being provided by the initial updated (2023-2024 Formula) COVID-19 vaccine dose. Cost effectiveness of an additional dose depends on COVID-19 hospitalization rates in the coming months and the patient risk factors for severe illness due to COVID-19. As COVID-19 epidemiology changes with time, additional dose recommendations may not be needed in the future.

Considerations for an additional dose recommendation

Considerations for an additional dose recommendation
Pro Cons
Provide flexibility for those ≥65 years to get an additional dose if they or their healthcare provider feel they would benefit. Smaller, incremental benefit compared to that from initial 2023-2024 COVID-19 vaccine dose in the fall.
Restore vaccine effectiveness that may have waned since the initial 2023-2024 COVID-19 vaccine dose. May decrease vaccine confidence in the benefits of a single dose of 2023-2024 COVID-19 vaccine.
Acknowledges that risk of severe illness due to COVID-19 continues throughout the year for older adults, in addition to upticks during winter months. Additional recommendations may increase vaccine fatigue, potentially reducing uptake of vaccine next fall.

Balance of consequences

The majority of the Work Group felt that the balance between desirable and undesirable consequences is closely balanced or uncertain and the desirable consequences probably 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 for individuals based on shared clinical decision-making

Draft recommendation

ACIP recommends that persons ages 65 years and older may receive an additional dose of 2023-2024 Formula COVID-19 vaccine

ACIP considerations for an additional dose recommendation

During the ACIP meeting, ACIP members considered the “may” recommendation for an additional dose for older adults as advised by the WG. Ultimately, they felt that the evidence presented on the continuous risk of severe illness due to COVID-19 in older adults and challenges in implementing a “may” recommendation supported a stronger “should” recommendation.

Final deliberation and decision by ACIP

During the ACIP meeting, ACIP amended the vote language to move from a shared clinical decision-making recommendation to a full recommendation. On February 28, 2024, ACIP voted (11-1, with 1 abstention) in favor of recommending:

An additional dose of 2023-2024 Formula COVID-19 vaccine for persons ≥65 years of age

Final ACIP recommendation

ACIP recommends the intervention

ACIP recommends that persons ages 65 years and older should receive an additional dose of 2023-2024 Formula COVID-19 vaccine

References

Public Health Problem:

  1. CDC COVID Data Tracker. National Healthcare Safety Network (NHSN). https://covid.cdc.gov/covid-data-tracker/#trends_weeklyhospitaladmissions_select_00. Accessed February 23, 2024
  2. CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalization-network. Accessed February 23, 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 February 23, 2024
  4. 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 February 23, 2024
  5. https://covid.cdc.gov/covid-data-tracker/#nationwide-blood-donor-seroprevalence-2022
  6. CDC Respiratory Virus Activity Levels. https://www.cdc.gov/respiratory-viruses/data-research/dashboard/activity-levels.html. Accessed February 6, 2024
  7. CDC Respiratory Virus Activity Levels. National Healthcare Safety Network. https://www.cdc.gov/respiratory-viruses/data-research/dashboard/illness-severity.html. Accessed February 23, 2024
  8. 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

Benefits and Harms:

  1. https://www.cdc.gov/mmwr/volumes/73/wr/mm7308a5.htm
  2. https://www.cdc.gov/mmwr/volumes/73/wr/mm7304a2.htm?s_cid=mm7304a2_w
  3. https://www.cdc.gov/mmwr/volumes/72/wr/mm7221a3.htm
  4. https://www.cdc.gov/mmwr/volumes/71/wr/mm7129e1.htm
  5. https://www.cdc.gov/mmwr/volumes/71/wr/mm7139a2.htm
  6. https://pubmed.ncbi.nlm.nih.gov/38341293/
  7. https://www.sciencedirect.com/science/article/pii/S0264410X23015050#t0005
  8. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-02-28-29/06-COVID-Wallace-508.pdf
  9. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines

Values:

  1. COVID-19 Vaccination Coverage and Vaccine Confidence Among Adults. https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adults.html Accessed February 7, 2024
  2. KFF COVID-19 Vaccine Monitor (Oct. 31-Nov. 7, 2023) KFF COVID-19 Vaccine Monitor November 2023: With COVID Concerns Lagging, Most People Have Not Gotten Latest Vaccine And Half Say They Are Not Taking Precautions This Holiday Season | KFF Accessed November 17, 2023

Acceptability:

  1. CDC Unpublished Data. National Immunization Survey-Adult COVID Module (NIS-ACM). September 30, 2023-February 3, 2024
  2. CDC Unpublished Data. Omnibus Surveys. January 5-29, 2024
  3. COVID-19 Vaccination Coverage and Vaccine Confidence Among Adults. https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adults.html Accessed February 7, 2024
  4. CDC Unpublished Data. Omnibus Surveys. November 30, 2023-January 16, 2024
  5. CDC Unpublished Data. National Immunization Survey-Adult COVID Module (NIS-ACM). November 26-December 30, 2023

Resource Use:

  1. Prosser L. Economic analysis of an additional dose of COVID-19 vaccine. Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, GA; February 28, 2024. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-02-28-29/05-COVID-Prosser-508.pdf
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