The FDA approved Moderna’s coronavirus vaccine for emergency use on Friday, offering a new source of hope in the country’s fight against the pandemic. The Moderna vaccine is the second approved in the US for emergency use, after Pfizer’s vaccine got the green light last week.
The Moderna vaccine is approved for people 18 years of age or older. Six million first doses will soon be shipped nationwide.
“With the availability of two vaccines for the prevention of COVID-19, the FDA has taken another critical step in the fight against this global pandemic that is causing massive numbers of hospitalizations and deaths in the United States every day,” said FDA Commissioner Stephen Said M. Hahn in a press release announcing the decision.
The announcement comes a day after one advisory panel recommended the vaccine is approved. The Advisory Committee on Vaccines and Related Biological Products voted 20-0, with one abstention, in support of the vaccine.
Moderna said it aims to provide approximately 20 million doses of the vaccine by the end of the year and said it expects 85 to 100 million doses to be available in the US by the first quarter of 2021.
The Moderna vaccine is expected to be about 94.1% effective, comparable to Pfizer’s vaccine. But unlike Pfizer’s vaccine, Moderna does not need to be stored in freezing temperatures.
Both vaccines require two doses. The second dose of Pfizer should be given 21 days after the first, while Moderna’s should be 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 produce the Moderna COVID-19 vaccine from sequence to authorization in 11 months, while accelerating clinical development with a Phase 1, Phase 2 and Phase 3 pivotal study involving 30,000 participants. . ”
Moderna’s approval comes amid a massive vaccination campaign. The first Americans received the vaccine from Pfizer on Monday as the company worked to ship nearly 3 million initial doses to more than 600 locations across the country.
One of the first doses went to an intensive 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.
A health care provider 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.
At least 50,000 Americans were vaccinated on Friday, many of whom are health workers fighting on the front lines of the pandemic. Millions more doses are expected by the end of the year, with the US aiming to give 100 million Americans their first dose of a vaccine by April.
But the introduction of the vaccine has not come without controversy. More than 10 states have said 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.
Vice President Mike Pence, to build public confidence in the vaccine received publicly his first dose earlier Friday. President-elect Joe Biden and first lady Dr. Jill Biden will be vaccinated on Monday, with Vice President-elect Kamala Harris and her husband to follow a week later. At least 42 members of Congress, including Senate Leader Mitch McConnell and House Speaker Nancy Pelosi have also been vaccinated.
The permission also comes because the country is reporting staggering hospitalizations and deaths from the virus. In California, only 2% of the state’s IC beds are available – and in Southern California, not a single ICU bed is open. The Institute for Health Metrics and Evaluation now predicts that by April 1, more than 560,000 people across the country will have died from the virus.
President Trump responded to the vaccine news Twitter, writing “Congratulations, the Moderna vaccine is now available!” President-elect Biden also released a statement in which he wrote that the approval of the Pfizer and Moderna vaccines “assures us that better days are ahead.”
Mola Lenghi, Carter Evans and Stephen Sanchez contributed to the reporting.