US drug company releases protocol for Covid-19 vaccine trial

The American company Moderna, one of two currently conducting a phase 3 clinical trial in the United States for a Covid-19 vaccine, published the full trial protocol on Thursday, September 17 responding to requests for greater transparency.

The race to develop a vaccine against the coronavirus has become very political before the presidential elections on November 3 in the United States, with the repeated promises of President Donald Trump about the authorization of a first vaccine between now and October.

The statements by the president raised concerns about possible pressure on the US drug agency (FDA), which must authorize any treatment.

Experts and officials from the US administration itself say that the results of current trials cannot be predicted and that it is unlikely to have results before the end of 2020 or early 2021.

The doses will be very scarce in the first months, the health authorities also clarified.

Moderna itself considers it unlikely that conclusive results will be achieved before November.

“Our initial plan, the most likely, is November,” said the laboratory’s general director, Stephane Bancel, on CNBC on Thursday. infections in the country slow down in the coming weeks, which could postpone everything until December, our worst scenario. “

The company announced Thursday that it had recruited 25,296 participants from its target of 30,000, 28% of them from a minority.

Having enough African-American and Hispanic participants is crucial to obtain statistically representative results for those communities, heavily affected by the pandemic in the United States.