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

Summary of recent changes (last updated 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.

Appendices

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

The recommendations for people vaccinated outside of the United States depend on the number and type of vaccine(s) received. People who initiated vaccination outside of the United States should complete the recommended actions described below (Table A). For additional guidance on COVID-19 vaccination, see guidance for people who are not moderately or severely immunocompromised.

The recommended actions in Table A are based on the schedule and guidance for people who are not moderately or severely immunocompromised. These actions should be modified accordingly for people who are moderately or severely immunocompromised based on the schedule and guidance for people who are moderately or severely immunocompromised.

Table A. People who received COVID-19 vaccine outside the United States and are NOT moderately or severely immunocompromised*

Table A.1. Received a COVID-19 vaccine that is FDA-authorized

Received a COVID-19 vaccine that is FDA-approved or FDA-authorized
Vaccination history	Recommended actions
Received 1 or more monovalent mRNA vaccine dose(s)	Administer 1 bivalent mRNA vaccine dose if age 6 years and older.^† See Table 1 if age 6 months–5 years.
Received 1 or 2 Novavax vaccine dose(s)	Administer 1 bivalent mRNA dose.^†‡
Received 1 bivalent mRNA vaccine dose after completion of primary series	Do not repeat if age 5 years and older.^† See Table 1 if age 6 months–4 years. See Special situation (after table footnotes).

Table A.2. Received a COVID-19 vaccine listed for emergency use by WHO but not authorized by FDA^§¶

Received a COVID-19 vaccine listed for emergency use by WHO but not approved or authorized by FDA
Vaccination history	Recommended actions
Received all recommended primary series doses for that vaccine	Administer 1 bivalent mRNA vaccine dose.^†‡
Received partial primary series for that vaccine	Administer 1 bivalent mRNA vaccine dose if age 6 years and older.^† See Table 1 if age 6 months–5 years.
Received a monovalent booster dose after completion of primary series	Administer 1 bivalent mRNA vaccine dose.^†
Received 1 bivalent mRNA booster dose after completion of primary series	Do not repeat.^† See Special situation (after table footnotes).

Table A.3. Received all or some of the recommended doses of COVID-19 vaccines that are NOT FDA-authorized or among those listed for emergency use by WHO

Received all or some of the recommended doses of COVID-19 vaccines that are NOT FDA-authorized, FDA-approved, or among those listed for emergency use by WHO
Vaccination history	Recommended actions
Received any number and combination of vaccine doses	Do not count doses received toward vaccination in the US. Vaccinate according to the US schedule (Table 1). Start vaccination at least 28 days after the last dose of vaccine.

^*For guidance for people who are moderately or severely immunocompromised, see Table 2.

^†People ages 6 months and older should receive at least 1 age-appropriate bivalent mRNA vaccine dose at least 2 months after their last monovalent vaccine dose. People ages 65 years and older have the option to receive 1 additional bivalent mRNA vaccine dose at least 4 months after the first bivalent mRNA vaccine dose.

^‡A monovalent Novavax booster dose (instead of a bivalent mRNA dose) may be used after completion of primary vaccination in limited situations in people ages 18 years and older who have not received any previous booster dose(s). The Novavax booster dose is administered at least 6 months after the last primary series dose.

^§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.

^¶This scenario also includes people who received a heterologous primary series or booster dose composed of doses of COVID-19 vaccines listed for emergency use by WHO, at least one of which is not FDA-approved or FDA-authorized.

Special situation: Do not administer a second bivalent mRNA vaccine dose if the person previously received a bivalent Moderna or Pfizer-BioNTech mRNA vaccine dose containing the original SARS-CoV-2 strain and Omicron BA.1 variant unless the person is age 65 years or older: These people have the option to receive 1 additional bivalent mRNA vaccine dose at least 4 months after the first bivalent mRNA vaccine dose.

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Appendix B. People who received COVID-19 vaccine as part of a clinical trial

U.S. trial participants, along with non-U.S.-based participants in the same trial, who received all the recommended primary series doses of a vaccine that is not listed for emergency use by WHO but for which a U.S. data and safety monitoring board or equivalent has independently confirmed efficacy are considered up to date with their COVID-19 vaccines when they have received 1 bivalent mRNA vaccine dose. At this time, only the Medicago COVID-19 Vaccine in people ages 18 years and older and Sanofi-GSK COVID-19 Vaccine in people ages 18–59 years meet these criteria.

For information on COVID-19 vaccination, see guidance for people who are not moderately or severely immunocompromised and guidance for people who are moderately or severely immunocompromised.

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Appendix C. Vaccine administration errors and deviations

A vaccine administration error is any preventable event that might cause or lead to inappropriate use of vaccine or patient harm.

The FDA-issued 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, both as an administered dose and to account for inventory.
Report the error to the Vaccine Adverse Event Reporting System (VAERS), unless otherwise indicated in the table. Providers are required to report all COVID-19 vaccine administration errors—even those not associated with an adverse event—to VAERS. To file an electronic report, see the VAERS website.
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 of subsequent dose(s) unless otherwise noted in Table C.

The recommendations in the table below apply to all FDA-authorized COVID-19 vaccines and all doses unless otherwise stated.

Table C. 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.
Site/route	Incorrect route (e.g., subcutaneous)	Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.
Age	Unauthorized age group (recipients younger than age 6 months)	Do not give another dose at this time.*
Age	Recipients transitioning from age 4 years to 5 years who start a 3-dose Pfizer-BioNTech series with the product for ages 6 months–4 years (maroon cap and label border) and incorrectly receive the product for ages 5–11 years (orange cap and label border) for either dose 2 or 3	Do not repeat dose 2 or 3. If the error occurred with dose 2, administer the bivalent Pfizer-BioNTech product for ages 6 months–4 years (maroon cap and label border) for the third dose at least 8 weeks after the second dose.
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 patient 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.
	Monovalent mRNA vaccine dose administered for a bivalent mRNA dose	Repeat the dose using an age-appropriate bivalent mRNA vaccine. If dose given in error was the first dose, space repeat dose by at least 4 weeks; for other doses, space repeat dose after the dose given in error by at least the minimum interval (Table 1 and Table 2).^§
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).^§
Storage and handling	Dose administered past the expiration/beyond-use date	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).^§
Intervals	Any COVID-19 dose administered prior to the minimum interval^#	Repeat dose. Space repeat dose after the dose given in error by at least the minimum interval (Table 1 and Table 2).^§
Intervals	Any COVID-19 vaccine dose administered at any interval after the recommended interval	Do not repeat dose. There is no maximum interval. This deviation from CDC guidance does not require VAERS reporting.
Interchangeability	Bivalent mRNA vaccines from different manufacturers administered for initial vaccination to recipients ages 6 months–5 years	Recipients ages 6 months–4 years who received 1 Moderna and 1 Pfizer-BioNTech vaccine dose for the first 2 doses of a 3-dose series should receive a third dose of either Moderna or Pfizer-BioNTech vaccine at least 8 weeks after the second dose. If Moderna is used, administer 0.25 mL/25 ug (dark blue cap and gray label border. If Pfizer-BioNTech is used, administer 0.2 mL/3 ug (maroon cap and label border). Recipients age 5 years who received Moderna as a second dose following a first dose of Pfizer-BioNTech: If not moderately or severely immunocompromised, do not administer any more vaccine doses; considered a single-dose Pfizer-BioNTech vaccination series. If moderately or severely immunocompromised, administer a third dose of either Moderna (0.25mL/25 ug; dark blue cap and gray label border) or Pfizer-BioNTech (0.2mL/10 ug; orange cap and label border) at least 4 weeks after the second dose.
	Two or more doses of monovalent mRNA vaccine from different manufacturers previously administered to recipients ages 6 months–4 years	Administer 1 dose of either Moderna or Pfizer-BioNTech vaccine at least 8 weeks after last monovalent dose: If Moderna is used, administer 0.25 mL/25 ug (dark blue cap and gray label border). If Pfizer-BioNTech is used, administer 0.2 mL/3 ug (maroon cap and label border).
	Bivalent mRNA vaccine dose from one manufacturer administered to recipients ages 6 months–4 years who previously received 1 or more doses of a monovalent mRNA vaccine from a different manufacturer	If previously received 1 monovalent mRNA vaccine dose, do not repeat the dose and administer 1 dose of either Moderna or Pfizer-BioNTech vaccine at least 8 weeks after the first bivalent dose. If previously received 2 or 3 monovalent mRNA vaccine doses, do not repeat the dose; any combination of the recommended number of doses is considered valid.
	Bivalent Moderna dose(s) administered to recipients age 5 years who previously received monovalent dose(s) of Pfizer-BioNTech	Do not repeat dose(s).
	Bivalent mRNA vaccines from different manufacturers administered for the first 2 doses of a 3-dose initial vaccination series to recipients ages 6 years and older who are moderately or severely immunocompromised	Administer a third age-appropriate dose of either Moderna or Pfizer-BioNTech at least 4 weeks after the second dose.
Diluent (Pfizer-BioNTech COVID-19 Vaccine formulation only [orange cap and maroon cap])	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)	Contact the manufacturer for information on the stability of the vaccine.^¶ If the manufacturer does not have information to support the stability of the vaccine, 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. Inform patient of the potential for bacterial infection.
Diluent (Pfizer-BioNTech COVID-19 Vaccine formulation that should not be mixed with diluent, i.e., gray cap)	Vaccine is mixed with any diluent (i.e., any type or volume of diluent)	Contact the manufacturer for information on the stability of the vaccine.^¶ If the manufacturer does not have information to support the stability of the vaccine, repeat the dose immediately (no minimum interval).^§

^*Do not administer the second dose until the person becomes eligible to receive vaccination (either by reaching the authorized age or if the authorization is extended to include additional age groups), even if this results in the second dose being administered after the recommended interval between doses. In addition to the minimum age, some experts suggest delaying the second dose for 8 weeks after the invalid dose based on the potential for increased reactogenicity and the rare risk of myocarditis and pericarditis from mRNA COVID-19 vaccine.

^†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), lead to serious adverse reactions, 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 for certain situations where 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.

^§An 8-week interval between the first and second doses of mRNA and Novavax COVID-19 vaccines may be optimal for some people ages 6 months–64 years, especially for males ages 12–39 years, as it may reduce the small risk of myocarditis and pericarditis associated with these vaccines. The authorized interval (4 weeks for Moderna and 3 weeks for Novavax and Pfizer-BioNTech) between the first and second doses remains the recommended interval for people who are moderately or severely immunocompromised; adults ages 65 years and older; and in situations in which there is increased concern about an individual’s higher risk of severe disease.

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

Pfizer: 1-877-VAX-CO19 (1-877-829-2619)
Moderna: 1-866-MODERNA (1-866-663-3762)
Janssen: US Toll Free: 1-800-565-4008; US Toll: 1-908-455-9922
Novavax: 1-844-NOVAVAX (1-844-668-2829)

See the package inserts and EUA provider factsheets 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.

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Appendix D. Triage of people with a history of allergies or allergic reactions

Triage of people with a history of allergies or allergic reactions
CONTRAINDICATION TO COVID-19 VACCINATION	PRECAUTION TO COVID-19 VACCINATION	NO CONTRAINDICATION OR PRECAUTION TO COVID-19 VACCINATION
History of the following: Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of a COVID-19 vaccine^1,2 Known (diagnosed) allergy to a component of a COVID-19 vaccine¹	Among people without a contraindication, a history of: Anaphylaxis after non-COVID-19 vaccines or injectable therapies³ Non-severe, immediate (onset within 4 hours) allergic reaction² after a previous dose of COVID-19 vaccine⁴ Note: People with an allergy-related contraindication to one type of COVID-19 vaccine have a precaution to the other types of COVID-19 vaccines.^4,5	Among people without a contraindication or precaution, a history of: Any allergy not listed as a contraindication or precaution
Actions: Do not vaccinate Consider referral to allergist-immunologist Consider alternate vaccine type if age appropriate^1,5	Actions: Risk assessment⁶ Should consider a 30-minute observation period^4,⁵ Consider referral to allergist-immunologist	Actions: Proceed with vaccination Should consider a 15-minute observation period per General Best Practice Guidelines

¹COVID-19 vaccine-specific FDA fact sheets and U.S. COVID-19 Vaccine Product Information can be consulted for a full list of ingredients. People with a contraindication to one of the mRNA COVID-19 vaccines should not receive doses of either of the mRNA vaccines. However, some of these people may be able to receive Novavax COVID-19 Vaccine after a detailed risk assessment (see footnote 5 below).

²An immediate allergic reaction to a vaccine or injectable therapy is defined as any hypersensitivity-related signs or symptoms such as urticaria (hives), angioedema (visible swelling), respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occurs within four hours following administration.

Severe allergic reactions include:

Possible anaphylaxis, a progressive life-threatening reaction that typically includes urticaria but also with other symptoms such as wheezing, difficulty breathing, or low blood pressure
Any angioedema affecting the airway (i.e., tongue, uvula, or larynx)
Diffuse rash which also involves mucosal surfaces (e.g., Stevens-Johnson Syndrome)

Non-severe allergic reactions might include:

Urticaria (hives) beyond the injection site
Angioedema (visible swelling) involving lips, facial skin, or skin in other locations. NOTE: Any angioedema affecting the airway (i.e., tongue, uvula, or larynx) would NOT be in this category and is considered a severe allergic reaction

³People with a history of anaphylaxis after a non-COVID-19 vaccine or injectable therapy that contains multiple components, one or more of which is a component of a COVID-19 vaccine, but it is unknown which component elicited the allergic reaction, have a precaution to vaccination with that COVID-19 vaccine. These people may benefit from consultation with an allergist-immunologist who can perform a more detailed risk assessment for COVID-19 vaccine receipt.

⁴For people with a history of an immediate, non-severe allergic reaction after one type of COVID-19 vaccine, vaccination with a subsequent dose of that same type of COVID-19 vaccine should only be undertaken in an appropriate setting under the supervision of a health care provider experienced in the management of severe allergic reactions. Administering a different type of COVID-19 vaccine is another option; this can be done in the usual vaccination setting.

⁵Polyethylene glycol (PEG) is an ingredient in both mRNA COVID-19 vaccines, and polysorbate 80 is an ingredient in Novavax COVID-19 Vaccine. PEG and polysorbate are structurally related, and cross-reactive hypersensitivity between these compounds might occur.

People with a known allergy to polysorbate have a contraindication to Novavax COVID-19 Vaccine and a precaution to mRNA COVID-19 vaccines (Moderna or Pfizer-BioNTech).
In all other cases, an allergy-related contraindication to one type of COVID-19 vaccine is a precaution to the others.

For people with these precautions, referral to an allergist-immunologist should be considered. Healthcare professionals and health departments may also request a consultation from the Clinical Immunization Safety Assessment COVIDvax project. In patients with these precautions, vaccination should only be undertaken in an appropriate setting under the supervision of a healthcare professional experienced in the management of severe allergic reactions.

⁶Risk assessment: The following considerations can be used to help the vaccination provider conduct a risk assessment for vaccination in people with a precaution to vaccination because of allergy:

Risk of exposure to SARS-CoV-2 virus (e.g., because of occupational or institutional setting)
Risk of severe disease or death due to COVID-19 (e.g., because of age, underlying medical conditions)
Unknown risk of anaphylaxis following COVID-19 vaccination in a person with a history of anaphylaxis after other vaccines or injectable therapies (Appendix D, footnote 3); consultation with an allergist-immunologist may help to clarify the risk assessment for these people
Ability of the patient to be vaccinated in a setting where appropriate medical care is immediately available for anaphylaxis; for people with a contraindication due to allergy to one type of COVID-19 vaccine who are receiving another type that has been deemed a precaution and for people with an immediate, non-severe allergic reaction after a previous dose of COVID-19 vaccine who are receiving vaccination with a subsequent dose of that COVID-19 vaccine type, vaccination should only be undertaken in an appropriate setting under the supervision of a healthcare professional experienced in the management of severe allergic reactions
For information on the management of anaphylaxis see Preparing for the Potential Management of Anaphylaxis after COVID-19 Vaccination and laboratory evaluation of people who experience anaphylaxis after vaccination

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References and Previous Updates

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, EVUSHELD^TMis 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 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.

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