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
Food and Drug Administration staff endorsed Moderna’s emergency use of coronavirus vaccine in a report released Tuesday. This is a critical step forward in obtaining formal approval for public administration.
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. The committee is expected to recommend Moderna’s vaccine. The FDA does not need to follow the committee’s recommendation, but it often does.
The FDA found that the clinical trial results and safety data “are in line with recommendations in FDA guidelines on approving the emergency use of vaccines to prevent COVID-19,” the staff wrote. “The FDA has determined that the sponsor has provided adequate information to ensure the quality and consistency of the vaccine for product approval under an EEA.”
Moderna is asking the FDA to approve use in people 18 years and older, while Pfizer’s vaccine has been approved for use in people 16 years of age and older. The low data in younger teenagers was a sticking point for the few advisory board members who last week voted against approving the Pfizer vaccine.
The FDA recommends pursuing cases of Bell’s palsy, a condition that causes sudden freezing or weakness in facial muscles, when the vaccine is cleared for use. The agency said there were three cases in the vaccine group and one in the placebo group. “The information currently available is insufficient to establish a causal link with the vaccine,” the agency wrote.
The most common side effects were injection site pain, fatigue, headache, muscle pain, and chills, according to the FDA. More serious reactions were more common after the second dose. Study participants told CNBC in September that symptoms were uncomfortable and at times very intense. Participants said they often went away after a day, sometimes sooner, and it was better than getting Covid-19.
The FDA said 13 deaths were reported as of December 3, including six in the vaccine group. Two deaths in the vaccine group were people over the age of 75 with pre-existing medical conditions, the agency said. One case was a 72-year-old vaccine recipient with Crohn’s disease and short bowel syndrome who was hospitalized for thrombocytopenia and acute kidney failure.
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 in preventing, safe and appearing to ward 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 gets the vaccine in order, it will be the second after Pfizer to be approved for use in the US. 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 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 the agency typically takes six months for full approval. Pfizer’s vaccine was approved for use in people aged 16 and over.
Moderna, of Cambridge, Massachusetts, announced that its vaccine would remain stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a regular household or medical refrigerator. It can be stored at minus 4 degrees Fahrenheit for up to six months. In comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.
Last week the federal government announced it would buy an additional 100 million doses of Moderna’s vaccine. In August, the US reached an agreement with Moderna to purchase 100 million cans for about $ 1.5 billion.
CNBC’s Will Feuer and Noah Higgins-Dunn contributed to this report.
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