Interim Clinical Considerations for Use of COVID-19 Vaccines: Appendices, References, and Previous Updates

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Summary of recent changes (last updated October 31, 2024):
  • People ages 65 years and older, vaccinated under the routine schedule, are recommended to receive 2 doses of any 2024–2025 COVID-19 vaccine (i.e., Moderna, Novavax, or Pfizer-BioNTech) separated by 6 months (minimum interval 2 months) regardless of vaccination history, with one exception: Unvaccinated people who initiate vaccination with 2024–2025 Novavax COVID-19 Vaccine are recommended to receive 2 doses of Novavax followed by a third dose of any COVID-19 vaccine 6 months (minimum interval 2 months) later.
  • People ages 6 months and older who are moderately or severely immunocompromised are recommended to receive:
    • Unvaccinated: A multidose initial series with an age-appropriate COVID-19 vaccine and 1 dose 6 months (minimum interval 2 months) after completion of the initial series; may receive additional doses under shared clinical decision making
    • Previously completed the multidose initial series: 2 age-appropriate doses of 2024–2025 COVID-19 vaccine 6 months (minimum interval 2 months) apart; may receive additional doses under shared clinical decision making

Appendices

Appendix A. People who received COVID-19 vaccine outside the United States

Everyone ages 6 months and older vaccinated outside the United States should receive at least 1 dose of 2024–­2025 COVID-19 vaccine regardless of past COVID-19 vaccination history (e.g., vaccine type[s], vaccine manufacturer[s], number of doses) unless they received a 2024­­–2025 COVID-19 vaccine that is FDA-approved or FDA-authorized (i.e., Moderna, Novavax, or Pfizer-BioNTech), or prequalified or listed for emergency use by the World Health Organization (WHO). COVID-19 vaccines that are pre-qualified or listed for emergency use by WHO, but are not approved or authorized by FDA, have not been evaluated for efficacy or safety by CDC or ACIP.

Recommendations for people who were vaccinated outside the United States, but have not received a 2024­­–2025 COVID-19 vaccine are as follows:

  • People ages 5 years and older
    • Previously received doses of COVID-19 vaccines that are FDA-approved, FDA-authorized or pre-qualified or listed for emergency use by WHO: Administer 1 age-appropriate dose of a 2024­­–2025 COVID-19 vaccine at least 8 weeks after the last COVID-19 vaccine dose (Table 1). NOTE: People ages 65 years and older should receive 2 doses of any 2024–2025 COVID-19 vaccine (Table 1).
    • Previously received doses of COVID-19 vaccines that are not FDA-approved, FDA-authorized, or prequalified or listed for emergency use by WHO: The doses do not count towards vaccination in the United States and these people are considered unvaccinated; initiate vaccination at least 8 weeks after the last COVID-19 vaccine dose (Table 1).
  • Children ages 6 months–4 years and people who are moderately or severely immunocompromised
    • Previously received doses of COVID-19 vaccines that are FDA-approved, FDA-authorized, or prequalified or listed for emergency use by WHO: The doses count towards vaccination in the United States; administer the number of age-appropriate doses of a 2024–2025 COVID-19 vaccine based on the schedule in Table 1 or Table 2.
    • Previously received doses of COVID-19 vaccines that are not FDA-approved, FDA-authorized, or prequalified or listed for emergency use by WHO: The doses do not count towards vaccination in the United States and these people are considered unvaccinated; initiate vaccination at least 8 weeks after the last COVID-19 vaccine dose Table 1 or Table 2.

Special situation: If unable to determine if a previously received vaccine dose was a 2024­­–2025 COVID-19 vaccine, do not count the dose and follow guidance for administering a 2024­­–2025 COVID-19 vaccine dose.

Appendix B. Vaccine administration errors and deviations

The package insert or EUA fact sheet for healthcare providers and U.S. COVID-19 Vaccine Product Information should be referenced for detailed information on storage and handling, dosing and schedule, dose preparation, and administration of COVID-19 vaccines. The information provided below on managing vaccine administration errors should not be interpreted as a recommendation or promotion of unauthorized use of the vaccines.

For all vaccine administration errors:

  • Inform the recipient of the vaccine administration error.
  • Consult with the jurisdiction immunization program and/or immunization information system (IIS) to determine how the dose should be entered into the IIS.
  • Determine how the error occurred and implement strategies to prevent it from happening again. A discussion on strategies to prevent errors can be found in Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). Additional resources can be found on CDC’s vaccine administration web page, including a job aid for preventing errors.
  • Follow the revaccination guidance in the table below, using an age-appropriate COVID-19 vaccine product. Then continue with the recommended schedule for subsequent dose(s) unless otherwise noted in Table B.

Vaccinators should consult Reporting of vaccine adverse events for information on reporting to the Vaccine Adverse Event Reporting System (VAERS) after COVID-19 vaccination. To file an electronic report, see the VAERS website.

Table B. Interim recommendations for COVID-19 vaccine administration errors and deviations

Interim recommendations for COVID-19 vaccine administration errors and deviations
Type Administration error/deviation Interim recommendation
Site/route
  • Incorrect site (i.e., site other than the deltoid muscle or vastus lateralis muscle)
  • Do not repeat dose.
  • Incorrect route (e.g., subcutaneous)
  • Do not repeat dose.
  • Inform the recipient of the potential for local and systemic adverse events.
Age
  • 2024–2025 mRNA vaccine administered to an unauthorized age group (recipients younger than age 6 months)
  • If the first dose is administered 5 or more days before age 6 months, repeat the dose on or after the date the recipient reaches 6 months; space the repeat dose at least 4 weeks after the invalid dose.*
  • 2024–2025 Novavax vaccine administered to an unauthorized age group (recipients ages 6 months–11 years)
  • If part of a multidose initial vaccination series (i.e., children ages 6 months–4 years or ages 6 months–11 years who are moderately or severely immunocompromised), count the dose; complete the initial series with a 2024–2025 mRNA vaccine; and space the next dose by at least the minimum interval (Table 1 and Table 2).†
    • For children ages 6 months–11 years who are moderately or severely immunocompromised, after completion of the initial series, administer 1 dose of any 2024–2025 mRNA vaccine 6 months (minimum interval 2 months) later; additional doses may be administered (Table 2).
  • For routine vaccination of children ages 5–11 years:
    • If previously received 1 or more doses of any mRNA vaccine, no further doses are needed.
    • If did not previously receive any doses of any mRNA vaccine, administer 1 dose of a 2024–2025 mRNA vaccine at least 4 weeks after the dose given in error.†
Product and dosage
  • Higher-than-authorized dose administered (e.g., incorrect dose volume, incorrect product resulting in higher-than-authorized dose)
  • Do not repeat dose.‡
  • Lower-than-authorized dose administered (e.g., leaked out of the syringe, equipment failure, recipient pulled away, incorrect product resulting in lower-than-authorized dose)
  • Repeat dose immediately (no minimum interval).†
  • However, if a half-volume dose of vaccine is administered to a recipient recommended for the full volume, another half-volume dose can be administered on the same clinic day, and the 2 doses can count as 1 full dose.
Storage and handling
  • Dose administered after improper storage and handling (i.e., temperature excursion)
  • Contact the manufacturer for information on the stability of the vaccine.§ If the manufacturer does not have data to support the stability of the vaccine, repeat the dose immediately (no minimum interval).†
  • Dose administered past the expiration/beyond-use date
  • Repeat the dose immediately (no minimum interval).†
Intervals
  • Any COVID-19 dose administered prior to the minimum interval
  • Repeat dose. Space the repeat dose after the dose given in error by at least the minimum interval (Table 1 and Table 2).†
Interchangeability#
  • mRNA vaccines from different manufacturers administered as part of an initial vaccination series
  • See Interchangeability of COVID-19 vaccines for detailed guidance on completion of vaccination when doses from different manufacturers are used.
  • If a previously completed 3-dose mRNA series did NOT include at least 1 dose of a 2024–2025 mRNA vaccine:
    • For routine vaccination of children ages 6 months–4 years, administer 1 dose of a 2024–2025 mRNA vaccine at least 8 weeks after the last dose (Table 1).
    • For people ages 6 months and older who are moderately or severely immunocompromised, administer 1 dose of an age-appropriate 2024–2025 COVID-19 vaccine at least 8 weeks after the last dose followed by a second dose of 2024–2025 vaccine 6 months (minimum interval 2 months) later; additional doses may be administered (Table 2).
  • One dose of 2024–2025 mRNA vaccine and 1 dose of 2024–2025 Novavax vaccine (in any order) administered to previously unvaccinated recipient age 12 years and older
  • For routine vaccination of people ages 12−64 years, no further doses needed.
  • For routine vaccination of people ages 65 years and older, administer 1 dose of any 2024–2025 vaccine 6 months (minimum interval 2 months) after the last dose.
  • For people who are moderately or severely immunocompromised, administer 1 dose of any 2024–2025 vaccine at least 4 weeks after the last dose to complete initial vaccination, followed by 1 dose of any 2024–2025 vaccine 6 months (minimum interval 2 months) later; additional doses may be administered (Table 2).
Diluent (2024–2025 Pfizer-BioNTech COVID-19 Vaccine formulation that should be mixed with diluent)
  • ONLY diluent administered (i.e., sterile 0.9% sodium chloride)
  • Administer the authorized dose immediately (no minimum interval).
  • No diluent, resulting in higher than authorized dose
  • Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.‡
  • Incorrect diluent type (e.g., sterile water, bacteriostatic 0.9% sodium chloride)
  • Repeat the dose immediately (no minimum interval).†
  • Vaccine is mixed with too little diluent
  • Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.‡
  • Vaccine is mixed with too much diluent
  • Repeat dose immediately (no minimum interval).†
  • Single-use vial of diluent is used to mix multiple vials of vaccine
Diluent (2024–2025 Pfizer-BioNTech COVID-19 Vaccine formulations that should not be mixed with diluent)
  • Vaccine is mixed with any diluent (i.e., any type or volume of diluent)
  • Repeat the dose immediately (no minimum interval).†

*In addition to the minimum age, for children who are not moderately or severely immunocompromised, an 8-week interval between the invalid dose and the repeat dose might be optimal for some people as it might reduce the rare risk of myocarditis and pericarditis associated with mRNA (Moderna or Pfizer-BioNTech) COVID-19 vaccines and the potential for increased reactogenicity.

†For people ages 6 months–64 years who are not moderately or severely immunocompromised, an 8-week interval between the dose given in error and the repeat dose might be optimal for some people as it might reduce the rare risk of myocarditis and pericarditis associated with Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines, particularly in males ages 12–39 years, and the potential for increased reactogenicity.

‡If the administration error resulted in a higher-than-authorized vaccine dose, in general a subsequent dose may still be administered at the recommended interval. However, if local or systemic side effects following vaccination are clinically concerning (outside of the expected side effect profile) or are ongoing at the time of the subsequent dose, this dose might be delayed, but this decision should be assessed on a case-by-case basis.

§As of the date of this update, current manufacturer contact information is:

  • Pfizer-BioNTech: 1-877-VAX-CO19 (1-877-829-2619)
  • Moderna: 1-866-MODERNA (1-866-663-3762)
  • Novavax: 1-844-NOVAVAX (1-844-668-2829)

See the package inserts and EUA fact sheets for the most up-to-date manufacturer information.

Vaccine doses administered up to 4 days before the minimum interval (i.e., grace period) may be counted and do not need to be repeated.

#See Interchangeability of COVID-19 vaccines for circumstances in which a COVID-19 vaccine from a different manufacturer may be administered; a VAERS report is not required in these circumstances.

References and Previous Updates

September 6, 2024

  • Recommendations for the use of 2024–2025 Novavax COVID-19 Vaccine in people ages 12 years and older
  • Updated guidance in the Interchangeability of COVID-19 vaccines section and in Appendix B on completion of an initial vaccination series if vaccine doses from different manufacturers are administered in certain circumstances

August 23, 2024

Recommendations for 2024–2025 Moderna COVID-19 Vaccine and 2024–2025 Pfizer-BioNTech COVID-19 VaccinePeople who are not moderately or severely immunocompromised

Initial vaccination

  • Ages 6 months–4 years
    • 2 doses of 2024–­2025 Moderna or 3 doses of 2024–­2025 Pfizer-BioNTech
  • Ages 5 years and older
    • 1 dose of 2024–2025 Moderna or 1 dose of 2024–2025 Pfizer-BioNTech

Received previous doses of a COVID-19 vaccine

  • Ages 6 months–4 years
    • 1 or 2 doses of 2024–­2025 mRNA vaccine from the same manufacturer as administered for initial vaccination, depending on the vaccine and the number of prior doses
  • Ages 5 years and older
    • 1 dose of 2024–­2025 Moderna or 1 dose of 2024–­2025 Pfizer-BioNTech

Additional dose: An additional dose of 2024–­2025 COVID-19 vaccine for people ages 65 years and older who are not moderately or severely immunocompromised is NOT currently recommended.

People who are moderately or severely immunocompromised

Initial vaccination

  • Ages 6 months and older
    • 3 doses of 2024–­2025 Moderna or 3 doses of 2024–­2025 Pfizer-BioNTech

Received previous doses of a COVID-19 vaccine

  • Recommended mRNA vaccine and number of 2024–­2025 doses are based on age and vaccination history

Additional doses: People who are moderately or severely immunocompromised ages 6 months and older may receive 1 or more age-appropriate doses of a 2024–2025 mRNA COVID-19 vaccine.

April 4, 2024

  • New guidance on COVID-19 vaccination and pemivibart (Pemgarda™), a monoclonal antibody authorized for COVID-19 pre-exposure prophylaxis in people who are moderately or severely immunocompromised and meet the FDA-authorized conditions for use

March 1, 2024

  • All people ages 65 years and older should receive 1 additional dose of any updated (2023–2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech). For detailed guidance, see Table 1 and Table 2.
  • Updated information for reporting adverse events to VAERS following administration of a COVID-19 vaccine.

February 12, 2024

  • Post-vaccination reaction information updated in sections on pre-vaccination counseling and safety considerations for mRNA and Novavax vaccines to better align with EUA fact sheets for healthcare providers and package inserts.
  • Information on the availability of the V-safe safety monitoring system for updated (2023–2024 Formula) Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines added to the section on reporting of vaccine adverse events.

January 18, 2024

  • Updated guidance on COVID-19 vaccine administration errors and deviations (Appendix B)

November 3, 2023

  • Guidance added to COVID-19 vaccination schedules for correct dosage and administration of updated (2023–2024 Formula) Moderna COVID-19 Vaccine in children ages 6 months–11 years.

October 24, 2023

  • Age transitions: Updated guidance for children who transition during the initial COVID-19 vaccination series from age 4 years to age 5 years and children who are moderately or severely immunocompromised and transition from age 11 years to age 12 years to receive the age-appropriate dosage based on their age on the day of vaccination.
  • Interchangeability of COVID-19 vaccines: Clarification of circumstances in which administration of COVID-19 vaccine doses from different manufacturers may be considered when doses from the same manufacturer are recommended.

October 6, 2023

  • The updated 2023–­2024 formulation of Novavax COVID-19 Vaccine is recommended for people ages 12 years and older as follows:
    • Initial vaccination: 2 doses of updated (2023–2024 Formula) Novavax COVID-19 Vaccine
    • Previously vaccinated with any Original monovalent or bivalent COVID-19 vaccine (Moderna, Novavax, Pfizer-BioNTech, Janssen): 1 dose of updated (2023–2024 Formula) Novavax Vaccine
  • People who are moderately or severely immunocompromised may receive 1 or more additional updated (2023–­­2024 Formula) Novavax vaccine doses.
  • People ages 12 years and older have the option of receiving either the updated (2023–2024 Formula) mRNA (Moderna, Pfizer-BioNTech) or updated (2023–2024 Formula) Novavax vaccine.

September 15, 2023

  • Recommendations for use of the 2023–­2024 formulations of Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine:
    • Everyone ages 5 years and older is recommended to receive 1 dose of updated (2023–­2024 Formula) mRNA COVID-19 vaccine
    • Children ages 6 months–4 years
      • Initial vaccination: should receive either 2 doses of updated (2023­–2024 Formula) Moderna or 3 doses of updated (2023–­2024 Formula) Pfizer-BioNTech COVID-19 vaccine
      • Received previous mRNA doses: need 1 or 2 doses of updated (2023–­2024 Formula) Moderna or updated (2023­–­2024 Formula) Pfizer-BioNTech COVID-19 vaccine, depending on the number of prior doses
    • People who are moderately or severely immunocompromised
      • Initial vaccination: should receive a 3-dose series of updated (2023–­2024 Formula) Moderna or updated (2023–­2024 Formula) Pfizer-BioNTech COVID-19 vaccine
      • Received previous mRNA doses: need 1 or 2 doses of updated (2023­–2024 Formula) Moderna or updated (2023–­2024 Formula) Pfizer-BioNTech COVID-19 vaccine, depending on the number of prior doses
      • May receive 1 or more additional updated (2023–­­2024 Formula) mRNA COVID-19 vaccine doses
    • Bivalent mRNA COVID-19 vaccines are no longer recommended in the United States
  • Updated guidance for COVID-19 vaccination and myocarditis or pericarditis
  • Updated guidance for COVID-19 vaccination and Multisystem Inflammatory Syndrome (MIS) in children (MIS-C) and in adults (MIS-A)
  • Reorganization and consolidation of sections on contraindications and precautions, including allergic reactions to COVID-19 vaccines

May 12, 2023

  • Guidance for use of Janssen COVID-19 Vaccine has been removed as the vaccine is no longer available in the United States

May 1, 2023

  • Revision of the mRNA COVID-19 vaccination schedule for people who are moderately or severely immunocompromised as follows:
    • At the time of initial vaccination, people ages 6 months and older are recommended to receive 3 bivalent mRNA doses
    • People ages 6 months and older who previously received only monovalent doses are recommended to receive 1 or 2 bivalent mRNA vaccine doses, depending on age and vaccine product
    • People who previously received a bivalent mRNA vaccine dose(s) have the option to receive 1 or more additional bivalent mRNA doses

April 22, 2023

  • Revision of the mRNA COVID-19 vaccination schedule as follows:
    • At the time of initial vaccination, depending on vaccine product, children ages 6 months–4 years are recommended to receive 2 or 3 bivalent mRNA vaccine doses; children age 5 years are recommended to receive 1 or 2 bivalent mRNA vaccine doses
    • People ages 6 years and older who are unvaccinated or previously received only monovalent vaccine doses are recommended to receive 1 bivalent mRNA vaccine dose
    • People ages 65 years and older may receive 1 additional bivalent mRNA vaccine dose

March 16, 2023

  • New recommendation for children ages 6 months–4 years who previously completed a 3-dose monovalent Pfizer-BioNTech primary series to receive 1 bivalent Pfizer-BioNTech booster dose at least 2 months after completion of the monovalent primary series.
  • Vaccination providers are now required to report cases of myocarditis and pericarditis after receipt of a Janssen COVID-19 Vaccine to the Vaccine Adverse Event Reporting System (VAERS).

January 27, 2023

  • As of January 26, 2023, EVUSHELDTM is not currently authorized for SARS-CoV-2 pre-exposure prophylaxis in the United States.

December 9, 2022

  • New recommendation for children ages 6 months–4 years who complete a Moderna primary series to receive 1 bivalent Moderna booster dose at least 2 months after completion of the primary series.
  • Children age 5 years who complete a Moderna primary series may receive either the previously authorized bivalent Pfizer-BioNTech booster dose or the newly authorized bivalent Moderna booster dose at least 2 months after completion of the Moderna primary series.
  • The previously authorized 3-dose Pfizer-BioNTech primary series for children ages 6 months–4 years has been revised as follows: a monovalent Pfizer-BioNTech vaccine is administered for the first and second doses, followed by 1 bivalent Pfizer-BioNTech vaccine as the third primary series dose, at least 8 weeks after the second monovalent primary series dose. A booster dose is not authorized for children in this age group who receive a Pfizer-BioNTech 3-dose primary series, including children who previously received a 3-dose monovalent Pfizer-BioNTech primary series.

October 19, 2022

  • Guidance for use of a monovalent Novavax COVID-19 booster dose in people ages 18 years and older in limited situations

October 12, 2022 

  • New COVID-19 booster recommendations for people ages 5 years and older to receive 1 bivalent mRNA booster after completion of a monovalent primary series or previously received monovalent booster dose(s); these recommendations replace all prior booster recommendations for this age group
    • Recommendations for use of a bivalent Moderna booster dose in people ages 6–17 years
    • Recommendations for use of a bivalent Pfizer-BioNTech booster dose in people ages 5–11 years

September 23, 2022

  • Reorganization and consolidation of the Interim Clinical Considerations to enhance usability. COVID-19 vaccination schedules and guidance are unchanged.

September 2, 2022

  • New booster recommendation for people ages 12 years and older to receive 1 bivalent mRNA booster after completion of a monovalent primary series; it replaces all prior booster recommendations for this age group
    • Recommendations for use of a bivalent Moderna booster dose in people ages 18 years and older
    • Recommendations for use of a bivalent Pfizer-BioNTech booster dose in people ages 12 years and older
  • Updated guidance for observation periods following COVID-19 vaccination
  • Updated guidance on COVID-19 vaccination and multisystem inflammatory syndrome (MIS) in children (MIS-C) and in adults (MIS-A)

August 22, 2022

  • Guidance for primary series vaccination using Novavax COVID-19 Vaccine in adolescents ages 12–17 years
  • Reorganization of Janssen COVID-19 Vaccine guidance into an appendix

August 11, 2022

  • Updated guidance on COVID-19 vaccination following exposure to SARS-CoV-2

July 20, 2022

  • Guidance for primary series vaccination using Novavax COVID-19 Vaccine in adults ages 18 years and older
  • Updated guidance on COVID-19 vaccination and myocarditis and pericarditis

June 30, 2022

  • New clinical considerations for coadministration of mRNA COVID-19 vaccines and orthopoxvirus vaccines

June 24, 2022

  • New guidance for use of Moderna COVID-19 Vaccine in children and adolescents ages 6–17 years

June 19, 2022

  • New guidance for use of Pfizer-BioNTech COVID-19 Vaccine in children ages 6 months–4 years
  • New guidance for use of Moderna COVID-19 Vaccine in children ages 6 months–5 years
  • Reorganization of sections on COVID-19 vaccination recommendations and schedules
  • Addition of new section in Special populations for infants and young children

May 20, 2022

  • New guidance for use of a Pfizer-BioNTech COVID-19 Vaccine booster dose in children ages 5–11 years
  • Updated guidance that the following people should receive a second COVID-19 booster dose:
    • People ages 12 years and older who are moderately or severely immunocompromised
    • People ages 50 years and older
  • Updated guidance for people who are moderately or severely immunocompromised and are treated with B-cell-depleting therapies
  • Clarification of COVID-19 vaccination guidance for multisystem inflammatory syndrome in children (MIS-C) and adults (MIS-A)
  • Updated guidance for primary series vaccination after SARS-CoV-2 infection

April 21, 2022

  • Added considerations for the option to receive a second COVID-19 vaccine booster dose
  • Updated guidance for COVID-19 vaccination after SARS-CoV-2 infection

March 30, 2022

  • Added guidance that people ages 12 years and older who are moderately or severely immunocompromised may choose to receive a second booster dose using an mRNA COVID-19 vaccine at least 4 months after the first booster dose
  • Added guidance that adults ages 50 years and older who are not moderately or severely immunocompromised may choose to receive a second booster dose using an mRNA COVID-19 vaccine at least 4 months after the first booster dose
  • Added guidance that people ages 18–49 years who are not moderately or severely immunocompromised and who received Janssen COVID-19 Vaccine as both their primary series dose and booster dose may receive a second booster dose using an mRNA COVID-19 vaccine at least 4 months after the first Janssen booster dose
  • Further clarification of safety issues including those related to multisystem inflammatory syndrome in children (MIS-C) and adults (MIS-A) and myocarditis
  • Updated information on the availability of Moderna COVID-19 Vaccine supplied in a vial with a red cap (0.25 mL dosage volume) and Moderna COVID-19 Vaccine supplied in a vial with a blue cap (0.5 mL dosage volume) for administration of a 50 µg booster dose.

February 22, 2022

  • Added considerations for an 8-week interval between the first and second doses of a primary mRNA vaccine schedule

February 11, 2022

  • Updated guidance for moderately or severely immunocompromised people
    • Clarification of existing recommendation to receive a 3-dose mRNA vaccine primary series followed by a booster dose for a total of 4 doses
    • New guidance to shorten the interval between completion of the mRNA vaccine primary series and the booster dose to at least 3 months (instead of 5 months)
    • New guidance for those who received the Janssen COVID-19 Vaccine primary series to receive an additional dose and a booster dose, for a total of 3 doses to be up to date
  • Updated guidance that it is no longer necessary to delay COVID-19 vaccination following receipt of monoclonal antibodies or convalescent plasma
  • Updated guidance on receiving a booster dose if vaccinated outside the United States
  • Updated contraindication and precaution section to include history of myocarditis or pericarditis after an mRNA COVID-19 vaccine as a precaution
  • Reorganized and condensed multiple sections

January 6, 2022

  • Updated guidance for use of Pfizer-BioNTech COVID-19 Vaccine as a booster in people ages 12–17 years
  • Updated guidance for administration of a COVID-19 vaccine booster dose at least 5 months after completion of an mRNA vaccine (Pfizer-BioNTech or Moderna) primary series
  • Updated guidance for use of an additional primary dose for moderately or severely immunocompromised people ages 5–11 years who received a Pfizer-BioNTech vaccine primary series
  • Updated recommendations for people who received COVID-19 vaccines outside the United States that are not FDA-authorized or approved

December 23, 2021

  • Updated information about a second formulation of Pfizer-BioNTech COVID-19 Vaccine that is authorized for use in persons ages 12 years and older
  • Updated information on vaccinating people during quarantine after a known SARS-CoV-2 exposure or during COVID-19 outbreaks
  • Update to alert providers of possible false positive Rapid Plasma Reagin (RPR; non-treponemal) test results in some people after COVID-19 vaccines
  • Updated information on vaccine administration errors and deviations

December 17, 2021

  • Updated guidance on use of Janssen (Johnson & Johnson) COVID-19 Vaccine

December 10, 2021

  • Updated guidance for use of Pfizer-BioNTech COVID-19 vaccine as a booster dose in persons aged 16 years and older

November 29, 2021

  • Updated recommendations for receipt of a COVID-19 vaccine booster dose

November 19, 2021

  • Updated guidance for COVID-19 booster doses in recipients of mRNA COVID-19 vaccines

November 17, 2021

  • Updated guidance in section on People who received COVID-19 vaccine outside the United States
  • Updated guidance in section on People who received COVID-19 as part of a clinical trial

November 3, 2021

  • Recommendations and clinical guidance for use of Pfizer-BioNTech COVID-19 Vaccine in children aged 5-11 years including updated section on Vaccination of children and adolescents
  • Updated guidance on COVID-19 vaccine dosing and schedule
  • Updated guidance for myocarditis and pericarditis after mRNA COVID-19 vaccination in new section on Considerations for mRNA COVID-19 vaccines: Pfizer-BioNTech and Moderna
  • New guidance for people who received passive antibody products in section on COVID-19 vaccination and SARS-CoV-2 infection
  • Updated guidance in section on People who received COVID-19 vaccine outside the United States
  • Updated guidance in section on People who received COVID-19 as part of a clinical trial in the United States
  • Updated guidance on Considerations for COVID-19 vaccination in moderately and severely immunocompromised people
  • Updated guidance in section on Contraindications and precautions
  • Updated Table in Appendix A: Vaccine administration errors and deviations
  • Updated Appendix B: Triage of people with a history of allergies or allergic reactions
  • Updated Appendix C: Ingredients included in COVID-19 vaccines
  • Updated Appendix D: Potential characteristics of allergic reactions, vasovagal reactions, and vaccine side effects following COVID-19 vaccination

October 25, 2021

  • Updated guidance in section on Considerations for use of a COVID-19 booster dose.
  • New section added on Overview of COVID-19 vaccines recommendations.
  • Updated guidance in section on COVID-19 vaccine dosage and schedule.
  • Updated guidance in section on People vaccinated for prevention of COVID-19 outside the United States.
  • Updated guidance in section on COVID-19 vaccination and SARS-CoV-2 infection for People with prior or current SARS-CoV-2 infection; People with a history of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A); People who received passive antibody products; and Vaccinated people who subsequently develop COVID-19.
  • New guidance on Considerations for COVID-19 revaccination in the section on Considerations for COVID-19 vaccination in moderately and severely immunocompromised people.
  • Updated Table in Appendix A: Vaccine administration errors and deviations.

September 27, 2021

  • New section on Considerations for use of a Pfizer-BioNTech COVID-19 Vaccine booster dose after completion of a Pfizer-BioNTech primary vaccine series.

September 15, 2021

  • Updated information in the section on COVID-19 vaccination and SARS-CoV-2 infection.
  • Updated information in the section on Vaccinating people with a known COVID-19 exposure or during COVID-19 outbreaks.
  • New section on Vaccinating people receiving medical care unrelated to COVID-19.
  • New section on Vaccinating people undergoing SARS-CoV-2 screening.

August 31, 2021

  • New Advisory Committee on Immunization Practices (ACIP) recommendation for use of the U.S. Food and Drug Administration (FDA)-approved Pfizer-BioNTech (COMIRNATY) COVID-19 Vaccine in persons aged ≥16 years.
  • Updated information in Key points to reflect currently available evidence.
  • Updated information on COVID-19 vaccines in the Background section.
  • Updated information in the section on Considerations for use of an additional dose of COVID-19 vaccine following a primary vaccine series.
  • Updated laboratory testing information on timing of immune-based tests for tuberculosis infection in relation to COVID-19 vaccine administration.

August 25, 2021

  • New section on people vaccinated for COVID-19 as part of a clinical trial in the United States.
  • Updated considerations for use of an additional mRNA COVID-19 vaccine dose after an initial 2-dose COVID-19 mRNA vaccine series for immunocompromised people.

August 13, 2021

  • New section on considerations for use of an additional dose of COVID-19 vaccine.
  • New section on considerations for use of an additional mRNA COVID-19 vaccine dose after an initial 2-dose mRNA COVID-19 primary vaccine series for immunocompromised people.

August 11, 2021

  • Updated considerations for people who are pregnant, lactating, trying to get pregnant now, or might become pregnant in the future.

August 6, 2021

  • Updated considerations for COVID-19 vaccination in people with a history of Guillain-Barré syndrome.
  • Updated information on vaccine administration errors and deviations in Appendix A (Table).

July 16, 2021

  • Updated considerations regarding mRNA vaccine dosing intervals.
  • Updated considerations for immunocompromised people.

July 2, 2021

  • New section on considerations for use of mRNA COVID-19 vaccines in people with a history of myocarditis or pericarditis added to considerations for vaccination of people with certain underlying medical conditions.
  • New information on the occurrence of myocarditis or pericarditis following vaccination with mRNA COVID-19 vaccines added to patient counseling.

June 1, 2021

  • Information on cases of myocarditis and pericarditis occurring after mRNA COVID-19 vaccination, particularly in adolescents and young adults.
  • Information on the efficacy of the Pfizer-BioNTech COVID-19 Vaccine in adolescents aged 12–15 years in patient counseling section.
  • Updated data on local and systemic symptoms following vaccination with mRNA COVID-19 vaccines in patient counseling section.
  • Clarification in contraindications and precautions and Appendix B of guidance for people with a history of an immediate allergic reaction to a vaccine or injectable therapy that contains a component also contained in a COVID-19 vaccine.
  • Updated list of ingredients in COVID-19 vaccines (i.e., lack of metals) in Appendix C.
  • Correction of footnote numbering.

May 14, 2021

  • Updated information for authorized age groups to include vaccination of adolescents aged 12–15 years with Pfizer-BioNTech COVID-19 Vaccine.
  • Updated information on coadministration of COVID-19 vaccines with other vaccines.
  • A new section on persons with a history of multisystem inflammatory syndrome added to considerations for vaccination of people with certain underlying medical conditions.
  • Updated recommendation for timing of COVID-19 vaccine administration in persons with a history of heparin-induced thrombocytopenia.
  • Updated information on vaccination of children and adolescents.

April 27, 2021

  • The Advisory Committee on Immunization Practices’ updated interim recommendation for the use of the Janssen (Johnson & Johnson) COVID-19 Vaccine.
  • Clarification that COVID-19 vaccination is recommended for all people 16 years and older added to key points and vaccine administration.
  • Updated information about the Janssen COVID-19 Vaccine added to background.
  • Requirements to be considered fully vaccinated added to vaccine administration and interchangeability of COVID-19 vaccine products.
  • New section added for people vaccinated with COVID-19 vaccines not authorized in the United States.
  • Clarification on COVID-19 vaccination and SARS-CoV-2 infection. People with prolonged post-COVID-19 symptoms should be offered COVID-19 vaccination.
  • New section added on antiviral therapy and COVID-19 vaccination.
  • Information on requesting a consultation from the Clinical Immunization Safety Assessment COVIDvax project added to considerations for vaccination of people with certain underlying medical conditions.
  • New section added on considerations for use of the Janssen COVID-19 Vaccine in certain populations.
  • Updated information and recommendations for vaccination of pregnant or lactating people.
  • Updated recommendations for vaccination of children and adolescents.
  • Updated information related to axillary lymphadenopathy added to patient counseling for mRNA COVID-19 vaccines.
  • Updated information on the Janssen COVID-19 Vaccine added to patient counseling.
  • Updated recommendations related to contraindications (polysorbate allergy) and precautions (most people with a precaution can and should be administered vaccine) for COVID-19 vaccines.

April 16, 2021

  • Recommended pause in the use of Janssen (Johnson & Johnson) COVID-19 Vaccine.
  • Recommendations for clinicians related to occurrence of cerebral venous sinus thrombosis (CVST) with thrombocytopenia after receipt of Janssen COVID-19 Vaccine.

March 5, 2021

March 3, 2021

  • Clinical considerations added for use of Janssen (Johnson & Johnson) COVID-19 Vaccine.
  • Updated recommendations for fully vaccinated people who subsequently develop COVID-19.
  • Updated recommendations related to COVID-19 vaccination timing for immunocompromised people.
  • Updated contraindications and precautions to mRNA COVID-19 vaccines.
  • Updated information on interpretation of SARS-CoV-2 antibody test results after vaccination.

February 10, 2021

  • New recommendations for preventing, reporting, and managing mRNA COVID-19 vaccine administration errors (Appendix A).
  • Clarification on contraindications and precautions. People with a known (diagnosed) allergy to PEG, another mRNA vaccine component, or polysorbate, have a contraindication to vaccination. People with a reaction to a vaccine or injectable therapy that contains multiple components, one of which is PEG, another mRNA vaccine component or polysorbate, but in whom it is unknown which component elicited the immediate allergic reaction have a precaution to vaccination.
  • Updated information on delayed, local injection-site reactions after the first mRNA vaccine dose. These reactions are neither a contraindication nor a precaution to the second dose.
  • Updated quarantine recommendations for vaccinated people. Fully vaccinated people who meet criteria will no longer be required to quarantine following an exposure to someone with COVID-19. Additional considerations for patients and residents in healthcare settings are provided.
  • Additional information and updated recommendations for testing for TB infection. TB testing can be done before or at the same time as mRNA COVID-19 vaccination, or otherwise delayed for ≥4 weeks after the completion of mRNA COVID-19 vaccination.
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