FDA clears Moderna’s coronavirus vaccine for emergency use


The FDA cleared Moderna’s coronavirus vaccine for emergency use on Friday, offering a new source of hope in the country’s fight against the pandemic. Moderna’s vaccine second to be cleared for emergency use in the United States, after Pfizer’s vaccine received the green light last week.
The Moderna vaccine has been approved for people 18 years of age or older. Six million initial doses will soon be shipped 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 which is causing a large number of hospitalizations and deaths in the United States every day”, said Stephen, commissioner of the FDA. Mr Hahn said in a press release announcing the decision.

The announcement comes a day after a recommended advisory committee the vaccine is authorized. The Vaccines and Related Biologics Advisory Committee voted 20-0, with one abstention, in favor of the vaccine.

Moderna has declared plans to deliver around 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 United States by the end of the year. the first quarter of 2021.

Moderna vaccine is expected to be around 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. The second dose of Pfizer should be given 21 days after the first, while Moderna is given 28 days after the first.

“I am proud of what the Moderna team has achieved in collaboration with our partners,” said CEO Stéphane Bancel 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 clearance comes amid a massive vaccination campaign. The first Americans received the vaccine from Pfizer 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 an intensive care nurse in New York. Before the public vaccination, Governor Andrew Cuomo called the vaccine “a weapon that will end the war.”

“This is the start of the last chapter of the book,” he says.

A health worker says she can “see the light at the end of the tunnel” now that she has been vaccinated. Another said the vaccine would allow him to kiss his mother for the first time in 10 months.

At least 50,000 Americans were vaccinated on Friday, many of whom are healthcare workers on the front lines of the pandemic. Millions of additional doses are expected by the end of the year, and the United States aims to give 100 million Americans their first dose of the vaccine by April.

But the deployment of the vaccine did not come without controversy. More than 10 states said they were told they would receive fewer doses of Pfizer’s vaccine next week than expected. Some states say they will now receive 40% fewer doses than expected.

To boost public confidence in the vaccine, Vice President Mike Pence publicly received her first dose earlier Friday. President-elect Joe Biden and First Lady Dr Jill Biden are expected 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 clearance also comes as the country reports hospitalizations and staggering deaths from the virus. In California, only 2% of intensive care beds in the state are available – and in Southern California, not a single intensive care bed is open. The Institute for Health Metrics and Evaluation now predicts that more than 560,000 people nationwide will have died from the virus by April 1.

President Trump reacted to vaccine news on Twitter, writing “Congratulations, Moderna vaccine is now available!” President-elect Biden also issued a statement, writing that the authorization of Pfizer and Moderna vaccines “assures us that better days lie ahead.”

Mola Lenghi, Carter Evans and Stephen Sanchez contributed reporting.


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