Massachusetts-based biotech company Moderna said it will request an Emergency Use Authorization from the Food and Drug Administration for its coronavirus vaccine on Monday as well as conditional approval from the European Medicines Agency.
Continue Reading Below
Moderna CEO Stephane Bancel told "Mornings with Maria" on Monday that the FDA is expected to consider the vaccine at a Dec. 17 meeting, and that he hopes for approval in the next several weeks.
"Our goal is to start vaccinating Americans within 24 hours after the FDA gives approval," Bancel said. "There were 30 severe cases in the study. All 30 were on placebo."
"I believe in the first quarter [of 2021] most people that want a vaccine, that are at higher risk with older age, severe disease, health care worker, frontline worker, should be able to get vaccinated. Second quarter, every American older than 18 years of age should be able to get vaccinated," Bancel continued.
Moderna said its vaccine’s efficacy against coronavirus was 94.1% and efficacy against severe coronavirus was 100%, according to primary efficacy analysis involving 30,000 participants.
Bancel said the company expects to start a clinical study on teenagers in the next week.
"I hope to have that data by the end of the spring ... so they can go back to school next September," he said.
The Phase 3 study of the vaccine has “exceeded” the minimum two-months of post-vaccination follow-up as required by the FDA, Moderna said in a press release.
The vaccine has presented “no serious safety concerns identified to date,” and the “most common" adverse reactions are injection site pain, fatigue, myalgia, arthralgia, headache and redness at the injection site, the company said.
Moderna said the FDA told the company to expect a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for its vaccine on Dec. 17.
"It's the first time in the company history that we've filed for commercial approval of a product," Bancel told "Mornings with Maria." "FDA has indicated to us that likely the advisory committee, the VRBPAC meeting, should happen on Dec. 17, and hopefully everything goes well in the next couple weeks. You could expect between, I would say, a day to two to three days after VRBPAC meeting for potential approval."
Bancel previously said that Nov. 25 would be the date the company would have enough safety data to put in an emergency use authorization request with the FDA.
At a dose level of 100 micrograms (which was given in the Phase 3 trial that started in July), Moderna said it can deliver 500 million doses per year and perhaps as many as 1 billion per year in 2021 as it works with Swiss drugmaker Lonza for its manufacturing needs.
Fox News' Chris Ciaccia and Alexandra Hein and FOX Business' Suzanne O'Halloran contributed to this report.