Moderna to Request Emergency FDA Approval for COVID Vaccine

Researchers work in a lab run by Moderna Inc. (Moderna Inc./Handout via Reuters)

The Food and Drug Administration on Tuesday found that Moderna’s coronavirus vaccine to be safe and “highly effective,” paving the way for the vaccine to become the second one authorized for emergency use.

The agency declared in a 54-page report released Tuesday that the Massachusetts biotech firm’s product is 94 percent effective at preventing the disease associated with the coronavirus said said there are no safety concerns associated with the vaccine. However, in people older than 65, Moderna’s vaccine had only an 86.4 percent rate of immunization success, according to the report.

Next, the FDA’s Vaccines and Related Biological Products Advisory Committee is set to convene on Thursday and recommend that the Moderna vaccine be approved for emergency use.

Moderna requested emergency-use approval for its coronavirus vaccine on November 30.

On Saturday, the FDA granted emergency-use authorization for drug-maker Pfizer’s coronavirus vaccine, developed with BioNTech, the first vaccine to be cleared for widespread use by the public. The first vaccinations outside of clinical trials were given on Monday, and a nurse in Long Island became the first to receive the shot in the United States.

Two more vaccines, developed by Johnson & Johnson and AstraZeneca, are also nearing the final stage of development and testing. The U.S. could have four vaccines with FDA approval by February or March, Health and Human Services Secretary Alex Azar said Monday.

“That’s the genius of Operation Warp Speed,” Azar said. “We spread our bets around not just multiple companies, but multiple platforms, technologies of vaccines.”

The White House has predicted that a coronavirus vaccine will be distributed to 20 million people by the end of December.

More than 300,700 people have died in the U.S. from the coronavirus since the pandemic began, according to data from Johns Hopkins University, and more than 16.5 million people have tested positive across the country. More than 1.6 million people have died globally.

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