Coronavirus

Moderna applies for emergency FDA approval for its coronavirus vaccine

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 headquarters of the drugmaker Moderna in Cambridge, Mass., on Nov. 19, 2020. Moderna said it would apply on Monday to the Food and Drug Administration to authorize its coronavirus vaccine for emergency use. Cody O'Loughlin / The New York Times

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The drugmaker Moderna announced highly encouraging results Monday, saying that complete data from a large study show its coronavirus vaccine to be 94.1% effective, a finding that confirms earlier estimates.

The company said it applied Monday to the Food and Drug Administration to authorize the vaccine for emergency use, and that if approved, injections for Americans could begin as early as Dec. 21.

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 Nov. 16 that found the vaccine to be 94.5% effective.

The study also showed that the vaccine was 100% 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.

Stéphane Bancel, chief executive of Moderna, said the company was “on track” to produce 20 million doses by the end of December, and from 500 million to 1 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 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.

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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.

“Be thinking people in nursing homes, the most vulnerable, be thinking health care workers who are on the front lines,” said Alex Azar, secretary for health and human services, said on the CBS program “This Morning” on Monday.

He said the CDC advisers would base their recommendations on the latest data on virus cases across the country. Asked about the role of states in the distribution process, he 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.

Although governors will determine which groups are prioritized, he said he hoped that they will follow the federal recommendations. He added that he would speak to governors Monday afternoon with Vice President Mike Pence. In response to a question about how officials could guard against people using money or connections to jump the proverbial line, Azar vowed to “call out any inequities or injustices that we see.”

The White House moved quickly to take credit for the progress on vaccines.

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“President Trump’s Operation Warp Speed is rapidly advancing on a trajectory of success to save millions of American lives — five times faster than any other vaccine in history,” Michael Bars, a spokesman for Trump, said in a statement.

Overall, about 13.3 million Americans have contracted the virus, and more than 265,900 have died. In November alone, there were more than 4 million new cases and 25,500 U.S. deaths. Worldwide, there have been nearly 62 million cases and almost 1.5 million deaths.

More than 70 coronavirus 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.

One of those is made by AstraZeneca, which announced positive but puzzling preliminary results Nov. 23: Its vaccine was 90% effective in people who received a half dose and then a full one, but 62% effective in those who received two full doses. Researchers are waiting for more data.

Moderna’s application for emergency use authorization included data from its Phase 3 study of 30,000 people. The application, several hundred pages long, also included several thousand pages of additional data.

FDA scientists will examine the information, and the application is likely to undergo a final review Dec. 17 by a panel of expert advisers to the agency, Bancel said, adding that he expected the advisers to make a decision within 24 to 72 hours. The FDA usually follows the recommendations of its advisory panels.

Officials at Operation Warp Speed, the government’s program to accelerate vaccine development, have said vaccinations could begin within 24 hours after the FDA grants authorization.

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Bancel said that Moderna had not yet begun shipping vaccines across the country, and that it would not do so until the emergency authorization is granted.

The government has arranged to buy vaccines from both Moderna and Pfizer and to provide it to the public free of charge. Moderna has received a commitment of $955 million from the U.S. government’s Biomedical Advanced Research and Development Authority for research and development of its vaccine, and the United States has committed up to $1.525 billion to buy 100 million doses.

Shares of Moderna’s stock surged Monday from the news, by 20%, to nearly $153 a share.

Both Moderna’s and Pfizer’s vaccines use a synthetic form of genetic material from the coronavirus called messenger RNA, or mRNA, to program a person’s cells to make many copies of a part of the virus. That viral fragment sets off alarms in the immune system and trains it to recognize and attack the real virus if it tries to invade.

No mRNA vaccine has reached the market before, and the candidates from Pfizer and Moderna have faced considerable skepticism from scientists and a wary public.

But the strong results from both vaccines have begun to quash the doubts.

So far, neither vaccine has had serious side effects, but many recipients have had headaches, mild fevers, fatigue, joint and muscle aches and sore arms for a day or two.

Of the 30,000 people in the Moderna study, half were vaccinated and half received placebo shots of salt water; neither the participants nor their doctors knew who got what. Then, researchers monitored the participants to see who contracted the coronavirus, and watched for side effects.

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To determine statistically whether the vaccine was effective, a total of 151 cases of COVID-19 were needed.

Because the coronavirus has been surging in the United States, Moderna wound up with 196 cases — 185 in the placebo group, and 11 in the vaccinated group, meaning that the vaccine was 94.1% effective at preventing COVID-19.

The 196 people who got sick with COVID-19 reflected the diversity of Moderna’s volunteers: Thirty-three were 65 or older. The group also included 29 Hispanic volunteers, six Black participants, four Asian Americans and three multiracial people. The efficacy and safety appeared the same in all of the subgroups and by gender, Moderna said in its announcement.

Thirty participants had severe cases, all in the placebo group. One died.

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

“This is why I think this vaccine is going to be a game-changer,” he said. The vaccine will reduce hospitalizations and deaths, he added, “and I hope get this country back to its pre-pandemic state.”

Moderna said it was also seeking authorization to market its vaccine in Europe, Canada, Britain, Israel and Singapore.

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