The Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for Novavax COVID-19 Vaccine, Adjuvanted to include use in adolescents 12 to 17 years of age for preventing COVID-19 caused by SARS-CoV-2.
Novavax COVID-19 Vaccine, Adjuvanted 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 expanded authorization was based on data from the ongoing randomized, placebo-controlled phase 3 PREVENT-19 trial (ClinicalTrials.gov Identifier: NCT04611802), which included 2247 adolescents 12 to 17 years of age in the US. Participants were randomly assigned 2:1 to receive 2 intramuscular injections of either Novavax COVID-19 Vaccine, Adjuvanted 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 participants at baseline.
Findings demonstrated overall vaccine efficacy of 78.29% (95% CI, 37.55-92.45) at a time when the Delta variant was predominantly circulating in the US. Moreover, antibody titers were found to be higher in adolescents compared with young adults.
The most common solicited adverse reactions reported by vaccine recipients were injection site pain/tenderness (75.0%), headache (56.9%), fatigue/malaise (57.9%), muscle pain (49.0%), nausea/vomiting (19.9%), joint pain (16.2%), fever (16.9%), injection site swelling (8.0%), and injection site redness (7.5%).
“Having more vaccine options for use in both adults and adolescents, like the Novavax COVID-19 Vaccine, Adjuvanted will hopefully help increase vaccination rates, particularly as we prepare for ongoing surges of COVID-19 with the start of fall and the back-to-school season,” said Stanley C. Erck, President and CEO, Novavax. “We hope that our vaccine, developed using an innovative approach to recombinant protein vaccine technology, may have a special role in adolescent vaccination based on parents’ and caregivers’ familiarity with protein-based vaccines used in other disease areas.”
Novavax COVID-19 Vaccine, Adjuvanted 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.
- U.S. FDA grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for adolescents aged 12 through 17. News release. Novavax, Inc. August 19, 2022. Accessed August 22, 2022. https://www.prnewswire.com/news-releases/us-fda-grants-emergency-use-authorization-for-novavax-covid-19-vaccine-adjuvanted-for-adolescents-aged-12-through-17-301609432.html
- 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 August 22, 2022. https://www.fda.gov/media/159897/download