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Newly Authorized COVID-19 Vaccine-Novavax (for persons 18 years and older)

Newly Authorized COVID-19 Vaccine-Novavax (for persons 18 years and older)

Wednesday, July 27, 2022

On July 13, 2022, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Novavax COVID-19 vaccine for use among people ages 18 years and older for primary series vaccination. On July 19, 2022, CDC’s Advisory Committee on Immunization Practices (ACIP) recommended use of the Novavax COVID-19 vaccine in this population. Then on July 20, 2022, CDC endorsed the ACIP’s recommendation that the Novavax COVID-19 vaccine be used as an option for adults ages 18 years and older.

Emergency Use Authorization Fact Sheets for Novavax can be found here:

The Novavax COVID-19 vaccine is the first COVID-19 protein subunit vaccine recommended for use in the United States. Having multiple types of vaccines offers more options and flexibility for people receiving COVID-19 vaccines, as well as jurisdictions and vaccine providers.

On July 20, 2022, the CDC issued updates to their Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. The updates include guidance for primary series vaccination using Novavax COVID-19 vaccine in adults ages 18 years and older as well as updated guidance on COVID-19 vaccination and myocarditis and pericarditis. Please refer to the interim clinical considerations for further details on coadministration, interchangeability, contraindications/precautions, patient counseling and more.  

Adults ages 18 years and older should receive a 2-dose primary series separated by 3-8 weeks. (A shorter interval of 3 weeks 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 COVID-19 community levels or an individual’s higher risk of severe disease.) Currently, a booster dose using any COVID-19 vaccine is not authorized for adults in this age group who receive a Novavax primary series. A limited number of doses of Novavax COVID-19 vaccine will be distributed and not all providers are expected to carry Novavax COVID-19 vaccine.

The Novavax vaccine is stable at standard vaccine refrigeration temperatures of 36°-46°F (2°C to 8°C). The packaging configuration of the vaccine is expected to be 10-dose vials in cartons of 10 vials each (100 doses total), with a minimum order quantity of 100 doses. Once opened, each vial must be used within 6 hours. Ancillary supplies will be provided, including a variety of 1-inch & 1.5-inch needles and syringes to support 100 doses of vaccine. Novavax COVID-19 vaccine does not require a diluent.

CDC will be holding a COCA (Clinician Outreach and Communication Activity) call on the recommendations for Novavax COVID-19 Primary Series in Adults Ages 18 years and Older on Thursday July 28, 2022, from 2:00-3:00 PM ET.

Free Continuing Education (CE) will be offered for this COCA Call and registration is not required. For call details, including zoom link, please visit Webinar Thursday, July 28, 2022 - Recommendations for the Novavax COVID-19 Primary Series in Adults Ages 18 and Older (cdc.gov)

We will keep you informed of any further updates we receive (e.g., ordering, allocation, etc.).

Below, you will find links to additional Novavax resources:

Novavax COVID-19, Adjuvanted Vaccine: Overview and Safety | CDC

Understanding Protein Subunit COVID-19 Vaccines | CDC

Stay Up to Date with Your COVID-19 Vaccines | CDC

COVID-19 Vaccines for People who are Moderately or Severely Immunocompromised | CDC