COVID-19 Vaccine

For adults aged 65 years or older, schedule a second 2024-2025 COVID-19 vaccine dose 6 months after the first current-season dose; a minimum interval of 2 months is permitted. This recommendation reflects the higher risk of severe COVID-19 outcomes in older adults and year-round SARS-CoV-2 circulation. CDC+1CDCCDC Recommends Second Dose of 2024-2025 COVID-19 Vaccine for People 65 Years and Older and for People Who are Moderately or Severely Immunocompromised | CDC NewsroomCDCAdvisory 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 | ACIP | CDC

For patients aged 6 months through 64 years with moderate or severe immunocompromise, recommend a second 2024-2025 dose 6 months after the first dose, with a minimum interval of 2 months. If ongoing immune impairment or clinical risk warrants further protection, additional current-season doses may be given under shared clinical decision-making, separated by at least 2 months. CDC+1CDCCDC Recommends Second Dose of 2024-2025 COVID-19 Vaccine for People 65 Years and Older and for People Who are Moderately or Severely Immunocompromised | CDC NewsroomCDCAdvisory 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 | ACIP | CDC

At each preventive visit, document the date and product of the most recent current-season dose, identify age 65 years or older or moderate/severe immunocompromise, and place a future order or recall for the 6-month dose. Do not use post-vaccination antibody results to determine whether a patient is protected or requires vaccination; serology characterizes antibody responses but does not establish a clinical protection threshold for individual decision-making. science+1scienceSerology assays to manage COVID-19scienceMultiplexed, quantitative serological profiling of COVID-19 from blood by a point-of-care test

Before administering an mRNA vaccine, ask specifically about anaphylaxis after a prior Pfizer-BioNTech COVID-19 vaccine dose or after exposure to a component of the intended product. A known severe allergic reaction to a product component is a contraindication to COMIRNATY; Moderna labeling likewise contraindicates use after severe allergic reaction to a Moderna vaccine component. fda+1fdaModerna COVID-19 Vaccine Health Care Provider Fact ...fdaPackage Insert and Patient Package Insert - COMIRNATY

Vaccinate only in a setting with immediate access to personnel, equipment, and medications capable of managing an acute anaphylactic reaction. This is a product-label requirement rather than an optional precaution. fda+1fdaModerna COVID-19 Vaccine Health Care Provider Fact ...fdaPackage Insert and Patient Package Insert - COMIRNATY

Administer COMIRNATY intramuscularly according to its current FDA-approved age- and risk-based indication. The 2025 labeling describes approval for persons aged 65 years or older and for persons aged 5 through 64 years with at least one condition placing them at high risk for severe COVID-19 outcomes. fdafdaPackage Insert and Patient Package Insert - COMIRNATY

Postmarketing analyses have identified increased myocarditis and pericarditis risk after mRNA COVID-19 vaccines. Symptom onset is typically within the first week after vaccination, and the observed risk is highest among males aged 12 through 24 years. fdafdaPackage Insert and Patient Package Insert - COMIRNATY Population data also found increased myocarditis risk during the 1-to-28-day period after certain vaccine doses and after a positive SARS-CoV-2 test, supporting direct assessment of both recent vaccination and recent infection in the history. NatureNatureRisks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection | Nature Medicine

For chest pain, dyspnea, palpitations, presyncope, or syncope within a week of vaccination, obtain an ECG and cardiac troponin promptly and assess for alternative acute cardiopulmonary diagnoses. Escalate patients with abnormal ECG findings, elevated troponin, ventricular dysfunction, arrhythmia, hemodynamic instability, or persistent symptoms for urgent cardiology-directed evaluation.

Do not dismiss post-vaccination chest pain as a routine systemic adverse effect. The decision point is objective evidence of myocardial injury or electrical/functional cardiac abnormality, not the temporal association alone. Document vaccine product, dose number, injection date, symptom onset, SARS-CoV-2 testing history, ECG, troponin trend, echocardiography findings when obtained, and disposition.

Prior SARS-CoV-2 infection enhances subsequent vaccine-associated B-cell and T-cell responses, and vaccination after infection has been associated with sustained protection beyond 1 year in observational data. The Lancet+1The LancetB and T cell response to SARS-CoV-2 vaccination in health ...NEJMProtection against SARS-CoV-2 after Covid-19 Vaccination ... These immune-response findings support the concept of hybrid immunity but should not be used to defer the recommended second current-season dose in older adults or moderately/severely immunocompromised patients. CDCCDCAdvisory 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 | ACIP | CDC

Use nucleic acid amplification testing or other direct viral testing, rather than serology, when the clinical question is acute SARS-CoV-2 infection. RT-PCR detects viral nucleic acid and is described as the diagnostic gold standard for COVID-19; antibody assays instead characterize past exposure or immune response. sciencescienceMultiplexed, quantitative serological profiling of COVID-19 from blood by a point-of-care test

Anti-nucleocapsid antibody positivity can suggest prior infection in research settings, while spike-directed antibodies may reflect vaccination or infection. Neither result establishes an individual protective threshold, determines the need for repeat current-season vaccination, or rules out acute infection. science+2scienceSerology assays to manage COVID-19scienceSARS-CoV-2 BA.1 variant is neutralized by vaccine booster–elicited serum but evades most convalescent serum and therapeutic antibodiesscienceMultiplexed, quantitative serological profiling of COVID-19 from blood by a point-of-care test

Build an electronic health record prompt that fires when an adult reaches age 65 years or when a patient is coded as moderately or severely immunocompromised and the first 2024-2025 dose was administered approximately 6 months earlier. Include the 2-month minimum interval in order-set logic to prevent invalid early administration while permitting earlier dosing when clinically necessary. CDCCDCAdvisory 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 | ACIP | CDC

At specialty visits for immune-mediated disease, transplantation, hematologic malignancy, advanced HIV, or immunosuppressive therapy, reconcile vaccine records before changing immunosuppression or discharging the patient from follow-up. If the patient is moderately or severely immunocompromised, document whether an additional dose beyond the second current-season dose is being offered through shared clinical decision-making and record the rationale. CDC+1CDCCDC Recommends Second Dose of 2024-2025 COVID-19 Vaccine for People 65 Years and Older and for People Who are Moderately or Severely Immunocompromised | CDC NewsroomCDCAdvisory 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 | ACIP | CDC

After every vaccination encounter, capture product, lot, date, dose number, injection route, prior vaccine reaction history, and any acute event. For clinically significant suspected adverse events, document the diagnostic evaluation and report through applicable vaccine safety reporting processes as required by the product's adverse-event reporting instructions. fda+1fdaEmergency Use Authorization (EUA) of the Moderna ...fdaJanssen COVID-19 Vaccine EUA Fact Sheet for Healthcare ...