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Re: Red, I don't see anything about 2373 not being rolled out until July - here is article saying MaySirVax: I assume that you are referring to a discussion that involved some confusion on the primary endpoint, which is efficacy among the HIV+ and HIV- grouped together. From the NVAX data release: A complete analysis of vaccine efficacy among 147 PCR-positive cases (51 cases in the vaccine group and 96 in the placebo group) demonstrated an overall efficacy of 48.6% against predominantly variant strains (95% CI: 28.4, 63.1). From the SA trial protocol: Hypothesis testing of the primary efficacy endpoint will be carried out sequentially against the 2 prespecified null hypotheses: H0: VE ≤ 0% first and then H0: VE ≤ 30%. Rejection of the null hypothesis, H0: VE ≤ 0% demonstrates a statistically significant vaccine effect for the primary endpoint. If the primary endpoint meets the success criterion of the lower bound > 0%, additional hierarchical testing of the primary endpoint against the more stringent success criterion of the lower bound > 30% will be carried out. This hazy analysis says it might not have made it. And the vaccine has been rejected by SA - something like "not fit for use". We know that the knowledgable people in SA should demand a vaccine that is 100% effective against severe disease, even if it fails its primary endpoint. They also know that 50% efficacy against symptomatic disease will not stop the pandemic, even if 100% are vaccinated. Yesterday we got a NVAX presentation that seems to say that they "achieved 51% on primary endpoint" (SA strain only with HIV-, which is not a primary endpoint), and "primary endpoint achieved - 49% in total population" (HIV+ and HIV-). For the latter, is this consistent with the protocol? |
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Msg # | Subject | Author | Recs | Date Posted |
121240 | Re: Red, I don't see anything about 2373 not being rolled out until July - here is article saying May | luckijack | 0 | 4/8/2021 9:00:07 AM |
121241 | Re: Red, I don't see anything about 2373 not being rolled out until July - here is article saying May | muddyc | 7 | 4/8/2021 9:04:59 AM |
121246 | Re: Red, I don't see anything about 2373 not being rolled out until July - here is article saying May | SirVax | 0 | 4/8/2021 10:18:38 AM |