Modern chief executive Stephen Bansell said the company could see emergency approval for its coronavirus vaccine candidate in December.
Speaking at the Wall Street Journal’s Tech Live online event, Bansell said that in order for the Food and Drug Administration to file an Emergency Use Authority (EUA), the company needed adequate safety and efficacy data. If all goes according to plan, it may happen in the later part of November.
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When he expected interim data on efficacy in November, he said “it is difficult to predict exactly which week as it depends on the cases, the number of sick people.” The first analysis will occur when 53 participants have symptomatic COVID-19. However, if the company misses the mark, Bansell said it could pursue potential emergency approvals in late January or early February, with 106 symptomatic cases with a second interim study in December.
The FDA states that emergency approval for the COVID-19 vaccine would require two months of safety data on half of the study participants. Modern expects this data in late November.
If everything goes according to plan, the company can file for approval of emergency use.
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“I expect the FDA to review everything for a few weeks and make sure everything is in order so that, presumably, if the data is good enough to get emergency use approval sometime in December,” Bansell he said.
Meanwhile, the company plans to provide 20 million doses by the end of the year, which would be sufficient for 10 million people, given the two-dose diet.
The CEO said Modern expects to have at least 500 million doses in 2021, and will continue to ramp up to one billion doses. They also resolved challenges to meet demands more quickly.
“Sometimes when you make a recipe at home, on the contrary, if you miss an ingredient, you can still decide to go ahead and make your meal, but in our case we don’t. Can, ”Bansell explained the need for space, equipment, training and. Supplies.
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Modern is working with Swiss-based Lonja Ltd. to increase its manufacturing capacity, and is therefore able to meet US demand.
The US government has already signed a $ 1.5 billion deal with Modern for 100 million doses, with the option to purchase another 400 million doses. Banksel said that if the government decides to buy more, the supply chain should be able to handle the request without any problems.
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