The Centers for Disease Control and Prevention’s (CDC) Director Rochelle P. Walensky, MD, MPH, has endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation that the Novavax COVID-19 Vaccine, Adjuvanted be used as a 2-dose primary series in individuals 18 years of age and older for the prevention of COVID-19. The recommendation comes after the Food and Drug Administration (FDA) granted Emergency Use Authorization for the vaccine.
“Today, we have expanded the options available to adults in the US by recommending another safe and effective COVID-19 vaccine,” said Walensky. “If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated.”
The Novavax COVID-19 Vaccine, Adjuvanted contains purified, full-length recombinant spike protein and the Company’s saponin-based Matrix-M™ adjuvant to enhance and prolong immune responses. According to the CDC, protein subunit vaccines have been used for more than 30 years in the US. The vaccine is administered intramuscularly as a 2-dose primary series (0.5mL each), separated by 3 weeks.
The authorization was based on data from the pivotal phase 3 PREVENT-19 trial (ClinicalTrials.gov Identifier: NCT04611802), which evaluated the efficacy, safety and immunogenicity of the Novavax COVID-19 Vaccine, Adjuvanted in 29,945 participants 18 years of age and older in the US and Mexico. Findings from the trial showed vaccine efficacy of 90.4% efficacy (95% CI, 83.8-94.3; P <.001), with no moderate or severe COVID-19 cases reported in the vaccine arm. The vaccine was found to be 78.6% effective in participants 65 years of age and older.
The most common adverse reactions reported by vaccine recipients were injection site pain/tenderness (82.2%), fatigue/malaise (62.0%), muscle pain (54.1%), headache (52.9%), joint pain (25.4%), nausea/vomiting (15.6%), injection site redness (7.0%), injection site swelling (6.3%), and fever (6.0%). Myocarditis and pericarditis following administration of the Novavax COVID-19 Vaccine, Adjuvanted have been reported in clinical trials.
The Novavax COVID-19 Vaccine, Adjuvanted will be available in the coming weeks and is supplied as a suspension in a carton containing 10 multidose vials; each vial contains 10 doses of 0.5mL each. An unpunctured multidose vial should be refrigerated between 36-46°F (2 to 8°C). After the first needle puncture of the vial, the vial can be stored between 36-77°F (2 to 25°C) for up to 6 hours; the vial must be discarded 6 hours after the first puncture.
- CDC recommends Novavax’s COVID-19 Vaccine for adults. News release. Centers for Disease Control and Prevention. July 19, 2022. Accessed July 20, 2022. https://www.cdc.gov/media/releases/2022/s0719-covid-novavax-vaccine.html
- US CDC Advisory Committee unanimously recommends Novavax COVID-19 Vaccine, Adjuvanted as a primary series for individuals aged 18 and older. News release. Novavax, Inc. July 19, 2022. Accessed July 20, 2022. https://www.prnewswire.com/news-releases/us-cdc-advisory-committee-unanimously-recommends-novavax-covid-19-vaccine-adjuvanted-as-a-primary-series-for-individuals-aged-18-and-older-301589582.html