US-based Moderna expects interim results of its covid vaccine trials next month. And if the company gets positive interim results from the large clinical trial, the US government could authorize emergency use of the company’s experimental Covid-19 vaccine in December, its chief executive said.
Speaking during The Wall Street Journal’s annual Tech Live conference on Monday, Chief Executive Stephane Bancel said if sufficient interim results from the study takes longer to get, government authorization of the vaccine may not occur until early next year.
US-based Moderna has one of the leading Covid-19 vaccines in development, along with a vaccine co-developed by Pfizer Inc and BioNTech.
Last week, Pfizer Inc had said that it could file in late November for U.S. authorization of the COVID-19 vaccine it is developing. “So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” Pfizer Chief Executive Albert Bourla said.
In July, Moderna started a 30,000-person study in the US to test its vaccine candidate.
In the trial, half of the study subjects receive the vaccine and half receive a placebo, and researchers then count how many get symptomatic Covid-19.
That first analysis is likely to occur in November, but “it’s hard to predict exactly which week because it depends on the cases, the number of people getting sick,” Moderna CEO Bancel said.
Moderna had earlier this month said that it will soon apply for real-time reviews of its experimental COVID-19 vaccine in Europe, days after the EU health regulator launched rolling reviews of shots from its rivals.
The European Medicines Agency this month launched real-time reviews of COVID-19 vaccines being developed by U.S. drugmaker Pfizer and Germany’s BioNTech, following a similar announcement for AstraZeneca’s.
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