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  1. Coronavirus Disease 2019 (COVID-19)

COVID-19 Frequently Asked Questions

 

General Information 


Vaccines, Biologics, Human Tissues, and Blood Products

A:  Individuals may receive a single booster dose of one of the authorized bivalent mRNA COVID-19 vaccines, when eligible, as follows:

Children who are 6 months through 5 years of age who received primary vaccination with Moderna COVID-19 Vaccine may receive a single booster dose of the Moderna COVID-19 Vaccine, Bivalent at least two months after completion of primary vaccination.

Children who are 5 years of age who received primary vaccination with Moderna COVID-19 Vaccine may receive either the Moderna COVID-19 Vaccine, Bivalent or Pfizer-BioNTech COVID-19, Bivalent as a single booster dose at least two months after completion of primary vaccination.

Children who are 5 years of age who received primary vaccination doses  with Pfizer-BioNTech COVID-19 Vaccine, including children whose third dose was with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, may receive only the Pfizer-BioNTech COVID-19 Vaccine, Bivalent as a single booster dose at least two months after completion of primary vaccination.

Individuals who are 6 years of age and older may receive a single booster dose with either the Moderna COVID-19 Vaccine, Bivalent or the Pfizer-BioNTech COVID-19, Bivalent at least 2 months after either:

  • Completion of a primary series with any FDA-authorized or approved COVID-19 vaccine.

or

  • The most recent booster dose with any FDA-authorized or approved monovalent COVID-19 vaccine.
Certain individuals may receive a monovalent COVID-19 vaccine authorized for use as a single booster dose as follows:

The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use as a first booster dose in the following individuals at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine:

  • Individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate.
  • Individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
The Janssen COVID-19 Vaccine is also authorized for use as a single booster dose in certain individuals 18 years of age and older.* 

*FDA has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.


Drugs (Medicines)


Medical Devices Including Tests for COVID-19


Food Products


Animals, Pets and Animal Drug Products

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