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Full title of FDA's announcement: "FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration’s Fight Against Pandemic".

Note 1: "potential promising treatment" - why the caveating?

Note 2: "another achievement in administration's fight against pandemic - sounds like PR; trying to score points?




to 1, check the actual data available - it's not final since the clinical trials are still ongoing, but the benefits shown so far is significant enough to allow emergency use. This also happens typically for cancer treatments where survival rates look significantly better vs gold standard treatments. See the evidence from the announcement below.

> In these assays, an ID50 titer cutoff of 250 in the Broad Institute assay was chosen to distinguish between high titer and low titer plasma. This value correlated with an Ortho VITROS IgG assay signal to cutoff (S/C) of 12. Based on titer data using the Broad Institute assay, the data submitted in the EUA demonstrate the following findings: o There was no difference in 7-day survival in the overall population between subjects transfused with high versus low titer CCP. o In the subset of non-intubated patients, there was a 21% reduction in 7-day mortality (from 14% to 11%, p=0.03) in subjects transfused with high versus low titer CCP. o There was no apparent association between neutralizing antibody titers and 7-day mortality in intubated subjects. o In additional analyses of a post-hoc subgroup of patients less than 80 years of age who were not intubated and who were within 72 hours of diagnosis, a stronger relationship between neutralizing antibody titers and 7-day mortality is observed. When titers are binned to low versus high at a threshold of 250, the sponsor reports a significant reduction in 7-day mortality from 11.3 to 6.3% (p = 0.0008). o In additional analyses of survival using a Kaplan-Meier approach, the survival trends observed at 7 days persisted over a longer time period, with significantly improved survival in non-intubated patients (Figure 2, p=0.032) and a larger benefit in the subset of patients not intubated at the time of treatment, less than 80 years of age, who were treated within 72 hours of diagnosis (Figure 3, p=0.0081)


Thanks.

I found the following explanation at https://www.statnews.com/2020/08/23/is-convalescent-plasma-s...

"A study released Aug. 13 — but not yet peer-reviewed — suggested that using convalescent plasma to treat patients with severe Covid-19 soon after their diagnosis was associated with a lower likelihood of death. But the study had serious scientific limitations that make interpreting the findings difficult.

The Mayo Clinic study, which enrolled more than 35,000 patients, showed that patients who received transfusions within three days of their Covid-19 diagnosis had a seven-day death rate of 8.7%, while patients who received plasma treatment after four or more days had a mortality rate of 11.9%. The difference met the standard for statistical significance.

The study didn’t include a placebo group for comparison, however, so it’s unclear exactly how impactful the plasma treatment might be. The study was sponsored by the National Institutes of Health and sought to broaden access to convalescent plasma, part of a so-called “expanded access” program not designed to definitively test how well the treatment works, but instead to quickly get it to patients.

More rigorous randomized, placebo-controlled studies of convalescent plasma are ongoing."


Holy cow, if that doesn’t come off as biased, I don’t know what does.


Suuuure sounds like it’s politically motivated, no?




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