The US Food and Drug Administration, on Monday, approved a second COVID-19 vaccine, developed by Moderna. The vaccine will be marketed as Spikevax and it is the second coronavirus vaccine to attain full regulatory approval in the US. Individuals above 18 years of age are eligible for the vaccine.
This is a huge feat for Moderna as this is the pharmaceutical giant’s first FDA-approved product in the US. Moderna was granted complete approval based on clinical trial data of around 30,000 people.
“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D.
With over 200 million doses, Moderna had previously received an emergency use authorization (EUA) in the country, according to the CDC.
Further, Moderna’s booster or third dose against COVID-19 is available under emergency use authorization.
The Pfizer vaccine for children aged six months to five years is expected to be distributed at the end of February, according to a report by the Washington Post on Monday.
