Today, Novavax announced that its candidate vaccine NVX-CoV2373 has reached its main endpoint in Phase 3 clinical trials in the UK, protecting the COVID-19 from symptoms by 89.3%.
the trial demonstrated the vaccine's effective protection against the B.1.1.7 strain that was prevalent in the UK during clinical trials.
, Novavax also announced the results of the company's Phase 2b clinical trial in South Africa.
participants in this Phase 2b clinical trial, NVX-CoV2373 showed only 49.4% protective effect.
researchers say the decline in conservation effectiveness may be related to the B.1.351 strain that was prevalent in South Africa during clinical trials.
since the emergence of new coronavirus strains around the world, several studies have shown that some of the genetic mutations they carry allow the new coronavirus to evade the identification of antibodies.
and Novavax's results show the effects of these mutants on vaccine protection effectiveness with the results of clinical trials.
NVX-CoV2373 is a recombinated protein candidate vaccine based on the genetic sequence of the new coronavirus.
it is produced using Novavax's recombinant nanoparticle technology to produce antigens for the new coronavirus pyrethroid protein.
It also contains Novavax's proprietary saponin-based Matrix-M advent, which enhances the immune response and stimulates high levels of mesothetic antibody production by stimulating antigen delivery cells to enter the injection site and enhancing antigen delivery in the local lymph nodes.
uk Phase 3 clinical trial results: 89.3 per cent protective effect This clinical trial recruited more than 15,000 subjects aged 18-84, 27 per cent of whom were over 65.
end point of the Phase 3 clinical trial was based on the number of Serologically Negative Adult Adult Subjects who first developed symptoms at least 7 days after being given the second dose of the new corona vaccine.
's first interim analysis was based on 62 cases, of which 56 cases of COVID-19 were observed in the placebo group and 6 cases of COVID-19 were observed in the NVX-CoV2373 group, resulting in a vaccine effectiveness of 89.3% (95% CI:75.2-95.4).
62 cases, 61 were mild or moderate and 1 was severe (from the placebo group).
analysis showed that more than 50 per cent of cases detected B.1.1.7 mutant strains prevalent in the UK (32 B.1.1.7 variants, 24 non-variant strains, 6 unknown).
based on post-mortem analysis of 56 confirmable cases of the strain, NVX-CoV2373 was 95.6% effective against new coronavirus strains without mutations and 85.6% effective against B.1.1.7 mutant strains.
South Africa Phase 2b Clinical Results: Approximately 90% of COVID-19 cases were attributed to B.1.351 mutants In Phase 2b clinical trials conducted in South Africa, NVX-CoV2373 was 60% effective in HIV-negative participants (95% CI:19.9-80.1).
29 patients in the placebo group and 15 in the vaccine group.
case occurred in the placebo group, all other cases were mild or moderate.
NVX-CoV2373 was 49.4% effective (95% CI:6.1-72.8) in the entire trial population that included HIV-positive and negative subjects.
the study included more than 4,400 patients starting in August 2020 and counting COVID-19 cases from September 2020 to mid-January 2021.
this time, three key mutations carrying the prickly protein binding domain (RBD) and multiple mutations other than RBD, the B.1.351 mutation, were widespread in South Africa.
27 of the 44 COVID-19 cases in the united States obtained preliminary sequencing data, of which 92.6% (25 out of 27 cases) were B.1.351 mutant strains.
" combined with the results of Phase 3 clinical trials in the UK and Phase 2b in South Africa, we have reported trial data on the NVX-CoV2373 vaccine involving more than 20,000 subjects.
, our clinical trials in the U.S. and Mexico have randomized more than 16,000 subjects.
NVX-CoV2373 is the first vaccine candidate to demonstrate not only a high degree of protection against COVID-19, but also significant clinical importance for rapidly emerging new coronavirus strains.
," said Stanley C. Erck, President and CEO of Novavax.
Novavax has launched the development of a candidate vaccine for new strains in early January and expects to identify candidate-enhanced or secondary vaccines for new strains in the coming days.
the company plans to launch clinical trials of the new vaccines in the second quarter of this year.