The FDA employees report confirms the emergency use of Moderna’s Covid vaccine in an important step in direction of approval
Tony Potts, a 69-year-old retiree who lives in Ormond Beach, will receive his first injection as a participant in a Moderna-sponsored Phase 3 COVID-19 clinical vaccine trial on August 4, 2020 at Accel Research Sites in DeLand, Florida.
Paul Hennessy | NurPhoto | Getty Images
The Food and Drug Administration announced Tuesday that Moderna’s coronavirus vaccine data meets emergency expectations and confirms the vaccine is safe and effective.
It takes two days for the FDA’s Vaccines and Related Biological Products Advisory Panel, a group of outside medical advisors, to review Moderna’s vaccine. The group recommended Pfizer’s emergency vaccine last Thursday and the FDA approved it for emergency use the next day.
Moderna submitted its Covid vaccine data to the FDA on November 30th. A final analysis of its Phase 3 clinical trial of 30,000 participants found the Covid vaccine to be more than 94% effective at preventing, safe and appearing to fight off dire disease. The vaccine uses messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response.
The published documents provide insight into the FDA’s view of the vaccine.
If the FDA approves the vaccine, it will be the second after Pfizer to be approved for use in the United States. General Gustave Perna, who oversees the logistics for President Donald Trump’s Operation Warp Speed vaccination program, said Monday that the US plans to ship close to 6 million doses of Moderna’s Covid-19 vaccine once the FDA approves the vaccine Emergency granted.
Such authorization is not the same as full approval, which can typically take months. Moderna, like Pfizer, only submitted two months of safety data, but it typically takes the agency six months for full approval. Pfizer’s vaccine was approved for use in people aged 16 and over.
CNBC’s Will Feuer and Noah Higgins-Dunn contributed to this report.
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