Moderna COVID-19 vaccine has 'favorable safety profile,' FDA documents show, putting it closer to approval
'No specific safety concerns identified that would preclude issuance of an EUA,' FDA writes
The Food and Drug Administration released documents detailing Moderna's coronavirus vaccine candidate's "favorable safety profile" on Tuesday ahead of the Vaccines and Related Biological Products Advisory Committee meeting scheduled for Thursday.
The documents revealed no safety objections from the FDA, which puts a second vaccine closer to approval. Pfizer and BioNTech vaccine doses began to be administered Monday after approval last week.
"Safety data from a November 11, 2020 interim analysis of approximately 30,350 participants ... with a median of 7 weeks of follow-up after the second dose supported a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA," according to an FDA document. "These safety data are the primary basis of FDA’s safety review."
HHS SECRETARY AZAR: HOW OPERATION WARP SPEED DELIVERED A COVID VACCINE IN RECORD TIME
Moderna, a Massachusetts-based biotech company, requested emergency use authorization for its vaccine candidate on Nov. 30.
Stephane Bancel, chief executive officer of Moderna, said Monday the company could see emergency approval for its coronavirus vaccine candidate in December. (iStock)
It's possible the U.S. could have four coronavirus vaccines with FDA approval by February or March as Moderna, Johnson & Johnson and AstraZeneca approach the finish line, Health and Human Services Secretary Alex Azar told "Varney & Co." on Monday.
"That’s the genius of Operation Warp Speed," Azar said. "We spread our bets around not just multiple companies, but multiple platforms, technologies of vaccines. Moderna, which we're incredibly excited about, if everything's on track, we could see approval this week."
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| MRNA | MODERNA INC. | 43.06 | -0.33 | -0.76% |
Moderna CEO Stephane Bancel said his company's coronavirus vaccine has demonstrated a "gamechanger" safety record in ongoing studies, along with 94.5% effectiveness in preventing COVID-19.
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"People who did get our vaccine did not get any severe disease, which is of course a gamechanger," Bancel told "Mornings with Maria" in November.
Fox News' Madeline Farber contributed to this report.