The MRNA-1273 vaccine from the Moderna laboratory is being developed smoothly. The US company announced in August that its COVID-19 study had produced antibodies that neutralized the disease. And now He set an estimate date for the completion of the test.
This vaccine is one of two currently undergoing a Phase 3 clinical trial in the United States. and following demands for increased transparency from researchers about the experiments, This Thursday, they announced their release to the FDA, the US Government’s Food and Drug Administration.
“Our first plan, the most likely, is November“The director general of the laboratory, Stephane Bancel, told CNBC on Thursday.
And I add: “Our best forecasts are for October, it is unlikely but possible. And if the rate of infection in the country slows down in the next few weeks, it could postpone everything until December, our worst-case scenario ”.
In addition, they announced it the doses will be very lean during the first months and Moderna itself considers that it is unlikely that decisive results will be achieved before November.
The company announced this Thursday has recruited 25,296 participants of his goal of 30,000 for trials. Also, indicated that 1
The Phase 3 test protocol is the confidential document negotiated with the FDA. It describes in detail the development, the rules for the random distribution of participants to the vaccinated or placebo group, the persons considered to be at risk, the rules for confirming possible cases of COVID-19 and, above all, the conditions under which an independent expert committee will be able to look at the data and stop the trial to say if the vaccine works or is dangerous.
“There is the key information for the detention rules, the interim analyzes and the efficiency hypotheses. I celebrate its transparency“Eric Topol, an expert who led, calls for greater transparency in clinical trials to avoid interference from political power,” he told AFP.
Unlike the AstraZeneca Plc lawsuit which must be discontinued to investigate possible adverse neurological reactions, The modernists’ essay has not had to be interrupted to investigate potential security issues, according to Bancel.
Phase three will test the vaccine in 30,000 American participants. Modern assured that it is about to deliver at least 500 million doses per year starting in 2021Partly thanks to the agreement with the Swiss manufacturer Lonza, which makes it possible to manufacture up to 1 billion doses.