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. 

“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 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. 

Moderna’s authorization comes amid a massive vaccination campaign. At least 50,000 Americans have already received a dose of the Pfizer vaccine, and millions more doses are expected by the end of the year. The goal is to give 100 million Americans their first dose of a vaccine before April. 

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. 

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!” 

Mola Lenghi and Carter Evans contributed reporting. 

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