Moderna details final stage COVID-19 vaccine trial protocol

The file recommends the very first analysis of the trial may not take place until late December, and there might not suffice info then to identify if the vaccine is effective. The company has two subsequent analyses set up for March and May, which are more most likely to provide an answer, The New York Times reported..

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Scientists have been asking vaccine makers to share their study procedure so outside experts could review them, and Moderna is so far the only of the nine companies with vaccines in late-stage trials to do so, according to the Times. Drugmakers are usually unwilling to release procedure for competitive factors, Dr. Zaks stated..

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Maia Anderson –
Thursday, September 17th, 2020

Moderna CEO Stephane Bancel informed The Boston Globe Sept. 17 that Moderna will probably understand in November if the vaccine is safe and efficient and could deliver 100 million dosages to the government in the very first couple of months of next year, appearing to oppose the trial protocol..

Tal Zaks, PhD, Modernas CMO, said the very first analysis would most likely not happen before November. The vaccine could, in theory, be found reliable at that point, however the odds are not high, Dr. Zaks told the Times..

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Moderna launched a 135-page file Sept. 17 that information how it is performing its phase 3 COVID-19 vaccine trial and states how safety and effectiveness will be figured out..

Eric Topol, MD, a scientific trial specialist at Scripps Research in San Diego, informed the Times he offers Moderna “huge congratulations” for releasing the procedure, but that he was dissatisfied by some of it, including that the trial includes some individuals who had reasonably mild cases of COVID-19 rather than just consisting of moderate to extreme cases..

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