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Unlike messenger RNA shots that turn the body’s cells into vaccine factories, Novavax’s shot sparks an immune response by mimicking the coronavirus spike protein. It requires two doses three weeks apart and can be stored at refrigerator temperatures, making it easier to transport than some other immunizations.
European regulators have cleared a two-shot regimen for adults, and Gaithersburg, Maryland-based Novavax filed last month for U.S. authorization for use in adults.
Still, the U.S. market for Novavax’s vaccine may be limited. There are already three alternatives for adults, and the vaccine from Pfizer Inc. and BioNTech SE was cleared for adolescents in May. Since then, 57% of the country’s 12- to 17-year-olds have been fully vaccinated.
Though the Pfizer-BioNTech shot is the only one authorized for U.S. children and teens, Moderna Inc. hopes to soon secure Food and Drug Administration clearance for its shot. Moderna has faced delays as regulators study the risk of myocarditis, a rare form of heart inflammation.
Novavax executives said in a media briefing that they still see an opportunity to reach teens, given low levels of vaccination compared with adults and the shot’s performance against variants. Novavax said it plans to begin studying the shot in even younger children in the second quarter.
The trial was conducted at 73 U.S. sites last year while the delta variant was still dominant. Two-thirds of participants received the vaccine, and one-third were given a placebo. The shot was 82% effective in preventing symptomatic Covid cases caused by delta and consistent across all ages, Novavax said. Immune responses were generated against several variants, including omicron, and 12- to 17-year-olds had a stronger response than adults.
“We are encouraged by the results in this adolescent population given the ongoing need for alternative vaccine options,” Chief Medical Officer Filip Dubovsky said. “We believe the Novavax vaccine could be a differentiated option for this younger population given its established protein-based technology already used in other vaccines, and the positive responses demonstrated against variants.”
European regulators have cleared a two-shot regimen for adults, and Gaithersburg, Maryland-based Novavax filed last month for U.S. authorization for use in adults.
Still, the U.S. market for Novavax’s vaccine may be limited. There are already three alternatives for adults, and the vaccine from Pfizer Inc. and BioNTech SE was cleared for adolescents in May. Since then, 57% of the country’s 12- to 17-year-olds have been fully vaccinated.
Though the Pfizer-BioNTech shot is the only one authorized for U.S. children and teens, Moderna Inc. hopes to soon secure Food and Drug Administration clearance for its shot. Moderna has faced delays as regulators study the risk of myocarditis, a rare form of heart inflammation.
Novavax executives said in a media briefing that they still see an opportunity to reach teens, given low levels of vaccination compared with adults and the shot’s performance against variants. Novavax said it plans to begin studying the shot in even younger children in the second quarter.
The trial was conducted at 73 U.S. sites last year while the delta variant was still dominant. Two-thirds of participants received the vaccine, and one-third were given a placebo. The shot was 82% effective in preventing symptomatic Covid cases caused by delta and consistent across all ages, Novavax said. Immune responses were generated against several variants, including omicron, and 12- to 17-year-olds had a stronger response than adults.
“We are encouraged by the results in this adolescent population given the ongoing need for alternative vaccine options,” Chief Medical Officer Filip Dubovsky said. “We believe the Novavax vaccine could be a differentiated option for this younger population given its established protein-based technology already used in other vaccines, and the positive responses demonstrated against variants.”
Novavax COVID-19 vaccine (Nuvaxovid): Data on side effects
This Snapshot feature offers an overview of Nuvaxovid, Novavax's COVID-19 vaccine, and what we currently know about its potential side effects.
www.medicalnewstoday.com