By Pooja Toshniwal PahariaApr 27 2023 In a recent study published in JAMA Network Open, researchers evaluated the efficacy, immunogenicity, and safety of Novavax’s NVX-CoV2373 vaccine in preventing coronavirus disease 2019 among 12-to 17-year-old adolescents.
The PREVENT-19 phase 3 trial findings demonstrated that the recombinant SARS-CoV-2 spike protein-encoding and Matrix-M-adjuvanted NVX-CoV2373 vaccine was effective and safe among adults in preventing symptomatic SARS-CoV-2 infections. Following the results, the trial was expanded to include vaccine assessments among adolescents.
A total of 57 adolescents with immunosuppressive conditions or prior COVID-19 history were excluded from the analysis. Therefore, out of 2,304 adolescents screened initially, 2,247 were 2:1 randomized to receive either two 0.50 mL intramuscular NVX-CoV2373 vaccine injections or placebo , 3.0 weeks apart.
In addition, serological human angiotensin-converting enzyme-2 -binding inhibition antibody titers and anti-S protein immunoglobulin G titers were determined using enzyme-linked immunosorbent assays . Further, a post hoc analysis was performed by measuring humoral responses against SARS-CoV-2 variants of concern , such as the Alpha VOC, Beta VOC, Gamma VOC, Delta VOC, and Omicron VOC, and variants of interest such as the Mu VOI.
Within 64 days of the follow-up period, 20 cases of mild COVID-19 were reported, including six cases in the NVX-CoV2373 vaccine recipient group and 14 cases in the placebo group. The incidence rates among NVX-CoV2373 vaccinees and placebo recipients were 2.9 and 14, respectively, yielding a 79.50% efficacy for NVX-CoV2373.