FDA Approves Moderna's COVID-19 Vaccine for Emergency Use

This is the second coronavirus vaccine approved by the agency for use in the United States; Americans could receive the Moderna shot as soon as Monday

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File photo: a nurse gives volunteer Melissa Harting an injection of a COVID-19 vaccine, developed by the National Institutes of Health and Moderna, July 27, 2020.
File photo: a nurse gives volunteer Melissa Harting an injection of a COVID-19 vaccine, developed by the National Institutes of Health and Moderna, July 27, 2020.Credit: Hans Pennink / AP

Moderna Inc's coronavirus vaccine on Friday became the second to receive emergency use authorization (EUA) from the U.S. Food and Drug Administration, welcome news to a nation with a staggering COVID-19 death toll of over 307,000 lives lost.

The FDA announced the authorization the day after the agency's panel of outside experts endorsed its use.

The decision marks the first regulatory authorization in the world for Moderna's vaccine and validation of its messenger RNA technology, less than a year after the first COVID-19 case was identified in the United States.

The biotech company has worked with the U.S. government to prepare for the distribution of 5.9 million shots as early as this weekend.

The FDA decision is based on results from a late-stage study of 30,000 volunteers that found the vaccine was nearly 95% effective at preventing illness from COVID-19 with no serious safety concerns.

The authorization follows an EUA granted for a similar vaccine from Pfizer Inc and German partner BioNTech SE that has been put into the arms of thousands of U.S. healthcare workers this week in a massive nationwide rollout.

Moderna's shot is expected to be used in harder-to-reach locations, such as rural hospitals. The vaccine needs to be stored and shipped frozen, but does not require the ultra-cold temperatures of the Pfizer/BioNTech shot.

Once thawed, the Moderna vaccine can be kept at typical refrigerator temperatures. It is administered in two shots 28 days apart.

Moderna has deals with the U.S. government to provide 20 million doses this year and a total of 200 million doses by the end of June 2021.

In June, Israel signed a deal with Moderna, but an expanded deal was signed two weeks ago that would allow the country to receive three times more vaccines in 2021, from 2 million vaccines to 6 million - enough doses for 3 million Israeli citizens. Pfizer has committed to providing Israel with 4 million doses by the end of December. At the time, the deal was perceived to be a risky move by Israel's government, yet now Israel is expected to be one of the first countries to inoculate its citizens with the Moderna vaccine. 

Israel is expected to begin its widespread vaccination campaign on Saturday night, starting with Prime Minister Benjamin Netanyahu in a live broadcast.  

On Sunday, health care workers in health maintenance organizations and hospitals will be first to receive the vaccine, and the general public will be able to be inoculated through their HMOs on Monday.

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