tipirneni
10-20-2020, 08:08 PM
Moderna CEO says coronavirus vaccine emergency approval could come in December
If all goes well, the company could file for emergency use approval in late November
https://www.foxbusiness.com/lifestyle/moderna-ceo-says-coronavirus-vaccine-emergency-approval-could-come-in-december
Stephane Bancel, chief executive officer of Moderna, said Monday the company could see emergency approval for its coronavirus vaccine candidate in December.
Speaking at a Wall Street Journal’s Tech Live online event, Bancel said that in order to file an emergency use authorization (EUA) to the Food and Drug Administration, the company needs enough safety and efficacy data. If all goes according to plan, this could happen in the later part of November.
While he expects interim data on efficacy in November, he said "it's hard to predict exactly which week because it depends on the cases, the number of people getting sick." The first analysis will happen when 53 participants have symptomatic COVID-19. However, if the company misses this mark, Bancel said it could follow up with a second interim study in December, with 106 symptomatic cases, pushing potential emergency approval to late January or early February.
The FDA has also said emergency approval for a COVID-19 vaccine will require two months of safety data on half of the study participants. Moderna expects this data in late November.
If all goes according to plan, the company could file for emergency use approval.
"I would expect the FDA to take a few weeks to review everything and to make sure everything is well so that, potentially if the data is good to get an emergency use approval sometime in December," Bancel said.
Meanwhile, the company plans to make 20 million doses available by the end of the year, which would be enough for 10 million people given the two-dose regimen.
The CEO said Moderna expects at least 500 million doses in 2021, and will continue to ramp up to a billion doses. He also addressed the challenges to meet demand more quickly.
"Unlike sometimes when you make a recipe at home, if you miss one ingredient you might decide to still go ahead and make your meal but in our case we cannot do that," Bancel said, explaining the need for space, equipment, training and supplies.
If all goes well, the company could file for emergency use approval in late November
https://www.foxbusiness.com/lifestyle/moderna-ceo-says-coronavirus-vaccine-emergency-approval-could-come-in-december
Stephane Bancel, chief executive officer of Moderna, said Monday the company could see emergency approval for its coronavirus vaccine candidate in December.
Speaking at a Wall Street Journal’s Tech Live online event, Bancel said that in order to file an emergency use authorization (EUA) to the Food and Drug Administration, the company needs enough safety and efficacy data. If all goes according to plan, this could happen in the later part of November.
While he expects interim data on efficacy in November, he said "it's hard to predict exactly which week because it depends on the cases, the number of people getting sick." The first analysis will happen when 53 participants have symptomatic COVID-19. However, if the company misses this mark, Bancel said it could follow up with a second interim study in December, with 106 symptomatic cases, pushing potential emergency approval to late January or early February.
The FDA has also said emergency approval for a COVID-19 vaccine will require two months of safety data on half of the study participants. Moderna expects this data in late November.
If all goes according to plan, the company could file for emergency use approval.
"I would expect the FDA to take a few weeks to review everything and to make sure everything is well so that, potentially if the data is good to get an emergency use approval sometime in December," Bancel said.
Meanwhile, the company plans to make 20 million doses available by the end of the year, which would be enough for 10 million people given the two-dose regimen.
The CEO said Moderna expects at least 500 million doses in 2021, and will continue to ramp up to a billion doses. He also addressed the challenges to meet demand more quickly.
"Unlike sometimes when you make a recipe at home, if you miss one ingredient you might decide to still go ahead and make your meal but in our case we cannot do that," Bancel said, explaining the need for space, equipment, training and supplies.