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Guidelines for Vaccines for Persons Who Received COVID-19 Vaccines Outside the United States or as Part of a Clinical Trial within the United States
Primary series with FDA-authorized or approved vaccines
Individuals who were vaccinated outside the United States with an FDA-authorized or approved COVID-19 vaccine and who have received all the recommended doses are considered fully vaccinated.
Individuals who received the 1st dose of an FDA-authorized or approved mRNA COVID-19 vaccine that requires two doses do not need to restart the vaccine series in the U.S. but should receive the 2nd dose as close to the recommended time as possible.
Primary series with World Health Organization (WHO)-approved vaccines
Individuals part of a clinical trial who received all recommended World Health Organization Emergency Use Listing (WHO-EUL) COVID-19 vaccine doses are considered fully vaccinated.
Individuals who received all recommended doses of a COVID-19 vaccine that is not currently approved or authorized in the United States by the FDA but is listed for emergency use by the World Health Organization (WHO) are considered fully vaccinated.
Individuals who have not received all the recommended doses of a COVID-19 vaccine that is listed for emergency use by WHO should be offered a complete, FDA-authorized COVID-19 vaccine series (PfizerBioNTech, Moderna or Janssen COVID-19 vaccines). The minimum interval between the last dose of a WHO-listed vaccine and an FDA-authorized or approved COVID-19 vaccine is 28 days.
The following are COVID-19 vaccines currently approved for use by the WHO: Sinovac-Coronavac, AstraZeneca-Oxford (Covishield, Vaxzevria), Sinopharm BBIBP-CorV (Vero Cells), Pfizer-BioNTech (Comirnaty, Tozinameran), Janssen (Johnson & Johnson), Moderna (Takeda, Spikevax) and Bharat Biotech (Covaxin).
Primary series with non-FDA or non-WHO approved vaccines
Individuals who received all or some of the recommended doses of a COVID-19 vaccine that is neither authorized nor approved by FDA nor listed for emergency use by WHO should be offered a complete, FDA-authorized or approved COVID-19 vaccine series (Pfizer-BioNTech, Moderna or Janssen COVID-19 vaccines). The minimum interval between the last dose of a non-FDA approved/authorized vaccine or a non-WHO listed vaccine and an FDA-approved or authorized COVID-19 vaccine is 28 days. These individuals are not recommended to receive an additional primary or booster COVID-19 vaccine dose at this time.
Emergency use instructions for additional doses for certain immunocompromised persons and for booster doses
On November 17, CDC issued Emergency Use Instructions (EUI) about giving Pfizer-BioNTech COVID-19 vaccine (Comirnaty®) to individuals who have received COVID-19 vaccines outside the United States or in a clinical trial that are not authorized or approved by the FDA.
- Persons 12 years of age or older who are moderately or severely immunocompromised and have completed a COVID-19 vaccine primary series with vaccines that are not FDA-authorized or approved, are eligible to receive an additional (3rd) dose of Pfizer-BioNTech COVID-19 vaccine at least 28 days after receiving the second dose of their primary series.
- Persons 18 years of age and older who completed a COVID-19 vaccine primary series with vaccines that are not FDA-authorized or approved are eligible to receive a booster dose of Pfizer-BioNTech COVID-19 vaccine at least 6 months after completion of the primary series.
For more information see Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States.
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