Moderna details final stage COVID-19 vaccine trial protocol

Moderna released a 135-page document Sept. 17 that details how it is conducting its phase 3 COVID-19 vaccine trial and says how safety and efficacy will be determined. 

The document suggests the first analysis of the trial may not happen until late December, and there may not be enough information then to determine if the vaccine is effective. The company has two subsequent analyses scheduled for March and May, which are more likely to provide an answer, The New York Times reported. 

But Moderna CEO Stephane Bancel told The Boston Globe Sept. 17 that Moderna will probably know in November if the vaccine is safe and effective and could deliver 100 million doses to the government in the first few months of next year, seeming to contradict the trial protocol. 

Tal Zaks, PhD, Moderna's CMO, said the first analysis would probably not take place before November. The vaccine could, in theory, be found effective at that point, but the odds are not high, Dr. Zaks told the Times

Scientists have been asking vaccine makers to share their study protocol 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 reluctant to release protocol for competitive reasons, Dr. Zaks said. 

Eric Topol, MD, a clinical trial expert at Scripps Research in San Diego, told the Times he gives Moderna "big kudos" for releasing the protocol, but that he was disappointed by some of it, including that the trial includes some people who had relatively mild cases of COVID-19 rather than only including moderate to severe cases. 

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