From the NDDoH: COVID Vaccine Update: Novavax COVID-19 Vaccine, COMIRNATY® (Pfizer) Approval

Novavax COVID-19 Vaccine:

The Advisory Committee on Immunization Practices (ACIP) met July 19th to discuss Novavax COVID-19 vaccine. CDC has endorsed ACIP’s recommendation of the NOVAVAX COVID-19 vaccine. Please see below for a Novavax overview.

ACIP voted to recommend 12 YES - 0 NO “a two dose Novavax COVID-19 vaccine, adjuvanted, is recommended as a COVID-19 primary series for persons 18 years and older under the EUA issued by FDA.” No specific recommendations were made today for immunocompromised individuals or booster doses of Novavax, but clinical guidance and future ACIP meetings are to come. See all ACIP slides.

The interim clinical considerations will be updated in the near future. Here are key highlights from the interim clinical considerations presented at the ACIP meeting.

• For people who are not moderately or severely immunocompromised, Novavax COVID-19 vaccine for adults 18+ first and second doses should be administered 3-8 weeks apart.  
• For people who are moderately or severely immunocompromised, Novavax COVID-19 vaccine for adults 18+ first and second doses should be administered 3 weeks apart. 
• The following are NOT currently authorized for people receiving a Novavax COVID-19 Vaccine primary series:
• 3rd primary dose for people who are moderately or severely immunocompromised
• Booster dose using ANY COVID-19 vaccine after a Novavax primary series 
• CDC will provide clinical guidance for what FDA authorizes; once authorized, these doses can be added to the COVID-19 vaccination schedule

Novavax COVID-19 Vaccine Characteristics:

• Age indication: 18 years and older primary series
• Interval: 2 dose primary series 21 days apart 
• Dose: 5 mcg SARS-CoV-2rS 50 mcg Matrix-M™ adjuvant 
• Injection volume: 0.5 mL 
• Preparation: Do not dilute 
• Doses per vial: 10 doses Injection route/site: Intramuscular/deltoid
• Storage: Refrigerator 2° to 8°C (36°to 46°F) DO NOT FREEZE 
• Beyond use time: 6 hours after first puncture
• Expiration: No expiration date is printed on the vial or carton

A limited number of doses of Novavax were purchased for use in the United States. Novavax doses are not yet available for use in North Dakota. In the future when Novavax vaccine is available providers will be able to order vaccine if they have patients who will not be vaccinated otherwise. Providers will be notified when doses are available.

Additional Resources:

Fact Sheet for Healthcare Providers Administering Vaccine     

Fact Sheet for Recipients and Caregivers

Educational Opportunities:

 CDC COCA Webinar: Webinar Thursday, July 28, 2022 - Recommendations for the Novavax COVID-19 Primary Series in Adults Ages 18 and Older (cdc.gov)

 

FDA Approval of COMIRNATY® (Pfizer) For Adolescents 12 through 15 Years of Age:

Late last week the FDA announced that they have expanded their approval of the Pfizer COMIRNATY® product down to 12 years of age. This means that the COMIRNATY® product is now fully licensed for use 12 years and older in the United States. FDA-approved COMIRNATY ® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA-authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use. 

At this time the COMIRNATY ® product is not available for use by providers in North Dakota. Providers should continue to administer the Pfizer-TRIS 12+ (Gray Cap) product to this population as appropriate.

Please do not reply directly to this email as immunization staff will not receive it.  Please email covidvaccine@nd.gov if you have questions.