The Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to the Novavax COVID-19 Vaccine (NVX-CoV2373), Adjuvanted for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
The Novavax COVID-19 Vaccine is engineered from the genetic sequence of SARS-CoV-2 using the Company’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. The vaccine contains the Company’s saponin-based Matrix-M™ adjuvant technology to enhance and prolong immune responses. It is administered intramuscularly as a 2-dose primary series (0.5mL each), separated by 3 weeks.
The authorization was based on data from the phase 3 PREVENT-19 trial (ClinicalTrials.gov Identifier: NCT04611802), a randomized, placebo-controlled study that evaluated the efficacy, safety and immunogenicity of the Novavax COVID-19 Vaccine in 29,945 participants 18 years of age and older in the US and Mexico.
Participants were randomly assigned 2:1 to receive 2 intramuscular injections of either Novavax COVID-19 Vaccine or placebo administered 21 days apart. The primary endpoint was the first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least 7 days after the second dose in serologically negative adult participants at baseline.
Results showed that the Novavax COVID-19 Vaccine met the primary endpoint demonstrating vaccine efficacy of 90.4% (95% CI, 83.8-94.3; P <.001), with 17 cases observed in the vaccine arm compared with 79 in the placebo arm. There were no moderate or severe COVID-19 cases reported in the vaccine arm compared with 9 cases of moderate COVID-19 and 4 cases of severe COVID-19 in the placebo arm. Moreover, the vaccine was found to be 78.6% effective in participants 65 years of age and older.
The safety population was comprised of approximately 26,000 participants who received the vaccine (21,000 vaccine recipients had at least 2 months of safety follow-up after the second dose) and 25,000 participants who received placebo. 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 has been reported in clinical trials.
“After a comprehensive analysis and evaluation of the data, and assessment of the manufacturing processes and information, as well as input from the FDA’s committee of external independent advisors, the FDA’s medical and scientific experts have determined that the vaccine meets the FDA’s high standards for safety and effectiveness for emergency use authorization,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Novavax COVID-19 Vaccine, Adjuvanted provides another alternative for adults and adds another vaccine to the COVID-19 vaccine supply for the United States.”
The Novavax COVID-19 Vaccine 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.
- Coronavirus (COVID-19) update: FDA authorizes emergency use of Novavax COVID-19 Vaccine, Adjuvanted. News release. US Food and Drug Administration. Accessed July 14, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-emergency-use-novavax-covid-19-vaccine-adjuvanted
- Fact sheet for healthcare providers administering vaccine (vaccination provider): Emergency Use Authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted to prevent coronavirus disease 2019 (COVID-19). Accessed July 14, 2022. https://www.fda.gov/media/159897/download
- US FDA grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for individuals aged 18 and over. News release. Novavax, Inc. Accessed July 14, 2022. https://www.prnewswire.com/news-releases/us-fda-grants-emergency-use-authorization-for-novavax-covid-19-vaccine-adjuvanted-for-individuals-aged-18-and-over-301586272.html