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Moderna applied for emergency F.D.A. vaccine authorization
source:The New York Times 2020-12-01 [Medicine]
and says first injections could begin by Dec. 21.

The Moderna headquarters in Cambridge, Mass.Credit...Cody O'Loughlin for The New York Times

As the drugmaker Moderna said it applied to the Food and Drug Administration on Monday to authorize its coronavirus vaccine for emergency use, the health secretary Alex M. Azar II reiterated that distribution would begin quickly after the expected approvals of the Moderna and Pfizer vaccines vaccine.

“We could be seeing both of these vaccines out and getting into people’s arms before Christmas,” he said on “CBS This Morning” on Monday.

If its vaccine is approved, Moderna said that injections for Americans could begin as early as Dec. 21. The company also announced highly encouraging results, saying that complete data from a large study show its coronavirus vaccine to be 94.1 percent effective, a finding that confirms earlier estimates.

Stéphane Bancel, the company’s chief executive, said in an interview that it was “on track” to produce 20 million doses by the end of December, and from 500 million to a billion in 2021. Each person requires two doses, administered a month apart, so 20 million doses will be enough for 10 million people.

Asked about the role of states in the distribution process, Mr. Azar said that doses would be shipped out through normal vaccine distribution systems, and governors would be “like air traffic controllers” determining which hospitals or pharmacies receive shipments. While governors will determine which groups are prioritized, he said he hoped that they would follow the federal recommendations.

The first shots of the two vaccines are likely to go to certain groups, including health care workers; essential workers like police officers; people in other critical industries; and employees and residents in nursing homes. More than 100,000 Covid deaths have occurred in U.S. nursing homes and other long-term care centers.

On Tuesday, a panel of advisers to the Centers for Disease Control and Prevention will meet to determine how to allocate initial supplies of vaccine.

Mr. Azar said that C.D.C. experts will base their recommendations on the latest data on virus cases around the country.

But generally, “Be thinking people in nursing homes, the most vulnerable, be thinking health care workers who are on the front lines,” he said.

Even though some of the largest outbreaks have occurred in the nation’s prisons, the C.D.C. advisory committee has prioritized correctional officers and others who work in jails and prisons — but not inmates.

Now several groups, including the American Medical Association, are calling for coronavirus vaccines to be given to inmates and employees at prisons, jails and detention centers, citing the unique risks to people in confinement — and the potential for outbreaks to spread from correctional centers, straining community hospitals.

In Kentucky, Gov. Andy Beshear said Monday that 26,000 residents and employees of nursing homes and other long-term care facilities would be the first in his state to get vaccinated against the coronavirus, along with 12,000 of the state’s more than 200,000 health care workers.

Moderna is the second vaccine maker to apply for emergency use authorization; Pfizer submitted its application on Nov. 20. Pfizer has said it can produce up to 50 million doses this year, with about half going to the United States. Its vaccine also requires two doses per person.

The hopeful news arrives at a particularly grim moment in the U.S. health crisis. Coronavirus cases have surged and overwhelmed hospitals in some regions, and health officials have warned that the numbers may grow even worse in the coming weeks because of travel and gatherings for Thanksgiving.

The new data from Moderna show that its study of 30,000 people has met the scientific criteria needed to determine whether the vaccine works. The findings from the full set of data match an analysis of interim data released on Nov. 16 that found the vaccine to be 94.5 percent effective. It also showed that the vaccine was 100 percent effective at preventing severe disease from the coronavirus.

More than 70 vaccines are being developed around the world, including 11 that, like Pfizer’s and Moderna’s vaccines, are in large-scale trials to gauge effectiveness.

— Denise Grady and Karen Zraick