FDA Expands Emergency Use Authorization for Novavax COVID Vaccine in Kids

As the COVID pandemic progresses and infection rates fluctuate, public health officials and organizations seek to provide more options to protect against illness. On August 19, Novavax announced that its emergency use authorization (EUA) for the COVID vaccine has been expanded for children between the ages of 12 and 17.

This action makes it the third COVID vaccine — alongside the Pfizer and Moderna vaccines — available to this age bracket. The Novavax vaccine was initially issued an EUA for use in adults over 18 in July 2022.

According to the Novavax press statement, this vaccine is the first and only COVID vaccine on the market in the United States that is protein-based.

The CDC advises that this vaccine should be given as a two-dose series, with the second dose being administered approximately three weeks after the first. Furthermore, the FDA states that the second dose can be administered up to eight weeks after the first before the series would need to be restarted.

As stated in the Novavax press release, this approval comes after multiple clinical trials of the vaccine on pediatric patients. Phase III results of the Novavax vaccine in adolescents aged 12 through 17 showed an 82% efficacy against the delta variant.

Additionally, the company noted heightened immune responses against all variants. Pediatric patients’ immune responses were up to four times as much as the adult immune responses.

Finally, the study concluded that the vaccine is safe for all age ranges, with the most common side effects, including injection site pain, headache, and fatigue, being relatively mild.

As we approach the fall months, where infection risk may grow due to increased indoor activity and close contact, having an additional option to protect pediatric patients may widen access to preventative measures and provide increased immunity.

In addition to pediatric vaccinations, adults who have not received their primary vaccination series are strongly urged to receive one of the vaccinations available and approved in the US. Furthermore, people eligible for a booster should contact a healthcare professional as fall boosters may help reduce COVID-related illness, mortality, and healthcare spending.

"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. 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,” stated Stanley C. Erck, President and Chief Executive Officer, Novavax, in the press release.