FDA says preliminary analysis confirms effectiveness, safety of Moderna COVID-19 vaccine
WASHINGTON - The Food and Drug Administration said its preliminary analysis confirmed the effectiveness and safety of Moderna’s COVID-19 vaccine, a key step toward approval of a second coronavirus vaccine in the U.S.
A panel of outside experts will offer their recommendation Thursday, with a final FDA decision expected soon thereafter.
The FDA’s briefing document released Tuesday revealed no safety objections from the agency and deemed the vaccine to have a “favorable safety profile.”
"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 the analysis. "These safety data are the primary basis of FDA’s safety review."
The high efficacy of Moderna’s vaccine was noted at 94.5%, assessed at least 14 days after the second dose.
Moderna, which developed the vaccine candidate in partnership with the National Institutes of Health, requested emergency use authorization on Nov. 30.
The positive news comes as hospitals ramped up vaccinations with the shot developed by Pfizer and BioNTech, which the FDA cleared last week.
Packed in dry ice to stay at ultra-frozen temperatures, shipments of Pfizer’s COVID-19 vaccine will arrive at 400 additional hospitals and other distribution sites Tuesday, one day after the nation’s death toll surpassed a staggering 300,000.
The first 3 million shots are being strictly rationed to front-line health workers and elder-care patients, with hundreds of millions more shots needed over the coming months to protect most Americans.
A second vaccine can’t come soon enough as the country’s daily death count continues to top 2,400 amid over 210,000 new daily cases, based on weekly averages of data compiled by Johns Hopkins University.
The devastating toll is only expected to grow in coming weeks, fueled by holiday travel, family gatherings and lax adherence to public health measures meant to curb the spread of the virus.
The first vaccine deliveries have provided a measure of encouragement to exhausted doctors, nurses and hospital staffers around the country.
This story was reported from Cincinnati. The Associated Press contributed.