1. The Novavax vaccine provided high efficacy for the prevention of Covid-19.
2. The Novavax vaccine provided high efficacy against Covid-19 variants of concern or interest.
Evidence Rating Level: 1 (Excellent)
Study Rundown: The Novavax vaccine (NVX-CoV2373) is an adjuvanted, recombinant spike protein nanoparticle vaccine that has been previously shown to have clinical efficacy for the prevention of Covid-19 in the United Kingdom and South Africa. However, there is a gap in knowledge as to understand its efficacy in North America and against common variants such as alpha, beta, P.1, B.1.427, B.1.429, and B.1.526. This study found that the Novavax vaccine is safe and highly protective against SARS-CoV-2 strains, and can prevent moderate-to-severe Covid-19 as well as any symptomatic Covid-19 in people who are at high risk for infection. This study was limited by the imbalance in the number of unblinding requests by trial participants at the early stages of the trial, as well as vaccine efficacy being assessed over a relatively short period due to the rapidly evolving pandemic. Nevertheless, these study’s findings are significant, as they demonstrate that the Novavax vaccine is a new vaccine that can be included in the current portfolio of vaccines that are safe and highly effective against preventing Covid-19 infection and its associated strains and variants.
Relevant Reading: Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19
In-Depth [randomized control study]: This randomized control study took place in the United States and Mexico in 2021, with 29,949 participants. 19,714 patients received the vaccine and 9868 received a placebo. Patients who were 18 years or older and were healthy, or who had stable chronic conditions such as diabetes mellitus type 2 or HIV infection were included in the study. Patients with known previous Covid-19 infection or known immunosuppression were excluded from the study. The primary outcome was the efficacy of the Novavax vaccine for the prevention of the first occurrence of a PCR-confirmed Covid-19 infection, whether mild, moderate, or severe, with onset at least 7 days after the second dose. Outcomes in the primary analysis were assessed via per-protocol efficacy analysis, and two observation periods were used, one starting at dose 1 and the other starting 7 days after dose 2. Based on the analysis, over a period of 3 months, there were 77 cases of Covid-19 recorded, with 14 in the vaccine group and 63 in the placebo group (vaccine efficacy, 90.4%; 95% confidence interval [CI], 82.9 to 94.6). The incidence of Covid-19 was 21.2 cases per 1000 person-years (95% CI, 16.2 to 27.7) in the Novavax vaccine group and 51.9 cases per 1000 person-years (95% CI, 40.9 to 66.0) in the placebo group. There were 10 moderate and 4 severe cases, all in the placebo group, which demonstrates 100% vaccine efficacy in moderate-to-severe disease (95% CI, 87 to 100). Furthermore, vaccine efficacy against any variant or other strains of concern was 92.6% (95% CI, 83.6 to 96.7). Overall, this study demonstrated that the Novavax vaccine can serve as a safe and highly protective vaccine against Covid-19 infection, and can also prevent moderate-to-severe Covid-19 as well as Covid-19 in people at high risk for infection and transmission, which will aid efforts to contain the ongoing pandemic.
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