First Edition: Dec. 11, 2020
Today's early morning highlights from the major news organizations.
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)
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)
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)
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)
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)
The Washington Post:
FDA Advisers Recommend Pfizer-BioNTech Coronavirus Vaccine, With Agency Action Expected Soon
Federal advisers endorsed the Pfizer-BioNTech coronavirus vaccine on Thursday, making it all but certain the Food and Drug Administration will authorize the vaccine on an emergency basis within hours or days, kicking off an unprecedented effort to inoculate enough Americans to stop a rampaging pandemic. ... The thumbs’ up from the FDA’s vaccine advisory committee was the culmination of an all-day meeting during which the panel heard presentations on the safety and effectiveness of the vaccine, including plans to monitor its longer-term safety. The key moment came just after 5:30 p.m., when the agency asked its independent advisers: “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?” (McGinley, Johnson and Achenbach, 12/10)
The Wall Street Journal:
FDA Panel Endorses Covid-19 Vaccine
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)
AP:
US Panel Endorses Widespread Use Of Pfizer COVID-19 Vaccine
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 New York Times:
F.D.A. Panel Gives Green Light To Pfizer's Covid Vaccine
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)
The Hill:
Biden Says FDA Panel Vote On Pfizer Vaccine A 'Bright Light In A Needlessly Dark Time'
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)
The Hill:
FDA Panel Member Says She Voted Against Vaccine Authorization Because Of Limited Data On 'Younger Participants'
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)
Reuters:
Moderna Begins Study Of COVID-19 Vaccine In Adolescents
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)
US News & World Report:
Moderna Begins Trials Of Coronavirus Vaccine In Adolescents
"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)
The Wall Street Journal:
Covid-19 Vaccine Candidate Scrapped After False Positives On HIV Tests
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)
Reuters:
Australia Halts Local COVID-19 Vaccine Development Due To False HIV Positives
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)
BBC News:
Australian Vaccine Abandoned Over False HIV Response
The Australian government said it had now entered an agreement for the Novavax vaccine, and upped its existing order of the Oxford/AstraZeneca vaccine. (12/11)
Stat:
Sanofi Suffers Major Setback In Development Of A Covid-19 Vaccine
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)
Reuters:
Sanofi And GSK Delay COVID-19 Vaccine, Marking Setback To Global Fight
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)
AP:
GSK, Sanofi Say COVID-19 Shot Won't Be Ready Until Late 2021
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)
AP:
Probe: CDC Official Says She Was Ordered To Delete Email
A senior manager with the Centers for Disease Control and Prevention told congressional investigators she was ordered to delete an email suggesting attempted political interference by the Trump administration in coronavirus reports to the public, according to a transcript released Thursday. Rep. James Clyburn, D-S.C., who released the partial transcript, said the testimony of Dr. Charlotte Kent raises “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.” Kent testified that she believed CDC Director Robert Redfield ordered the deletion of the email. (Alonso-Zaldivar, 12/10)
The Washington Post:
CDC Director Allegedly Ordered Deletion Of Email Showing Effort To Interfere With Coronavirus Guidance, Lawmaker Says
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)
Politico:
CDC’s Redfield Told Staff To Delete Email, Official Tells House Watchdog
"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)
ABC News:
House Democrats Raise New Questions About Whether Senior CDC Officials Tried To Hide Interference In The Agency's Coronavirus Response
Rep. Jim Clyburn, D-S.C., chair of the House committee investigating reports of political interference at the CDC, presented the allegation in a letter Thursday to Trump administration officials. In the letter, Clyburn described the committee’s interview with Dr. Charlotte Kent, who leads the CDC Scientific Publications Branch. Kent told those congressional investigators she was asked to delete the Aug. 8 email from former CDC political appointee Paul Alexander. The agency has not turned the alleged email over to the committee, and Kent, who was on vacation at the time, told investigators that when she returned it was gone. (Siegel, 12/10)
NPR:
House Oversight Committee Chair: Testimony Points To Political Interference At CDC
A new kerfuffle is unfolding in a House oversight committee with the Democratic chair accusing White House appointees of political meddling and attempting to influence the Centers for Disease Control and Prevention strategies on the coronavirus pandemic in a manner that paints the administration in a more favorable light. In a Thursday letter to the secretary of the Department of Health and Human Services, Rep. James Clyburn 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 CDC. (Romo, 12/10)
The Wall Street Journal:
GOP Leaders See Bipartisan Group’s Covid-Aid Effort Falling Short
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)
Politico:
‘Get Off Our Damn Asses’: Stimulus Debacle Exposes Broken Washington
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)
The Hill:
Sanders, Hawley Team Up To Demand Vote On Second Round Of Stimulus Checks
Sens. Bernie Sanders (I-Vt.) and Josh Hawley (R-Mo.) are teaming up to push for a vote on a second round of stimulus checks — an unusual alliance that underscores the wide political spectrum that supports more direct payments. The two senators introduced a proposal on Thursday that would provide a second $1,200 stimulus check to individuals who make up to $75,000, mirroring language included in the March CARES Act. (Carney, 12/10)
NPR:
Unemployment Claims Jump Just Before Critical Aid Programs Are Set To Expire
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)
AP:
Some Oklahomans To Get $400 For Losing Wages Due To Pandemic
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)
The Hill:
Veterans Healthcare Fight Snagging Government Funding Deal
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)
NPR:
Republican N.H. House Speaker Dies Of COVID-19
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)
The Washington Post:
After New Hampshire Speaker’s Death, Democrats Ask The State For Coronavirus Tests
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)
AP:
One-Day US Deaths Top 3,000, More Than D-Day Or 9/11
Just when the U.S. appears on the verge of rolling out a COVID-19 vaccine, the numbers have become gloomier than ever: Over 3,000 American deaths in a single day, more than on D-Day or 9/11. One million new cases in the span of five days. More than 106,000 people in the hospital. The crisis across the country is pushing medical centers to the breaking point and leaving staff members and public health officials burned out and plagued by tears and nightmares. (Hollingsworth and Renault, 12/11)
Reuters:
Americans Get Stern Holiday COVID Warning: 'No Christmas Parties'
A top coronavirus adviser to President-elect Joe Biden delivered a stern holiday message to Americans on Thursday - “no Christmas parties” - and warned they face a COVID-19 siege for weeks to come despite the latest moves toward U.S. government approval of a vaccine. “The next three to six weeks at minimum ... are our COVID weeks,” Dr. Michael Osterholm, a member of Biden’s coronavirus advisory board, told CNN. “It won’t end after that, but that is the period right now where we could have a surge upon a surge upon a surge.” (Heavey and Caspani, 12/10)
The Hill:
Biden COVID-19 Adviser: 'There Is Not A Safe Christmas Party In This Country Right Now'
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)
The Hill:
CDC Director: US COVID-19 Deaths Likely To Exceed 9/11 Toll For 60 Days
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)
NPR:
U.S. Purchase Of More Pfizer Coronavirus Vaccine Doses Could Be Tricky
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)
The Washington Post:
Vaccine Politics Will Complicate Biden’s Path To A Unified Pandemic Respons
Cold, hard science powered the race that produced the first coronavirus vaccine, expected to win clearance imminently after gaining a positive vote from a Food and Drug Administration advisory committee Thursday night. The challenge next moves to more-fraught terrain — getting impatient Americans to understand that, while a vaccine is here, most will have to wait. Hospital systems are experiencing a surge of covid-19 this month, and it will almost certainly take several months or longer in 2021 before people can resume their pre-pandemic lives. Indeed, now is the time to be more careful than ever. (Rowland, 12/10)
The Hill:
Democrats Urge Biden To Address 'Infodemic' Of COVID-19 Disinformation, Misinformation
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)
The Atlantic:
The Vaccine Is Here. Now for the Hard Part
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)
NPR:
When Will You Get Your COVID-19 Vaccine?
The CDC recommends prioritizing health care facility workers who could get exposed to COVID-19 on the job — including doctors, nurses, nursing home aides, cafeteria workers and janitorial staff. The staff and residents of long-term care facilities (such as nursing homes and assisted living facilities) should also be prioritized in the first phase of vaccination, the CDC says, because that population accounts for only 6% of cases but 40% of COVID-19 deaths. (Huang, 12/10)
Stat:
Covid-19 Vaccine-Distribution Timeline Will Keep Slipping, Experts Say
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)
CIDRAP:
On Cusp Of COVID Vaccines, Experts Discuss Rollout Challenges
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)
The New York Times:
Airlines Gear Up To Transport Vaccines That Could Revive Travel
Months before anyone knew which of the coronavirus vaccine candidates would pull ahead or when they’d be available, airlines were trying to figure out how to transport doses around the world. Over the summer, American Airlines, Delta Air Lines and United Airlines spoke with government officials, pharmaceutical companies and experts to understand where vaccines might be produced, how they would be shipped and how best to position people and planes to get them moving. More recently, they have flown batches of vaccines for use in trials and research or to prepare for wider distribution. (Chokshi, 12/10)
USA Today:
Airline Workers Push To Be Among First Groups To Get COVID-19 Vaccine
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)
Reuters:
More Women Than Men In U.S. Nervous About Fast Rollout Of COVID Vaccine, And That's A Problem: Reuters/Ipsos Poll
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)
Modesto Bee:
Do I Have To Get A Vaccine If I’ve Already Had COVID?
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)
The Washington Post:
Medical Research Again Leaves Pregnant Women Waiting For A Vaccine — This Time For Coronavirus
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)
Boston Globe:
Biogen Conference In Boston Likely Linked To As Many As 300,000 COVID-19 Cases Worldwide, Researchers Say
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)
The Washington Post:
Covid-Related Rashes And Swelling Not Likely Signs Of Allergy
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)
Genomweb:
LabCorp Receives Approval For The Industry's First Over-The-Counter Home COVID-19 Test
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)
Los Angeles Times:
Illicit COVID-19 Tests Seized Off Flight At San Diego Airport
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)
The Hill:
Authorities Seize $600K Worth Of Counterfeit N95 Masks From Texas Warehouse
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)
Modern Healthcare:
CMS Wants To Force Insurers To Ease Prior Authorization
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)
Stat:
Supreme Court Upholds Controversial Arkansas Law That Regulates Pharmacy Benefit Managers
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)
The Washington Post:
Abortion Medication Restrictions Remain Lifted During Pandemic, Judge Rules
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)
The Hill:
Erectile Dysfunction Drug Packaged With Antidepressant In 'Product Mix-Up'
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)
Stat:
Boehringer Warns FDA A Single Word Threatens Biosimilar Competition
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)
Boston Globe:
Startup Backed By Third Rock Launches With $81 Million To Go After ALS
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)
The Washington Post:
Amazon’s Halo Band Wearable Tracks Your Voice And Body Fat, But Isn’t Helpful
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)