FDA Authorizes Moderna Vaccine for Emergency Use in the US

By: Sumaya Hussein (husseinsumaya1@gmail.com)

Thumbnail photo courtesy of Reuters

The Food and drug Administration (FDA) authorized the COVID-19 vaccine developed by Moderna, which joins the Pfizer-BioNTech as the second vaccine available for use in the US.

The announcement on Friday came a day after a committee of outside experts endorsed the use of the Moderna vaccine across the US, saying the benefits outweigh the risks.

“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,” said FDA Commissioner Stephen Hahn, in a press release.

Moderna experiemental COVID-19 vaccine. Photo courtesy of Getty Images.

The vaccine which was 94% effective against symptomatic COVID-19 in clinical trials can now be given to adults 18 years and older. Data presented by Moderna also hints that the vaccine could prevent asymptomatic infection as well.

Both the Moderna and Pfizer vaccine will be available under Emergency Use Authorization, a designation that lets the FDA sign off on products faster than the normal review process during an emergency like a pandemic.

The Moderna vaccine can be easily stored compared to the Pfizer vaccine, which requires to be kept at ultra-cold temperatures.

Moderna can be stored in a refrigerator for up to 30 days, making it easier to distribute to places without the infrastructure to maintain extremely low temperatures.

“We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease,” Stéphane Bancel, CEO of Moderna said in a press release.

The United States ordered 200 million doses of the Moderna vaccine, enough to vaccinate 100 million people.

Patient receiving a dose of the Moderna vaccine. Photo courtesy of the New York Times.

The first doses will be given to health care workers and residents in long-term care facilities within days.

Moderna has about 5.9 million doses ready for shipment set to begin during the weekend, according to operation Warp Speed, the US government’s vaccine development program. The first Moderna vaccines are expected to be administered on Monday.

Moderna has said it plans to deliver approximately 20 million doses to the US government this year, and will provide the 200 million doses by end of June 2021.


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