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- Moderna announced it will file for emergency use-authorization with the US Food and Drug Administration on Monday.
- CEO Stéphane Bancel said the company aims to start vaccinating Americans within “24 hours after the FDA gives an approval.”
- Moderna said the vaccine was 94.1% effective at preventing COVID-19 in an analysis of a late-stage trial, and prevented against 100% of “severe” cases in the early data.
- Experts project all Americans will realistically have access to the vaccine by mid-2021.
- Visit Business Insider’s homepage for more stories.
Moderna will waste no time vaccinating Americans after a potential FDA greenlight.
After the company announced it would file for emergency-use authorization with the US Food and Drug Administration on Monday, the biotech company’s CEO, Stéphane Bancel, said in an interview that Americans will start getting vaccinated “within 24 hours after the FDA gives an approval.”
“The FDA has indicated to us that likely the the [Vaccines and Related Biological Products Advisory Committee] meeting should happen on December 17 and, hopefully, if everything goes well in the next couple of weeks, you could expect between a day to 2-3 days after the VRBPAC meeting production approval,” Bancel told Fox Business on Monday morning.
“The goal is to start vaccinating Americans within 24 hours after the FDA gives an approval,” he said.
Moderna also released the results of an analysis of 196 COVID-19 cases in a late-stage trial on Monday, which showed the vaccine was 94.1% effective at preventing COVID-19, the disease caused by the new coronavirus, in that sample. Bancel said the company agreed to provide the FDA with an analysis of cases of at least 151 cases of disease to have a “robust analysis” prior to filing for emergency-use authorization.
The vaccine rollout could provide communities significant relief as COVID-19 continues to spread globally. The US hit record COVID-19 cases and hospitalizations in November, and more than a quarter of a million Americans have died.
Moderna said the vaccine prevented against 100% of "severe" COVID-19 cases in a preliminary analysis of 30 cases. Bancel said he "was almost tap dancing in the house" after hearing the vaccine's effectiveness against severe cases in the trial.
"If you think about what has happened in the company, people get infected, if you get a severe disease, you end up in the hospital. If you get a bad case, you end up in the ICU and the worst case outcome is, of course, death — if you can stop that whole cascade, that is, I believe, a game changer," Bancel said in a separate interview with Yahoo Finance on Monday.
Pharmaceutical giant Pfizer filed for emergency use authorization of its vaccine on November 20. Pfizer's vaccine is 95% effective at preventing COVID-19, the company said. Johnson & Johnson resumed trials for a coronavirus vaccine after pausing last month. AstraZeneca and the University of Oxford said on November 23 that their vaccine was 70% effective at preventing COVID-19, but later pledged to run another study due to inconsistencies in the analysis.
The US bought 100 million vaccines each from Pfizer and Moderna. Alex Azar, the secretary of the Department of Health and Human Services, said vulnerable populations like the elderly and healthcare workers will begin getting vaccinated in 2020. Experts say Americans will realistically have access to the vaccine by mid-2021.
Business Insider reached out to Moderna for additional comment.
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