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

Summary of recent changes (last updated 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

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 for the primary series and/or booster dose(s). People who initiated vaccination outside of the United States are considered to be up to date with their COVID-19 vaccines when they have completed the recommended actions described below.

Age-appropriate Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccine products can be used in people ages 6 months and older to initiate or complete the primary series. Age-appropriate Moderna and Pfizer-BioNTech COVID-19 vaccines can be used in people ages 5 years and older for booster vaccination. For additional guidance on primary and booster vaccination, see guidance for people who are not moderately or severely immunocompromised and guidance for people who are moderately or severely immunocompromised.

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

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

Received a COVID-19 vaccine that is FDA-approved or FDA-authorized
Vaccination history Recommended actions*
Received all recommended primary dose(s)
  • Do not repeat primary series.
  • Administer booster dose(s) if eligible.
Received a partial mRNA (i.e., Moderna or Pfizer-BioNTech) or Novavax COVID-19 vaccine primary series
  • Do not restart primary series.
  • Complete primary series as close to the recommended time as possible with the same vaccine.
  • Administer booster dose(s) if eligible.
Received a booster dose after completion of primary series
  • Administer a second booster dose if eligible.

Table A.2. Received a COVID-19 vaccine listed for emergency use by WHO but not approved or 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 doses for that vaccine
  • Do not repeat primary series.
  • Administer booster dose(s) if eligible.
Received partial primary series for that vaccine
  • Complete the primary series with Moderna, Novavax, or Pfizer-BioNTech vaccine dose(s) as close to the recommended time as possible. Space from the last WHO-EUL vaccine by at least 28 days.
  • Administer booster dose(s) if eligible.
Received a booster dose after completion of primary series
  • Do not repeat booster dose.
  • Administer a second booster dose if eligible.

Table A.3. Received a heterologous primary series or booster dose composed of doses of a COVID-19 vaccine listed for emergency use by WHO, at least one of which is not FDA-approved or FDA-authorized

Received a heterologous primary series composed of doses of a COVID-19 vaccine listed for emergency use by WHO, at least one of which is not FDA-approved or authorized
Vaccination history Recommended actions*
Received a complete primary series
  • Do not repeat primary series.
  • Administer booster dose(s) if eligible.
Received a booster dose after completion of primary series
  • Do not repeat the booster dose.
  • Administer a second booster dose if eligible.

Table A.4. 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

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.
  • Start primary series at least 28 days after the last dose of vaccine.
  • Administer booster dose(s) if eligible.

*People ages 5 years and older who received a COVID-19 vaccine that is FDA-authorized, FDA-approved, or listed for emergency use by WHO should receive 1 booster dose if eligible; those ages 12 years and older are able to receive a second booster dose if eligible. For information on booster doses, see guidance for people who are not moderately or severely immunocompromised and guidance for people who are moderately or severely immunocompromised.

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.

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

Participants in clinical trials within or outside the United States who received all the recommended primary series doses of a vaccine listed for emergency use by WHO (i.e., not placebo) that is not FDA-approved or FDA-authorized are considered to be up to date with their COVID-19 vaccines when they have completed the recommended actions described below. In addition, 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 completed the recommended actions described below; at this time, only the Medicago COVID-19 Vaccine in people ages 18 years and older meet these criteria.

If clinical trial participants have questions about whether they should receive an additional and/or booster dose outside of the clinical trial, they should consult with their healthcare provider. Clinical trial participants who did not receive all the recommended doses, or who received other vaccines not listed above, should consult with their healthcare provider to determine if they should receive an FDA-approved or FDA-authorized COVID-19 vaccine series.

Appendix C. Vaccine administration errors and deviations

A vaccine administration error is any preventable event that may 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, please 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 (see footnotes to this Appendix).
    • For doses recommended to be repeated, 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 from an mRNA COVID-19 vaccine (i.e., Moderna or Pfizer-BioNTech) or Novavax COVID-19 Vaccine, particularly in groups at increased risk for myocarditis (e.g., males ages 12–39 years). Individual risk for COVID-19 and the likelihood for an adverse event following COVID-19 vaccination should be taken into consideration when recommending a longer interval. It is acceptable to administer the repeat dose at an interval earlier than 8 weeks if the interval is not sooner than the minimal interval noted in this table.

The recommendations in the table below apply to all FDA-approved or FDA-authorized COVID-19 vaccines and all doses (i.e., primary series and booster doses), unless otherwise stated.

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

Table. 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
  • Unauthorized age group (recipients younger than age 6 months)
  • Do not give another dose at this time.*
  • Unauthorized age group (recipients ages 6 months–17 years)
  • If Moderna vaccine administered:
    • As a booster dose, do not repeat the dose with Pfizer-BioNTech vaccine
  • If Novavax vaccine administered:
    • As a primary dose, do not repeat the dose with Moderna or Pfizer-BioNTech vaccine and continue the age-appropriate mRNA COVID-19 vaccine primary series
    • As a booster dose, do not repeat the dose with Pfizer-BioNTech vaccine
  • If Janssen vaccine administered
    • As a primary dose, do not count the dose and begin or continue the age-appropriate mRNA COVID-19 vaccine primary series (Table 2) at least 28 days after the Janssen vaccine dose
    • As a booster dose, do not count the dose and repeat the dose with Pfizer-BioNTech vaccine at least 28 days after the Janssen vaccine dose
Product and dosage
  • If the incorrect product/dosage is administered, resulting in a higher-than-authorized dose
  • Do not repeat dose.
  • If the incorrect product/dosage is administered, resulting in a lower-than-authorized dose
  • Repeat dose immediately (no minimum interval) with the age-appropriate product/dosage.
  • 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 from mRNA (i.e., Moderna or Pfizer-BioNTech) or Novavax COVID-19 vaccines, especially in males ages 12–39 years.§‡
  • Higher-than-authorized dose volume administered of the correct product
  • Do not repeat dose.
  • Lower-than-authorized dose volume administered of the correct product (e.g., leaked out of the syringe, equipment failure, recipient pulled away)
  • 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.
  • See Appendix D for guidance on addressing situations in which a booster dose is administered prior to completing the primary series.
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
  • 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
  • An mRNA (i.e., Moderna or Pfizer-BioNTech) or Novavax primary series dose administered prior to the recommended interval#
  • Repeat dose. Space repeat dose after the dose given in error by at least the recommended interval (Table 2 and Table 3).§
  • Booster dose administered prior to the minimum interval (i.e., for the first booster dose, prior to 2 months after Janssen primary series or 3 months after mRNA vaccine primary series)
  • Repeat dose if this is the first booster dose. Space repeat dose after the dose given in error by at least the minimum interval.§
    • 2-month minimum interval after Janssen vaccine primary series
    • 3-month minimum interval after mRNA vaccine primary series
  • Do not repeat dose if this is the second booster dose.
  • 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.
  • Tixagevimab/cilgavimab (EVUSHELD™) administered less than 14 days after COVID-19 vaccination
  • In general, do not repeat vaccine dose. However, based on clinical judgement, a repeat dose of vaccine may be administered at an interval of at least 28 days after the dose of vaccine. §
Mixed primary series
  • Incorrect COVID-19 vaccine product inadvertently administered as part of a 2- or 3-dose primary series
  • Do not repeat dose.
  • Any combination of Moderna, Novavax, or Pfizer-BioNTech vaccines is considered a complete primary series provided the indicated number of doses is administered. People who received a mixed series with an mRNA and Novavax vaccine can follow the age-appropriate mRNA or Novavax schedule for subsequent doses.
  • If Janssen vaccine is administered, this counts as a single-dose series and no more primary doses are indicated.
  • Children ages 6 months–4 years who receive different mRNA products for the first 2 doses of an mRNA COVID-19 vaccine series should follow a 3-dose schedule. A third dose of either mRNA vaccine should be administered 8 weeks after the second dose to complete the 3-dose primary series.
  • Children ages 5–17 years who receive a mixed mRNA COVID-19 vaccine primary series can follow the Pfizer-BioNTech COVID-19 Vaccine schedule and receive a booster dose.
Unauthorized booster dose
  • Any COVID-19 booster dose administered after Novavax primary series
  • Do not repeat dose.
  • Janssen vaccine administered as a second booster dose
  • Do not repeat dose.
Diluent (Pfizer-BioNTech COVID-19 Vaccine formulations only [purple cap and orange 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 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 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.

For FDA EUA dosing options for children who turn from age 4 years to 5 years (Pfizer-BioNTech), age 5 years to 6 years (Moderna), and age 11 years to 12 years (Moderna and Pfizer-BioNTech) during vaccination, 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.

§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 from mRNA (i.e., Moderna or Pfizer-BioNTech) and Novavax COVID-19 vaccines, particularly in groups at increased risk for myocarditis (e.g., males ages 12–39 years). Individual risk for COVID-19 and the likelihood for an adverse event following vaccination should be taken into consideration when recommending a longer interval. It is acceptable to administer the repeat dose at an interval earlier than 8 weeks if the interval is not sooner than the minimal interval noted in this table.

For the purpose of the public health definition of fully vaccinated, primary series doses administered with an interval error prior to October 25, 2021, do not need to be repeated.

For the purpose of the public health definition of up to date, first booster doses administered with an interval error prior to March 30, 2022 do not need to be repeated.

#Vaccine doses administered up to 4 days before the minimum interval may be counted and do not need to be repeated.

**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); medinfo@modernatx.com
  • Janssen: US Toll Free: 1-800-565-4008; US Toll: 1-908-455-9922
  • Novavax: 1-844-NOVAVAX (1-844-668-2829)

Please see the package inserts and EUA provider factsheets for the most up-to-date manufacturer information.

Appendix D. Schedule guidance for people who are moderately or severely immunocompromised

D.1. People who are moderately or severely immunocompromised and initiate a Janssen COVID-19 Vaccine primary series

D1. People who are moderately or severely immunocompromised and initiate a Janssen COVID-19 Vaccine primary series
COVID-19 vaccination history And Then Next dose due
1 dose The dose was Janssen COVID-19 Vaccine Administer a second (additional) dose using an mRNA vaccine at least 28 days after the 1st dose
  • Moderna 0.5mL (red cap), or
  • Pfizer: 0.3mL
Administer a booster dose at least 2 months after the 2nd dose.*
  • Moderna: 0.25mL (red cap) or 0.5 mL (blue cap), or
  • Pfizer: 0.3mL, or
  • Janssen: 0.5mL (mRNA is recommended over Janssen)

Administer a second booster dose if eligible.

2 doses Both doses are Janssen COVID-19 Vaccine Administer a third (additional) dose using an mRNA vaccine at least 2 months after the 2nd dose
  • Moderna: 0.5mL (red cap), or
  • Pfizer: 0.3mL, or
Administer a second booster dose if eligible.
1 dose of Janssen COVID-19 Vaccine and
1 dose of an mRNA COVID-19 vaccine (given as booster dose, i.e., Moderna 0.25mL [red cap], or Moderna 0.5mL [blue cap]), or Pfizer 0.3mL‡
Administer a third (additional) dose using an mRNA vaccine at least 2 months after the 2nd dose
  • Moderna: 0.5mL (red cap), or
  • Pfizer: 0.3mL
Administer a second booster dose if eligible.
1 dose of Janssen COVID-19 Vaccine and
1 dose of an mRNA COVID-19 vaccine (given as additional dose, i.e., Moderna 0.5mL [red cap], or Pfizer 0.3mL)‡
Administer a booster dose of any COVID-19 vaccine 2 months after the 2nd dose*
  • Moderna: 0.25mL (red cap) or 0.5mL (blue cap), or
  • Pfizer: 0.3mL, or
  • Janssen: 0.5mL (mRNA is recommended over Janssen)
Administer a second booster dose if eligible.

*mRNA vaccines are recommended.

For information on who is eligible for a second booster dose, see guidance for people who are moderately or severely immunocompromised.

When reviewing vaccination history, doses of the Moderna COVID-19 Vaccine received prior to February 7, 2022 should be considered to have been the booster dosage (0.25 mL; 50 µg).

D.2. People who are moderately or severely immunocompromised and initiate an mRNA COVID-19 vaccine primary series

D2. People who are moderately or severely immunocompromised and initiate an mRNA COVID-19 vaccine primary series
COVID-19 vaccination history And Then* Next dose due*
1 dose The dose was an mRNA vaccine Administer a second primary series dose of the same mRNA vaccine
  • 4 weeks after the first dose, if Moderna
  • 3 weeks after the first dose, if Pfizer-BioNTech
Administer a third primary series dose of the same mRNA vaccine
  • At least 4 weeks after the second dose for most people
  • At least 8 weeks after the second dose if ages 6 months–4 years and receiving Pfizer-BioNTech vaccine

Then, administer a booster dose at least 3 months after the third dose if eligible. Administer a second booster dose if eligible.

2 doses The 2 doses are the same mRNA vaccine (both Moderna or both Pfizer-BioNTech) Administer a third primary series dose of the same mRNA vaccine
  • At least 4 weeks after the second dose for most people
  • At least 8 weeks after the second dose if ages 6 months–4 years and receiving Pfizer-BioNTech vaccine
Administer a booster dose at least 3 months after the third primary series dose if eligible. Administer a second booster dose if eligible.
The 2 doses are different mRNA vaccines (1 dose Moderna and 1 dose Pfizer-BioNTech) Administer a third primary series dose of either mRNA vaccine
  • At least 4 weeks after the second dose for most people
  • At least 8 weeks after the second dose if ages 6 months–4 years
Administer a booster dose at least 3 months after the third primary series dose if eligible. Administer a second booster dose if eligible.
The 2 doses are different types of vaccines (1 dose of an mRNA vaccine and 1 dose of Janssen) This is considered a Janssen COVID-19 Vaccine primary series. Administer an additional dose of Moderna or Pfizer-BioNTech at least 28 days after the Janssen COVID-19 Vaccine dose. Administer a booster dose at least 2 months after the additional mRNA vaccine dose. Administer a second booster dose if eligible.
3 doses 3 primary series doses of an mRNA vaccine (includes 3 doses of the same mRNA vaccine or a mixed mRNA vaccine series) Administer a booster dose at least 3 months after the last dose given if eligible. Administer a second booster dose if eligible.
2 primary series doses of an mRNA vaccine and
1 booster dose of any vaccine
Administer a third primary dose (fourth total dose) of an mRNA vaccine at least 3 months after the last dose given. Administer a second booster dose if eligible.

*mRNA vaccines are recommended for all primary doses and the first booster dose; only mRNA vaccines can be used for the second booster dose.

For information on who is eligible for booster dose(s), see guidance for people who are moderately or severely immunocompromised.

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

Appendix E: Triage of people with a history of allergies or allergic reactions
CONTRAINDICATION TO COVID-19 VACCINATION PRECAUTION TO COVID-19 VACCINATION MAY PROCEED WITH 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 vaccine1,2
  • Known (diagnosed) allergy to a component of a COVID-19 vaccine1
Among people without a contraindication, a history of:
  • Any immediate allergic reaction3 to other vaccines (non-COVID-19) or injectable therapies4
  • Non-severe, immediate (onset <4 hours) allergic reaction2 after a previous dose of COVID-19 vaccine6

Note: People with an allergy-related contraindication to one type of COVID-19 vaccine have a contraindication or precaution to the other types of COVID-19 vaccines. See footnotes 5 and 6 for guidance on what type of COVID-19 vaccine may be administered.

Among people without a contraindication or precaution, a history of:
  • Allergy (including anaphylaxis) to oral medications (including the oral equivalent of an injectable medication)
  • History of food, pet, insect, venom, environmental, latex, etc., allergies, including anaphylaxis
  • Family history of allergies
Actions:
  • Do not vaccinate
  • Consider referral to allergist-immunologist
  • Consider alternate vaccine type if age appropriate1,5
Actions:
  • Risk assessment
  • 30-minute observation period if vaccinated (see footnotes 5 and 6 for information on vaccination setting)
  • Consider referral to allergist-immunologist
Actions:
  • 30-minute observation period: people with history of anaphylaxis (due to any cause)
  • 15-minute observation period: all other people

Note: This table is specific to allergy-related contraindications and precautions and is not inclusive of all COVID-19 vaccine contraindications and precautions.

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 (Pfizer-BioNTech or Moderna). However, some of these people may be able to receive Novavax or Janssen COVID-19 vaccine after a detailed risk assessment and possibly allergy testing (see footnote 5 below).

2Severe 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 may 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

3Immediate allergic reaction to a vaccine or injectable therapy is defined as any hypersensitivity-related signs or symptoms consistent with urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within four hours following administration.

4People with a history of an immediate allergic reaction to 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 and possibly allergy testing.

5Polyethylene glycol (PEG) is an ingredient in both mRNA COVID-19 vaccines, and polysorbate 80 is an ingredient in Novavax and Janssen COVID-19 vaccines. PEG and polysorbate are structurally related, and cross-reactive hypersensitivity between these compounds may occur. People with an allergy-related contraindication to one type of COVID-19 vaccine have a contraindication or precaution to the other types of COVID-19 vaccines.

  • People with a known allergy to polysorbate have a contraindication to both Novavax and Janssen COVID-19 vaccines and a precaution to mRNA COVID-19 vaccines (i.e., Moderna, 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.

6For 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 with a 30-minute observation period in a usual COVID-19 vaccination setting.

References and Previous Updates

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

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.
Page last reviewed: July 20, 2022