Moderna's COVID-19 vaccine becomes 2nd to be fully approved by the FDA
A second COVID-19 vaccine has been fully approved in the United States.
The Food and Drug Administration on Monday fully approved the COVID-19 vaccine from Moderna for those over the age of 18. That makes the Moderna vaccine, which will be marketed as Spikevax, the second fully-approved coronavirus vaccine in the U.S. after the vaccine made by Pfizer and BioNTech was approved in August 2021.
"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," Acting FDA Commissioner Janet Woodcock said.
Subscribe to The Week
Escape your echo chamber. Get the facts behind the news, plus analysis from multiple perspectives.
Sign up for The Week's Free Newsletters
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
Though the Moderna vaccine was already being administered under an emergency use authorization, even more data is required for a vaccine to earn full FDA approval. For that reason, Woodcock said the vaccine's approval "may instill additional confidence in making the decision to get vaccinated." Data has shown that Moderna's vaccine is safe and effective against COVID-19 and that a booster dose provides protection against the Omicron variant.
Moderna CEO Stéphane Bancel celebrated the FDA's step as a "a momentous milestone in Moderna's history," noting the vaccine is "our first product to achieve licensure in the U.S."
Sign up for Today's Best Articles in your inbox
A free daily email with the biggest news stories of the day – and the best features from TheWeek.com
Brendan worked as a culture writer at The Week from 2018 to 2023, covering the entertainment industry, including film reviews, television recaps, awards season, the box office, major movie franchises and Hollywood gossip. He has written about film and television for outlets including Bloody Disgusting, Showbiz Cheat Sheet, Heavy and The Celebrity Cafe.
-
Will Biden's AI rules keep the genie in the bottle?
Talking Points A new blow in the race for 'geopolitical superiority'
By Joel Mathis, The Week US Published
-
Israel and Hamas reach long awaited Gaza ceasefire
The Explainer After more than a year of violence that has left tens of thousands dead and pushed the Middle East toward broader regional war, negotiators say an end is in sight
By Rafi Schwartz, The Week US Published
-
Hang 10 at El Zonte, a surfer's paradise in El Salvador
The Week Recommends Catch some waves and a great cup of coffee
By Catherine Garcia, The Week US Published
-
How close are we to a norovirus vaccine?
Today's Big Question A new Moderna trial raises hopes of vanquishing a stomach bug that sickens millions a year
By David Faris Published
-
Marty Makary: the medical contrarian who will lead the FDA
In the Spotlight What Johns Hopkins surgeon and commentator Marty Makary will bring to the FDA
By David Faris Published
-
California declares bird flu emergency
Speed Read The emergency came hours after the nation's first person with severe bird flu infection was hospitalized
By Rafi Schwartz, The Week US Published
-
Bird flu one mutuation from human threat, study finds
Speed Read A Scripps Research Institute study found one genetic tweak of the virus could enable its spread among people
By Peter Weber, The Week US Published
-
Dark chocolate tied to lower diabetes risk
Speed Read The findings were based on the diets of about 192,000 US adults over 34 years
By Peter Weber, The Week US Published
-
ACA opens 2025 enrollment, enters 2024 race
Speed Read Mike Johnson promises big changes to the Affordable Care Act if Trump wins the election
By Peter Weber, The Week US Published
-
McDonald's sued over E. coli linked to burger
Speed Read The outbreak has sickened at least 49 people in 10 states and left one dead
By Rafi Schwartz, The Week US Published
-
Israel, UN agree to Gaza pauses for polio vaccinations
Speed Read Gaza's first case of polio in 25 years was confirmed last week in a 10-month-old boy who is now partially paralyzed
By Rafi Schwartz, The Week US Published