Moderna seeks emergency use authorization for COVID-19 vaccine
The company says its vaccine is more than 94% effective and presents "no serious safety concerns"
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Staten Island Advance, N.Y.
CAMBRIDGE, Mass. — Moderna announced that it is requesting emergency use authorization from the U.S. Food and Drug Administration for a coronavirus (COVID-19) vaccination that the biotechnology company claims is over 94% effective.
The company also is seeking conditional approval from the European Medicines Agency following a study of its vaccine, mRNA-1273, involving 30,000 people, including 196 individuals with COVID-19, according to information posted on the Moderna website.
After two doses, the vaccine is 94% effective against the virus and 100% efficacious against severe cases of COVID-19. The results were consistent despite differences in age, race, ethnicity and gender among people who received the immunizations, according to the manufacturer.
The vaccine raised "no serious safety concerns," but Moderna said "the most common adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose."
The clinical trials were conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health ( NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
"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," said Stéphane Bancel, chief executive officer of Moderna. "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."
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