FDA Approves 2nd Coronavirus Vaccine in U.S. Developed by Moderna

AP Photo/Hans Pennink, File
AP Photo/Hans Pennink, File

The U.S. Food and Drug Administration Friday evening granted an Emergency Use Authorization (EUA) for the coronavirus vaccine developed by American company Moderna, making it the second one available in the United States.

“To have two vaccines against a novel virus authorized and distributed within a year is extraordinary, and to have one of these vaccines developed by scientists at the NIH [National Institutes of Health] should be a great source of pride for every member of the HHS family and every American,” U.S. Department and Health and Human Resources Secretary Alex Azar declared in a statement.

“Authorization of Moderna’s vaccine means we can accelerate the vaccination of frontline healthcare workers and Americans in long-term-care facilities, and, ultimately, bring a faster end to this pandemic,” he also said, adding:

On January 7, before China had reported even one death from the novel coronavirus or confirmed human-to-human transmission, NIH  scientists and innovators at Moderna agreed to begin work on the vaccine that received FDA authorization today.

In March, BARDA [Biomedical Advanced Research and Development Authority] scientists joined the partnership and worked with Moderna and NIH to reach commercialization, building on support BARDA has provided since 2016 for the remarkable mRNA technology. … Authorization of Moderna’s vaccine means we can accelerate the vaccination of frontline healthcare workers and Americans in long-term-care facilities, and, ultimately, bring a faster end to this pandemic.

NIH and BARDA are components of HHS.

Acting Secretary of Defense Christopher Miller added in another statement Friday:

The swift authorization of a second vaccine by the FDA is great news for the American people. The DoD [Department of Defense], with the work of General Perna and Operation Warp Speed, stands ready to work with our public and private-sector partners to ensure doses reach Americans as soon as possible. Together, we will bring this pandemic to an end.

FDA Commissioner Stephen Hahn’s approval of the Moderna product came a week after the agency backed the EUA request for the vaccine developed by American company Pfizer and Germany’s BioNTech.

The same panel that recommended that the FDA approve Pfizer’s vaccine (95 percent effective) for emergency use last Thursday, a day before the agency did just that, made the same recommendation for Moderna’s product.

This Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted in favor of approving Moderna’s vaccine (over 94 percent effective) for emergency use.

The panel, made up of vaccine and infectious disease experts, was the same one that recommended approval last Thursday of the November 20 EUA request made by Pfizer-BioNTech, which developed the first approved vaccine in the U.S.

Dr. Hahn and the U.S. Centers for Disease Control and Prevention (CDC) still had to approve the FDA’s panel’s decision officially.

Moderna requested a EUA on November 30. If the Pfizer process is any indication, the company will begin delivering the product on Sunday, allowing vulnerable Americans to receive the first dose of the vaccine early next week.

Early this month, a CDC panel advised, not mandated, states to administer the first batch of shots to healthcare employees and others vulnerable to contract the disease, including residents and staff of nursing homes and other long-term care facilities.

It is up to states to follow the recommendations. Some have already deviated and plan to include inmates among those who will receive the vaccine first.

Operation Warp Speed officials have said Moderna has produced more vaccines than Pfizer to be shipped soon after approval— an estimated six million doses versus Pfizer’s nearly three million. Both vaccines require two doses.

The Trump Administration’s Operation Warp Speed is a private-public effort to develop vaccines and therapeutics in record time. Until last Friday, there were no vaccines for coronaviruses in humans.

Azar noted, “The public-private partnership of Operation Warp Speed has helped Moderna, an American startup, become one of the first two companies to receive FDA authorization for a COVID-19 vaccine.”

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