August 22, 2022
1 min read
Source/Disclosures
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Disclosures:
Erck is employed by Novavax. Walensky has no relevant financial disclosures.
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The CDC on Monday recommended Novavax’s COVID-19 vaccine for use in adolescents aged 12 to 17 years.
CDC Director Rochelle P. Walensky, MD, MPH, signed a decision memo saying the vaccine can be used as third option for primary COVID-19 vaccination in this age group. The FDA issued an emergency use authorization (EUA) for the vaccine on Friday.
Novavax’s COVID-19 vaccine was granted an emergency use authorization by the FDA. Source: Adobe Stock
The two-dose, protein-based vaccine differs from the Pfizer-BioNTech and Moderna messenger RNA vaccines, which are available for children as young as 6 months.
Experts have said that the availability of a non-mRNA vaccine could help reduce COVID-19 vaccine hesitancy.
According to phase 3 trial results Novavax released in February, overall vaccine efficacy in a cohort of more than 2,200 adolescents was 79.5% against PCR-positive mild, moderate or severe COVID-19 cases occurring 7 days or more after the second dose. Efficacy was consistent between two age groups — 12 to 14 years and 15 to 17 years.
Stanley C Erckpresident and CEO of Novavax, said the EUA would “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,” Erck said.
The FDA granted an EUA for the vaccine in adults last month.
References:
CDC recommends Novavax COVID-19 vaccine for adolescents. https://www.cdc.gov/media/releases/2022/s0822-novax-vaccine.html. Published August 22, 2022. Accessed August 22, 2022.
Novavax announces positive results of COVID-19 vaccine in pediatric population of PREVENT-19 phase 3 clinical trial. https://ir.novavax.com/2022-02-10-Novavax-Announces-Positive-Results-of-COVID-19-Vaccine-in-Pediatric-Population-of-PREVENT-19-Phase-3-Clinical- trial Published Feb. 10, 2022. Accessed Aug. 22, 2022.
US FDA grants emergency use authorization for Novavax COVID-19 vaccine, adjuvanted for adolescents aged 12 through 17. https://ir.novavax.com/2022-08-19-US-FDA-Grants-Emergency-Use-Authorization-for -Novavax-COVID-19-Vaccine,-Adjuvanted-for-Adolescents-Aged-12-Through-17. Published Aug. 19, 2022. Accessed Aug. 22, 2022.
perspective
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Diego R Hijano, MD MSc
I read the news from the FDA about authorizing the Novavax vaccine for children aged 12 to 17 years with mixed feelings. Although I remain overall hopeful and welcome additional options for parents, I’m skeptical that this will make a dent in the pandemic.
Many are optimistic at the prospect of having a protein-based vaccine given the concerns parents have expressed toward mRNA vaccines. However, I do not think parents who have not vaccinated their children after seeing the impact of delta and omicron in children will be swayed by having this alternative. In addition, this vaccine has also been linked to myocarditis, and although it is still a very rare side effect — as seen with mRNA vaccines — and significantly lower than the risk for myocarditis associated with COVID-19, it does not give parents the sense of absolute security they are expecting.
An estimated 7.7 million children 12 to 17 have yet to receive their first COVID-19 vaccine, and parents’ intentions to vaccinate their older children have not changed since the start of the year. These children are mostly living in states with an extremely complex sociopolitical scenario that continues to limit the COVID-19 response, leading to preventable deaths.
Disinformation continues to be exponentially amplified because of social media, already making this vaccine a focus of attention, persuading individuals and health care workers against receiving or recommending it.
Although scientific advances should always be applauded, and this vaccine may convince some parents to vaccinate their children, until we tackle disinformation, the role of politics in health and long-standing health inequities within the United States, new vaccines will not be enough to move us forward.
Diego R Hijano, MD MSc
Infectious diseases specialist
Deputy medical director, occupational health
St. Jude Children’s Research Hospital
Memphis, Tennessee
Disclosures: Hijano reports serving as a co-investigator in trials for Pfizer’s pediatric COVID-19 vaccine.
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