A booster dose of the Novavax COVID-19 vaccine can now be given to adults who are unable or would otherwise not receive a messenger RNA (mRNA) updated (bivalent) COVID-19 booster.
The U.S. Food and Drug Administration (FDA) has amended the emergency use authorization for the Novavax COVID-19 vaccine to authorize a Novavax COVID-19 booster dose for adults age 18 years and older at least 6 months after completion of the primary series. The Centers for Disease Control and Prevention (CDC) updated its COVID-19 booster recommendations to include the option of a monovalent Novavax booster in certain situations, such as if a person is unable to receive an mRNA vaccine (i.e., allergies to ingredients, past severe reactions) or would otherwise not receive a booster dose.
Novavax’s COVID-19 vaccine uses a more familiar vaccine technology using protein subunits. Vaccines using protein subunits have been used for more than 30 years in the United States, beginning with the first licensed hepatitis B vaccine. Other protein subunit vaccines used in the United States today include those to protect against influenza, shingles, and whooping cough (acellular pertussis).
The two-dose primary series (5 mcg/0.5 mL) is given intramuscularly 3-8 weeks apart for previously unvaccinated individuals 12 years and older. The Novavax booster (only for adults ages 18 years and older) has the same dose amount as the primary series (5 mcg/0.5 mL) and can be administered at least 6 months from the second dose of the primary series.
Novavax is packaged in 10 multidose vials (100-dose cartons) and does not require dilution. It can be stored in the refrigerator (2 degrees to 8 degrees Celsius/36 degrees to 46 degrees Fahrenheit). It should not be stored in a freezer.
- Orders for Novavax can be placed through the ImpactSIIS Vaccine Ordering Management System (VOMS). VOMS is open for providers to place orders 24 hours a day, 7 days a week
- The minimum order quantity is 100 doses
- Orders can be placed using the COVID-19 – Janssen and Novavax order set
- Providers must enter the total quantity requested for each vaccine in the “Doses Requested” field in multiples of 100
- The ability to administer 10 doses within 6 hours once a vial is opened should be a planning consideration for orders. Sites should consider currently configured vial size (10-dose vials) when scheduling vaccinations to optimize use of the supply.
- Novavax can be stored in the refrigerator (2º to 8º C or 36º to 46º F). It should not be stored in any type of freezer.
- After the first puncture, the vaccine can be stored at room temperature for up to 6 hours at 2º C to 25º C (36º F to 77º F). Providers should record the date and time of first puncture on the vial.
- The Novavax vial and carton do not have a printed expiration date. To find the expiration date, access NovavaxCovidVaccine.com, navigate to the United States Healthcare Professional section of the website, and enter the lot number printed on the carton or vial into the “Expiry Date Checker” tool.
- No diluent is required, and the vaccine is preservative free.
- To maximize doses administered per vial and minimize wastage, providers are encouraged to schedule appointments for Novavax if possible.
- UPDATED – Novavax Fact Sheet for Healthcare Providers
- UPDATED – Novavax Fact Sheet for Recipients and Caregivers
- Novavax Expiry Checker.
The Ohio Department of Health (ODH) COVID-19 Provider website is a hub for a variety of resources for vaccine providers. Vaccine providers with questions may call the ODH Provider Call Center at 844.9ODHVAX (844.963.4829) between 8 a.m. and 5:30 p.m. Mondays through Fridays or email COVIDVACCINE@odh.ohio.gov.