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In a 17-4 vote, with one abstention, a panel of advisers to the Food and Drug Administration recommended Thursday that the COVID-19 vaccine being developed by Pfizer and BioNTech be authorized for emergency use during the coronavirus pandemic. The vote in favor of the vaccine was taken to answer the agency's question: Do the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risks for use in people age 16 and older? The agency typically follows the advice of its expert advisers. (Hensley and Harris, 12/10)

In its vote to approve, the panel said the benefits of the vaccine outweigh the risks for people 16 years of age and older. “The efficacy is overwhelming” for the vaccine, said Eric Rubin, a Harvard microbiologist, panel member and editor-in-chief of the New England Journal of Medicine. “It’s very strong.” (Burton and Hopkins, 12/10)

Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the expert committee’s recommendation. “This is a light at the end of the long tunnel of this pandemic,” declared Dr. Sally Goza, president of the American Academy of Pediatrics. (Neergaard and Perrone, 12/10)

The vote caps a whirlwind year for Pfizer and its German partner BioNTech, which began working on the vaccine 11 months ago, shattering all speed records for vaccine development, which typically takes years. It is also a triumph for the F.D.A., which has upheld its reputation as the world’s gold standard for drug reviews despite months of political pressure from President Trump, who has sought to tie his political fortunes to the success of a vaccine. (Thomas, Weiland and LaFraniere, 12/10)

A member of a federal panel that voted Thursday to move forward with an emergency use authorization for Pfizer's coronavirus vaccine said that she voted against the candidate citing a lack of data on younger participants. Archana Chatterjee, Dean of the Chicago Medical School, told CNN anchor Erin Burnett during a panel segment on "OutFront" that she is for the use of a coronavirus vaccine in legal adults. (Choi, 12/10)

President-elect Joe Biden called a Food and Drug Administration (FDA) panel’s endorsement of Pfizer’s coronavirus vaccine on Thursday a “bright light in a needlessly dark time.” “We are grateful to the scientists and researchers who developed this vaccine. And, we are grateful to the scientists and public health experts who evaluated the safety and efficacy of this vaccine free from political influence. The integrity of science led us to this point,” Biden said in a statement shortly after the panel's vote. (Chalfant, 12/10)

Moderna Inc said on Thursday it had dosed the first participants in a mid-to-late stage study testing its COVID-19 vaccine candidate in adolescents aged 12 to less than 18, and aims for data ahead of the 2021 school year. The trial will enroll 3,000 healthy participants in the United States and will assess the safety and effectiveness of two doses of the company’s vaccine candidate, mRNA-1273, given 28 days apart. (12/10)

Moderna has dosed the first adolescents in a phase 2/3 clinical trial designed to position its COVID-19 vaccine for use in children as young as 12 years old before the start of the 2021-22 school year. Having shown mRNA vaccine mRNA-1273 is safe and effective in adults, Moderna is now running a 3,000-subject trial in adolescents. Moderna is aiming to deliver data in adolescents in the spring of 2021, setting it up to get an expanded label in time for a vaccination campaign ahead of the next school year. (Taylor, 12/11)

"Our goal is to generate data in the spring of 2021 that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year," Moderna CEO Stéphane Bancel said. Bancel said the primary results from phase three studies in adults are encouraging and will "help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population." (Lardieri, 12/10)

One of the world’s leading vaccine manufacturers has suffered a major setback in its work to produce a Covid-19 vaccine. The problem will push the timeline for deployment of Sanofi Pasteur’s vaccine — if it is approved — from the first half of 2021 into the second half of the year, the company said Friday. ... In effect, participants in the trial received too little vaccine. (Branswell, 12/11)

Using an adjuvant from GSK, Sanofi developed a recombinant protein-based COVID-19 vaccine. The approach took longer than the creation of mRNA and viral vectored vaccines but offered potentially better results due to its combination of established vaccine technologies. That hypothesis took a hit Friday when Sanofi and GSK shared an update on the program. Interim data from a phase 1/2 trial showed the vaccine triggered immune responses in people aged 18 to 49 years that were comparable to those seen in convalescent COVID-19 patients. However, Sanofi and GSK saw “a low immune response” in older adults. (Taylor, 12/11)

GSK and Sanofi said they were confident of their vaccine’s ultimate success due to positive results from other tests. In adults 18 to 49, the vaccine produced an immune response comparable to patients who had recovered from COVID-19, the companies said. In addition, they reported positive results from a “challenge study” in which non-human primates were intentionally exposed to the virus. “Following these results and the latest encouraging new preclinical data, we will now work to further optimize our candidate to achieve this goal,” said Thomas Triomphe, head of Sanofi’s vaccine unit. “No single pharma company can make it alone. The world needs more than one vaccine to fight the pandemic.” (12/11)

The news, which came on the same day as Australia axed a domestic vaccine project, is also a blow for many governments that have booked hundreds of millions of doses of the shot, including the European Union, United States and Britain. (12/11)

An Australian produced coronavirus vaccine candidate has been scrapped after trial participants returned false positive test results for HIV, developers announced Friday. The inoculation, which had yet to progress beyond Phase 1 trials, was being jointly developed by the University of Queensland and Australian biotech company CSL. Australia had hoped the vaccine would be available by mid-2021. (Westcott, Watson and Lockwood, 12/11)

While the vaccine had elicited a “robust” immune response to the novel SARS-COV-2 virus without serious adverse effects in a Phase 1 trial with 216 participants, re-engineering a fix could take another 12 months, they said. (Duran, 12/10)

The episode illustrates why governments have sought access to multiple vaccines and more doses than needed for their populations. Some vaccines might not prove effective, adverse reactions might arise and manufacturing constraints could limit how many doses can be produced. ... “We can take our time,” Australian Health Department Secretary Brendan Murphy said. “We’re in a good position because we’ve controlled the virus.” (Cherney, 12/10)

Centers for Disease Control and Prevention (CDC) Director Robert Redfield issued a stark warning about the worsening death toll from the coronavirus on Thursday, saying that in a coming brutal stretch of time the country is likely to see more deaths from the virus each day than from the Sept. 11 attacks or Pearl Harbor. “We are in the timeframe now that probably for the next 60 to 90 days we're going to have more deaths per day than we had at 9/11 or we had at Pearl Harbor,” Redfield said during an event hosted by the Council on Foreign Relations. (Sullivan, 12/10)

The Centers for Disease Control and Prevention (CDC) on Wednesday predicted that the number of newly reported coronavirus-related deaths will likely increase over the next month, with the potential for a total death count of up to 362,000 by Jan. 2. The CDC made the prediction in its weekly “ensemble forecast,” which combines national and stave-level forecasts into an aggregate prediction on the state of COVID-19 over the next four weeks. (Castronuovo, 12/10)

Pennsylvania Gov. Tom Wolf (D) unveiled a new set of coronavirus restrictions Thursday in an attempt to mitigate the spread of the disease. Under the restrictions, all indoor dining will be closed, while outdoor dining and take-out services can continue. (Williams, 12/10)

A new wave of coronavirus-related restrictions was introduced in the Washington region Thursday, with more Maryland jurisdictions eliminating indoor dining and Virginia imposing a statewide curfew to keep residents home late at night. The executive order from Virginia Gov. Ralph Northam (D) also includes an expanded mask mandate and lowers the number of people allowed in social gatherings. The measures, which will take effect at 12:01 a.m. Monday, do not change rules for restaurants, stores or houses of worship. (Vozzella, Chason, Cox and Brice-Saddler, 12/10)

Coronavirus infections among Louisiana’s nursing home residents are hitting levels not seen since the peak of the second wave over the summer, a worrying trend even with the prospect of the first doses of a vaccine being administered by the end of the month. Nursing homes reported more than 400 new COVID-19 cases among residents in the past week, the most since mid-August. Similarly, there were 365 new infections among nursing home staff -- considered the most likely way for the virus to gain a foothold in those buildings -- also the highest since August. (Roberts III and Rddad, 12/10)

In the Southern California oceanside city of Manhattan Beach, one arm of government is urging residents to stay home except for essential needs while another is encouraging them to get out and shop and even providing places where they can sit down to relax, eat takeout and watch the sun set on the Pacific. It’s one example of confusing messages from governments as most of California is under a broad shutdown order that includes an overnight curfew to try to stem record-breaking coronavirus cases that threaten to overwhelm the hospital system. (Taxin, Dovarganes and Rodriguez, 12/11)

A member of President-elect Joe Biden’s COVID-19 advisory board is urging Americans to avoid large Christmas parties this year as health officials worry of a sharp spike in cases following the December holidays. Speaking on CNN early Thursday, Michael Osterholm said people should only hold gatherings with people they’ve been quarantining with, or those with whom they’ve “podded.” (Axelrod, 12/10)

Jewish Americans from a variety of branches of the faith are celebrating Hanukkah with smaller-than-usual gatherings this year, in hopes of keeping the year-end holiday safe but still joyful as coronavirus cases spike across the country. Many Jewish Americans are already accustomed to more intimate celebrations of a holiday focused more on the home than on the synagogue, including Haredim or ultra-Orthodox communities. So the recent successful Supreme Court challenge to New York restrictions on in-person worship by some Orthodox groups won’t mean much as far as their Hanukkah plans. (Schor and Henao, 12/11)

KHN: Going Home For The Holidays? For Many Americans, That’s A Risky Decision 

Vivek Kaliraman, who lives in Los Angeles, has celebrated every Christmas since 2002 with his best friend, who lives in Houston. But, this year, instead of boarding an airplane, which felt too risky during the COVID pandemic, he took a car and plans to stay with his friend for several weeks. The trip — a 24-hour drive — was too much for one day, though, so Kaliraman called seven hotels in Las Cruces, New Mexico — which is about halfway — to ask how many rooms they were filling and what their cleaning and food-delivery protocols were. (Knight, 12/11)

It likely took just one of the 175 people gathered in February at a Biogen conference at the Boston Marriott Long Wharf hotel to ignite a COVID-19 wildfire. Within a week, attendees began falling ill. More than 99 would ultimately test positive. By then, many of them had hopped aboard planes to head home or even attend other conferences. And the spread only exploded from there. (Krueger, 12/10)

With Pfizer's COVID-19 vaccine poised for Food and Drug Administration authorization for emergency use, there's speculation about when the United States will buy another batch of doses — and whether the Trump administration already missed its chance. Although a Pfizer board member says the government declined to buy more doses beyond the initial 100 million agreed upon in July, Health and Human Services Secretary Alex Azar told PBS Newshour that this is inaccurate. The company never made a formal offer saying how many doses it would deliver and when — two things that are needed to sign an additional deal. (Lupkin, 12/10)

Shifting timelines are already apparent with Covid-19 vaccine distribution in the U.S. — even before the rollout starts in the coming days. The Trump administration declared in May that 300 million vaccine doses would be available by January 2021, with the first distributed in October of this year. By October, that had shifted to 100 million doses by the end of the year, according to Health and Human Services Secretary Alex Azar. Currently, the plan is for 40 million doses to be distributed in December, though some in health care are skeptical of even that prediction. (Goldhill, 12/11)

“It’s going to get worse before it gets better,” said Dr. John Swartzberg, an infectious disease expert and professor emeritus at the University of California-Berkeley. “Unless something remarkable is going to happen and people meticulously follow the orders, we’re going to see things continue to get worse through probably the third week of January.” Andrew Noymer, an epidemiologist and population health scientist at UC-Irvine, said that while the vaccines expected to be distributed in coming days are “the best thing to happen in a long time,” they are “coming a little too late to have a major influence over the dynamics of the current wave” of infections. (Woolfolk, 12/10)

In a historic moment during the darkest days of the COVID-19 pandemic, an FDA advisory committee voted today in favor of authorizing the first vaccine against COVID-19. The formal implementation of this recommendation, which would allow the vaccine to be given to anyone 16 or older, is expected to follow imminently. This marks the beginning of a new and hopeful phase in a crisis that has killed nearly 300,000 Americans and caused widespread economic collapse. Having endured more deaths than any other country, the U.S. has manufactured hundreds of thousands of doses in anticipation of this moment. Vaccines should be available for some Americans next week, with doses going to health-care workers and older adults at the highest risk of serious complications from COVID-19. (Hamblin, 12/10)

A Centers for Disease Control and Prevention advisory panel earlier this month recommended that front-line healthcare workers and residents of long-term nursing care facilities be given the highest priority for getting the vaccine. But there won't be enough doses initially for all of the people in the the CDC's highest tier and the federal government didn't recommend either group go first, leaving it to the states to decide. Given how quickly COVID-19 spreads through a nursing home, representatives for the sector would like to see the doses go there first. (Johnson and Christ, 12/10)

Health care workers and residents in long-term care facilities will likely be among the first to have access to a COVID-19 vaccine. Who's next in line could be from among a pool of essential workers, and educators hope they're at the top of that list. "I would love enough vaccines to be available so teachers and educators and education support personnel could be moved up on the list as quickly as possible," Michael Lubelfeld, superintendent of the North Shore School District 112 in Highland Park, Illinois, told ABC News. (Deliso, 12/11)

As a COVID-19 vaccine is on the cusp of rolling out in the United States, frontline airline workers are campaigning to move up in the vaccine priority line. More than a dozen airline and aviation unions asked the Advisory Committee on Immunization Practices in a Thursday letter to prioritize "frontline aviation workers in the next phase of vaccine allocation (Phase 1b) after health workers and residents in long term facilities in your upcoming recommendations to the Centers for Disease Control and Prevention (CDC)." (Thompson, 12/10)

KHN: Farmworkers, Firefighters And Flight Attendants Jockey For Vaccine Priority

With front-line health workers and nursing home residents and staff expected to get the initial doses of COVID vaccines, the thornier question is figuring out who goes next. The answer will likely depend on where you live. While an influential federal advisory board is expected to make its recommendations later this month, state health departments and governors will make the call on who gets access to a limited number of vaccines this winter. (Bluth and Galewitz, 12/11)

Operation Warp Speed officials have already told states how many doses of the initial allotment of vaccines they will get, and will begin shipping them out to 636 locations once EUAs are issued, according to Operation Warp Speed CEO Gen. Gustave Perna. Once the vaccines are shipped to the states, they will be administered in a variety of settings, from hospitals to nursing homes to pharmacies to special vaccination sites. But the federal government is responsible for only part of the effort to get the vaccine into people's arms. States and a network of health departments, hospitals, doctors' offices, and pharmacies will play the biggest role. (Dall, 12/10)

KHN: Supply Is Limited And Distribution Uncertain As COVID Vaccine Rolls Out 

High stakes and big challenges await as the U.S. prepares to roll out vaccines against COVID-19, with front-line health care workers and vulnerable nursing home residents recommended as the top priority. Doses could be on their way very soon. An independent advisory committee to the Food and Drug Administration on Thursday gave a green light to the first vaccine candidate, made by Pfizer in conjunction with the German company BioNTech — a recommendation expected to be approved by the agency within days. The committee is scheduled to consider a second candidate, made by Moderna, Dec. 17. (Appleby, 12/11)

Around 70 percent of health-care workers worldwide are women, meaning many are on the front lines of the coronavirus pandemic and, in theory, toward the front of the line for a vaccine shot as they begin to be distributed. But there’s a catch: Vaccination programs from Russia to the United Kingdom are excluding women who are pregnant, breastfeeding or planning for a pregnancy because the vaccine candidates were not clinically tested on these populations as part of their initial trials. (Berger, 12/10)

American women, who traditionally make most of the healthcare decisions in their families, are more wary than men of the new, rapidly developed COVID-19 vaccines, according to a Reuters/Ipsos poll, presenting a potential challenge to efforts to immunize the public. The Dec. 2-8 national opinion survey showed that 35% of women said they were “not very” or “not at all” interested in getting a vaccine, an increase of 9 points from a similar poll conducted in May when vaccines were still being developed. (Kahn and Beasley, 12/11)

KHN: KHN On The Air This Week 

KHN senior correspondent JoNel Aleccia discussed the demand for COVID-19 vaccines with Newsy’s “Morning Rush” on Thursday. ... KHN Editor-in-Chief Elisabeth Rosenthal discussed COVID vaccine distribution and its potential hiccups with RNN TV’s “Richard French Live” on Tuesday. The exchange starts at about the three-minute mark. (12/11)

Covid-19 can lead to neurological complications, including strokes, seizures and movement disorders, researchers have found. The complications, which go well beyond cognitive impairment, can occur even in moderate cases, according to a study published Wednesday in the journal Neurology: Clinical Practice. (Prior, 12/10)

When Morgan McElroy suddenly stopped being able to smell and taste earlier this month, she wasn’t all that surprised. Her mother, whom she lives with in Dayton, Ohio, had recently started showing symptoms of covid-19, the disease caused by the novel coronavirus, and McElroy, 20, figured that she had also been infected. What McElroy didn’t expect, though, was to find herself in the emergency room a day later — swollen and covered in a red, itchy, hivelike rash that was spreading all over her body. (Chiu, 12/10)

In recent weeks, pharmaceutical giants Pfizer and Moderna published data showing their vaccines to be more than 90% effective -- results hailed as a major scientific achievement. "I wasn't even sure if we'd be able to do it -- or if the vaccines would work at all," Dr. David Kimberlin, an infectious disease pediatrician at the University of Alabama and prior president of the Pediatric Infectious Disease Society, told ABC News. (Fathy, 12/11)

Much remains unknown about the coronavirus, such as why some healthy people get sick and die while others recover unscathed. The mysteries also include how long natural immunity lasts after infection. But one thing is clear: experiencing COVID-19 is more risky than not. That’s why health experts recommend getting the coronavirus vaccine when one is authorized and available in your state — even if you’ve already been sick and recovered. (Camero, 12/9)

In a letter to CDC Director Robert R. Redfield and his superior, Health and Human Services Secretary Alex Azar, Rep. James E. Clyburn (D-S.C.) expressed “serious concern about what may be deliberate efforts by the Trump Administration to conceal and destroy evidence that senior political appointees interfered with career officials’ response to the coronavirus crisis at the Centers for Disease Control and Prevention.” (Bernstein and Sun, 12/10)

According to the letter, Dr. Charlotte Kent, chief of the scientific publications branch and editor-in-chief of the Morbidity and Mortality Weekly report at CDC, told subcommittee staff earlier this week that she was told to delete an email sent on August 8 by Health and Human Services senior adviser Dr. Paul Alexander. The letter states that the panel was not given the email by the department despite its request, but notes that an excerpt was published in the media. It includes an excerpt in which Alexander is critical of the CDC, saying, according to the letter, "CDC tried to report as if once kids get together, there will be spread and this will impact school reopening .... Very misleading by CDC and shame on them. Their aim is clear ... This is designed to hurt this Presidnet [sic]." (Foran and Fox, 12/10)

"I was instructed to delete the email," MMWR editor Charlotte Kent told investigators. Kent, who was on vacation when Alexander sent the email, said that she was informed of the request by a colleague who filled in for her, and that she understood the request to be from Redfield. Kent said that she never saw the email herself. "I went to look for it after I had been told to delete it, and it was already gone," she told investigators on Monday. (Diamond, 12/10)

"I would never tell somebody to delete an email," CDC Director Robert Redfield said Thursday when asked about the report at an event hosted by the Council on Foreign Relations. "I instructed CDC to ignore Dr. Alexander's comments and they didn't need to reply to his email." (Sullivan, 12/10)

Top Senate Republicans signaled Thursday they wouldn’t accept a bipartisan group’s efforts to craft a compromise on state and local governments and liability protections during the pandemic, undercutting the coalition’s attempt to break the months-long impasse over a coronavirus relief package. Democrats continued to throw their support behind the bipartisan group working on a $908 billion proposal, leaving in question whether they would be willing to support an aid bill without funding for states and localities. (Peterson and Duehren, 12/10)

An emerging $900 billion COVID-19 aid package from a bipartisan group of lawmakers has all but collapsed after Senate Majority Leader Mitch McConnell said Republican senators won’t support $160 billion in state and local funds as part of a potential trade-off in the deal. McConnell’s staff conveyed to top negotiators Thursday that the GOP leader sees no path to an agreement on a key aspect of the lawmakers’ existing proposal — a slimmed-down version of the liability shield he is seeking for companies and organizations facing potential COVID-19 lawsuits — in exchange for the state and local funds that Democrats want. (Mascaro and Taylor, 12/11)

Congressional leaders are barely talking. Renegade centrists are trying to cut a deal that Republicans don’t like. And the president is predominantly focused on overturning an election that he lost. It’s the latest evidence Washington is broken: at the peak of the worst public health crisis in a century, the White House and Congress are struggling to deliver another round of relief. And time in the lame duck is quickly running out. (Everett, Caygle and Ferris, 12/10)

Some Oklahomans who lost wages due to the coronavirus pandemic will receive a one-time payment of $400 from the state starting next week, Oklahoma Employment Security Commission Director Shelley Zumwalt said Thursday. The OESC has received permission from the Federal Emergency Management Agency to distribute Lost Wage Assistance funds. The payment will go to those who received $100 in benefits from any claim type and certified their employment was affected by COVID-19 during the week of Sept. 6-12. (Miller, 12/11)

Unemployment claims jumped sharply last week as a surge in coronavirus hospitalizations and deaths put new pressure on the U.S. economy just before critical coronavirus aid programs are set to expire. The Labor Department said 853,000 people filed new claims for state unemployment benefits during the week that ended on Dec. 5 — a sharp increase of 137,000 from the previous week. (Horsley, 12/10)

A fight over how to pay for veterans' health care is the final big hurdle to getting a deal on a massive government funding omnibus, senators said Thursday. Negotiators have been working for weeks to try to cut an agreement on a mammoth omnibus — which would fund the government until Oct. 1, 2021 — and have until Dec. 18 to pass the bill, after using a stopgap measure to delay the deadline a week past Dec. 11. (Carney, 12/10)

Democratic lawmakers on Thursday urged President-elect Joe Biden to take immediate steps after taking office to combat the "infodemic" of disinformation and misinformation surrounding COVID-19. “Understanding and addressing misinformation – and the wider phenomena of declining public trust in institutions, political polarization, networked social movements, and online information environments that create fertile grounds for the spread of falsehoods – is a critical part of our nation’s public health response,” the lawmakers wrote in a letter to Biden. (Miller, 12/10)

Rep. Dick Hinch, a Republican who was elected speaker of the New Hampshire House just one week ago, died of COVID-19 on Wednesday. This comes about a month before the state legislature, the largest in the U.S., is expected to convene for its regularly scheduled annual session. (Barrick, Bookman and Rogers, 12/10)

Members of the Republican-controlled New Hampshire House of Representatives fear they may have been exposed to the novel coronavirus after the newly sworn-in speaker died on Wednesday. Dick Hinch (R), 71, died from covid-19 a week after the 400-person state house had its swearing-in ceremony outdoors at the University of New Hampshire. (Shepherd, 12/11)

In a blow to pharmacy benefit managers, the U.S. Supreme Court ruled that an Arkansas law can be used to regulate these controversial middlemen in the pharmaceutical supply chain. The state law governs reimbursements rates that pharmacy benefit managers, or PBMs, must pay to pharmacies. (Silverman, 12/10)

A federal judge has rejected the Trump administration’s effort to reinstate rules requiring women seeking abortion medication to visit a doctor’s office or clinic in person during the coronavirus pandemic. U.S. District Judge Theodore D. Chuang in Maryland said the health risks have “only gotten worse” since he first blocked restrictions in the summer in response to concerns about exposure to the coronavirus. (Marimow, 12/10)

A federal judge denied a request from the Trump administration to reinstate a longstanding rule requiring that people seeking abortion pills obtain them in person in a health care setting. U.S. District Judge Theodore Chuang declined to lift his earlier order blocking the Food and Drug Administration (FDA) from enforcing the policy during the pandemic, siding with the American Civil Liberties Union (ACLU), which argued the requirement needlessly exposes patients to COVID-19 risk. (Hellmann, 12/10)

Lillian E. Blancas, a widely respected lawyer in El Paso, always wanted to be a judge. She was expected to achieve her goal on Saturday in a runoff election, in which she was the favorite. Ms. Blancas died at a hospital in the city on Monday. She was 47. The cause was Covid-19, her brother Moises Blancas said. Ms. Blancas, was an assistant district attorney and public defender for nearly a decade before she opened her own law firm in 2019, came in first in a field of three on Nov. 3 in the race for an open seat in El Paso’s municipal court. Because she did not win a majority of the votes, the race went to an automatic runoff. (Risen, 12/10)

The Trump administration on Thursday proposed changes that aim to improve patient and provider access to medical records and reform prior authorization. The proposed rule would require payers—including Medicaid, Children's Health Insurance Program and exchange plans—to build application program interfaces to support data exchange and prior authorization. According to CMS, the changes would allow providers to know in advance what documentation each payer would require, streamline documentation processes and make it easier for providers to send and receive prior authorization information requests and responses electronically. (Brady, 12/10)

The proposed rule, released Thursday by the Centers for Medicare & Medicaid Services (CMS), requires payers in certain government programs to build application programming interfaces (APIs) for data exchange and prior authorization. The rule tackles a common complaint from providers that prior authorization has increased in use among plans and takes up too much time away from patients. “Prior authorization is a necessary and important tools for payers to ensure program integrity, but there is a better way to make the process work more efficiently to ensure that care is not delayed and we are not increasing administrative costs for the whole system,” said CMS Administrator Seema Verma in a statement. (King, 12/11)

The Centers for Medicare and Medicaid Services has posted updates to frequently asked questions and an infographic about coverage and payment for monoclonal antibodies to treat COVID-19. The FAQs include general payment and billing guidance on lab testing, hospital services and inpatient prospective payment system payments, including questions on different setting types.  (Morse, 12/10)

Xavier Becerra has long supported moving the United States to a “Medicare for all” system. As President-elect Joe Biden’s pick to run Health and Human Services, he may have opportunities to speed up such a transition. The Health and Human Services secretary oversees an array of waivers that states can use to cover new groups or provide different types of health plans. Because these waivers do not require congressional approval, they could become a crucial policymaking tool for the Biden administration if Republicans retain control of the Senate. (Kliff, 12/10)

President-elect Joe Biden’s choice for secretary of health and human services, Xavier Becerra, has previously supported transitioning to a single-payer system – and if approved for the new Cabinet role he would be able to advance that policy if he wanted. Becerra said in a 2017 interview with Fox News that he “absolutely” supports Medicare-for-All and had done so for all 24 years. (De Lea, 10/8)

LabCorp said on Wednesday that it has received Emergency Use Authorization for an over-the-counter version of its COVID-19 home test. With the EUA, LabCorp is able to sell the test kit directly to consumers without requiring a prescription. The kit is the first over-the-counter at-home collection kit for SARS-CoV-2 to receive EUA. (Bonislawski, 12/10)

Pharmaceutical distributor AvKare issued a voluntary recall of 100 mg tablets of both sildenafil, an erectile disfunction medication, and trazodone, an antidepressant, after a mix-up led to some of the prescription drugs being packaged together. “These products have been recalled due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a 3rd party facility,” the company said in a Wednesday announcement. (Pitofsky, 12/10)

Arguing the Food and Drug Administration is precluding competition for biosimilar manufacturers, Boehringer Ingelheim has petitioned the agency to alter its interpretation of the word “strength” found in a federal law that has made it possible to sell these medicines. The move reflects a wonky, behind-the-scenes dispute that, nonetheless, holds potentially great significance for the burgeoning growth of biosimilar treatments in the U.S., which is expected to reach $80 billion in aggregate sales over the next five years, according to one recent forecast. (Silverman, 12/10)

Amazon has a new health-tracking bracelet with a microphone and an app that tells you everything that’s wrong with you. You haven’t exercised or slept enough, reports Amazon’s $65 Halo Band. Your body has too much fat, the Halo’s app shows in a 3-D rendering of your near-naked body. (Fowler and Kelly, 12/10)

A new biotechnology company was launched Thursday in Cambridge with $81 million in funding, joining a growing number of biotechs in the area that are based on an emerging field in cell biology. Faze Medicines will work on “biomolecular condensates,” which it believes can be studied to develop drugs that could slow, halt, or reverse certain diseases. Condensates are membrane-less organelles, or clusters of molecules such as proteins and nucleic acids, that help cells perform vital functions. (Gardizy, 12/10)

Most Americans now teleworking from home want to keep doing so, with more than half saying they would work remotely after the pandemic, a new Pew Research Center report finds. The national survey of U.S. adults reveals that while the coronavirus may have changed the location of our jobs — whether in an office or from home — it hasn’t significantly reshaped our work duties and culture for a majority of employed adults. (Arvedlund, 12/11)

This has not been a very good year for sleep. With the coronavirus pandemic, school and work disruptions and a contentious election season contributing to countless sleepless nights, sleep experts have encouraged people to adopt a variety of measures to overcome their stress-related insomnia. Among their recommendations: engage in regular exercise, establish a nightly bedtime routine and cut back on screen time and social media. But many people may be overlooking another important factor in poor sleep: diet. A growing body of research suggests that the foods you eat can affect how well you sleep, and your sleep patterns can affect your dietary choices. (O'Connor, 12/10)

Ellen DeGeneres announced on Thursday that she has tested positive for Covid-19. The popular talk show host tweeted the news from her verified Twitter account. "Hi Everyone," DeGeneres wrote. "I want to let you all know that I tested positive for Covid-19. Fortunately, I'm feeling fine right now. Anyone who has been in close contact with me has been notified, and I am following all proper CDC guidelines. I'll see you all again after the holidays. Please stay healthy and safe." (Respers France, 12/10)

Approximately 188 million doses of the flu vaccine have been distributed throughout the U.S., the most ever during a single influenza season, according to data published Wednesday by the Centers for Disease Control and Prevention (CDC). The CDC noted that the country hit the record late last month, with an estimated 44.5 million adult flu vaccinations administered in pharmacies by Nov. 21, a 46 percent increase from 2019. (Castronuovo, 12/10)

As a freshly minted psychiatrist, the last step on my path to practicing medicine was to complete an application for medical licensing in my home state. Every physician, after completing residency training, is required by law to apply and obtain a license in the state he or she intends to practice. On the application, I came across the ominous question: Have you currently or in the past been diagnosed with a mental illness that might affect your ability to perform your job? (Safai, 12/10)

KHN: I Found My Secret To Feeling Younger And Stronger. The Pandemic Stole It Away. 

Back in early January, before COVID-19 was as familiar as the furniture, I went in for my annual physical. My doctor looked at my test results and shook his head. Virtually everything was perfect. My cholesterol was down. So was my weight. My blood pressure was that of a swimmer. A barrage of blood tests turned up zero red flags. “What are you doing differently?” he asked, almost dumbfounded. (Horovitz, 12/11)

Authorities this week seized from a warehouse in Texas more than $600,000 worth of counterfeit N95 surgical masks intended for hospital workers on the front line of the coronavirus pandemic. Customs and Border Protection (CBP) officers intercepted the shipment of 100,090 fake 3M N95 surgical masks Monday at Ysleta Cargo Facility, according to a press statement from Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI). The masks were reportedly in transit from El Paso to a hospital on the East Coast. (Gstalter, 12/10) 

The shipment that arrived at the San Diego International Airport from Mexico was labeled as “plastic card.” Instead, the the two parcels held 251 illicit COVID-19 testing kits, authorities said this week. The Dec. 1 seizure at the Port of San Diego is part of a larger trend seen at border crossings and commercial ports, as the black market rises to profit off the demand for testing. (Davis, 12/10)

New Mexico on Thursday suspended all nonessential surgeries and activated “crisis care” standards, a move that clears the way for a system of rationing amid a coronavirus surge that has overwhelmed the state’s capacities. Under the twin orders by the state’s health department, elective surgeries will be banned until Jan. 4. Health-care providers, meanwhile, will be permitted to begin implementation of a statewide plan for stretching the state’s increasingly scarce health-care resources. The system ultimately could allow doctors to determine which patients receive care, depending on who is likeliest to survive. (Witte, 12/10)

A health center in Canton will be the first in the country to receive mobile hospital rooms to help patients with COVID-19, according to a health official. Four units are set to arrive Friday to G.A. Carmichael Family Health Center to be assembled into one pod structure that will be used for patients getting tested for the coronavirus, said Dr. James Coleman, the health center's chief executive. The sterile, mobile hospital rooms will improve efficiency in separating patients with preexisting conditions from those who potentially have the coronavirus. (Szymanowska, 12/10)

Florida state police released body camera videos Thursday afternoon showing officers waiting before they entered the home of a former state data scientist and the testy confrontation that followed when she exited -- providing new context about a controversial police raid that has attracted national attention this week. Officers were serving a search warrant Monday morning at the home of Rebekah Jones, a coronavirus data scientist who was fired from the state and has accused Florida officials of covering up the extent of the pandemic. (Tolan and Devine, 12/10)

On Nov. 25, one Twitter user wondered why the state issued guidance for people who socialize with other households after Gov. Scott issued a ban on multi-household gatherings. "Multi-family gatherings are prohibited right now," the Vermont Health Department replied. "However, we know that some people might not follow this mandate & we want to ensure we are keeping the community safe. If people decide to break the rule, we are asking them to quarantine." Anne Sosin, program director at the Dartmouth Center for Global Health Equity, outlined Vermont's messaging tactics in a Dec. 9 tweet thread. She framed different strategies, like communicating with empathy and putting data into perspective, as strengths in Vermont's technique. (Syed, 12/10)

The White House Coronavirus Task Force has recommended to President Donald Trump that the United States begin allowing travelers into the country from Brazil, the United Kingdom and the 27 countries in the European Union, according to two officials involved in the discussions. (Tausche, 12/9)

Mexico’s coronavirus spokesman said Thursday the country’s median age of death from COVID-19 was a shockingly young 55, as compared to an average of 75 in many European countries. Assistant Health Secretary Hugo López-Gatell said that nonetheless, Mexico’s future coronavirus vaccination program would target the oldest Mexicans first. (12/11)

Russia reported on Friday its highest COVID-19 daily death tally a day after official data revealed a surge in excess deaths in October that made it Russia’s most deadly month in a decade. Russia, which began vaccinating vulnerable people in Moscow on Saturday, has resisted imposing a strict lockdown as it did in the spring, relying on targeted measures instead, though the Kremlin says places like St Petersburg are nearing a “red line”. (12/11)

The staff at Moscow's Polyclinic No. 5, syringes at the ready, waited for the expected flood of people as the first phase of mass coronavirus vaccinations rolled out this week. And waited. And waited some more. Rows of empty seats lined the waiting area. Staff members, with little to do, squabbled about where to put a small vase of dried pink flowers. (Dixon, 12/11)

The Hong Kong government said Friday it had secured coronavirus vaccine supplies from both Pfizer and China’s state-backed Sinovac, with millions of doses to begin arriving early next year. A first batch of the Sinovac vaccine will arrive in January, Chief Executive Carrie Lam said, with priority given to frontline health-care workers and the elderly. The Pfizer vaccine, made in the United States, will arrive in the first quarter of 2021. The Hong Kong government is separately in talks with makers of the Oxford-AstraZeneca vaccine, too. (Mahtani, 12/11)

Shipments of Beijing-based biopharmaceutical company Sinovac's Covid-19 vaccine CoronaVac have arrived in Indonesia in preparation for a mass vaccination campaign, with another 1.8m doses due to arrive by January. But the vaccine is yet to finish its late-stage trials, which begs the question: what exactly do we know about this Chinese vaccine? (12/10)

For over six years, 38-year-old Wuhan restaurant owner Lai Yun started most days the same way - with a trip to the Huanan Seafood Wholesale Market, just ten minutes walk from his house. “I’d send the kids to school, have breakfast and then walk over to the market. It was very convenient,” he said. That changed on Dec. 31, 2019, after four cases of a mystery pneumonia were linked to the market and it was shuttered overnight. By the end of the month, the city had begun a gruelling 76-day lockdown that came with just hours notice and barred people from leaving their homes. (Cadell, 12/11)

As the world fell victim to the coronavirus pandemic early this year, the field seemed wide open for the scores of pharmaceutical companies and universities that rushed to develop vaccines to curb Covid-19. But now that Pfizer Inc. and its partner BioNTech SE are rolling out a coronavirus shot, with rival Moderna Inc. not far behind, dozens of drugmakers further back in the development pack are suddenly facing a sobering possibility: The window to develop a successful vaccine before the field becomes crowded could be closing. That may leave some laggards unable to easily enroll enough volunteers in the trials needed to win regulatory authorization. In fact, drugmakers that are too many months behind might find themselves locked out of the vast U.S. market, which also is usually the most lucrative. (Paton, Fay Cortez and Langreth, 12/10)

The original “God Committee” had seven members: a surgeon, a minister, a banker, a labor leader, a housewife, a government worker, and a lawyer. They convened in the summer of 1961 in Seattle because a professor of medicine at the University of Washington had invented a new method of dialysis that could indefinitely filter the blood of people whose kidneys were failing. His device, hailed as the first artificial human organ, resided in an unobtrusive annex of Seattle’s Swedish Hospital, and it seemed like a true medical miracle. Suddenly people with less than a month to live could be restored to health, provided they could be dialyzed regularly. But at the time, roughly 100,000 Americans were dying of end-stage kidney disease. There were hundreds, possibly thousands, of viable candidates. The program could take only 10. Who should get the lifesaving care? (Kisner, 12/8)

Once a month, after the kids are in bed, Margie Yeager and her husband convene at the dining room table. She opens her computer and pulls up the spreadsheet where she tracks the family budget. There is one column that’s caused far more stress this year than any other: child care. Yeager and her husband have three kids — ages 3, 6 and 7 — and child care has always been expensive. But with schools and many day cares closed during the pandemic, the cost has skyrocketed: from $1,850 per month before the coronavirus hit to $5,300 in December. She used to pay nothing for her two oldest children, both enrolled in public school where she lives in Washington, D.C. Now they’re part of a learning “pod” led by a woman who used to work in their school cafeteria. (Kitchener, 12/7)

That pandemic, like the coronavirus today, seemed to roll across the United States in waves. The winter holidays in 1918 were marked by grievous loss. They came during a relative lull after the deadliest wave, in the fall. Another, smaller surge would peak shortly after New Year’s Day. But the national conversation around private family gatherings appeared to have been less charged in 1918 than it is today, as many weary from months of restrictions bristle at guidance from health agencies to stay home. (Fortin, 12/9)

A committee of leading U.S. vaccine scientists recommended Thursday that the FDA authorize the first COVID-19 vaccine for Americans. For many Americans, this vaccine roll-out may seem unprecedented, but folks with longer memories have gone through this before with the polio vaccine. The poliovirus was a constant threat through the mid-1950s. Every summer, thousands of children were stricken with the highly infectious virus that often caused infantile paralysis. Children placed into iron lungs – tank respirators shaped like torpedoes that helped them breathe – was a nightmare for parents and children. (Suess, 12/10)

Alice McGraw, 2 years old, was walking with her parents in Lake Tahoe this summer when another family appeared, heading in their direction. The little girl stopped. “Uh-oh,” she said and pointed: “People. She has learned, her mother said, to keep the proper social distance to avoid risk of infection from the coronavirus. In this and other ways, she’s part of a generation living in a particular new type of bubble — one without other children. They are the Toddlers of Covid-19. (Richtel, 12/9)

After logging many hours on Zoom, Sarah Hayes became distressed. “I noticed my face was starting to look older: fine lines and droopy,” said the senior program manager for a financial firm in New Hampshire. “I’m definitely bothered by my lines more on video than in real life.” So, she decided to get Botox. Call it a Zoom boom. Or an opportune moment. Plastic surgeons across the globe are anecdotally reporting an unprecedented number of requests for procedures. (Braff, 12/8)

It starts in utero. A mass of cells divides and develops, splits and stretches, and from a single layer of embryonic tissue, two seemingly separate but inherently interconnected systems are born: the brain and the skin. They are bound for life. When one senses embarrassment, the other blushes. When one senses pain, the other processes it. And when one bears the burden of a pandemic, political unrest, systemic racism and the ever worsening effects of climate change … well, the other gets a pimple. (DeFino, 12/8)

Botox is often the punchline for folks desperate to ward off the aging process, and it's most commonly used is to smooth out the wrinkles in the face. The injections use a toxin that paralyzes the muscles on the brow, smooths out wrinkles and holds the muscles in place. The treatment can also relax muscles in the back of the neck to relieve migraines. The bladder is really just one large bag of muscles, said Stewart, a physician with Norton Health Care's Norton Urogynecology Center. Essentially Botox works the same way on the bladder as it does when you're trying to roll back the clock. (Menderski, 12/9)

The installation of steak grown from human cells at the Design Museum in London was intended to criticize the meat industry’s rising use of living cells from animals. It ended up triggering a roiling debate about bioethics and the pitfalls of artistic critique. Orkan Telhan, an artist and associate professor of fine arts at the Stuart Weitzman School of Design at the University of Pennsylvania, spent the last year imagining how climate change might impact the future of food consumption. He collaborated with scientists to create a project that included 3-D printed pancakes, bioengineered bread and genetically-modified salmon. But it was their provocative, and less appetizing, development of what they call “Ouroboros Steak,” meat cultivated from human cells and expired blood, that challenged the sustainability practices of the nascent cellular agriculture industry, which develops lab-grown products from existing cell cultures. (Small, 12/7)

Polina Lishko will tell you she began studying reproductive biology accidentally. But her deep-seated interest in what ignites the body’s bioelectrical signals has opened up new possibilities for how to address infertility and introduce new options for contraception. Tens of millions of women use some form of birth control in the United States. In 2019, the number of unintended pregnancies hit an all-time low, yet still accounted for 45 percent of all pregnancies, according to the Brookings Institution. Reproductive health experts say that the figure could rise as people lose their health insurance — a trend that was already unfolding before the COVID-19 pandemic forced tens of millions of Americans out of work, severing them from their livelihood and insurance coverage when they needed both the most. (Santhanam, 12/3)

It’s bad enough when our political leaders promote quack theories about coronavirus and its treatment; but what do we do about the doctors who enable them and use their medical authority to promote pseudoscience? Take Scott Atlas, a former Stanford University radiologist with no training or expertise in public health or infectious disease. As President Trump’s special adviser on coronavirus, he cast doubt on the efficacy of face masks, long after science had confirmed their efficacy. He was a staunch proponent of herd immunity — a recommendation that would almost certainly have resulted in vast mortality. (Richard A. Friedman, 12/11)

President Trump's shameful legacy will be the needless death and vast devastation of the covid-19 pandemic. More than 3,100 Americans died from the novel coronavirus on Wednesday, a shocking all-time high, with the virus currently the nation's leading cause of death. The health and economic impacts of covid-19 were always going to be brutal, but Trump made everything much worse than it had to be. And he has capped his mismanagement of the crisis by making it more difficult not just to persuade Americans to comply with life-saving preventative efforts but by also sowing doubt about the vaccines that are the way out of this crisis.  (Eugene Robinson, 12/10)

Drug regulators only have two speeds, as an old gag puts it: Too fast, and too slow. That’s certainly the perception in this pandemic. As Western nations begin to roll out the first batch of promising vaccines against Covid-19, with the U.K. leading the charge and the U.S. the latest to follow suit, the gatekeepers whose job it is to supervise their efficacy, safety and distribution are in a very tough spot. (Lionel Laurent, 12/11)

Recent days brought good news and bad news about coronavirus vaccines. The developments could add up to months of delay in getting most Americans inoculated. But there’s a way to make use of the good news to speed up herd immunity. The bad news is that in July the U.S. passed up an opportunity to secure by June 2021 more than 100 million doses of the Pfizer vaccine, now expected to receive emergency-use authorization in the next few days. Instead, officials followed a balanced-portfolio strategy that reserved as many as 300 million doses of the AstraZeneca vaccine, whose prospects are unclear. (Michael Segal, 12/10)

There was another key step in the incredibly thorough US drug approval process toward a vaccine today as an FDA panel recommended approval for Pfizer. Final approval could come within days. Health and Human Services Secretary Alex Azar, who has now met with President-elect Joe Biden's health policy team, said Thursday that 20 million Americans could be vaccinated within weeks. (Zachary B. Wolf, 12/11)

According to a document from the Department of Health and Human Services, a total of 108 doses of Regeneron’s monoclonal antibody cocktail have been allocated to Washington, which had 265 new coronavirus cases on Wednesday alone. Somehow Rudy Giuliani, Donald Trump’s lawyer, got one of those doses. In an interview with a New York radio station on Tuesday, Giuliani did us all the favor of explaining why he qualified for privileged treatment. “I had very mild symptoms,” he told the radio station, WABC. “I think if it wasn’t me, I wouldn’t have been put in the hospital. Sometimes when you’re a celebrity, they’re worried if something happens to you; they’re going to examine it more carefully and do everything right.” He said on another show on the same station that the president’s physician was involved in his care. (Michelle Goldberg, 12/10)

Rudy Giuliani, the former New York City mayor and current lawyer for President Donald Trump, was hospitalized over the weekend after testing positive for Covid-19. He was discharged Wednesday afternoon after four days in Georgetown University Hospital. During his illness, amid his attempts to overturn the certification of election results, Giuliani quickly made medical matters worse. (Kent Sepkowitz, 12/10)

The first Covid-19 lockdowns in March jolted a lot of us into new habits. Some of these changes were healthy; others, not so much. We started cooking more, which is generally healthier than eating in restaurants. We’re washing our hands a lot more. Some demographic groups, including older people, started exercising more. But we’re also drinking more alcohol, especially if we’re women. We spend eight hours more a week watching TV. Lots of us are exercising less and spending more time doomscrolling. Pandemic anxiety has disturbed our sleep. Boredom has encouraged some of us to do a little too much impulsive online shopping. Mental health has suffered during this pandemic, and habits like these don’t alleviate the suffering. Over time, too much of any of these activities will leave a person (or her bank account) depleted. (Sarah Green Carmichael, 12/10)

This isn’t the moment for a massive reopening of schools in California. Not with COVID-19 levels as bad as they are and getting worse. But it is time to start planning for reopening classrooms as soon as hospitalization and infection rates drop again. President-elect Joe Biden wants to help most of the country’s schools reopen by April 30, but that’s not ambitious enough. By that point, nearly a whole academic year would be lost. (12/10)

Caveat lector: Two weeks ago, I discussed here the potential harm that the Democrats’ plans could do to U.S. health care and to “We the People.” Comments in response were primarily ad hominem attacks, without any evidence. This country was founded on respectful dialogue between persons with differing opinions. To those who disagree with what I write here, please limit your comments to evidence you believe refutes my conclusions. (Dr. Deane Waldman, 12/10)

Mergers and acquisitions have long been a vehicle for growth in the pharmaceutical industry. They allow major companies to rapidly expand their research and development pipelines and grow their portfolios into new therapeutic areas while giving emerging biotech companies a quick and profitable exit or the opportunity to become part of a larger brand. (Cecile Riboud, 12/11)