Check out what’s clicking on FoxBusiness.com.
Moderna said Monday that U.S. health regulators from the Food and Drug Administration have granted full approval to the company’s COVID-19 vaccine.
MODERNA BEGINS STUDY FOR OMICRON-SPECIFIC BOOSTER SHOT
“This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the U.S.,” Moderna CEO Stéphane Bancel said in a statement. “We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic.”
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| MRNA | MODERNA INC. | 165.60 | +6.13 | +3.84% |
The approval comes after the company distributed 807 million doses of its vaccine globally in 2021. Moderna’s vaccine has already received approval in more than 70 countries, including Canada, Japan, the European Union, the U.K. and Israel.
CLICK HERE TO READ MORE ON FOX BUSINESS
The FDA, like regulators in Europe and elsewhere, initially allowed emergency use of Moderna’s vaccine based on a study that tracked 44,000 people 18 and older for at least two months — the time period when serious side effects typically arise. That’s shorter than the six months of safety data normally required for full approval, so Moderna continued that study. The FDA also kept watch for serious side effects that have proved to be very rare.
An employee shows the Moderna COVID-19 vaccine at Northwell Health’s Long Island Jewish Valley Stream hospital in New York, Dec. 21, 2020. Reuters/Eduardo Munoz
In the U.S., Moderna is used only by adults. The company said last fall that FDA had delayed deciding whether to clear the shots for 12- to 17-year-olds as it examined a rare risk of heart inflammation seen mostly in young men and teen boys.
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| PFE | PFIZER INC. | 52.65 | -1.68 | -3.09% |
| JNJ | JOHNSON & JOHNSON | 171.61 | -0.13 | -0.08% |
Meanwhile, the FDA granted full approval of Pfizer’s vaccine last August. Johnson & Johnson has not yet applied for full approval of its COVID-19 vaccine.
The Associated Press contributed to this report
