What is the recommended Covid-19 (Coronavirus disease 2019) vaccine protocol?

COVID-19 Vaccination Protocol Recommendations

Everyone aged 6 months and older should receive a 2024-2025 COVID-19 vaccine dose, regardless of previous vaccination history, with timing based on last COVID-19 vaccine dose or infection. 1

General Population Vaccination Schedule

The current COVID-19 vaccination protocol follows these guidelines:

• Previously vaccinated individuals (≥12 years):

  • Receive 1 dose of 2024-2025 COVID-19 vaccine (Moderna, Pfizer-BioNTech, or Novavax)
  • Wait at least 8 weeks after last COVID-19 vaccine dose 1

• Previously unvaccinated individuals (≥12 years):

  • Moderna or Pfizer-BioNTech: 1 dose
  • Novavax: 2 doses, 3-8 weeks apart 1

• Children (6 months-11 years):

  • Unvaccinated: 2 doses of Moderna vaccine (4-8 weeks apart) or 3 doses of Pfizer-BioNTech (3-8 weeks between doses 1-2, ≥8 weeks between doses 2-3)
  • Previously vaccinated: 1 dose of 2024-2025 COVID-19 vaccine at least 8 weeks after last dose 1

Special Populations

Immunocompromised Individuals

• Immunocompromised individuals who have completed an initial series and received at least 1 dose of a 2024-2025 COVID-19 vaccine may receive 1 additional age-appropriate dose at least 2 months after the last recommended dose 1

Cancer Patients

• Vaccination recommended for all persons with cancer or previously treated for cancer
• Vaccination should occur at least 2 weeks before starting immunosuppressive therapies when possible 1
• Hematopoietic cell transplant recipients should receive vaccination 6 months post-transplant (consider earlier vaccination at 3 months during community outbreaks) 1

Rheumatologic and Autoimmune Diseases

Medication timing considerations:

• No modifications needed for:

  • Hydroxychloroquine, apremilast, IVIG, glucocorticoids (<20 mg/day prednisone equivalent)
  • Sulfasalazine, leflunomide, mycophenolate mofetil, azathioprine, oral cyclophosphamide, TNF inhibitors, IL-6R, IL-1Ra, IL-17, IL-12/IL-23, IL-23, belimumab, oral calcineurin inhibitors 2

• Methotrexate: Withhold for 1 week after each vaccine dose (if disease well-controlled) 2

• JAK inhibitors: Withhold for 1 week after each vaccine dose 2

• Abatacept (SC): Withhold 1 week before and 1 week after first vaccine dose only; no interruption for second dose 2

• Abatacept (IV): Time administration so first vaccination occurs 4 weeks after infusion; postpone subsequent infusion by 1 week 2

• Rituximab:

  • Schedule vaccination ~4 weeks prior to next scheduled rituximab cycle 2
  • Delay rituximab 2-4 weeks after second vaccine dose if disease activity allows 2
  • For patients on 6-month cycles, initiate vaccination ~5 months after prior rituximab cycle 2

• Cyclophosphamide (IV): Time administration to occur ~1 week after each vaccine dose when feasible 2

Transplant Patients

• Vaccination recommended early in the course of underlying disease
• After transplantation, postpone vaccination for 3-6 months
• If first dose received before transplantation, administer second dose at least 4 weeks after transplantation
• A third dose may be warranted for optimal immunity 2

Liver Disease/Transplant

• Recommended for patients with chronic liver disease, with priority for higher MELD scores
• Patients on transplant list should receive two doses before transplant
• For liver transplant recipients who received first dose before transplant, next dose can be given 6 weeks to 3 months after transplant
• Withhold vaccination in liver transplant recipients with active acute cellular rejection or those on high-dose corticosteroids until condition resolves 2

Vaccine Effectiveness and Safety

• The 2024-2025 COVID-19 vaccines have demonstrated:

  • 33% effectiveness against COVID-19-associated ED/UC visits among adults ≥18 years
  • 45-46% effectiveness against COVID-19-associated hospitalization among immunocompetent adults ≥65 years
  • 40% effectiveness against COVID-19-associated hospitalization among immunocompromised adults ≥65 years 1

• Common reactions include injection site pain, fatigue, headache, and muscle pain

• Serious adverse events are rare 1

Important Considerations

1. Timing is flexible: If timing in relation to immunomodulatory drugs is not under control, vaccination should be given rather than delayed 2

2. Prior COVID-19 infection: Research suggests one vaccine dose may be sufficient to increase both cellular and humoral immune response in COVID-19-recovered subjects 3, but current guidelines still recommend following the standard protocol for all individuals 1

3. Older adults: COVID-19 vaccines appear to be well-tolerated in older adults with similar immunogenicity across all age groups after a boost dose 4

4. Adverse event reporting: Report adverse events to the Vaccine Adverse Event Reporting System (VAERS), especially for vaccines under Emergency Use Authorization 1

The COVID-19 vaccination protocol continues to evolve as new evidence emerges, but following these current guidelines will help maximize protection against severe disease, hospitalization, and death from COVID-19.