In a paper recently published in JAMA Network Open, researchers evaluated the efficacy, immunogenicity, and protection of Novavax’s NVX-CoV2373 vaccine for preventing coronavirus disease 2019 (COVID-19) in adolescents aged 12 to 17 years.
COVID-19 has caused unprecedented morbidity and mortality in both adults and children. Mitigating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections requires expanding the immunization policy to other team people of all ages for the global fitness burden of COVID-19, namely the burden of intellectual fitness among adolescents.
Results from the Phase 3 PREVENT-19 trial demonstrated that the recombinant vaccine encoding SARS-CoV-2 spike protein (S) and NVX-CoV2373 with Matrix-M adjuvant was effective and in adults in preventing symptomatic SARS-CoV-2 infections Following the results, the trial was expanded to include vaccine evaluations in adolescents.
In the existing randomized controlled trial (RCT), researchers investigated whether NVX-CoV2373 is safe, immunogenic, and effective in adolescents.
The ongoing placebo-controlled, observer-blinded, PREVENT-19 trial conducted at 73 centers in the United States (USA). Follow-up testing related to vaccine protection to provide active vaccines to all people.
A total of 57 adolescents with immunosuppressive situations or a history of COVID-19 were excluded from the analysis. Thus, of the 2304 adolescents examined first, 2247 were randomized 2:1 to receive two 0. 50 mL intramuscular (IM) injections NVX-CoV2373 vaccine (comprising 5. 0 μg and 50. 0 μg SARS-CoV-2 spike protein and adjuvant, respectively) or placebo (normal saline, NS), 3. 0 weeks apart.
The number one outcomes of the study were serological non-inferiority of neutralizing antibody (nAb) responses in adolescents compared to those of the PREVENT-19 young adult cohort, adding those aged 18 to 25 years; vaccine effectiveness against SARS-CoV-2 infection, and evaluation of protection and reactogenicity.
Data on locally and systemically requested adverse events (AEs) were received through electronic diaries for one week after each injection. Unsolicited adverse events have been reported after the initial dose up to 4. 0 weeks after the current dose. SARS-CoV-2 nAb titers were measured in serum samples received at baseline (day 0) and 35 days after microneutralization assays.
In addition, serological titers of human angiotensin-converting enzyme-binding enzyme 2 (hACE2) binding inhibitors and anti-protein S immunoglobulin G (IgG) titers were determined using the enzyme-linked immunosorbent assay (ELISA). In addition, a special research was conducted measuring the opposite humoral responses to fear variants (VOCs) of SARS-CoV-2, such as Alpha VOC, Beta VOC, Gamma VOC and Omicron VOC and Omicron VOC VOC, and variants of interest (VOI) such as Mu VOI. Prior exposure to SARS-CoV-2 was made based on the serological presence of anti-nucleoprotein antibodies and/or positive effects of reverse transcription polymerase chain reaction (RT-PCR) for SARS-CoV-2, analyzed using nasal swab samples received from participants at the beginning of the study.
The efficacy of NVX-CoV2373 in preventing symptomatic COVID-19 verified by RT-PCR [according to U. S. Food and Drug Administration (FDA) guidelines]U. S. ] with initiation after ≥ 1. 0 weeks after the time vaccination was evaluated to be consistent with the protocol’s evaluation of vaccine efficacy The team agreed with total genome sequencing (WGS) in samples tested for SARS-CoV-2-positive via RT-PCR with a sufficiently good load of SARS-CoV-2 ribonucleic acid (RNA).
Among 2232 adolescents, 1487 and 745 adolescents belonged to the NVX-CoV2373 vaccination organization and the placebo organization, respectively. The average age of participants 14 years; 53% (n=1172) were male, 74% (n=1660) were Caucasian, and 16% (n=359) had a history of COVID-19. After COVID-19 vaccination, a price of 1. 5 was observed geometrically dividing mean titers (GMT) from nAb in adolescents to titers in young adults.
Within 64 days (median) of the follow-up period, 20 cases of mild COVID-19 were reported, adding six cases in the NVX-CoV2373 vaccinated organization and 14 cases in the placebo organization. Occurrence rates (number of COVID-19 cases per hundred individual years) between those vaccinated with NVX-CoV2373 and those receiving placebo were 2. 9 and 14, respectively, giving an efficacy of 79. 50% for NVX-CoV2373.
The WGS was aware of SARS-CoV-2 Delta VOC among 11 participants, with a vaccine efficacy against Delta VOC of 82%. GMT nAbs and humoral responses were particularly superior in those vaccinated than in those receiving placebo. On day 35. 0, physically potent IgG titers opposed wild-type strain peak proteins and all tested variants, adding Omicron sub-VOC BA. 1, BA. 2 and BA. 5.
Antibody titers inhibiting the HACE2 receptor were largely similar to anti-S titers IgG, decreasing for Omicron subCOVs. Transient and mild to moderate reactogenicity was observed, with an increase in frequency after the time of vaccination with NVX-CoV2373. Rarely observed and none of the AEs caused the exam to stop.
The maximum requested local AEs observed were injection site pain and tenderness for ≤ 2. 0 days, and the maximum documented requested systemic AEs were headache, fatigue, myalgia and malaise. The frequencies of unsolicited RAs were comparable in both groups.
In conclusion, based on the effects of the study, vaccination with NVX-CoV2373 was immunogenic, effective and in the prevention of SARS-CoV-2 infections, adding VOC Delta infections, in adolescents. Vaccine-induced SARS-CoV-2 nAb titers were comparable in adolescents and young adults.
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Toshniwal Paharia, Pooja Toshniwal Paharia. (2023, April 27). The NVX-CoV2373 COVID vaccine is effective in preventing COVID-19 in adolescents. Retrieved April 28, 2023, https://www. news-medical. net/news/20230427/NVX-CoV2373-COVID-vaccine–and-effective-in-the-prevention-of-COVID-19-in-adolescents. aspx.
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Toshniwal Paharia, Pooja Toshniwal Paharia. ” NVX-CoV2373 COVID vaccine and effective to save you from COVID-19 in adolescents”. News-Medical. 28 April 2023. .
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Toshniwal Paharia, Pooja Toshniwal Paharia. ” NVX-CoV2373 COVID vaccine and effective to save you COVID-19 in adolescents”. Medical news. https://www. news-medical. net/news/20230427/NVX-CoV2373-COVID- vacuna–y-efectivo-en-save youing-COVID-19-in-adolescent. aspx. (accessed April 28, 2023).
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Toshniwal Paharia, Pooja Toshniwal Paharia. 2023. La COVID vaccine NVX-CoV2373 is effective in preventing COVID-19 in adolescents. News-Medical, accessed April 28, 2023, https://www. news-medical. net/news/ 20230427/NVX-CoV2373-COVID-vaccine–and-efective-in-preventing-COVID-19-in-adolescentArrayaspx.
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