The drugmaker Moderna said it applied Monday to the Food and Drug Administration to authorize it's covid-19 vaccine for emergency use, and that if approved, injections for Americans could begin as early as Dec. 21.
The company announced highly encouraging results Monday, saying that complete data from a large study shows its vaccine to be 94.1% effective, a finding that confirms earlier estimates.
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 shows 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.
Stephane 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.
The first shots of the two vaccines are likely to go to certain groups, including health care workers, essential workers such as police officers, people in other critical industries and employees and residents in nursing homes. More than 100,000 covid-19 deaths have occurred in U.S. nursing homes and other long-term care centers.
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A panel of advisers to the Centers for Disease Control and Prevention will meet today 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."
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.
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 White House moved quickly to take credit for the progress on vaccines.
"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.
70 VACCINES
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.
Johnson & Johnson also is in final-stage testing in the U.S. and several other countries to see if its vaccine candidate could work with just one dose.
Both the Johnson & Johnson and AstraZeneca vaccines work by using harmless cold viruses to carry the spike protein gene into the body and prime the immune system.
The different technologies have ramifications for how easily different vaccines could be distributed globally. The AstraZeneca shots won't require freezer storage like the Pfizer and Moderna vaccines.
Candidates made with still other technologies are in late-stage testing, too. Another U.S. company, Novavax Inc., announced Monday that it has finished enrolling 15,000 people in a late-stage study in Britain and plans to begin recruiting even more volunteers for final testing in the U.S. and Mexico "in the coming weeks."
HOLIDAY'S OVER
On Monday, Americans returning from Thanksgiving break faced strict new coronavirus measures around the country, as health officials brace for a disastrous worsening of the nationwide surge because of holiday gatherings over the long weekend.
Los Angeles County imposed a stay-at-home order for its 10 million residents, and Santa Clara County, in the heart of Silicon Valley, banned high school, college and professional sports and decreed a quarantine for those who have traveled more than 150 miles outside the county.
In Hawaii, the mayor of Hawaii County said trans-Pacific travelers arriving without a negative covid-19 test must quarantine for 14 days, and even those who have tested virus-free may be randomly selected for another test upon arrival. New Jersey is suspending all youth sports.
"The red flags are flying in terms of the trajectory in our projections of growth," said California Gov. Gavin Newsom. "If these trends continue, we're going to have to take much more dramatic, arguably drastic, action."
Health experts had pleaded with Americans to stay home over Thanksgiving and not gather with anyone who didn't live with them. Nevertheless, almost 1.2 million people passed through U.S. airports Sunday, the most since the pandemic gripped the country in March, and others took to the highways to be with family and friends.
Overall, about 13.5 million Americans have contracted the virus, and more than 267,800 have died. In November alone, there were more than 4 million new cases and 25,500 U.S. deaths. Worldwide, there have been over 63 million cases and more than 1.4 million deaths.
The country on average is seeing more than 160,000 new cases per day and over 1,400 deaths -- a toll on par with what the nation witnessed in mid-May, when New York City was the epicenter.
HOSPITALIZATIONS SOAR
A record 90,000 people were in the hospital with the virus in the U.S. as of Sunday, pushing many medical institutions to the limit.
West Virginia Gov. Jim Justice said hospitals across the state will reduce elective surgeries to ensure there is room for coronavirus patients. The number of people hospitalized with covid-19 jumped 29% in the past week. In Kansas City, Kan., hospital and nursing officials said they fear there will not be enough nurses to staff new hospital beds in the metro area if covid-19 cases continue unchecked. Health officials on Monday added 4,425 confirmed infections and 87 hospitalizations to the state's pandemic tally since Friday.
Rhode Island's hospitals reached their covid-19 capacity on Monday, the same day the state's two-week pause took effect. Under restrictions announced by Gov. Gina Raimondo, some businesses will be required to shut down, while others are restricted. Residents are also asked to limit their social circles to people in their household.
"This will not be easy, but I am pleading with you to take it seriously," Raimondo said in a statement.
In Missouri, St. Louis County Executive Sam Page warned area residents Monday that the county is in "crisis mode" as covid-19 cases keep rising and hospitals strain to treat new patients.
Page said area hospitals could run out of intensive care beds sometime this week and the National Guard could be asked to help with response to the pandemic.
"We are in a crisis mode and the virus is winning," Page said.
The Mercy hospital system announced Monday that it will begin treating some patients with mild covid-19 symptoms at home through its Mercy COVID Care Home unit to free more hospital beds.
Mercy said in a news release that it will offer virtual monitoring for those who may need low-flow rates of oxygen. The virtual care team will monitor patients and adjust oxygen levels as needed. If a patient's symptoms worsen, a Mercy Virtual team member and emergency medicine physician will determine the level of care needed, which could include evaluation in an outpatient clinic or going to the hospital.
TRUMP ADVISER RESIGNS
Additionally, Dr. Scott Atlas, a science adviser to Trump who was skeptical of measures to control the coronavirus outbreak, is leaving his White House post.
A White House official confirmed that the Stanford University neuroradiologist, who had no formal experience in public health or infectious diseases, resigned at the end of his temporary government assignment. Atlas confirmed the news in a Monday evening tweet.
Atlas joined the White House this summer, where he clashed with top government scientists, including Dr. Anthony Fauci and Dr. Deborah Birx, as he resisted stronger efforts to contain the covid-19 pandemic.
Atlas has broken with government experts and the overwhelming consensus of the scientific community to criticize efforts to encourage face covering to slow the spread of the virus. Just weeks ago on Twitter he responded to Michigan's latest virus restrictions by encouraging people to "rise up" against the state's policies.
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His views also prompted Stanford to issue a statement distancing itself from the faculty member, saying Atlas "has expressed views that are inconsistent with the university's approach in response to the pandemic."
"We support using masks, social distancing, and conducting surveillance and diagnostic testing," the university said Nov. 16. "We also believe in the importance of strictly following the guidance of local and state health authorities."
Information for this article was contributed by Denise Grady of The New York Times; and by Zeke Miller, Lauran Neergaard, Tammy Webber, Heather Hollingsworth, Daisy Nguyen, Alan Clendenning, Jeff McMillan, John Raby, Michelle Monroe, William J. Kole, Paul Davenport and staff members of The Associated Press.