The Cambridge, Mass.-based biotech firm said its vaccine, known as mRNA-1273, showed a 94.1% effectiveness rate in a Phase 3 trial. The vaccine's efficacy against "severe COVID-19" was 100%, the company added in a statement released on Nov. 30.
It previously said the vaccine had a 94.5% efficacy on the first 95 participants in the trial with confirmed COVID-19 diagnoses.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” said Moderna CEO Stéphane Bancel in the statement.
Earlier this week, documents released by the FDA showed the vaccine has a "favorable safety profile," putting it close to approval.
Prior to the Pfizer vaccine getting emergency use approval from the FDA, Health and Human Services assistant secretary Dr. Brett Giroir said both the Moderna vaccine and the Pfizer vaccine were safe, urging Americans to get vaccinated when they can.
“All indications are this is an extremely safe vaccine, the Pfizer and Moderna, and very, very effective, over 95% effective,” Giroir said on “State of the Union” last month. Giroir stressed the need to “immunize for impact,” which would see the highest risk populations prioritized.
Ahead of the FDA panel meeting, which is expected to run from 9 a.m. to 5:15 p.m. on Thursday, are a few facts to know about Moderna's vaccine, compiled by FOX Business.
Somewhere between $32 and $37 per dose.
On the company's August earnings call, Bancel said pricing for smaller volumes will likely range between $32 and $37 per dose, while larger volumes could be lower.
Number of doses:
Perhaps as many as 500 million per year.
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.
Age of approval:
Moderna is asking the FDA for approval in people 18 and older. By comparison, Pfizer's vaccine can be used on people 16 and older.
What happens after the panel:
Though the FDA does not always follow the recommendations of the panel, it often does. If the panel votes in favor of the Moderna vaccine, the FDA will vote on whether it will approve it for emergency use approval. In the case of Pfizer and BioNTech's vaccine, that came the next day.
Though it was deemed to have a "favorable safety profile" and the FDA document said there were "no specific safety concerns identified that would preclude issuance of an EUA," there are still side-effects associated with Moderna's vaccine.
The most common were injection site pain, fatigue, headaches, muscle pain, joint pain and chills. Approximately 21.4% of vaccine recipients younger than 65 complained of Lymphadenopathy (axillary swelling and tenderness of the vaccination arm), while 12.4% of those older than 65 also reported having Lymphadenopathy. This compares to 7.5% and 5.8%, respectively, from those that received the placebo.
"There were no anaphylactic or severe hypersensitivity reactions with close temporal relation to the vaccine. Throughout the safety follow-up period to date, there were three reports of facial paralysis (Bell’s palsy) in the vaccine group and one in the placebo group," the FDA added in the document.
Potential revenue to Moderna:
At least $1 billion.
The U.S. government has previously struck a deal with Moderna for 100 million doses of the vaccine as part of Operation Warp Speed, with an option to buy an additional 400 million doses.
In the company's third-quarter earnings release, Moderna said it had received more than $1.1 billion in deposits for the vaccine from governments around the world.
FOX Business' Suzanne O'Halloran, Evie Fordham, Peter Aiken and Fox News' Alexandria Hein contributed to this story.
*This story, originally published on 11/30/20, has been updated.