This page describes the recommendations for the 2024–2025 season, published in September 2024. Vaccine formulas and recommendations are updated as the virus changes; check current CDC guidance before acting on them.
On June 27, 2024, the Advisory Committee on Immunization Practices (ACIP) recommended vaccination with a 2024–2025 COVID-19 vaccine, approved or authorized by the Food and Drug Administration (FDA), for everyone aged 6 months and older. The committee voted 11 to zero, with one abstention. CDC published the recommendations in Morbidity and Mortality Weekly Report on September 10, 2024.
Why a new vaccine
The 2023–2024 vaccines, recommended since September 2023, were monovalent vaccines based on the XBB.1 strain of SARS-CoV-2. They protected against XBB-sublineage strains, but those strains were no longer the main ones in the United States. Since winter 2023–2024, strains of the Omicron JN.1 lineage, including JN.1 itself and KP.2, had been circulating widely. Protection from COVID-19 vaccines is also known to fade over time.
In August 2024 FDA acted on vaccines matched to the new lineage:
| Date | Vaccine | Strain | Ages 12 years and older | Ages 6 months–11 years |
|---|---|---|---|---|
| August 22, 2024 | Moderna, Pfizer-BioNTech | KP.2 | approved | authorized under Emergency Use Authorization (EUA) |
| August 30, 2024 | Novavax | JN.1 | authorized under EUA | — |
Because the Novavax vaccine and all vaccines for children aged 6 months–11 years were available under EUA, the recommendations covering them were interim.
The burden of COVID-19
The report noted that COVID-19 was still causing thousands of hospitalizations and hundreds of deaths in the United States each week.
- Hospitalization by age. From October 2023 to May 2024, hospitalization rates were highest among adults aged 75 and older, then infants younger than 6 months, then adults aged 65–74.
- Children. From July 2023 to March 2024, 50% of children and adolescents aged 17 and younger who were hospitalized with COVID-19 had no underlying medical condition. Underlying conditions were less common among infants younger than 6 months (25%) and more common among adolescents (78%). Of hospitalized children and adolescents with no underlying condition, 18% were admitted to intensive care.
- Race and ethnicity. Age-adjusted hospitalization rates were highest among non-Hispanic American Indian or Alaska Native people and non-Hispanic Black or African American people.
- Deaths. From May 2023 to April 2024, monthly death rates were highest among adults aged 75 and older, then those aged 65–74. In 2023, 44,059 COVID-19–associated deaths were reported among people aged 65 and older, 5,634 among those aged 20–64, 125 among those aged 1–19 and 58 among infants younger than 1 year.
How the committee weighed the evidence
ACIP had held 40 public meetings on COVID-19 vaccines since June 2020. Its COVID-19 Vaccines Work Group met nine times from March to June 2024 on a single question: should 2024–2025 vaccination be recommended for everyone aged 6 months and older? The group rated the certainty of the evidence with the GRADE approach (Grading of Recommendations, Assessment, Development and Evaluation), looking at updated vaccines (bivalent or 2023–2024) used in the United States from September 2022 to May 2024 as the best guide to what the 2024–2025 vaccine could be expected to do. It then used the Evidence to Recommendations framework to consider the size of the problem, benefits and harms, cost, people's values, acceptability, feasibility and equity.
Effectiveness. In adolescents and adults, pooled estimates for an updated vaccine compared with no updated vaccine were:
| Outcome | Vaccine effectiveness | 95% confidence interval |
|---|---|---|
| Emergency department or urgent care visit for COVID-19 | 43% | 30%–54% |
| COVID-19–associated hospitalization | 44% | 34%–52% |
| COVID-19–associated death | 23% | 8%–36% |
Certainty was rated low for all three. For infants and children, a single study found 80% effectiveness against medically attended COVID-19 (95% CI 42%–96%), also of low certainty. No published study measured protection against hospitalization or death in children, so it was inferred from adult data and rated very low certainty.
Newer CDC data on 2023–2024 vaccine doses showed how protection waned. In adults, effectiveness against hospitalization was 49% 7–59 days after vaccination and fell to 14% at 120–179 days. Protection against critical illness appeared to last somewhat longer: 69% at 7–59 days and 32% at 120–179 days. Against symptomatic infection 60–119 days after vaccination, effectiveness was 58% for likely XBB-sublineage infection and 37% for likely JN.1-sublineage infection. Data for children and adolescents were limited, though effectiveness against medically attended illness looked similar in children and adults.
Safety. Certainty about the prespecified adverse events, myocarditis or pericarditis and anaphylaxis, remained low for adults and adolescents and very low for infants and children. The Vaccine Safety Datalink flagged two statistical signals for mRNA vaccines in 2023–2024:
- Guillain-Barré syndrome in people aged 65 and older. No link had been found before that season, and evidence on whether the signal reflected a real risk was inconclusive.
- Ischemic stroke in adults aged 50 and older. A similar signal had been seen for the bivalent vaccine and reviewed by ACIP in October 2023. The data had not shown clear and consistent evidence of a problem, and a follow-up study was under way.
The report stressed that any real or theoretical risk must be weighed against the vaccines' benefits in preventing COVID-19 and its serious complications, stroke among them.
Cost-effectiveness. Modeling found the vaccines most cost-effective in adults aged 65 and older, who have the highest rates of severe illness: $23,308 per quality-adjusted life year (QALY), a result that held up when assumptions changed. Ratios for younger groups were higher and less certain: $113,248 per QALY at ages 50–64, $212,225 at 18–49, $202,621 at 12–17 and $200,445 at 5–11. They looked more favorable if the vaccine had more impact, hospitalization risk or the quality-of-life cost of illness was higher, or the vaccine was cheaper.
Who needs how many doses
People without moderate or severe immunocompromise
- Aged 5–11 years: 1 dose of 2024–2025 Moderna or Pfizer-BioNTech vaccine.
- Aged 12 and older: 1 dose of 2024–2025 Moderna, Novavax or Pfizer-BioNTech vaccine. Anyone in this group who has never had a COVID-19 vaccine and chooses Novavax should get 2 doses.
- Aged 6 months–4 years: a multidose initial series when first vaccinated, so more than 1 dose, at least 1 of them a 2024–2025 vaccine.
People who are moderately or severely immunocompromised
- Everyone aged 6 months and older should get at least 1 dose of 2024–2025 vaccine; more may be recommended depending on vaccination history.
- Unvaccinated, aged 6 months–11 years: an initial series of 3 doses of a 2024–2025 mRNA vaccine, all from the same manufacturer.
- Unvaccinated, aged 12 and older: either 3 doses of a 2024–2025 mRNA vaccine from the same manufacturer or 2 doses of 2024–2025 Novavax.
- Those who have finished an initial series and had at least 1 dose of 2024–2025 vaccine may get 1 more age-appropriate dose at least 2 months later. Further doses, each at least 2 months after the last, can be given based on a provider's clinical judgment and the person's preferences and circumstances.
Paying for the vaccine and reporting problems
Since 2023, COVID-19 vaccines have been sold on the commercial market. The Affordable Care Act requires insurers to cover vaccines that ACIP routinely recommends, without cost-sharing, by the next coverage year, and Section 3203 of the CARES Act speeds coverage of COVID-19 vaccines further. Medicare Part B and nearly all Medicaid coverage pay for them without cost-sharing, and the Vaccines for Children Program, which serves about half of U.S. children and teens under 19, provides them free. CDC's Bridge Access Program, which gave free 2023–2024 vaccines to uninsured and underinsured adults, ended in August 2024 and did not cover the 2024–2025 vaccine.
Before vaccinating, providers should give the EUA Fact Sheet, package insert or Vaccine Information Statement and explain expected side effects. Adverse events should be reported to the Vaccine Adverse Event Reporting System (VAERS) at https://vaers.hhs.gov or 1-800-822-7967. For licensed vaccines given to people aged 12 and older, reporting any clinically significant event is encouraged even when the vaccine may not be the cause; for vaccines given under EUA, providers are required to report certain events.
Sources
- Panagiotakopoulos L, Moulia DL, Godfrey M, et al. "Use of COVID-19 Vaccines for Persons Aged ≥6 Months: Recommendations of the Advisory Committee on Immunization Practices — United States, 2024–2025." MMWR 2024;73(37). https://www.cdc.gov/mmwr/volumes/73/wr/mm7337e2.htm
- GRADE evidence profile: https://www.cdc.gov/vaccines/acip/recs/grade/covid-19-2024-2025-6-months-and-older.html; Evidence to Recommendations framework: https://www.cdc.gov/vaccines/acip/recs/grade/covid-19-2024-2025-6-months-and-older-etr.html
- Clinical considerations, with dose schedules by age and history: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html
Licence: CC0 1.0 (public domain) · Adapted from www.cdc.gov
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