Massachusetts biotech company Moderna said it would apply for 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.
Moderna CEO Stephane Bancel told “Mornings with Maria” on Monday that the FDA is expected to review the vaccine at a December 17 meeting and hopes for approval in the coming weeks.
“Our goal is to start vaccinating Americans within 24 hours of FDA approval,” Bancel said. “There were 30 severe cases in the study. All 30 were on placebo. ”
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“I believe in the first trimester [of 2021] most people who want a vaccine, who are more at risk with old age, serious illness, health care worker, frontline worker, should be able to get the vaccine. In the second quarter, all Americans over 18 should be able to get vaccinated, ”continued Bancel.
Moderna said its vaccine against the coronavirus was 94.1% effective and its effectiveness against severe coronavirus was 100%, according to a primary efficacy analysis involving 30,000 participants.
Bancel said the company plans to launch a clinical study in adolescents next week.
“I hope to have this data by the end of the spring… so that they can go back to school next September,” he said.
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The Phase 3 vaccine study has “passed” the minimum two-month post-vaccination follow-up as required by the FDA, Moderna said in a press release.
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The vaccine has shown “no serious safety concerns identified to date” and the “most common” side effects are injection site pain, fatigue, myalgia, arthralgia, headache and pain. redness at the injection site, the company said.
Moderna said the FDA told the company to expect a meeting of the Vaccines and Related Biologics Advisory Committee (VRBPAC) for its vaccine on December 17.
“This is the first time in the history of the company that we are seeking commercial approval for a product,” Bancel said “Mornings with Maria”. “The FDA has told us that the advisory committee, the VRBPAC meeting, is scheduled to take place on December 17th and hopefully everything will be fine in the coming weeks. after VRBPAC meeting for potential approval. ”
Bancel previously said November 25 would be the date the company had enough safety data to apply for emergency use authorization with the FDA.
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Bancel said in August that the price of the smaller volumes of the vaccine, called mRNA-1273, would likely be between $ 32 and $ 37 per dose, while larger volumes could be lower.
At a dose level of 100 micrograms (which was given in the Phase 3 trial which began in July), Moderna said it could deliver 500 million doses per year and possibly up to 1 billion per year in 2021, as it works with Swiss drug maker Lonza. for its manufacturing needs.
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Chris Ciaccia and Alexandra Hein of Fox News and Suzanne O’Halloran of FOX Business contributed to this report.