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Early Data Show Moderna’s Coronavirus Vaccine Is 94.5% Effective

The drugmaker Moderna announced on Monday that its coronavirus vaccine was 94.5 percent effective, based on an early look at the results from its large, continuing study.

Researchers said the results were better than they had dared to imagine. But the vaccine will not be widely available for months, probably not until spring.

Moderna is the second company to report preliminary data on an apparently successful vaccine, offering hope in a surging pandemic that has infected more than 53 million people worldwide and killed more than 1.2 million. Pfizer, in collaboration with BioNTech, was the first, reporting one week ago that its vaccine was more than 90 percent effective.

The need is urgent. U.S. cases are soaring, setting new records every day. There have been more than 11 million cases and 246,000 deaths. The disease is killing more than 1,100 Americans a day, and the last million cases occurred in just six days. Some states and cities are reinstating lockdowns, restricting gatherings and closing schools once again.

Pfizer and Moderna were the first to announce early data on large studies, but 10 other companies are also conducting big Phase 3 trials in a global race to produce a vaccine, including efforts in Australia, Britain, China, India and Russia. More than 50 other candidates are in earlier stages of testing.

The Food and Drug Administration has said that coronavirus vaccines should be at least 50 percent effective to be approved.

Moderna also reported on Monday that its vaccine has a longer shelf life under refrigeration and at room temperature than previously reported, which should make it easier to store and use.

The financial markets were lifted in early trading on Monday, with shares of Moderna increasing by a little more than 6 percent, to almost $95 a share.

Researchers test vaccines by inoculating some study participants and giving others placebos, and then watching the two groups to see how many people get sick. In Moderna’s study, 95 people contracted the coronavirus: five who were vaccinated, and 90 who received placebo shots of saltwater. Statistically, the difference between the two groups was highly significant. And of the 95 cases, 11 were severe — all in the placebo group.

The 95 cases included 15 people 65 or older and 20 people who were Hispanic, Black, Asian or multiracial. The company said the vaccine appeared equally safe and effective in all the subgroups.

The results were analyzed by an independent data safety monitoring board, appointed by the National Institutes of Health.

Moderna, based in Cambridge, Mass., developed its vaccine in collaboration with researchers from the Vaccine Research Center, part of the National Institute of Allergy and Infectious Diseases.

Dr. Anthony S. Fauci, director of the institute, said in an interview: “I had been saying I would be satisfied with a 75 percent effective vaccine. Aspirationally, you would like to see 90, 95 percent, but I wasn’t expecting it. I thought we’d be good, but 94.5 percent is very impressive.”

At a news briefing on Monday, Dr. Fauci and Dr. Francis Collins, director of the National Institutes of Health, emphasized that the hopeful news did not mean people could let down their guard. On the contrary, they implored the public to “double down” on mask-wearing, distancing, hand-washing and avoiding crowds, and to stay that course until vaccine becomes available.

Stéphane Bancel, the chief executive of Moderna, said in a statement that the results had provided “the first clinical validation that our vaccine can prevent Covid-19 disease, including severe disease.”

Pfizer’s chief executive, Dr. Albert Boula, tweeted congratulations to Moderna.

Pfizer and Moderna each announced the findings in news releases, not in peer-reviewed scientific journals, and the companies have not yet disclosed the detailed data that would allow outside experts to evaluate their claims. Therefore, the results cannot be considered conclusive. The studies are continuing, and the figures on effectiveness may change.

The companies’ products open the door to an entirely new way of creating vaccines — and creating them fast. Both use a synthetic version of coronavirus genetic material, called messenger RNA or mRNA, to program a person’s cells to churn out many copies of a fragment of the virus. That fragment sets off alarms in the immune system and stimulates it to attack, should the real virus try to invade. Although a number of vaccines using this technology are in development for other infections and cancers, none have yet been approved or marketed.

“The fact that two different vaccines made by two different companies with two different kinds of structures, in a new messenger RNA concept, both worked so effectively confirms the concept once and for all that this is a viable strategy not only for Covid but for future infectious disease threats,” said Dr. Barry R. Bloom, a professor of public health at Harvard.

Natalie E. Dean, a biostatistician at the University of Florida, said an important finding was that the vaccine appeared to prevent severe disease. Pfizer did not release information about disease severity when reporting its results.

Researchers say the positive results from Pfizer and Moderna bode well for other vaccines, because all of the candidates being tested aim at the same target — the so-called spike protein on the coronavirus that it uses to invade human cells.

Dr. Bloom said that the success of the two vaccines meant that measures of immunity used in earlier phases of the studies — participants’ antibody levels — were reliable, and that other companies could use those measures as proof of effectiveness to shorten the testing and approval process for their vaccines.

It will be important to determine whether the vaccines work equally well in older and younger people, experts say. Researchers also want to know if the vaccines prevent people from spreading the virus — an ideal result that could help quash the pandemic.

Another big unknown is how long the immunity provided by the vaccines will last.

An additional concern is that both vaccines must be stored and transported at low temperatures — minus 4 degrees Fahrenheit for Moderna, and minus 94 Fahrenheit for Pfizer — which could complicate their distribution, particularly to low-income areas in hot climates. Although both vaccines are made of mRNA, their temperature requirements differ because they use different, proprietary formulations of fat to encase and protect the mRNA, Ray Jordan, a Moderna spokesman, said.

Other coronavirus vaccines being developed will need only refrigeration. If handled improperly, vaccines can become inactive.

But on Monday, Moderna said researchers had found that its vaccine had a longer shelf life in the refrigerator than previously thought: 30 days, not seven. And it will last 12 hours at room temperature, the company said.

Dr. William Schaffner, an infectious disease expert at Vanderbilt University, said the relative ease of handling the Moderna vaccine would give it a big advantage.

“This vaccine presents the opportunity of using doctors’ offices, clinics and pharmacies as vaccination sites,” he said, adding that he would not be surprised, should both vaccines become available, if vaccination sites requested Moderna’s.

Both companies said they expected to apply within weeks to the F.D.A. for emergency authorization to begin vaccinating the public. In addition to the evidence for effectiveness, the companies must also submit two months of safety data on at least half of the participants.

So far, studies of the two vaccines have not found serious side effects, but participants have reported sore arms, fatigue, fever and joint and muscle aches that last for a day or two.

Moderna’s study did not include children. Dr. Tal Zaks, the company’s chief medical officer, said the company planned to test it in them in the coming months, starting with adolescents.

Moderna said it would have 20 million doses ready by the end of 2020; Pfizer said it would have about 50 million by then. Both vaccines require two shots, so 20 million doses would be enough for 10 million people.

On Friday, Moncef Slaoui, the chief scientist for Operation Warp Speed, the Trump administration’s program to accelerate development of vaccines and treatments for Covid-19, said that if any early vaccine candidates received permission for emergency use, immunization could begin sometime in December. Health experts have said the initial doses would go to high-risk people like health care workers, first responders, other front-line workers and frail people in nursing homes. Dr. Fauci said the vaccines would probably start becoming more widely available by April.

The U.S. government will buy the vaccines and give them to the public free of charge. But both companies expect to profit, and not to provide their products at cost. Moderna said it would charge other governments from $32 to $37 per dose. The charge to the United States, which has already committed about $2.5 billion to help develop Moderna’s vaccine and buy doses, comes out to about $24.80 a shot, according to Mr. Jordan, the company spokesman.

Pfizer did not take any money from the U.S. government to develop or test its vaccine. But Operation Warp Speed has promised Pfizer $1.95 billion to provide 100 million doses, which comes out to $19.50 per dose.

Both of the companies’ vaccine candidates began large human trials on the same date, July 27.

Moderna had planned a first interim analysis of its trial data when the number of Covid-19 cases among participants reached 53. But the recent surge in cases drove the number to 95, and it is likely to speed completion of the study.

The company announced on Oct. 22 that it had completed enrollment of its 30,000-person study, and that 25,650 participants had already received two shots. The company had slowed enrollment in September to ensure diversity among participants, and ultimately included 37 percent from communities of color, and 42 percent from populations considered at high risk because they were over 65 or had conditions like diabetes, obesity or heart disease.

As in Pfizer’s study, half of the participants were given the experimental vaccine and half a placebo shot of saltwater, with neither the patients nor their doctors knowing which one they had received. Moderna’s vaccine requires four weeks between shots, and Pfizer’s needs three weeks.

Dr. Zaks said Moderna’s study results were so strong that the company felt an ethical obligation to offer the vaccine to the placebo group as soon as possible.

Moderna said it could produce 500 million to one billion doses in 2021.

The company is working with the Swiss company Lonza and Laboratorios Farmacéuticos Rovi of Spain to make doses of the vaccine outside the United States.

Dr. Bloom noted that Moderna had never marketed a vaccine before, and he questioned whether the company had the capacity to manufacture hundreds of millions of doses.

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.

Moderna has already taken the early steps needed to apply to government agencies in Britain, Canada and Europe to market its vaccine, and the company has made deals to sell 50 million doses to Japan and unspecified amounts to Qatar and Israel.

Carl Zimmer and Michael de la Merced contributed reporting.

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Doctors Are Calling It Quits Under Stress of the Coronavirus

Two years ago, Dr. Kelly McGregory opened her own pediatric practice just outside Minneapolis, where she could spend as much time as she wanted with patients and parents could get all of their questions answered.

But just as her practice was beginning to thrive, the coronavirus hit the United States and began spreading across the country.

“As an independent practice with no real connection to a big health system, it was awful,” Dr. McGregory said. At one point, she had only three surgical masks left and worried that she could no longer safely treat patients.

Families were also staying away, concerned about catching the virus. “I did some telemedicine, but it wasn’t enough volume to really replace what I was doing in the clinic,” she said.

After her husband found a new job in a different state, Dr. McGregory, 49, made the difficult decision to close her practice in August. “It was devastating,” she said. “That was my baby.”

Many other doctors are also calling it quits. Thousands of medical practices have closed during the pandemic, according to a July survey of 3,500 doctors by the Physicians Foundation, a nonprofit group. About 8 percent of the doctors reported closing their offices in recent months, which the foundation estimated could equal some 16,000 practices. Another 4 percent said they planned to shutter within the next year.

Other doctors and nurses are retiring early or leaving their jobs. Some worry about their own health because of age or a medical condition that puts them at high risk. Others stopped practicing during the worst of the outbreaks and don’t have the energy to start again. Some simply need a break from the toll that the pandemic has taken among their ranks and their patients.

Another analysis, from the Larry A. Green Center with the Primary Care Collaborative, a nonprofit group, found similar patterns. Nearly a fifth of primary care clinicians surveyed in September say someone in their practice plans to retire early or has already retired because of Covid-19, and 15 percent say someone has left or plans to leave the practice.

The clinicians also painted a grim picture of their lives, as the pandemic enters a newly robust phase with record case counts in the United States. About half already said their mental exhaustion was at an all-time high. Many worried about keeping their doors open: about 7 percent said they were not sure they could remain open past December without financial help.

For some, family obligations left them no choice.

“Honestly, if it hadn’t been for the pandemic, I would have still been working because it was not my plan to retire at that point,” said Dr. Joan Benca, 65, who worked as an anesthesiologist in Madison, Wis.

But her daughter and son-in-law hold administrative positions in a hospital intensive care unit, treating the sickest Covid patients, and they have two small children. When cases climbed in the spring, their day care center closed, and Dr. Benca’s daughter desperately needed someone she trusted to look after the children.

“It wasn’t the way I wanted to end my career,” Dr. Benca said. “I think for most of us, we would say, you would fall on your sword for your family but not for your job,” she said, adding that she knows other female colleagues who have stayed home to care for children or older relatives.

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Credit…Lauren Justice for The New York Times

Dr. Michael Peck, 66, an anesthesiologist in Rockville, Md., decided to leave after working in April in the hospital’s intensive care unit, intubating critically ill patients, and worrying about his own health. “When the day was over, I just said, ‘I think I’m done’ — I want to live my life, and I don’t want to get ill,” said Dr. Peck, who had already been cutting back his hours.

He is now spending a few hours a day as the chief medical officer for a start-up.

Still, most practices have proved resilient. The Paycheck Protection Program — authorized by Congress to help businesses, including medical practices, with the economic fallout of the pandemic — helped many doctors remain afloat. That money “kind of made me solid,” said Dr. Ripley Hollister, a family physician in Colorado Springs who serves as chairman of the research committee for the Physicians Foundation. The volume now “is really coming back,” he said.

But, depending on the future course of the pandemic, Dr. Lisa Bielamowicz, a co-founder of Gist Healthcare, a consulting firm, predicts “another wave of financial stress hitting practices.” Many doctors’ groups will seek a buyer, whether a hospital, an insurance company or a private equity firm that plans to roll up practices into a larger business.

One doctor, who asked not to be identified because the discussions are confidential, said she and her partner had already been talking with the nearby hospital nearby about buying their pediatric practice before the pandemic arrived in the United States.

Although federal aid has helped, patient visits are still 15 percent below normal, she said, and they are continually worried about making payroll and having enough doctors and staff to see patients. As the number of virus cases balloons in the Midwest, her employees must deal with increasingly agitated parents.

“They’re yelling and cussing at my staff,” she said. Working for a telemedicine firm might be an alternative, she added. “It’s a hard job to begin with, to own your own business,” she said.

The coronavirus crisis has amplified problems that doctors were already facing, whether they own their practice or are employed. “A lot of physicians were hanging on by a thread from burnout before the pandemic even started,” said Dr. Susan R. Bailey, the president of the American Medical Association.

In particular, smaller practices continue to have difficulty finding sufficient personal protective equipment, like gloves and masks. “The big hospitals and health care systems have pretty well-established systems of P.P.E.,” she said, but smaller outfits might not have a reliable source. “I was literally on eBay looking for masks,” she said. The cost of these supplies has also become a significant financial issue for some practices.

Doctors are also stressed by the never-ending need to keep safe. “There is a hunker-down mentality now,” Dr. Bailey said. She is concerned that some doctors will develop PTSD from the chronic stress of caring for patients during the pandemic.

Even those who are not responsible for running their own practices are leaving. Courtney Barry, 40, a family nurse practitioner at a rural health clinic in Soledad, Calif., watched the cases of coronavirus finally ebb in her area, only to see wildfires break out. Many of her patients are farmworkers and work outside, and they became ill from the smoke.

In 14 years as a nurse, Ms. Barry has never experienced anything “like this that is just such a high level of stress and just keeps going,” she said, adding, “The other hard part is there’s no end in sight.”

She tried working fewer days but decided eventually that she would stop altogether for several months beginning in early December. Ms. Barry hasn’t figured out what’s next for her.

“My intention is to stay in medicine, although I would not be totally opposed to doing something in a totally different area, which is something that I would not have said in the past,” she said.

And patients have indeed felt the effects. The pandemic has developed into “a really huge disruption,” said Dr. Hollister, the family physician, who thinks closed practices are likely to result in “a significant impairment to patients’ access to medical care.” In his community, where both specialists and primary care doctors are leaving, he is tending to more patients who no longer have a doctor.

It is an issue that Dr. McGregory, who took a job at the University of Wisconsin School of Medicine and Public Health in Madison, worries about. There were some families in her practice whom she could not convince to find another pediatrician immediately. She said they “are waiting, which I discouraged, because I think every child should have a medical home.”

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Purdue Pharma Pleads Guilty to Criminal Charges for Opioid Sales

Purdue Pharma, the maker of OxyContin, has agreed to plead guilty to criminal charges related to its marketing of the addictive painkiller, and faces penalties of roughly $8.3 billion, the Justice Department announced on Wednesday. The settlement could pave the way for a resolution of thousands of lawsuits brought against the company for its role in a public health crisis that has killed more than 450,000 Americans since 1999.

The company’s owners, members of the wealthy Sackler family, have agreed to pay $225 million in civil penalties. Prosecutors said the agreement did not preclude the filing of criminal charges against Purdue executives or individual Sacklers.

The federal settlement does not end all of the extensive litigation against Purdue, but it does represent a significant advance in the long legal march by states, tribes, cities and counties to hold the most prominent opioid maker accountable.

In a statement issued after the announcement of the deal, Steve Miller, chairman of the company board, said: “Purdue deeply regrets and accepts responsibility for the misconduct detailed by the Department of Justice in the agreed statement of facts.”

Members of the Sackler family said in a statement that they “acted ethically and lawfully.” Issued on behalf of members who had served on the company’s board, the family statement added: “The board relied on repeated and consistent assurances from Purdue’s management team that the company was meeting all legal requirements.”

OxyContin, which came on the market in the mid-90s, is seen as an early, ferocious driver of the opioid epidemic and Purdue is regarded as the architect of muscular, misleading drug marketing. But it is unlikely the company will pay anything close to the $8.3 billion negotiated in the settlement deal. That is because Purdue sought bankruptcy court protection amid the onslaught of lawsuits, and so the federal government will now have to take its place in a long line of creditors. Typically, creditors end up collecting pennies on the dollar in bankruptcy proceedings.

The settlement does give the Justice Department and the Trump administration a high-profile achievement that the president can tout on the campaign trail. Mr. Trump won the 2016 election in part because he vowed to combat an opioid addiction crisis that had gripped large swaths of the country and continues to be an issue in important swing states.

But state attorneys general from Massachusetts, New York and North Carolina, among others, have raised questions about just how much of an effect the settlement will have with respect to holding the Sackler family to account. Purdue was keen to settle its federal legal troubles under a Trump administration, which it sensed would cut a better deal than a new Biden administration. The $225 million that the Sacklers would pay as part of their civil settlements is small relative to the family’s net worth, estimated to be at least $13 billion, much of it generated from sales of OxyContin.

Joe Rice, a negotiator for local governments that are suing Purdue, said, “Purdue is doing everything they can to get this deal done in this administration. It’s advantageous to both sides.”

This federal case against Purdue is distinct from thousands of opioid-related lawsuits against other drug manufacturers, as well as distributors and pharmacy chains, still pending in federal and state courts.

Purdue has long demanded that the federal charges against it be resolved before it would agree to a larger settlement with cities, tribes, states and individuals, who claim that its relentless marketing of OxyContin directly contributed to a crisis of addiction and overdoses, resulting in towering costs in health care, law enforcement and unemployment. Lawyers close to negotiations expect that the final settlement may emerge early next year.

In the federal settlement, the company agreed to plead guilty to felony charges of defrauding federal health agencies and violating anti-kickback laws. The penalties include $3.54 billion in criminal fines and $2 billion in criminal forfeiture of profits, the largest penalties ever levied against a pharmaceutical manufacturer. The company pleaded guilty to marketing opioids to more than 100 doctors that it suspected of writing illegal prescriptions and lying about this to the federal Drug Enforcement Administration.

Purdue also pleaded guilty to paying illegal kickbacks to doctors and to an electronic health records company, Practice Fusion. In January Practice Fusion paid $145 million in fines for taking kickbacks from drug manufacturers in exchange for embedding pop-up alerts to physicians, intended to boost opioid prescriptions.

The Purdue settlement also includes $2.8 billion in civil penalties, related to allegations that the company violated the False Claims Act by using aggressive marketing tactics to convince doctors to unnecessarily prescribe opioids — frivolous prescriptions that experts say helped fuel a drug addiction crisis that has ravaged America for decades. Those prescriptions were often paid for by federal health care programs like Medicare and Medicaid.

Mr. Miller, the Purdue chairman, said that the resolution of the Justice Department’s charges was an essential step in the company’s bankruptcy restructuring. “Purdue today is a very different company,” he added. “We have made significant changes to our leadership, operations, governance and oversight.”

This is the first time since 2007 that Purdue has pleaded guilty to federal criminal charges for misleading doctors, patients and the government about its drug. At the time, the company paid $600 million in fines.

To resolve thousands of local lawsuits, Purdue has proposed a global settlement that it values at about $10 billion. That figure includes future profits from drugs still in development as well as a $3 billion contribution from the Sacklers, which is separate from the $225 million the family has agreed to pay the federal government.

A year ago, under the weight of opioid litigation, Purdue filed for bankruptcy, and it is expected to emerge at some point as a new company. At least two other opioid manufacturers, Insys Therapeutics and Mallinckrodt, have also sought bankruptcy protection because of litigation.

Judge Robert D. Drain, who is overseeing the Purdue bankruptcy case in White Plains, N.Y., will have to approve the terms of the federal settlement and will review the billions of dollars in federal penalties alongside a long line of unsecured creditors. When the bankruptcy is finalized, Purdue said in the federal agreement, it would post documents related to the prosecutions on a public website.

But one bucket of sanctions, the $2 billion in criminal forfeiture of profits, is more likely to be paid in full. The Justice Department said on Wednesday that it would require that Purdue directly pay the U.S. Treasury just $225 million, but would earmark the remaining $1.775 billion for municipalities, states and tribes, on condition that they allocate the money to abate local opioid crises.

A second condition of the settlement has prompted an outcry from some two dozen state attorneys general: the ownership of Purdue, after it emerges from bankruptcy.

Purdue has proposed that the company be run as a “public benefit corporation,” with proceeds from continuing limited sales of OxyContin and several overdose-reversing medications under development to go toward opioid abatement. The Justice Department endorses that model.

But in a forceful letter addressed to Attorney General William P. Barr earlier this month, the state attorneys general decried the public trust model. Governments should not be in the opioid business, they said. Instead, they argued that Purdue should be run privately, with government oversight.

Another objection to the new settlement centers on the resolution of civil claims against individual Sacklers, raised by private families who are suing. A forensic audit last year by Purdue found that the Sacklers directed at least $10.7 billion in the company’s proceeds to family-controlled trusts and holding companies, even as Purdue was facing legal scrutiny. Much of those proceeds, the Sacklers have said, went toward tax payments.

In a letter to Mr. Barr, a coalition of relatives of opioid victims said the agreement was premature and too little.

Massachusetts, for example, has scheduled depositions against some Sacklers in November, during which more information may come to light.

“The D.O.J. failed,” said Maura Healey, the Massachusetts attorney general. “Justice in this case requires exposing the truth and holding the perpetrators accountable, not rushing a settlement to beat an election. I am not done with Purdue and the Sacklers, and I will never sell out the families who have been calling for justice for so long.”

During a news briefing on the federal settlement, Deputy Attorney General Jeffrey A. Rosen pushed back on critics who said that the deal was not tough enough on Purdue and the Sackler family. He said that the department had taken “very substantial” and “very significant” punitive action against Purdue, which pleaded guilty to three criminal charges, and he noted that the family would turn over ownership of the company.

A contentious issue with respect to the Sacklers is that the family itself is not seeking bankruptcy protection and has been seeking release from litigation as a condition of settling the Purdue claims.

Mr. Rice, the negotiator for thousands of local governments, favors the broad contours of a public benefit trust. “You have to figure out what you do with the limited need there may be for some opioids. You don’t maximize the value of the Purdue asset if you destroy the product totally,” he said. “And you want to make sure that the people who abused the right to sell narcotics pay for what they did. The Sacklers lose their name, their company and substantially more.”