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Moderna may have to wait until December to analyze data from its Covid-19 vaccine test, longer than it takes to live up to the Trump administration’s hopes of issuing an emergency approval before the US election.
The Boston-based biotech company said Thursday it had enrolled more than 25,000 participants in its trial, and more than 10,000 of them had already received both doses in the course of the vaccine.
It also set a slower analysis timeline than rival Pfizer and its partner BioNTech, which said they would have their key data by the end of October. Moderna shares fell 2.4 percent to $ 67.22 on the news.
Stéphane Bancel, Moderna’s chief executive, told CNBC that if the infection rate in the United States slows in the coming weeks, he may not be able to examine the data until December.
But he added that the most likely scenario was an interim analysis in November, and if infection rates rose, it could be earlier. “Our best plan is October. I think it is unlikely, but it is possible. ”
The Trump administration is rejecting estimates by public health experts for when a vaccine may become widely available. Robert Redfield, director of the Centers for Disease Control and Prevention, said Tuesday that this would not happen until the end of 2021. President Donald Trump accused Dr. Redfield of making a “mistake” and insisted that a vaccine would not It could only be approved but also distributed in October.
Speaking on Moderna’s Investor Day, Bancel said that a successful Covid-19 vaccine could generate a “multi-million dollar revenue line” in 2021.
He added that it could also validate the company’s entire portfolio of potential vaccines, which includes candidates for rare diseases, Zika and influenza, because they are all based on the same technology, the messenger ribonucleic acid molecule, which carries genetic instructions.
“That’s the power of an information molecule,” he said, adding that it could be a “unique and historic turning point” for the company, which does not yet have any products on the market.
The speed of vaccine trials depends on infection rates. To show that the vaccine is effective, trials must show that more people in the placebo group, who did not receive the actual vaccine, were infected. The structure of the trial also means that Moderna does not know how many participants have been infected with Covid-19 so far.
Interim analysis dates are estimates based on when the trial began in July, how quickly participants were enrolled in the first few weeks, and infection rates in the regions where the vaccine was administered, the company said.
You won’t begin evaluating the data until 53 participants develop the disease, with a second analysis when 106 people develop symptoms. The final analysis can’t be done until at least 151 participants are sick, which they estimate might not be until May next year. But a vaccine can receive emergency approval based on an interim review.
Moderna also published its protocol for the phase 3 stage of its vaccine trial that is now underway for the first time.
