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Word 1st COVID-19 recombinant protein vaccine | Phase III data announced
Word 1st COVID-19 recombinant protein vaccine | Phase III data announced. Phase III clinical data of the world’s first COVID-19 recombinant protein vaccine announced.
Novavax vaccine has recruited more than 15,000 volunteers aged 18 to 84 in the UK’s Phase III clinical trial, 27% of whom are over 65 years old. The main clinical endpoint is to compare the number of symptomatic infections confirmed by nucleic acid testing in the vaccine group and the placebo group 7 days after the second dose of vaccine.
The current interim result is that 62 cases were observed, of which 56 were in the placebo group and 6 were in the vaccine group, with an effective rate of 89.3% (95% confidence interval 75.2-95.4).
But what we are most concerned about is the effectiveness of the COVID-19 vaccine against variants.
In the in vitro experiments of the E484K mutation, 9 out of 11 rehabilitated serum samples reduced antibody binding, and the neutralizing ability of some serum samples decreased by more than 10 times. In the trials of Moderna vaccine and Pfizer vaccine, it was also observed that the sera of the vaccinated volunteers showed a greater reduction in the ability to neutralize the E484K mutation.
The Novavax vaccine in South Africa is a phase IIb clinical trial involving 4400 volunteers. One big difference between volunteers in South Africa and other places is that 6% of volunteers are HIV positive.
In the preliminary analysis of phase IIb clinical trials, there were 44 infections in the HIV-negative group, 29 of which were in the placebo group and 15 in the vaccine group, with an effective rate of 60%. If the HIV-positive group is added, the effective rate of the entire population drops to 49.4%.
(source:internet, reference only)