FDA authorizes Moderna's coronavirus vaccine for emergency use
The FDA on Friday authorized Moderna's coronavirus vaccine for emergency use, offering a new source of hope in the nation's fight against the pandemic. Moderna's vaccine is the second to be authorized for emergency use in the U.S., after Pfizer's vaccine was given the green light last week.
The Moderna vaccine has been authorized for people aged 18 or older. Six million initial doses will soon be shipped out across the country.
"With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day," FDA Commissioner Stephen M. Hahn said in a press release announcing the decision.
The announcement comes a day after an advisory panel recommended the vaccine be authorized. The Vaccines and Related Biological Products Advisory Committee voted 20-0, with one abstention, in support of the vaccine.
Moderna said it aims to provide about 20 million doses of the vaccine by the end of the year and said it expects that 85 to 100 million doses will be available in the U.S. by the first quarter of 2021.
The Moderna vaccine is expected to be about 94.1% effective, similar to Pfizer's vaccine. But unlike Pfizer's vaccine, Moderna's does not need to be stored at sub-zero temperatures.
Both vaccines require two doses. Pfizer's second dose must be given 21 days after the first, while Moderna's is given 28 days after the first.
"I am proud of what the Moderna team has achieved in collaboration with our partners," CEO Stéphane Bancel said in a press release. "We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants."
Moderna's authorization comes amid a massive vaccination campaign. The first Americans received Pfizer's vaccine on Monday, as the company worked to send nearly 3 million initial doses to more than 600 sites across the country.
One of the first doses went to a critical care nurse in New York. Ahead of the public vaccination, Governor Andrew Cuomo called the vaccine "the weapon that will end the war."
"This is the beginning of the last chapter of the book," he said.
One health care worker said she can "see the light at the end of the tunnel" now that she's been vaccinated. Another said the vaccine will allow her to hug her mother for the first time in 10 months.
As of Friday, at least 50,000 Americans have been vaccinated, many of whom are health care workers fighting on the frontlines of the pandemic. Millions more doses are expected by the end of the year, and the U.S. aims to give 100 million Americans their first dose of a vaccine before April.
But the vaccine rollout has not come without controversy. More than 10 states have said that they have been told they will receive fewer doses of Pfizer's vaccine next week than expected. Some states say they will now receive 40% fewer doses than expected.
To deepen public confidence in the vaccine, Vice President Mike Pence publicly received his first dose earlier Friday. President-elect Joe Biden and first lady Dr. Jill Biden are set to be vaccinated on Monday, and Vice President-elect Kamala Harris and her husband will follow a week later. At least 42 members of Congress, including Senate Majority Leader Mitch McConnell and House Speaker Nancy Pelosi, have also been vaccinated.
The authorization also comes as the nation is reporting staggering hospitalizations and deaths from the virus. In California, only 2% of the state's ICU beds are available — and in Southern California, not a single ICU bed is open. The Institute for Health Metrics and Evaluation now predicts more than 560,000 people nationwide will have died of the virus by April 1.
President Trump reacted to the vaccine news on Twitter, writing "Congratulations, the Moderna vaccine is now available!" President-elect Biden also released a statement, writing that authorization of the Pfizer and Moderna vaccines "assures us that brighter days lie ahead."
Mola Lenghi, Carter Evans and Stephen Sanchez contributed to this report.