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A third COVID-19 vaccine is available for adolescents ages 12-17 years.
The Centers for Disease Control and Prevention (CDC) recommended use of the Novavax vaccine for this group Monday, following the Food and Drug Administration’s (FDA’s) issuance of emergency use authorization (EUA) late last week.
The authorization of the protein subunit vaccine comes as about 7.5 million adolescents have not received any doses of a COVID vaccine, according to CDC data.
"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," Novavax CEO Stanley C. Erck said in a press release. "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."
The EUA for adolescents comes just over a month after being granted for adults. The vaccine has been authorized as a two-dose primary series with doses three weeks apart. Clinical trials included more than 2,200 adolescents ages 12-17 years and showed the vaccine was 78% effective against symptomatic infection with the delta variant, according to Novavax. Antibody titers also were higher in adolescents than young adults.
Reactogenicity was similar to adults. The most common adverse reactions among teens were injection site pain (75%), fatigue (58%), headache (57%), muscle pain (49%), nausea/vomiting (20%) and fever (17%), according to Novavax. Most were mild to moderate.
Vaccine manufacturer Pfizer-BioNTech also announced Monday it has requested an EUA for its bivalent COVID vaccine booster containing the omicron/BA.4/5 spike protein for use in people 12 years and older. Moderna has created a similar booster. Those vaccines could be available in September and the CDC has released a guide to help vaccinators and jurisdictions prepare.
Resources
- Information from the FDA on the Novavax COVID-19 vaccine
- CDC clinical considerations for administering COVID-19 vaccines
- Information from the CDC on COVID-19 vaccination of children and teens
- AAP COVID vaccination resources
- AAP pediatric COVID-19 vaccine dosing quick reference guide
- AAP/Health and Human Services COVID vaccine toolkit
- Information from HealthyChildren.org on preparing children for a COVID-19 vaccine
