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Interim Clinical Considerations for Use of COVID-19 Vaccines: Appendices, References, and Previous Updates						Print
																Related Pages
										Healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals ages 6 months through 11 years should ensure the correct volume of the vaccine (0.25 mL) is withdrawn from the vial and administered to the recipient. Discard vial and excess volume after extracting a single dose.
For additional information, see FDA Announcement and Moderna COVID-19 Vaccine (2023-2024 Formula) Healthcare Provider Fact Sheet (fda.gov)
Summary of recent changes (last updated 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 health care 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.AppendicesAppendix A. People who received COVID-19 vaccine outside the United StatesEveryone ages 6 months and older vaccinated outside the United States should receive at least 1 dose of an updated (2023–­2024 Formula) COVID-19 vaccine regardless of past COVID-19 vaccination history (e.g., vaccine type[s], vaccine manufacturer[s], number of doses) unless they received an updated (2023­­–2024 Formula) COVID-19 vaccine that is FDA-approved or FDA-authorized (i.e., Moderna, Novavax, Pfizer-BioNTech) or listed for emergency use by the World Health Organization (WHO). COVID-19 vaccines that are 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 an updated (2023–­­2024 Formula) 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 listed for emergency use by WHO: Administer 1 age-appropriate dose of an updated (2023–­­2024 Formula) COVID-19 vaccine at least 8 weeks after the last COVID-19 vaccine dose (Table 1).
Previously received doses of COVID-19 vaccines that are **not** FDA-approved, FDA-authorized, 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 listed for emergency use by WHO: The doses count towards vaccination in the United States; administer the number of age-appropriate doses of an updated (2023–2024 Formula) mRNA 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 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 an updated (2023­–­2024 Formula) COVID-19 vaccine, do not count and follow guidance for administering an updated (2023­–­2024 Formula) COVID-19 vaccine dose.
Table of ContentsAppendix B. Vaccine administration errors and deviationsA vaccine administration error is any preventable event that might cause or lead to inappropriate use of vaccine or to patient harm.The package insert or EUA Fact Sheet for Healthcare Providers Administering Vaccines 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 state 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 the “Vaccine Administration” chapter of 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.COVID-19 vaccine administration errors—even those not associated with an adverse event—should be reported to the Vaccine Adverse Event Reporting System (VAERS). 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 recommendationSite/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
Updated (2023–2024 Formula) 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.*Updated (2023–2024 Formula) 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 people ages 6 months and older who are moderately or severely immunocompromised) count the dose; continue the series with an updated (2023–2024 Formula) mRNA vaccine; and space the next dose by at least the minimum interval (Table 1 and Table 2).§ If the last dose in the series, no further doses are needed.
For children ages 5–11 years who are NOT moderately or severely immunocompromised:
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 an updated (2023–2024 Formula) 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
Updated (2023–2024 Formula) mRNA vaccines from different manufacturers administered as part of a 2- or 3-dose initial vaccination series to previously unvaccinated recipients
Children ages 6 months–4 years who are NOT moderately or severely immunocompromised:
Administer 1 dose of either updated (2023–2024 Formula) Moderna or updated (2023–2024 Formula) Pfizer-BioNTech vaccine at least 8 weeks after the second dose.
If moderately or severely immunocompromised, administer 1 dose of either updated (2023–2024 Formula) Moderna or updated (2023–2024 Formula) Pfizer-BioNTech vaccine as follows:
Ages 6 months–4 years: At least 8 weeks after the second dose
Ages 5 years and older: At least 4 weeks after the second dose.Two or more doses of Original monovalent and/or bivalent mRNA vaccine from different manufacturers previously administered to recipients ages 6 months–4 years
Administer 1 dose of either updated (2023–2024 Formula) Moderna or updated (2023–2024 Formula) Pfizer-BioNTech vaccine at least 8 weeks after last dose.One dose of an updated (2023–2024 Formula) mRNA vaccine and 1 dose of updated (2023–2024 Formula) Novavax vaccine administered as part of a 2- or 3-dose initial vaccination series to  previously unvaccinated recipients ages 12 years and older
For people who are NOT moderately or severely immunocompromised, no further doses needed.
For people who are moderately or severely immunocompromised, administer 1 dose of any updated (2023–2024 Formula) COVID-19 (i.e., Moderna, Novavax, or Pfizer-BioNTech) at least 4 weeks after the last dose for a total of 3 doses.Diluent (updated [2023–2024 Formula] Pfizer-BioNTech COVID-19 Vaccine formulation that should be mixed with diluent, i.e., yellow cap; yellow label)
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
Do not repeat dose.
See General Best Practices Guidelinesfor information on infection control and sterile technique.Diluent (updated [2023–2024 Formula] Pfizer-BioNTech COVID-19 Vaccine formulations that should not be mixed with diluent, i.e., blue cap; blue label and gray cap; gray label)
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, some experts suggest delaying the repeat dose for 8 weeks after the invalid dose based on the potential for increased reactogenicity and the rare risk of myocarditis and pericarditis associated with mRNA COVID-19 vaccines.
†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.
‡FDA authorization allows for dosing options in certain situations when a child ages from a younger to older age group; see Transitioning from a younger to older age group. If the dosing is in accordance with the FDA EUA, it is not considered an error and VAERS reporting is not indicated.
§For people ages 6 months–64 years who are not moderately or severely immunocompromised, some experts suggest delaying the dose for 8 weeks after the dose given in error based on the potential for increased reactogenicity and the rare risk of myocarditis and pericarditis observed in mRNA (Moderna or Pfizer-BioNTech) and Novavax COVID-19 vaccine recipients, particularly males ages 12–39 years. For additional information, see Considerations for extended intervals for COVID-19 vaccine doses.
¶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 healthcare providers for the most up-to-date manufacturer information.
#Vaccine doses administered up to 4 days before the minimum interval may be counted and do not need to be repeated.
Table of ContentsReferences and Previous UpdatesReferencesThe Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020
The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Moderna COVID-19 Vaccine — United States, December 2020
The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Janssen COVID-19 Vaccine — United States, February 2021
Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients—United States, April 2021
The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12–15 years — United States, May 2021
Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021
Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices — United States, July 2021
Use of Pfizer-BioNTech COVID-19 Vaccine in Persons Aged ≥16 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, September 2021
The Advisory Committee on Immunization Practices’ Interim Recommendations for Additional Primary and Booster Doses of COVID-19 Vaccines — United States, 2021
The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5–11 Years — United States, November 2021
Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices — United States, December 2021
The Advisory Committee on Immunization Practices’ Recommendation for Use of Moderna COVID-19 Vaccine in Adults Aged ≥18 Years and Considerations for Extended Intervals for Administration of Primary Series Doses of mRNA COVID-19 Vaccines — United States, February 2022
Interim Recommendations of the Advisory Committee on Immunization Practices for Use of Moderna and Pfizer-BioNTech COVID-19 Vaccines in Children Aged 6 Months–5 Years — United States, June 2022
Interim Recommendation of the Advisory Committee on Immunization Practices for Use of the Novavax COVID-19 Vaccine in Persons Aged ≥18 years — United States, July 2022.
Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ≥12 Years — United States, August 31–October 23, 2022.
Interim Recommendations from the Advisory Committee on Immunization Practices for the Use of Bivalent Booster Doses of COVID-19 Vaccines — United States, October 2022
Interim Recommendations for Use of Bivalent mRNA COVID-19 Vaccines for Persons Aged ≥6 Months — United States, April 2023
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
Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Healthcare Providers (fda.gov)
Moderna COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers (fda.gov)
Novavax COVID-19 Vaccine, Adjuvanted | FDA
Janssen COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers (fda.gov)
Emergency Use Instructions for Healthcare Providers: Pfizer-BioNTech COVID-19 Vaccine for Primary, Additional, and/or Booster Doses (cdc.gov)
Emergency Use Instructions for Healthcare Providers: Moderna COVID-19 Vaccine for Primary, Additional, and/or Booster Doses (cdc.gov)
ACIP General Best Practice Guidelines for Immunization
Interim considerations: preparing for the potential management of anaphylaxis after COVID-19 vaccinationPrevious Updates**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, EVUSHELDTMis 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**
Public health recommendations for vaccinated people have been moved to: www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html.**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.Top of Page
							
					
							Last Reviewed:  February 9, 2024						Source: 	National Center for Immunization and Respiratory Diseases
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