The American biotechnology group Moderna, one of two companies conducting clinical trials in the third phase in the United States, on an experimental
anti-COVID-19 vaccine, on Thursday, announced the complete protocol for its trials, in response to calls for more transparency.
The race to find a vaccine has become a political dimension in the United States with the approaching presidential elections on November 3, as President Donald Trump promised a vaccine by October, raising doubts about possible pressures on the pharmaceutical agency that must make the decision to approve it.
Experts and officials from the Trump administration said that the results of the current experiments cannot be expected and it is unlikely to obtain them before the end of 2020 and early 2021. As for the doses, they will only be available in limited quantities in the first months, according to the health authorities.
Moderna said it did not expect results until November.
“Our most likely base plan is in November. Our most optimistic plan is in October, and it is unlikely, but it is possible,” its general manager, Stephane Bennasil, told ANBC.
And if the rate of infections in the country slows in the coming weeks, this may be delayed until December, which is the worst-case scenario. ”
Moderna also announced Thursday that it has contracted with 25,296 subscribers out of 30,000 it needs, of whom 28% belong to minorities. The company said that getting a sufficient number of black participants, especially Hispanic, is essential to obtain results that are statistically representative of these groups affected by this pandemic more than others in the United States.
10,025 participants received a second dose, which was given 28 days after the first dose.
The protocol for the third phase experiment, which the company is negotiating with the US Medicines Agency, details the course of the experiment and the rules for distributing participants to different groups according to certain criteria, especially the conditions for an independent committee of experts to see the data and the possibility of stopping or continuing the experiment if it is dangerous.