Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine

Abstract

BACKGROUNDEarly clinical data from studies of the NVX-CoV2373 vaccine (Novavax), a recombinant nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that contains the full-length spike glycoprotein of the prototype strain plus Matrix-M adjuvant, showed that the vaccine was safe and associated with a robust immune response in healthy adult participants. Additional data were needed regarding the efficacy, immunogenicity, and safety of this vaccine in a larger population. METHODSIn this phase 3, randomized, observer-blinded, placebo-controlled trial conducted at 33 sites in the United Kingdom, we assigned adults between the ages of 18 and 84 years in a 1:1 ratio to receive two intramuscular 5-μg doses of NVX-CoV2373 or placebo administered 21 days apart. The primary efficacy end point was virologically confirmed mild, moderate, or severe SARS-CoV-2 infection with an onset at least 7 days after the second injection in participants who were serologically negative at baseline. RESULTSA total of 15,187 participants underwent randomization, and 14,039 were included in the per-protocol efficacy population. Of the participants, 27.9% were 65 years of age or older, and 44.6% had coexisting illnesses. Infections were reported in 10 participants in the vaccine group and in 96 in the placebo group, with a symptom onset of at least 7 days after the second injection, for a vaccine efficacy of 89.7% (95% confidence interval [CI], 80.2 to 94.6). No hospitalizations or deaths were reported among the 10 cases in the vaccine group. Five cases of severe infection were reported, all of which were in the placebo group. A post hoc analysis showed an efficacy of 86.3% (95% CI, 71.3 to 93.5) against the B.1.1.7 (or alpha) variant and 96.4% (95% CI, 73.8 to 99.5) against non-B.1.1.7 variants. Reactogenicity was generally mild and transient. The incidence of serious adverse events was low and similar in the two groups. CONCLUSIONSA two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant.

Overview of the Main Anti-SARS-CoV-2 Vaccines: Mechanism of Action, Efficacy and Safety

“…As of June 28, 2021, VAERS (Vaccine Adverse Events Reporting System) has received 780 reports of myocarditis or pericarditis among people 30 years and younger who received a Covid-19 vaccine. 34,42 On July 14th, US FDA includes risk of Guillain-Barré Syndrome (GBS) in Janssen COVID-19 vaccine pertaining to an observed increased risk of GBS following vaccination (source: US Food and Drug Administration https:// www.fda.gov/news-events/press-announcements/corona virus-covid-19-update-july-13-2021).…”

Genomic surveillance to combat COVID-19: challenges and opportunities

“…Furthermore, the alpha variant was detected in more than 60% of confirmed cases, suggesting good vaccine effectiveness. 28 By contrast, in 4400 patients in a South African phase 2b trial of the same vaccine, the efficacy was only 49•4% (95% CI 6•1-72•8). Further sequencing data revealed that 92•7% of cases were the beta variant.…”

Anti-COVID-19 Vaccination in Patients with Autoimmune-Autoinflammatory Disorders and Primary/Secondary Immunodeficiencies: The Position of the Task Force on Behalf of the Italian Immunological Societies

“…Anti-COVID-19 vaccines of the traditional type that are composed of inactivated virus or recombinant Spike protein and adjuvant [19], for which wider scientific knowledge and clinical experience are available, could preferentially be indicated in patients with AIAIDs, PIDs, and SIDs. However, despite demonstrated efficacy for the NVX-CoV2373 of 89.7% [20], no traditional vaccines are approved by the European Medicines Agency (EMA) yet (Table 4. )…”