FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine in Ages 12-17

Vaccine developer Novavax announced on Sunday that the US Food and Drug Administration (FDA) had authorized the emergency use of the company's COVID-19 vaccine, adjuvanted in adolescents aged 12 through 17.

The new vaccine, approved as a two-dose primary series, is a protein subunit vaccine that delivers 5 mcg of the fully formed spike protein along with an adjuvant that focuses the attention of the innate immune system on the spike antigen. This technology is also used, among others, in the hepatitis B and HPV vaccines.

"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," Stanley C. Erck, president and chief executive officer at Novavax said in a statement.

The FDA's decision was based on data from the ongoing pediatric expansion of Phase 3 clinical trial of 2,247 adolescents aged 12 through 17. The vaccine achieved its clinical efficacy of 78.29% overall at a time when the Delta variant was the predominant strain in the US.

In the trial, participants experienced side effects following administration of any dose of the vaccine, such as 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%).

Last month, the FDA issued an emergency use authorization for the Novavax vaccine as the primary series among people ages 18 and older. In the clinical trial, which enrolled approximately 30,000 participants aged 18 years and over in the US and Mexico, the vaccine demonstrated 90.4% efficacy.

Novavax said in July that clinical data demonstrate that the vaccine offers broad immune responses against circulating variants, such as the Omicron BA.4/5, that now account for more than 90% of cases in the US.

The company said it would accelerate its focus on the latest Omicron variants and expects to provide an Omicron-containing vaccine in the last quarter of 2022.

Resources:

1. Novavax. U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Adolescents Aged 12 Through 17.

2. Novavax. U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Individuals Aged 18 and Over.

3. Novavax. Novavax Statement on Prototype Vaccine’s Broad Immune Responses and Accelerated Focus on Omicron BA.4/5 as Recommended by the FDA.