FDA authorizes Moderna vaccine for emergency shipment
The Food and Drug Administration has granted emergency distribution of the Moderna vaccine Friday evening.
The news comes after the FDA advisory panel voted to approve Moderna’s highly effective coronavirus vaccine.
Earlier, Health and Human Services Secretary Alex Azar said shipments of Moderna’s coronavirus vaccine, which has been shown to be safe and nearly 95% effective in trials, will begin this weekend if the FDA grants emergency use authorization as expected Friday.
“Trucks will roll, planes will fly this weekend, 5.9 million doses of Moderna vaccine allocated for next week,” Azar told ABC’s “Good Morning America” on Friday.
Azar said the Moderna vaccine is “shockingly effective” and he expected to get vaccinated next week, if the White House physician cleared him to do so. Azar’s wife has tested positive for COVID-19, and he is quarantining now.
The drug known as mRNA-1273 was developed by the National Institutes of Health in cooperation with the biotechnology company based in Cambridge, Massachusetts.
»PREVIOUS COVERAGE: U.S. vaccinations ramp up as second COVID-19 shot nears
The Moderna vaccine can’t come soon enough as the country’s death toll has surpassed 310,000 amid more than 210,000 new cases daily, based on weekly averages of data compiled by Johns Hopkins University. The devastating toll is expected to only grow in coming weeks, fueled by holiday travel, family gatherings and lax adherence to basic public health measures.
The Vaccines and Related Biological Products Advisory Committee voted unanimously to approve the vaccine, saying the benefits outweighed its risks for individuals 18 and older. The vote was 20-0 with one abstention.
Preliminary studies before now have confirmed the effectiveness and safety of the Moderna vaccine, bringing it to the cusp of being used on the frontlines of the pandemic.
The positive news comes as the nation’s largest vaccination campaign got underway last week with the emergency approval and distribution of a vaccine made by Pfizer and BioNTech, with hospitals and nursing homes ramping up inoculations.
The Moderna vaccine will be approved for adults only. Pregnant women and women who are nursing were not included in the study of more than 30,000 individuals.
People with severe health conditions also were not included in the study group. Some people reported side effects such as arm pain, fatigue and muscle aches, but no one experienced any real health emergency.
Recipients also tend to experience temporary flu-like side effects that can include fever, fatigue and aches, especially after the second dose as the vaccine revs up their immune system.
The first vaccine deliveries have provided a measure of encouragement to exhausted doctors, nurses and hospital staffers around the country who hail the new vaccine as a “remarkable scientific achievement.”
“To go from having a sequence of a virus in January to having two vaccines available in December is a remarkable achievement,” said Dr. James Hildreth, a committee member, immunologist, and president and CEO of Meharry Medical College in Nashville, Tennessee, according to USA Today.
Information provided by The Associated Press was used to supplement this report.
About the Authors
ArLuther Lee is a visual editor and occasionally covers national and world news for The Atlanta Journal-Constitution. He holds a bachelor's degree in journalism from The University of Florida and has been a journalist for more than 25 years.
Stephanie has been telling stories her whole life. Her interest in the written word started with short stories and journal entries about run-ins with classroom bullies as a child and matured to writing for her high school newspaper over the years. She has written and edited for The Tennessean, Augusta Chronicle and American City & County.
Kelcie Willis is a writer and online content producer for The Atlanta Journal-Constitution. She graduated cum laude with a Bachelor of Arts in Journalism and Sociology from the University of Georgia. At the AJC, she covers state, regional and national news with the Content Curation Desk.
