Travelers wearing protective masks receive nasal swabs from nurses at a COVID-19 test site inside Terminal B at Los Angeles International Airport (LAX), on Sunday, Nov. 22, 2020.
Bing Guan | Bloomberg | Getty Images
The Biden administration will end its Covid-19 vaccine mandates for federal employees, contractors and international air travelers next week.
The White House said in a statement Monday that those vaccine requirements will end on May 11, the same day the Covid public health emergency expires.
“While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary,” the White House said.
Although Covid cases, hospitalizations and deaths have declined dramatically this year, the virus is still killing more than 1,000 people per week.
The Health and Human Services Department also will start phasing out its vaccine mandate for health-care facilities that participate in Medicare and Medicaid, the White House said. In addition, it will end vaccination requirements for Head Start programs.
And the Department of Homeland Security will lift vaccination requirements for people entering the U.S via its land borders with Canada and Mexico, according to the Biden administration. U.S. citizens, nationals and permanent residents were never subject to those requirements.
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HHS and DHS will provide more details on the end of these vaccine requirements in the coming days, the White House said.
The Biden administration implemented the vaccine requirements for health workers, federal employees, contractors, and international air travelers as part of its drive to boost lackluster vaccination rates and slow the spread of the virus as the delta variant surged in late 2021 followed by omicron in the winter of 2022.
The mandates faced fierce opposition and lawsuits from critics who decried the requirements as government overreach, while the White House stressed they were essential to protect public health.
Seniors with early Alzheimer’s disease will face major hurdles to get treated even if promising new drugs roll out more broadly in the coming years, putting them at risk of developing more severe disease as they wait months or perhaps years for a diagnosis.
The U.S. health-care system is not currently prepared to meet the needs of an aging population in which a growing number of people will need to undergo evaluation forAlzheimer’s, according to neurologists, health policy experts and the companies developing the drugs.
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There are not enough dementia specialists or the needed testing capacity in the U.S. to diagnose everyone who may benefit from a new treatment like Eisai and Biogen‘s Leqembi. After patients are diagnosed, the capacity may not exist — at least initially — to provide the twice monthly intravenous infusions for everyone who is eligible.
Researchers estimate that the wait time from the initial evaluation to the confirmatory diagnostic tests to the infusions could range anywhere from a year and a half to four years or longer. Those months are critical for people with Alzheimer’s.
“The whole process from that time of the family physician conversation to the point of infusion, I worry how long it will take and the complexities of the patient navigating through all of that to successfully get to the end,” Anne White, president of neuroscience at Eli Lilly, which is developing its own Alzheimer’s treatment, told CNBC.
There are promising innovations in development, such as blood tests and injections that patients would take at home, which could make it significantly easier to get diagnosed and treated in the future.
White also said Lilly is confident that more doctors will get into the field and help to alleviate capacity issues, as awareness grows that medicines are entering the market to treat Alzheimer’s.
But time spent waiting robs early patients of their memory and ability to live independently. Alzheimer’s gets worse with time, and as patients deteriorate into more advanced stages of the disease, they no longer benefit from treatments like Leqembi that are designed to slow cognitive decline early.
More than 2,000 seniors transition from mild to moderate dementia from the disease a day, according to estimates from the Alzheimer’s Association. At that stage, they become ineligible for Leqembi.
The central challenge is that a large and rapidly growing group of people have early memory loss and other thinking problems known as mild cognitive impairment. This condition is often, though not always, a sign of early Alzheimer’s disease.
An estimated 13 million people in the U.S. had mild cognitive impairment last year, according to a study published in the Alzheimer’s and Dementia Journal. As the U.S. population ages, the number of people with this condition is expected to reach 21 million by 2060, the study projected.
The U.S. health-care system will deal with major logistical challenges in diagnosing the growing population of people with early Alzheimer’s — even before patients face potential issues with accessing treatment.
“There’s a very large population of undiagnosed cognitive impairments that need to be evaluated in order to determine if people are eligible for treatment,” said Jodi Liu, an expert on health policy at the Rand Corporation.
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Access to drugs like Leqembi is severely restricted because Medicare for nowwill only cover the $26,500-per-year treatment for people participating in clinical trials. Medicare has promised to provide broader coverage if Leqembi receives full approval from the Food and Drug Administration, which Eisai expects to happen in July.
Eisai has estimated that 100,000 people in the U.S. will be diagnosed and eligible for Leqembi by the third year of the treatment’s rollout. The sum is a fraction of the total population that could benefit.
Those patients could have other options if new treatments emerge from trials with positive marks.
Eli Lilly will publish clinical trial data on its antibody infusion donanemab in the second quarter of this year. If the data is positive, the company will ask the FDA to approve the drug.
Eisai’s U.S. CEO Ivan Cheung and Lilly’s White said during the companies’ respective earnings calls in February that they are focused on working with the U.S. health system to address the challenges of rolling out of Alzheimer’s treatments.
“The primary goal right now during this launch phase […] is really get the market ready in terms of the diagnostic pathway, the infusion capacity, the education on how to monitor for this therapy, get all the hospitals and clinics ready,” Cheung said.
Long lines are expected at the offices of geriatricians, neurologists and radiologists as millions of people with mild cognitive impairment undergo evaluation to diagnose whether they have Alzheimer’s disease.
Demand for geriatricians — doctors who are experts in diseases that affect the elderly — is expected to outstrip the number of specialists available in the field through at least 2035, according to projections from the federal Health Resources and Services Administration.
The American Academy of Neurology told Medicare in a February letter that increased demand for Alzheimer’s treatments will put substantial pressure on neurologists, who will need additional resources. The federal data predicts a substantial shortage of these specialists in rural areas through at least 2035.
“You just look at the neurologists, look at geriatricians — there are fewer and fewer geriatricians per person in the U.S.,” Rand’s Liu said. “It’s just a few number of specialists to do this kind of work.”
White said Lilly has heard stories of patients waiting six to 12 months to see a neurologist or other doctors who treat dementia due to current capacity issues.
The number of radiologists — who also play a role in diagnosing the disease — is expected to decline in the U.S. through 2035 even as demand increases, the data shows.
In a study published in 2017, Liu and other Rand researchers estimated an initial wait of 18 months for patients to get evaluated by a dementia specialist, tested to confirm a diagnosis, and then treated in the first year that an Alzheimer’s antibody treatment becomes available. The wait would decrease to 1.3 months by 2030 as the patient backlog is cleared, they estimated at the time.
But more recent research found that the wait would actually increase as demand created by an aging U.S. population outstrips the supply of specialists.
Patients seeking a first specialist visit could face an initial wait of 20 months, according to a study by researchers at the University of Southern California published in the journal Alzheimer’s and Dementia in 2021. The delay could increase to about four years as early as 2028 and grow longer through 2050, the study found.
The journal is published by the Alzheimer’s Association.
Both studies are based on assumptions made before Leqembi received expedited approval from the FDA in January. Actual wait times could differ from the studies’ projections.
Two types of tests can diagnosis Alzheimer’s disease: PET scans and spinal taps. PET scans are accurate and safe diagnostic tools, but they are also cumbersome and expensive, said Dr. David Russell, a neurologist.
Patients are injected with a tracer that makes brain abnormalities visible to the machine that does the imaging. Tracers have to be made for each patient and used on the same day.
“We don’t have the infrastructure to roll out PET scanning on a major scale,” said Russell, director of clinical research at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. He is the principal investigator on the clinical trials of Leqembi and donanemab at the institute.
Medicare coverage of PET scans for Alzheimer’s patients is also limited right now. The insurance program for seniors will only cover one scan per lifetime, and only when the patient is participating in a clinical trail approved by the federal Centers for for Medicare and Medicaid Services.
“That’s concerning because people may actually test negative at one point but then obviously as they age, they may need to get tested again,” White said.
Early Alzheimer’s disease can also be diagnosed with a spinal tap, in which fluid around the spinal cord is extracted with a catheter and tested. While there’s plenty of capacity to do spinal taps, this option isn’t attractive to many patients due to unfounded fears that it’s painful and dangerous, Russell said.
Though “there’s a lot of resistance” to the procedure, it is well tolerated and safe, he noted.
“There are certainly areas that don’t have a PET scanner, rural areas, so people would need to travel to a health center that has a PET scanner,” Liu said.
In a large, sparsely populated rural state like New Mexico, many patients would have to drive three to five hours to get a PET scan in a city such as Albuquerque, said Dr. Gary Rosenberg, a neurologist and director of the New Mexico Alzheimer’s Disease Research Center.
“It’s not California or the East Coast where everything’s very compressed and people can travel and get to a center pretty easily and go through these kinds of treatments,” Rosenberg said.
The state has an estimated population of 43,000 people with dementia, and there are very few neurologists outside of the Albuquerque area, Rosenberg said. The New Mexico Alzheimer’s Disease Research Center in Albuquerque is one of only three such facilities funded by the federal National Institute of Aging in a vast region stretching west from Texas to Arizona.
To do a PET scan, a tracer has to be made for each patient off-site in Phoenix, flown on a private plane to Albuquerque and used within hours because the tracers have a short shelf life, according to Rosenberg. The whole process costs more than $12,000 per patient, he added.
“It’s logistically going to be very challenging,” Rosenberg said.
After spending months or possibly years waiting to get diagnosed with early Alzheimer’s, patients would then be eligible for intravenous infusions of Leqembi. But the U.S. doesn’t currently have the capacity to give infusions twice monthly for everyone who likely has the disease, Russell said.
“Having an IV infusion every two weeks would sort of ration people to availability and that’s a problem,” Russell said.
The University of New Mexico Hospital is already maxed out with demand for infusion therapies for cancer, rheumatoid arthritis and autoimmune diseases, and could have a “problem” adding new capacity, said Rosenberg.
Intravenous infusions of monoclonal antibodies like Leqembi aren’t difficult to administer, Russell said.
The infrastructure to offer infusions should expand rapidly once industry sees there’s demand for treatments like Leqembi. But the process of building out capacity could still take a couple years, Russell said. He believes big players like CVS will provide infusions for Alzheimer’s disease on a major scale if they see there’s a large and stable market.
“In one sense, capitalism works, and if it looks like that’s going to be the future, I think infusion centers will explode onto the scene,” the neurologist said.
Eisai and Biogen hope to move early Alzheimer’s patients to a single monthly dose of Leqembi after they’ve completed their initial course of twice monthly infusions, which could help alleviate some of the capacity issues with infusions over time. They plan to ask the FDA to approve this plan in early 2024.
Eli Lilly’s Alzheimer’s candidate antibody treatment donanemab is a single monthly dose, potentially making the logistics of administration easier if the drug gets approved. Dr. Dan Skovronsky, Lilly’s chief medical officer, told analysts during the company’s first-quarter earnings call that he expects many patients will be able to stop taking donanemab at 12 months.
Though the projected wait times to get diagnosed and treated are sobering, innovations on the horizon promise to significantly improve access to Alzheimer’s drugs over time.
Blood tests for Alzheimer’s are in development and some are already on the market. Primary-care doctors could administer the tests, which would ease the burden on patients, especially those in rural communities where the closest PET scan machine is hours away.
These tests detect proteins in the blood associated with Alzheimer’s. They promise to help diagnose the disease before people display cognitive symptoms, potentially giving patients the chance to get treated before they suffer irreparable brain damage, according to the National Institutes of Health.
At least three blood tests made by C2N Diagnostics, Quest Diagnostics and Qaunterix are currently on the market. But they are used to evaluate people who are already presenting symptoms and aren’t available on the mass scale needed for the expected increase in Alzheimer’s patients.
C2N’s PrecivityAD test costs $1,250 and is not covered by insurance — though the company has a financial assistance program. Quest Diagnostics’ AD-Detect test costs $650. Quest’s test is covered by some insurance plans but not Medicare at the moment. The company also has a financial assistance program. Quanterix wouldn’t disclose the price of its test, which insurance does not cover.
Right now, these are not stand-alone tests that can definitively diagnose Alzheimer’s. But the tests could help identify the patients who likely have the disease, which would narrow the population that needs further evaluation and reduce wait times for dementia specialists or confirmatory PET scans.
A study in the journal Alzheimer’s and Dementia estimated that a cognitive test combined with a blood test could slash wait times for dementia specialists from 50 months down to 12 months.
Eisai believes that inexpensive blood tests could completely replace PET scans and spinal taps by the fourth year of Leqembi’s rollout. The quicker diagnosiscould increase the number of people eligible for treatment.
Rosenberg said widespread availability of blood tests will allow mobile clinics to go into rural communities and identify who has markers associated with Alzheimer’s. This would allow patients in remote towns avoid the hours-long drive to cities with PET scan machines, Rosenberg said.
“It’s a game changer,” the neurologist said.
Lilly is developing at least two blood tests. The company is already using one test in clinical trials and hopes to commercialize it sometime this year. It is developing a second test through a collaboration with Roche. White said it is reasonable to expect that in a few years blood tests could replace more burdensome PET scans.
Biogen and Eisai are also developing an injectable form of Leqembi which patients could administer themselves with an autoinjector similar to insulin pens, saving the trip to a site that provides intravenous infusions. They plan to ask the FDA to approve these so-called subcutaneous injections in early 2024.
Eli Lilly is also conducting clinical trials on an antibody treatment called remternetug as a self-administered injection. But the promise of injections that can be administered at home could make companies reluctant to invest in building out intravenous infusion capacity, Russell said.
In the future, Alzheimer’s diagnosis and treatment could be folded into routine checkups with a family doctor, Russell said. When people turn 50 and head in to get a colonoscopy or a cholesterol check, the doctor could also run a blood test for Alzheimer’s.
If the test comes back positive, the doctor could then schedule patients for an MRI and get them started on an autoinjector treatment, Russell said.
“That’s going to be the way that we’re looking at it in the not too distant future,” he said.
Pills of Misoprostol, used to terminate early pregnancies, are displayed in a pharmacy in Provo, Utah, May 12, 2022.
George Frey | Reuters
New York and California are stockpiling massive quantities of an alternative abortion medication in case a federal judge’s order suspending the Food and Drug Administration’s approval of the main drug mifepristone goes into effect later this week.
New York Gov. Kathy Hochul on Tuesday ordered the state health department to immediately start purchasing 150,000 doses of misoprostol, a five-year supply of the pill. Hochul’s announcement comes a day after Gov. Gavin Newsom said California has secured 2 million pills of misoprostol.
Medication abortions are the most common way to terminate a pregnancy the U.S. Patients typically use a two drug-regimen in which mifepristone is taken first, followed by misoprostol. The second pill is used as a standalone abortion medication in parts of the world.
Misoprostol is FDA approved to treat gastric ulcers, so it will remain on the market if U.S. District Judge Matthew Kacsmaryk’s order suspending mifepristone takes effect at 12 a.m. central time on Saturday.
“One judge in Amarillo, Texas thinks he knows better than thousands of doctors and scientists and experts. And not to mention the countless women who’ve used this medication safely for decades,” Hochul said during a press conference with Planned Parenthood’s New York chapter Tuesday.
“This isn’t just an attack on abortion, it’s an attack on democracy. Courts have never before revoked a science backed decision made by the FDA,” the governor said.
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Hochul said she is working with New York’s legislature to require private insurers to cover misoprostol when it is prescribed off-label for abortions.
The World Health Organization and the American College of Obstetricians and Gynecologists recommend misoprostol as a standalone abortion medication when the two-drug regimen is not available. But misoprostol is not as effective when it is used on its own, according to obstetricians and gynecologists.
The FDA has approved the two-drug abortion regimen through the 10th week of pregnancy. Mifepristone stops the pregnancy from developing further by blocking a hormone called progesterone. Misoprostol induces contractions that empty the uterus.
Patients take 200 milligrams of mifepristone by mouth on day one, and then take 800 micrograms of misoprostol in the cheek pouch 24 to 48 hours later, according to the FDA’s label.
“This landmark agreement has the potential to transform the Middle East by realigning its major powers,” the journal Foreign Affairs declared, adding that the gambit is “weaving the region into China’s global ambitions. For Beijing, the announcement was a great leap forward in its rivalry with Washington.”
“ ‘China has seen a space where it is hard for the West to really block off — heading into issues [that the Western powers] feel are too intractable or too toxic to touch and trying to demonstrate that there might be a different way to mediate or involve yourself in these problems.’ ”
— Kerry Brown, King’s College London
“There are changes coming that haven’t happened in 100 years,” Xi told Putin as the self-described “dear friends” concluded their talks. “When we are together, we are driving these changes.”
China’s assertiveness comes after three years of COVID restrictions that saw the country close off from the world in an attempt to tame the virus, a policy that was suddenly scrapped in December.
“It has sunk in that China needs friends. It has ended up too isolated, and that has cut across the narrative of the Xi third term, which was due to be somewhat more sunny,” Kerry Brown, director of the Lau China Institute at King’s College London, told MarketWatch.
Others agreed. “China certainly is exiting a period of diplomatic isolation during the height of COVID,” said Victor Shih, the Ho Miu Lam chair in China and Pacific relations at the University of California, San Diego, and an expert on Chinese elite politics.
That exit has been swift, with Beijing taking concrete steps toward a belief that previously had been mostly rhetoric — that the U.S.-led global system is not the only path.
“China has seen a space where it is hard for the West to really block off — heading into issues [that the Western powers] feel are too intractable or too toxic to touch and trying to demonstrate that there might be a different way to mediate or involve yourself in these problems,” Brown said.
Those sentiments are increasingly pervasive across China, particularly in government, academia and media.
“The U.S., which is accustomed to enjoying the spotlight, is now puzzled for it never thought that one day China would be more popular than it,” state tabloid Global Times said in a front-page story last Thursday.
Wang Yong, director of the Center for International Political Economy and the Center for American Studies at Peking University, told MarketWatch, “The rise of China as a great power is facing an increasingly complicated situation, mainly because U.S. elites judge China as the foremost strategic and systemic threat, and attack China’s development.”
In fact, Taiwanese President Tsai Ing-wen is stopping over in the U.S. this week after visits to the island’s few remaining allies in Central America. Beijing has threatened for weeks against her being welcomed by any high-level American officials.
Those threats turned to ire on Monday, when Republican House Speaker Kevin McCarthy said he would meet with Tsai on Wednesday in California. China said this could lead to “serious confrontation” and that Beijing would “resolutely fight back” — without giving specifics.
“ ‘Why is it assumed we live in a U.S. world?’ ”
— Alan Ma, graduate student, Tsinghua University.
“Gradually deviating from the past promise of ‘one China,’ promoting Taiwan independence and using Taiwan to contain China’s development — these could trigger a China-U.S. war,” Peking University’s Wang said from Beijing.
Average citizens including younger people expressed frustration with U.S. policy.
Taiwan’s president, Tsai Ing-wen, arrives on Thursday at her hotel in New York.
AP/John Minchillo
“Why isn’t it China’s time to lead? Why is it assumed we live in a U.S. world?” asked 27-year-old Alan Ma, a graduate student in politics at Beijing’s Tsinghua University.
Other areas are reaching heightened levels of tension. China’s military said last month it drove out an American destroyer ship that had “illegally” entered the South China Sea. And the CEO of Chinese-owned video sensation TikTok appeared before U.S. lawmakers in hopes of preventing an American ban on the app over national-security concerns.
But China’s rise, however rapid, must be put in a realistic context, experts said.
“I don’t think that we can say China has entered a new period as a global power until it has deployed large troop contingents overseas on its own,” said UC San Diego’s Shih.
Tanner Brown covers China for MarketWatch and Barron’s.
A leading infectious-disease expert said this week that data is showing the coronavirus has moved to the endemic phase, meaning that COVID-19 is still with us but no longer causing huge waves of illness or clogging up healthcare systems.
Eric Topol, the chair of innovative medicine at Scripps Research in La Jolla, Calif., said all indications from genomic surveillance of the virus, wastewater and clinical outcomes that are still being tracked point to an endemic phase. The caveat is that monitoring is more limited now and tracking is happening at lower frequency.
Nonetheless, “there are no new SARS-CoV-2 variants that have yet cropped up with a growth advantage over XBB.1.5 (the recombinant with two significant mutations added on), which is dominant throughout much of the world, or its cousin, XBB.1.91.1,” Topol wrote in his Ground Truths Substack column.
“For all the talk about the convergent ‘variant soup’ that preceded the most recent wave, the XBBs took hold and are not giving way to a long list of omicron family sub-variants,” he added.
The New York Times daily tracker shows that cases are now averaging around 29,558 a day, down 15% from two weeks ago and at a level last seen around April 2022.
Hospitalizations are down 11% at 24,965 a day. But the daily average death toll stands at 401, up 21% from two weeks ago and an undesirably high number.
The Johns Hopkins University global tracker will stop collecting data on Saturday, which marks the third anniversary of the World Health Organization’s declaration of a global state of emergency.
The tracker shows there have been 676.6 million cases of COVID and 6.8 million deaths globally since the start of the crisis. The U.S. leads the world with 103.8 million cases and 1.12 million deaths.
The WHO counted nearly 4.5 million new COVID cases globally in the 28-day period through March 5, down 58% from the previous period, according to its weekly epidemiological update. The agency said some 32,000 deaths were reported, down 65% from the previous 28-day period.
As has become its practice, it cautioned that an overall pullback in testing means those numbers are likely an undercount as prevalence surveys show higher ones.
The WHO is now monitoring one variant of concern, namely omicron, and seven of its subvariants. The following table shows the weekly prevalence of those subvariants over time:
World Health Organization
A new Gallup poll, meanwhile, shows Americans are evenly divided over whether or not the pandemic is over: Some 49% say it is, while 51% say it’s not.
Gallup first started asking the American public its views on the topic in June 2021, a time when many states were lifting restrictions on movement as the vaccine rollout was underway. At the time, just 29% of those polled said they thought the pandemic was over, giving way to a less upbeat 18% by fall of that year.
“Since then, optimism has mostly only inched higher, rising to 34% last spring and to 44% in October before reaching 49% today,” said Gallup.
A quarter of those polled said they are very or somewhat worried about contracting COVID. That was split between 3% who are very worried and 22% who are somewhat worried. Concerns spiked at 50% in January 2022, when omicron first started to circulate.
The Gallup survey also found that many Americans are still at least partially isolating to protect themselves from the virus. Some 23% of those polled said they are still avoiding crowds, 18% are avoiding travel by air or public transportation and 14% are avoiding public places such as stores and restaurants. Just 10% are even avoiding small gatherings.
But most people are no longer wearing face masks, with just 31% saying they still use one.
Gallup
A small majority of those surveyed, or 52%, said they have tested positive for COVID. Another 13% said they had not, but believed they have had the virus.
As many as 83% of Americans may have some immunity against the virus due to the higher number that have had it and the 63% who are vaccinated, the survey found.
Medicare will not provide broader coverage of the Alzheimer’s drug Leqembi until it receives more evidence that the treatment is reasonable and necessary, according to the federal agency that runs the program for seniors.
The Centers for Medicare and Medicaid Services rejected a request from the Alzheimer’s Association for unrestricted coverage of antibody treatments approved by the Food and Drug Administration that target brain plaque associated with the devastating disease.
“After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration,” CMS said in a statement on Wednesday.
The FDA cleared Leqembi on an expedited basis in January after clinical trial results showed that the treatment slowed cognitive decline by 27% in patients with early Alzheimer’s disease. The drug also carries risks of brain swelling and bleeding.
Leqembi was developed by the Japanese pharmaceutical company Eisai and its partner Biogen. When drugs like Leqembi are approved on expedited basis, Medicare will only cover them for patients who are participating in clinical trials.
“As defined in statute, to provide coverage nationally, CMS is required to examine whether a medication is reasonable and necessary,” the agency said in its statement. “This standard differs from the criteria used by the FDA to assess whether medications are safe and effective.”
Eisai, which completed its phase three trial, has priced Leqembi at $26,500 per year. Due to the drug’s high price and Medicare’s coverage restrictions, seniors are unable to access the treatment.
“CMS’ role is to provide health care coverage. Their role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate. Their role is not to single out people living with Alzheimer’s and decide that their lives, their independence and their memories are not necessary,” said the association’s president Joanne Pike.
The letter the Alzheimer’s Association sent to CMS in December calling for unrestricted coverage was signed by more than 200 researchers and experts. The American Academy of Neurology has also told CMS that its experts reviewed Eisai’s clinical trial and concluded that the study was well designed and Leqembi provides a clinical benefit.
The Alzheimer’s Association estimates that 2,000 people ages 65 and older progress from mild dementia to a more advanced stage of the disease per day, which would make them ineligible for Leqembi.
CMS said it would provide broader coverage of Leqembi on the same day should the FDA fully approve the treatment. Eisai U.S. CEO Ivan Cheung told CNBC last week that the company expects to receive full FDA approval this summer.
But even with full approval, Medicare’s policy is to cover Alzheimer’s treatments for patients who agree to participate in research studies that collect real-world data. While coverage would be broader, such studies need to be set up and health-care providers have to agree to participate. This would likely still limit the number of people who can access the drug.
But Cheung told CNBC that Medicare could agree to even broader coverage, possibly with no restrictions, if CMS determines that there’s a high level of evidence supporting the treatment.
“With a high level of evidence … the restrictions should be very limited, or maybe even no restrictions and that is Eisai’s position,” Cheung said. “We believe Medicare beneficiaries should have unimpeded access, broad and simple access to Leqembi because the data fulfill those criteria.”
Members of Congress, including 20 senators and more than 70 House members, have called on CMS to change its policy and offer broader coverage of Alzheimer’s antibody treatments. People living in rural and underserved communities face a disadvantage because the institutions that host clinical trials are usually in bigger cities.
“Patients, families, and caregivers living in rural and underserved areas should have the same opportunity for access to treatment,” the House lawmakers told Health and Human Services Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure. “It is an enormous physical and financial burden for Medicare beneficiaries to spend countless hours traveling to limited research institutions that host the trials.”
Medicare adopted the coverage restrictions after controversy over the Alzheimer’s antibody treatment Aduhelm, which was also developed by Eisai and Biogen. The FDA approved that treatment over the objections of its independent advisors, who said the data did not demonstrate a benefit for patients. Three advisors resigned over the FDA decision, and a congressional investigation found irregularities in the approval process.
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reported better-than-expected earnings in the final three months of 2022, giving Wall Street exactly what it wanted as analysts remain positive on the Chinese tech giant.
The Food and Drug Administration’s independent advisors on Wednesday unanimously recommended over-the-counter use of the nasal spray Narcan to reverse opioid overdoses, which would significantly expand access to the life-saving treatment.
Emergent BioSolutions‘ Narcan is the most commonly sold treatment for opioid overdoses. The FDA is expected to make a decision by March 29 on whether to allow people to buy the four milligram nasal spray without a prescription. The agency is not required to accept its advisors recommendation, though it typically does so.
Emergent BioSolutions said Narcan would be available for the over-the-counter market by late summer if the FDA approves it next month. The company has not yet disclosed how much it would cost.
“We have been working on distribution plans with key stakeholders like retailers and government leaders,” said Matt Hartwig, a spokesperson for the company.
Most states have already issued blanket prescriptions that allow pharmacies to distribute Narcan, generically known as naloxone, without the patient having to present a script. But FDA approval of Narcan for over-the-counter use would allow more people to acquire the treatment more easily in more places.
“If naloxone becomes a nonprescription product, it may be sold in many venues previously unavailable to consumers, including vending machines, convenience stores, supermarkets and big box stores, just like other nonprescription products,” Jody Green, an official at the FDA’s nonprescription drug division, told the advisory committee Wednesday.
Since 1999, more than 564,000 people have died from opioids in the U.S. in three waves — first from prescription opioids, then from heroin and most recently from fentanyl, according to the Centers for Disease Control and Prevention. Opioid overdose deaths spiked 17% during the pandemic from about 69,000 in 2020 to nearly 81,000 in 2021.
The Trump administration first declared the opioid epidemic a public health emergency in 2017. The Biden administration has renewed the emergency declaration every 90 days since the president took office.
“Each day 187 people will die — this is absolutely tragic as we think of not only the individuals themselves, but the families, the communities, the workplaces. This has profound human impact and we are all impacted from this,” Manish Vyas, senior vice president of regulatory affairs at Narcan maker Emergent BioSolutions, told the committee.
Scott Hadland, head of adolescent medicine at Massachusetts General Hospital, said the widespread infiltration of fentanyl into the nation’s drug supply has increased the risk of overdoses. Many people who are exposed to fentanyl take counterfeit pills that they thought were prescribed but actually contain the highly potent and often deadly opioid, Hadland said.
“And increasingly there are secondhand exposures that are also rising,” Hadland, who participated in Emergent BioSolutions’ presentation, told the committee. “We’re seeing rising overdose deaths among toddlers who are coming across fentanyl in public settings or fentanyl that may be elsewhere in the home.”
Hadland said he tells parents to to keep Narcan at their home in case of an emergency. He compared it to a fire extinguisher that families should have for safety reasons but hopefully will never have to use.
“Unfortunately for most young people, families and community members all across this country, current avenues of access are challenging,” Hadland said.
Dr. Bobby Mukkamala of the American Medical Association said Narcan should be as easy to obtain as Tylenol to treat a headache or a decongestant for a stuffy nose. The life-saving nasal spray should be just as common in public places as AED devices that are used to treat people suffering from heart attacks.
Jessica Hulsey, executive director of the Addiction Policy Forum, told the committee during a public comment section that Narcan needs to be priced affordably at no more than $20 per dose if it’s sold over the counter. Narcan is packaged as single doses and it can take multiple doses to reverse an overdose from highly potent fentanyl.
Narcan displaces opioids that bind to receptor sites in a person’s nervous system. By displacing and blocking opioids, the nasal spray prevents fatal overdoses by reversing respiratory depression, said Gay Owens, head of global medical affairs at Emergent BioSolutions.
But Narcan has to be administered as soon as an overdose is suspected, which is why it’s crucial to make sure the instructions for using the nasal spray are simple, the FDA’s Green said.
In a study sponsored by Emergent BioSolutions, more than 90% of 71 participants understood over-the-counter label directions and used the Narcan device correctly during a simulated overdose emergency using mannequins. The participants included people with varying levels of literacy, and both adults and adolescents.
But some participants were confused by the five-step instructions because they were split across the side and back panels of the carton, said said , senior pharmacist at the FDA division that monitors errors in administering medicine. This confusion could result in delayed administration or errors in using the Narcan device correctly when time is of the essence, according to Shah.
These instances occurred despite the fact that the participants were allowed as much time as needed to familiarize themselves with the Narcan instructions, which may not be the case in a real-world overdose emergency, according to Shah.
“Therefore, the data collected does not capture this highest-risk use scenario,” said Shah.
The FDA has proposed that Emergent BioSolutions place all five instructions in sequential order on the back panel of the carton and also include instructions in the device blister pack. The company presented a mockup at the advisory meeting, but the FDA said it has not evaluated it yet.
The omicron subvariant that became dominant in the U.S. several weeks ago continued to extend its lead over other variants in the latest week, according to Centers for Disease Control and Prevention data that was updated on Friday.
XBB.1.5, the omicron sublineage that first emerged in small numbers in October, accounted for 66.4% of cases in the week through Feb. 4, the data shows. That’s up from 61.3% the previous week. The prior dominant variants, BQ.1.1 and BQ.1, together accounted for 27.2% of new cases, down from 31.1% the previous week.
In the CDC’s Region 2, which includes New York, New Jersey, the U.S. Virgin Islands and Puerto Rico, XBB.1.5 accounted for 92.4% of new cases, up from 91.1% the previous week.
The World Health Organization is monitoring XBB and its sublineages and has said that so far, it shows a growth advantage over other circulating variants — in other words, it’s more infectious — but there is still no data to suggest it’s any more lethal, or likely to cause severe illness or death.
The WHO said this week the pandemic is not yet over, although the world may be reaching an inflection point as higher immunity rates lower death rates. But it also urged countries to stay the course, while President Joe Biden has pledged to end twin COVID emergencies on May 11, a move that has dismayed healthcare experts.
Travel between Hong Kong and China will no longer require COVID-19 PCR tests nor be held to a daily limit, authorities announced Friday, as both places seek to drive economic growth, the Associated Press reported.
Hong Kong’s tourism industry has suffered since 2019 after months of political strife that at times turned into violent clashes between protesters and police, as well as harsh entry restrictions implemented during the pandemic.
The announcement came a day after Lee unveiled a tourism campaign aimed at attracting travelers to Hong Kong that includes 500,000 free air tickets for tourists to visit the semi-autonomous Chinese city.
In the U.S., the seven-day average of new U.S. COVID cases stood at 41,412 on Thursday, according to a New York Times tracker. That’s down 19% from two weeks ago. The daily average for hospitalizations was down 21% at 31,394. The average for deaths was 462, down 7% from two weeks ago.
Cases are now rising in 17 states, the tracker shows, led by Minnesota, where they are up 63% from two weeks ago. On a per capita basis, cases are highest in Kentucky at 22 per 100,000 residents.
• China’s COVID lockdowns, and the ending of them in December that sparked a wave of cases, are featuring prominently in U.S. fourth-quarter earnings, with Starbucks SBUX, -2.68% the latest company to highlight their impact on its performance. The coffee-shop chain’s stock was down 3.8% Friday, after it said same-store sales in China, a key market, fell 29% because of the case surge. That was enough to drag down international same-store sales, which had an overall drop of 13%. Still, Chief Financial Officer Rachel Ruggeri said on the call that, “excluding China, we had tremendous growth across markets.” She also said the company’s fiscal 2023 outlook remains unchanged.
• Some Georgia senators want to permanently block schools and most state and local government agencies from requiring people to get vaccinated against COVID, the AP reported. In 2022, lawmakers put a one-year ban into law, part of a nationwide conservative backlash against mandates meant to prevent the spread of the respiratory illness. But that ban expires on June 30 in Georgia if lawmakers don’t act. The Senate Health and Human Services Committee voted 7-2 this week to advance Senate Bill 1, which makes the ban permanent, to the full Senate.
• After a two-year hiatus due to the coronavirus pandemic that brutally brought one of Europe’s oldest Mardi Gras celebrations in Binche, Belgium to a halt, celebrations are back with a vengeance this winter, the AP reported. The earliest records of the Binche Mardi Gras, which draws thousands of revelers, date to the 14th century. Many Belgian towns hold ebullient carnival processions before Lent. But what makes Binche unique are the “Gilles”—local men deemed fit to wear the Mardi Gras costumes. Under rules established by the local folklore defense association, only men from Binche families or having resided there for at least five years are eligible to wear the Gille costume. Other characters—the Peasant, the Sailor, the Harlequin, the Pierrot or the Gille’s Wife—also play a role in the carnival.
The U.S. leads the world with 102.5 million cases and 1,110,856 fatalities.
The CDC’s tracker shows that 229.6 million people living in the U.S., equal to 69.2% of the total population, are fully vaccinated, meaning they have had their primary shots.
So far, just 51.4 million Americans, equal to 15.5% of the overall population, have had the updated COVID booster that targets both the original virus and the omicron variants.
The World Health Organization said nearly 20 million new COVID cases were recorded in the 28 days through Jan. 29, down 78% from the previous 28 days.
The WHO counted more than 114,000 deaths in the period, up 65% from the previous one.
The agency is switching to a 28-day interval to smooth out weekly fluctuations in cases and deaths, but it continues to caution that a reduction in testing and delays in reporting in many countries are distorting the numbers.
“Current trends in reported COVID-19 cases are underestimates of the true number of global infections and reinfections as shown by prevalence surveys,” the WHO said in its weekly epidemiological update.
The other three are BF.7, BQ.1 and BA.2.75, along with their sublineages. These are currently the ones showing a growth-rate advantage in some countries compared with other circulating variants.
U.S. cases are still declining. The seven-day average of new cases stood at 41,771 on Wednesday, according to a New York Times tracker. That’s down 23% from two weeks ago.
The daily average for hospitalizations was down 22% at 31,593. The average for deaths was 453, down 6% from two weeks ago, but still an undesirably high number heading into the third year of the pandemic and ahead of President Joe Biden’s plan to end the twin COVID emergencies on May 11.
• Quest Diagnostics Inc. DGX, -1.55%
is the latest healthcare company to report a steep drop in revenue from COVID-related products, in this instance a 74.6% slide in tests in its fourth quarter. Revenue from COVID tests fell to $184 million in the quarter from $722 million a year ago, when the omicron wave was about to crest. But the company still posted better-than-expected earnings, raised its quarterly dividend and added $1 billion to its share-buyback authorization, which has $311 million already available.
• Hong Kong will give away air tickets and vouchers to woo tourists back to the international financial hub as it races to catch up with other popular travel destinations in a fierce regional competition, the Associated Press reported. During the pandemic, the city largely aligned itself with mainland China’s zero-COVID strategy and has relaxed its entry rules months later than rival destinations such as Singapore, Japan and Taiwan. Even after it reopened its border with mainland China in January, tourism recovery was sluggish. On Thursday, Chief Executive John Lee launched a tourism campaign, “Hello Hong Kong,” saying the city will offer 500,000 free air tickets to welcome tourists from around the world in what he called “probably the world’s biggest welcome ever.”
• Washington state Gov. Jay Inslee has tested positive for COVID-19 for the second time, the AP reported separately. Inslee’s office said in a statement Wednesday that he had tested positive and was experiencing very mild symptoms, including a cough. He is consulting with his doctor about whether to receive Paxlovid antiviral treatments, according to the statement. He plans to continue working. Trudi Inslee, his spouse, has tested negative.
The U.S. leads the world with 102.5 million cases and 1,109,687 fatalities.
The CDC’s tracker shows that 229.6 million people living in the U.S., equal to 69.2% of the total population, are fully vaccinated, meaning they have had their primary shots.
So far, just 51.4 million Americans, equal to 15.5% of the overall population, have had the updated COVID booster that targets both the original virus and the omicron variants.
Vials and a medical syringe seen displayed in front of the Food and Drug Administration (FDA) of the United States logo. FDA finds the COVID-19 vaccine.
Pavlo Gonchar | LightRocket | Getty Images
The Food and Drug Administration on Tuesday said its emergency authorizations of Covid vaccines, tests and treatments will not be impacted by the end of the public health emergency this spring.
President Joe Biden is planning to terminate in May the public health and national emergencies declared in response to the Covid pandemic three years ago, the White House said Monday. The public health emergency gave U.S. health regulators expanded powers to respond faster to the pandemic.
The FDA’s emergency powers, however, aren’t directly tied to public health declaration, according to the agency.
Former Health Secretary Alex Azar made separate determinations in February and March of 2020 under the Food, Drug and Cosmetics Act that the circumstances of the pandemic justified the authorization of vaccines, treatments and tests for emergency use.
The FDA used its emergency powers to authorize the Pfizer, Moderna, Johnson & Johnson and Novavax vaccines. The agency also authorized the oral antivirals Paxlovid and molnupiravir, several antibody treatments as well as numerous tests and other medical devices on an emergency basis.
“Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met,” The FDA wrote in post on Twitter Monday.
Emergency authorizations allow the FDA to roll out medical products before they receive the agency’s full approval. This allows the agency to respond more swiftly to public health crises.
President Joe Biden will end the twin national emergencies for addressing COVID-19 on May 11, as most of the world gets closer to normalcy nearly three years after the emergencies were first declared, the Associated Press reported.
The move would formally overturn the federal response to the virus and change it to one where COVID is treated as an endemic threat to public health, much like the flu, which returns seasonally but can be managed without major disruption to the healthcare system.
The coronavirus pandemic is still a global health emergency, according to the World Health Organization, but an advisory panel has determined that it may be nearing an inflection point where higher levels of immunity will lead to fewer deaths.
But Tedros cautioned that weekly reported deaths have been climbing since the beginning of December, at a cost of more than 170,000 lives.
“And that’s just the reported deaths; we know the actual number is much higher,” Tedros said at the meeting. “We can’t control the virus, but we can do more to address the vulnerabilities in populations and health systems.”
Vaccination remains the key tool, he said, and countries must vaccinate 100% of their most at-risk groups and increase access to testing and early antiviral use. When there is a surge in cases, countries need context-specific measures, including maintaining and expanding laboratory networks.
“And it means fighting misinformation,” he said. “We remain hopeful that in the coming year, the world will transition to a new phase in which we reduce hospitalizations and deaths to the lowest possible level, and health systems are able to manage COVID-19 in an integrated and sustainable way. “
His comments comes as U.S. cases, hospitalizations and deaths continue to fall, with the seven-day average of new cases standing at 46,021 on Sunday, according to a New York Times tracker. That’s down 25% from two weeks ago.
The daily average for hospitalizations was down 22% to 33,451. The average for deaths was 521, down 8% from two weeks ago.
Cases are currently rising in just nine states, as well as in the U.S. Virgin Islands. Tennessee is leading with total case counts, which are up 104% in two weeks, and also on a per capita basis, with 51 cases per 100,000 residents.
• Chinese health officials are saying that the wave of cases that emerged after the government dropped strict COVID restrictions in December is “coming to an end,” BBC News reported. China’s Center for Disease Control and Prevention said there had been “no obvious rebound” in cases during Lunar New Year holiday gatherings last week. “In this time, no new variant has been discovered, and the country’s current wave is coming to an end,” said China’s CDC. China has understated its COVID numbers throughout the pandemic, but experts say the decline reported now corresponds with the expected timing of an end to this major wave.
What’s seen as the world’s largest annual human migration is under way again in China for the Lunar New Year, after the country lifted pandemic restrictions. The Wall Street Journal’s Yoko Kubota reports on how it’s expected to boost the economy — and the risk of new COVID-19 outbreaks. Photo: Cfoto/Zuma Press
• China announced it would resume issuing visas for Japanese travelers beginning Sunday, ending its nearly three-week suspension that was an apparent protest of Tokyo’s tougher entry requirements for tourists from China, the Associated Press reported. The statement was posted on the Chinese Embassy’s website. Japan reopened its borders for individual tourists in October, allowing travelers to show proof of vaccination instead of testing at airports unless they show symptoms, but on Dec. 30, Japan began requiring all travelers from China to show a predeparture negative test and take an additional test upon arrival.
• A former Russian Orthodox monk who denied that the coronavirus existed and defied the Kremlin was handed a seven-year prison sentence Friday, the AP reported separately. Nikolai Romanov, 67, who was known as Father Sergiy until his excommunication by the Russian Orthodox Church, urged his followers to disobey the Russian government’s lockdown measures and spread conspiracy theories about a global plot to control the masses. A court in Moscow convicted him of inciting hatred. His lawyer immediately announced plans to appeal.
The U.S. leads the world with 102.3 million cases and 1,107,646 fatalities.
The CDC’s tracker shows that 229.6 million people living in the U.S., equal to 69.2% of the total population, are fully vaccinated, meaning they have had their primary shots.
So far, just 51.4 million Americans, equal to 15.5% of the overall population, have had the updated COVID booster that targets both the original virus and the omicron variants.
The Centers for Disease Control and Prevention on Friday urged people with weak immune systems to take extra precautions to avoid Covid after the dominant omicron subvariants knocked out a key antibody treatment.
These precautions include wearing a high quality mask and social distancing when it’s not possible to avoid crowded indoor spaces, according to the CDC.
The guidance comes after the Food and Drug Administration on Thursday pulled its authorization of Evusheld, a combination antibody injection that people with weak immune systems took as an additional layer of protection to prevent Covid infection.
The FDA pulled Evusheld because it is not effective against 95% of the omicron subvariants circulating in the U.S. This includes the XBB subvariants which are now causing 64% of new cases, as well as the BQ family that is responsible for 31% of reported infections.
Although most Americans have largely returned to normal life as the Covid pandemic has ebbed, people with weak immune systems remain at higher risk of severe disease because they do not mount as strong of an immune response to the vaccines.
Still, it is important for people with weak immune systems to stay up to date on their Covid vaccines by receiving the omicron booster because the shots can slash the risk of severe disease, according to the CDC.
If you have a weak immune system and develop Covid symptoms, you should get tested as soon as possible and receive treatment with an antiviral within five to seven days, according to CDC.
Available antivirals include Paxlovid, remdesivir or molnupiravir, but patients should talk to their doctor to find out which treatment is best. Some people cannot take Paxlovid due to how it interacts with other drugs they are taking.
People with weak immune systems include cancer patients who are on chemotherapy, organ transplant patients who are taking medication for their transplant, people with advanced HIV infection, and those born with immune deficiencies.
Some 7 million adults in the U.S. have a condition, like cancer, that compromises their immune system, according to the CDC.
A Food and Drug Administration advisory panel voted unanimously Thursday for Americans to get a once-a-year booster against COVID-19, with the strain to be decided midyear for a fall campaign, the Associated Press reported.
“This is a consequential meeting to determine if we’ve reached the point in the pandemic that allows for simplifying the use of current COVID-19 vaccines,” said the FDA’s Dr. David Kaslow.
The panel agreed that people should get the same vaccine formula whether they’re receiving their initial vaccinations or a booster. Today, Americans get one formula based on the original coronavirus strain that emerged in 2020 for their first two or three doses, and their latest booster is a combination shot made by Pfizer PFE, -0.33%
or Moderna MRNA, -0.90%
that adds protection against omicron.
The FDA would have to decide how to phase in that change.
COVID-19 vaccines have saved millions of lives, and booster doses remain the best protection against severe disease and death. But Americans are tired of getting vaccinated. While more than 80% of the U.S. population has had at least one COVID-19 shot, only 16% of those eligible for the latest boosters — so-called bivalent doses updated to better match more recent virus strains — have gotten one.
Separately, the Centers for Disease Control and Prevention offered an update Friday on the strains that are dominant in the U.S., showing that XBB.1.5, the omicron sublineage that first emerged in small numbers in October, has extended its lead over other variants.
XBB.1.5 accounted for 61.3% of cases in the week through Jan. 28, the data shows, up from 49.1% a week ago. The prior dominant variants, BQ.1.1 and BQ.1, together accounted for 31.1% of new cases.
In the CDC’s Region 2, which includes New York, New Jersey, the U.S. Virgin Islands and Puerto Rico, XBB.1.5 accounted for 91.1% of new cases, up from 86.8% the previous week.
The World Health Organization said this week that it now has data on XBB.1.5 from 54 countries, showing it has a growth advantage over other circulating strains but still appears no more severe.
In its weekly epidemiological update, the agency said it has raised the confidence level of its risk assessment for XBB.1.5 to “moderate” from “low,” using these additional reports. The highest number of XBB.1.5 cases are showing up in the U.S., the U.K., Canada, Denmark, Germany, Ireland and Austria.
The news comes as the seven-day average of new cases stood at 46,300 on Thursday, according to a New York Times tracker. That’s down 24% from two weeks ago. The daily average for hospitalizations was down 24%, at 34,833. The average number of deaths was 549, down 3% from two weeks ago.
Cases are currently climbing in eight states — Illinois, Tennessee, Minnesota, Alaska, South Dakota, Vermont, Kentucky and Kansas — as well as in the U.S. Virgin Islands and Washington, D.C.
• China’s claim that COVID cases and deaths have peaked and are falling fast is failing to take on board that testing is not keeping up with infections, the Guardian reported. China ended its zero-COVID policy in December and promptly saw a wave of cases spread across the nation. Its health authorities said this week that the worst is behind it, but experts are wary that it is underreporting numbers, as it has since the start of the pandemic. Now the pullback in testing is a factor, according to the Guardian. Daily tests had dropped to 280,000 by Monday, down from 150 million on Dec. 9, and 7.54 million on Jan. 1. Some provinces had enacted systems for collecting the results of residents or allowing residents to self-report, but the figures were “affected by the willingness of residents to test.”
What’s seen as the world’s largest annual human migration is under way again in China for the Lunar New Year, after the country lifted pandemic restrictions. WSJ’s Yoko Kubota reports on how it’s expected to boost the economy–and the risk of new Covid-19 outbreaks. Photo: Cfoto/Zuma Press
• South Korea says it will continue to restrict the entry of short-term travelers from China through the end of February over concerns that the spread of COVID may worsen following the Lunar New Year holidays, the AP reported. South Korea in early January stopped issuing most short-term visas at its consulates in China, citing concerns about the virus surge in the country.
• Spain is set to end the mandatory use of face masks on public transport nearly three years after the start of the pandemic, the AP reported separately. Spanish Health Minister Carolina Darias said Thursday she would recommend that the government remove the health regulation when the cabinet meets on Feb. 7. Face masks will remain obligatory inside hospitals, health clinics, dentist offices and pharmacies.
The U.S. leads the world with 102.3 million cases and 1,107,559 fatalities.
The CDC’s tracker shows that 229.6 million people living in the U.S., equal to 69.2% of the total population, are fully vaccinated, meaning they have had their primary shots.
So far, just 51.4 million Americans, equal to 15.5% of the overall population, have had the updated COVID booster that targets both the original virus and the omicron variants.
A few days into the first Lunar New Year holiday since the lifting of pandemic restrictions in China, Chinese consumers are eager to travel but are also wary as a major COVID wave sweeps the nation, MarketWatch’s Tanner Brown reported.
The 15-day festival is considered the world’s largest annual migration, during which students and workers return to their hometowns in droves — that is, until COVID shut down travel in 2020.
The Food and Drug Administration is recommending that the U.S. decide each June which SARS-CoV-2 strains should be included in an annual fall booster shot.
Doing so would allow updated COVID-19 vaccines to be ready for distribution “no later than September” each year, according to documents published by the regulator.
The XBB.1.5 omicron subvariant that became dominant in the U.S. last week has gained more ground, according to data from the nation’s main health agency, accounting for 49.1% of new cases in the latest week, up from 43% a week ago.
BQ.1.1 accounted for 26.9% of new cases, down from 28.8% a week ago, while BQ.1 accounted for 13.3%, down from 15.9% a week ago.
In the New York region, which includes New Jersey, Puerto Rico and the U.S. Virgin Islands, XBB.1.5 accounted for 86.8% of new cases, up from 82.7% a week ago.
The World Health Organization has acknowledged that XBB.1.5, which was first detected in tiny numbers in the U.S. in October, has become the most transmissible variant yet thanks to a growth advantage. The agency said that it appears to have a greater ability to evade immunity than earlier variants.
In its weekly epidemiological update, the agency said the XBB line is one of four omicron subvariants that are showing transmission advantage over other circulating variants. The other three are BF.7, BQ.1 and BA.2.75.
For now, the WHO said it has no additional data on XBB.1.5, but BA.2.75.2 is showing the most neutralization resistance to sera from vaccinated and COVID-infected patients.
In the U.S., the seven-day average of new COVID cases stood at 50,839 on Thursday, according to a New York Times tracker. That’s down 20% from two weeks ago and below the recent peak of 70,508 on Christmas Eve.
The daily average for hospitalizations was down 18% at 39,272. The average for deaths was 498, up 5% from two weeks ago.
Cases are rising in just six states, as well as the U.S. Virgin Islands, Washington, D.C., and Puerto Rico, a significant improvement from recent trends. On a per capita basis, Illinois now has the most cases at 31 per 100,000 residents, followed by Kentucky at 30 and Rhode Island at 27.
• Japanese Prime Minister Fumio Kishida on Friday announced plans to downgrade the legal status of COVID-19 to the equivalent of seasonal influenza in the spring, a move that would further relax mask requirements and other preventive measures as the country seeks to return to normalcy, the Associated Press reported. Kishida said he has instructed experts and government officials to discuss the details on changing the status of COVID-19. A change would also remove self-isolation rules and other antivirus requirements and allow COVID-19 patients to seek treatment at any hospital instead of restricting them to specialized facilities.
• As Chinese people crowd onto trains and buses ahead of the Lunar New Year holiday, which begins on Jan. 21, officials are playing down fears that widespread travel over the popular family holiday will lead to a spreader event, Reuters reported. In comments reported by state media late Thursday, Vice Premier Sun Chunlan said the virus was at a “relatively low” level, while health officials said the number of COVID patients in the hospital and in critical condition was on the decline. But there are doubts about China’s official account of an outbreak that has overwhelmed hospitals and funeral homes since Beijing abandoned strict COVID controls and mass testing last month.
What’s seen as the world’s largest annual human migration is under way again in China for the Lunar New Year after the country lifted pandemic restrictions. The Wall Street Journal’s Yoko Kubota reports on how it’s expected to boost the economy — and the risk of new COVID-19 outbreaks. Photo: Cfoto/Zuma Press
• CureVac’s CVAC, +1.06%
promising Phase 1 data for flu and COVID-19 vaccine candidates is a signal to investors that its messenger RNA technology is competitive, according to UBS Securities analysts, who upgraded the company’s stock to buy from neutral on Thursday, as MarketWatch’s Jaimy Lee reported. They also more than doubled the price target, to $18 from $8. CureVac had attempted to develop a first-generation COVID vaccine but failed. “As the first data of the 2nd-gen platform’s immunogenicity in humans, this is a major inflection point for the story, and suggests potentially competitive mRNA platform relative to mRNA peers,” the analysts wrote.
The U.S. leads the world with 101.9 million cases and 1,103,681 fatalities.
The Centers for Disease Control and Prevention’s tracker shows that 229.5 million people living in the U.S., equal to 69.1% of the total population, are fully vaccinated, meaning they have had their primary shots.
So far, just 50.7 million Americans, equal to 15.3% of the overall population, have had the updated COVID booster that targets both the original virus and the omicron variants.
China has accused “some Western media” of bias and political manipulation in covering China’s abrupt dropping of COVID restrictions, which has led to a wave of new cases of the virus, the Associated Press reported.
An editorial in the Communist Party publication the People’s Daily outlined what it called China’s “optimization and control measures” and blasted reports by media outlets they didn’t identify as “completely biased hype, smear and political manipulation with ulterior motives.”
The news comes as the country braces for the Lunar New Year holiday, which starts Jan. 21, and typically sees people traveling all over the country to visit family.
Experts are concerned that this year’s holiday will become a spreader event, although the editorial stressed that may localities have “passed the peak of the epidemic, and production and life are speeding up to return to normal.”
China has rejected all criticism, foreign and domestic, of its zero-COVID policy and pushed back against World Health Organization calls for more information about the state of its outbreak. Unconfirmed estimates now put the number of new cases at tens of thousands a day, with up to 85% of the population in some provinces having become infected.
In the U.S., the seven-day average of new U.S. COVID cases stood at 54,015 on Wednesday, according to a New York Times tracker. That’s down 14% from two weeks ago and well below the recent peak of 70,508 on Christmas Eve.
The daily average for hospitalizations was down 16% at 39,473. The average for deaths was 482, up 6% from two weeks ago. The death rate appears to be steadying after climbing as much as 73% as recently as Tuesday.
The Times trackers posited that the spike in deaths had more to do with data anomalies in recent reporting, which tends to become distorted around holiday periods when hospitals and healthcare centers are more thinly staffed.
• A hoped-for boom in Chinese tourism in Asia over next week’s Lunar New Year holidays looks set to be more of a blip as most travelers are opting to stay inside China if they go anywhere, the AP reported. From the beaches of Bali to Hokkaido’s powdery ski slopes, the hordes of Chinese often seen in pre-COVID days will still be missing, tour operators say. It’s a bitter disappointment for many businesses that had been hoping lean pandemic times were over, although operators are expecting a return by late February, or early March.
Countries around the world are welcoming back Chinese tourists, once the largest source of tourism revenue globally. But even as China reopens its borders, the travel industry isn’t expecting things to bounce back to what they were just yet. Here’s why. Photo illustration: Adam Adada
• Hong Kong will no longer require people infected with COVID to quarantine from Jan. 30, removing one of the last major coronavirus restrictions in place in the Asian financial hub, Reuters reported. The scrapping of the isolation requirements is part of a decision to downgrade COVID-19’s status to an endemic disease from a severe respiratory disease and follows a similar move by China on Jan.8.
• Moderna MRNA, -2.09%
chief executive Stephane Bancel said his company was in active discussions to supply COVID vaccines to China, Reuters reported separately. Speaking to Reuters on the sidelines of the World Economic Forum annual meeting in Davos, he said the talks with Beijing also covered the topic of factories and other products including cancer treatments. “What I really want to understand is how do we help the Chinese government as to what are the needs they have from a healthcare standpoint,” he said.
The U.S. leads the world with 101.9 million cases and 1,102,286 fatalities.
The Centers for Disease Control and Prevention’s tracker shows that 229.4 million people living in the U.S., equal to 69.1% of the total population, are fully vaccinated, meaning they have had their primary shots.
So far, just 49.6 million Americans, equal to 15.9% of the overall population, have had the updated COVID booster that targets both the original virus and the omicron variants.
The World Health Organization has called on China to release more information about its current wave of COVID infections after China said nearly 60,000 people have succumbed to the virus since early December, the Associated Press reported.
The announcement “allows for a better understanding of the epidemiological situation,” said a WHO statement. Director-general, Tedros Adhanom Ghebreyesus talked by phone with Health Minister Ma Xiaowei, it said.
“WHO requested that this type of detailed information continued to be shared with us and the public,” the agency said.
The National Health Commission said only deaths in hospitals were counted, which means anyone who died at home is not part of the tally. It gave no indication of when or whether it might release updated numbers. China has seen a wave of cases ever since the government ended stringent restrictions on movement in December.
The WHO is now analyzing the data, which covers early December to Jan. 12. So far, the epidemiology is similar to what has been seen in other countries, “a rapid and intense wave of disease caused by known sub-variants of omicron with higher clinical impact on older people and those with underlying conditions,” said the statement.
The agency is hoping to get more information on the exact variants that are circulating. China has reported that two omicron sublineages, dubbed BA.5.2 and BF.7 are spreading but the WHO needs more sequences to be shared with open databases to get fully up to date.
Tens of thousands of people resumed travels in and out of China on Sunday as the country lifted almost all of its border restrictions, ending three years of strict pandemic controls. Some travelers expressed relief to be reunited with their families. Photo: Tyrone Siu/Reuters
In the U.S., the seven-day average of new U.S. COVID cases stood at 59,121 on Monday, according to a New York Times tracker. That’s flat from two weeks ago and below the recent peak of 70,508 on Christmas Eve.
The daily average for hospitalizations was down 8% at 45,052. The average for deaths stood at 562, up 78% from two weeks ago to continue the recent trend.
• The U.S. Centers for Disease Control and Prevention said its real-time surveillance system has met the statistical criteria to prompt additional investigation into whether there is a risk of ischemic stroke in people ages 65 and older who received the Pfizer/BioNTech PFE, -3.70%
BNTX, -1.28%
bivalent COVID vaccine. “Rapid-response investigation of the signal in the VSD (vaccine safety datalink) raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following vaccination,” the agency said in a statement. No such signal has been identified with the Moderna MRNA, -0.68%
bivalent vaccine, it added.
• Italian tennis player Camila Giorgi has denied allegations that she obtained a false COVID-19 vaccine certificate to allow her to travel, the AP reported. A doctor is under investigation in Italy for supplying false certificates and fake vaccines and Giorgi’s name was revealed in a long list of people implicated by an Italian newspaper. Giorgi is currently competing in the Australian Open.
Getting the flu can increase the risk of getting a second infection, including strep throat. WSJ’S Daniela Hernandez explains the science behind that, plus what it means for the rest of the winter and how we can protect ourselves from the tripledemic. Illustration: David Fang
• The New York State Department of Health is “exploring its options” after a state Supreme Court judge struck down a statewide mandate requiring healthcare workers to be vaccinated against COVID-19, the AP reported separately. Judge Gerard Neri wrote in a ruling released Friday that Democratic Gov. Kathy Hochul and the health department overstepped their authority by mandating a vaccine that’s not included in state public health law, the Syracuse Post-Standard reported. The mandate is “null, void, and of no effect,” the judge said. He sided with Medical Professionals for Informed Consent, a group of medical workers impacted by the vaccination mandate.
The U.S. leads the world with 101.7 million cases and 1,099,885 fatalities.
The Centers for Disease Control and Prevention’s tracker shows that 229.4 million people living in the U.S., equal to 69.1% of the total population, are fully vaccinated, meaning they have had their primary shots.
So far, just 49.6 million Americans, equal to 15.9% of the overall population, have had the updated COVID booster that targets both the original virus and the omicron variants.
