Novavax on Thursday introduced that its COVID-19 vaccine was round 80% efficient amongst adolescents aged 12 to 17 years in a section 3 trial.
The corporate, which not too long ago asked the FDA to authorize the vaccine for emergency use in adults, mentioned it will complement its international filings with knowledge from the pediatric trial someday within the first quarter of 2022.
Novavax’s protein-based vaccine differs from Pfizer’s messenger RNA vaccine, which is the one COVID-19 vaccine at present accepted for any pediatric inhabitants within the U.S. Consultants have mentioned that the supply of a non-mRNA vaccine could help reduce COVID-19 vaccine hesitancy.
The trial enrolled 2,247 adolescents aged 12 to 17 years and assigned two-thirds of them to obtain two injections of 5 g of vaccine plus 50 g of an adjuvant given 21 days aside. The opposite third obtained a placebo.
The trial started in April 2021 and concluded in September, with a lot of the efficacy knowledge being collected when delta was the dominant circulating SARS-CoV-2 variant.
Total vaccine efficacy was 79.5% in opposition to PCR-positive gentle, reasonable or extreme COVID-19 circumstances occurring 7 days or extra after the second dose, Novavax mentioned. Solely gentle circumstances had been recorded in both arm — six within the vaccine arm and 14 within the placebo arm. Efficacy was constant between two age teams — 12 to 14 years and 15 to 17 years.
Among the many 11 circumstances for which sequencing was accessible, all had been brought on by the delta variant — three within the vaccine arm and eight within the placebo arm. Efficacy in opposition to delta was calculated to be 82%.
“We will display the neutralizing antibodies that we made in adolescents should not inferior to these in adults, and we may declare that they work on the similar degree as an grownup,” Filip Dubovsky, MPH, chief medical officer at Novavax, mentioned throughout a name with reporters.
Adolescent neutralizing antibody responses utilizing wild-type SARS-CoV-2 had been roughly 1.5-fold larger amongst adolescents in contrast younger adults aged 18 to 25 years, assembly FDA-specified standards, Dubovsky mentioned. Furthermore, knowledge from the trial demonstrated that adolescents’ useful immune responses in opposition to variants had been 2.4- to 4-fold larger than adults’ responses.
Printed knowledge from the corporate’s giant section 3 trial confirmed the vaccine was additionally highly effective in adults.
“What we have proven you again and again is the consistency of [the] efficacy of our vaccine, whether or not or not it’s in opposition to the prototype pressure or the various pressure,” Dubovsky mentioned.
Information from the pediatric trial confirmed that the vaccine was effectively tolerated, with the commonest antagonistic reactions being injection web site tenderness or ache, complications, myalgia, fatigue and malaise.
“What we additionally did was evaluate this to the outcomes we acquired in adults, and after this one, they had been typically comparable with no improve in severity,” Dubovsky mentioned. “The one improve we actually noticed are some redness and erythema within the arms of the kids, and that is probably simply because they’ve thinner arms, and it was simpler to identify these reactions.”
He mentioned there was no improve in reactogenicity in 12- to 15-year-old adolescents in contrast with 15- to 18-year-old adolescents.