The Novavax COVID-19 vaccine has been granted emergency use authorization (EAU) status by the Food and Drug Administration (FDA), and the Advisory Committee on Immunization Practices has recommended it for adults ages 18 and older. The mechanism of action of this vaccine is like other vaccines the public is already familiar with receiving and doesn’t use mRNA vaccine technology.
Novavax was found to be 90.4% effective in preventing mild, moderate, or severe COVID-19 in clinical trials conducted during Alpha variant predominance, according to the FDA’s statement on the authorization. No cases of moderate or severe COVID-19 were reported in participants who received the vaccine, compared with nine cases of moderate COVID-19 and four cases of severe COVID-19 reported in placebo recipients. In the subset of participants 65 years of age and older, the vaccine was 78.6% effective. Since the clinical trial was conducted prior to the emergence of Delta and Omicron variants, current effectiveness is expected to be highly reduced.
The safety profile for Novavax is similar to that of the mRNA vaccines, including a risk of vaccine related myocarditis/pericarditis, but the rate of fever after Novavax COVID-19 vaccine was lower than that of the mRNA COVID vaccines.
Clinical considerations for Novavax COVID-19 vaccine:
- The Novavax COVID-19 vaccine is authorized for a two-dose primary series, administered three to eight weeks apart. The three-week interval is recommended for immunocompromised individuals and those age 65 years and older. No third primary series dose is authorized for this vaccine and no booster is authorized yet.
- It isn’t interchangeable with other vaccines for the primary series, unless a contraindication appears with the first dose. If that happens, a mRNA vaccine should be administered at least four weeks after the first dose.
- It can be co-administered with any other vaccine, except for an orthopoxvirus vaccine. An interval of at least four weeks is recommended after administering either ACAM2000 or JYNNEOS vaccines prior to administering any COVID-19 vaccine.
- Uptake will most likely be limited since only a small percentage of the unvaccinated are expressing an interest in the vaccine.
Intermountain clinics that administer COVID-19 vaccines can order the vaccine in VOMS (100 dose minimum order), or smaller numbers of doses of the vaccine can be transferred to them from the Supply Chain Center by ordering through the Medical Group COVID-19 vaccine ordering spreadsheet.
Additional information for caregivers and recipients:
- FDA Fact Sheet for Healthcare Providers Administering Vaccine
- Fact Sheet for Recipients and Caregivers