Vaccine Maker Moderna Applies for Emergency Approval from FDA

A nurse working with the World Health Organization (WHO) shows a bottle containing Ebola vaccine at the town all of Mbandaka on May 21, 2018 during the launch of the Ebola vaccination campaign. - The death toll in an outbreak of Ebola in the Democratic Republic of Congo (DRC) rose …

The pharmaceutical company Moderna is applying today for emergency authorization from the Food and Drug Administration (FDA) to produce a vaccine for the coronavirus.

The first vaccinations could be ready for Americans before Christmas, according to Moderna CEO Stephane Bancel.

The New York Times reported on the development:

Moderna’s application is based on data that it also announced on Monday, showing that its vaccine is 94.1 percent effective, and that its study of 30,000 people has met the scientific criteria needed to determine whether the vaccine works. The finding from the complete set of data is in line with an analysis of earlier data released on Nov. 16 that found the vaccine to be 94.5 percent effective.

The new data also showed that the vaccine was 100 percent effective at preventing severe disease from the coronavirus. The product was developed in collaboration with government researchers from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases.

Mr. Bancel said the company was “on track” to produce 20 million doses by the end of December, and 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. 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 logistics of getting the vaccine out to Americans will include deciding who will be prioritized for receiving it, with health care workers, first responders and others depending on what health officials in states deem to be “essential” workers, most likely to be first in line.

Last week, a panel of advisers to the Centers for Disease Control and Prevention (CDC) will meet to determine how to allocate initial supplies of vaccine.

An estimated 13.3 million Americans have contracted the virus, and more than 265,000 have died. 

“Moderna’s application for emergency use authorization will include data from its Phase 3 study of 30,000 people,” the Times reported. The application, several hundred pages long, will also include several thousand pages of additional data.”

Bancel said in the Times’ report that he expects the FDA to conclude its final review of the vaccine by Dec. 17.

Officials at Operation Warp Speed, President Donald Trump’s unprecedented effort to accelerate vaccine development, said vaccinations could begin within 24 hours after the F.D.A. authorizes it.

Under Trump’s plan, the federal government has arranged to buy vaccines from both Moderna and Pfizer and to provide them to the the public for free. Moderna has a commitment of $955 million from the federal Biomedical Advanced Research and Development Authority for research and development of its vaccine, and $1.525 billion to buy 100 million doses.

Bancel said the statistics about prevention of severe disease are the most important data from the study.

“This is why I think this vaccine is going to be a game-changer,” Bancel said, adding that it will reduce hospitalizations and deaths.

Bancel said he hopes the vaccine will “get this country back to its pre-pandemic state.”

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