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Have you got itchy feet?
The U.S. economy added 236,000 jobs in March, just shy of the 238,000 forecast by economists polled by the Wall Street Journal. The unemployment rate declined to 3.5% in March from 3.6% in February.
The latest data was calculated before the collapse of Silicon Valley Bank and Signature Bank last month, an event that…
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Hong Kong
CNN
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China has approved its first Covid-19 vaccine based on mRNA technology, months after the country lifted strict pandemic measures.
The vaccine was developed by CSPC Pharmaceutical Group, a homegrown firm based in the northern Chinese city of Shijiazhuang, it said in a Wednesday statement to the Hong Kong stock exchange. The vaccine targets the Omicron variant and was tested in China with over 5,500 people, it added.
The approval comes just weeks after China declared a “major and decisive victory” in its handling of the coronavirus outbreak that swept the country in recent months following an abrupt relaxation of its “zero-Covid” policy late last year.
“This is a positive step because there is strong scientific evidence that mRNA vaccines do much better than non-MRA vaccines,” Jin Dong-yan, a professor in molecular virology at the University of Hong Kong, told CNN.
“Whether this product … is as good as other products on market is still to be determined.”
CSPC said in the statement the results had demonstrated the vaccine’s “safety, immunogenicity and efficacy,” but it didn’t offer additional details.
Until now, China has approved only inactivated vaccines made by Sinovac Biotech and Sinopharm Group, two Beijing-based drugmakers.
The inactivated vaccines have been found to elicit lower levels of antibody response compared to ones using the newer messenger RNA technology. Biotech firms Pfizer
(PFE) and Moderna
(MRNA) make rRNA vaccines.
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Hong Kong
CNN
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The collapse of Silicon Valley Bank (SVB), which courted Chinese start-ups, has caused widespread concern in China, where a string of founders and companies rushed to appease investors by saying their exposure was insignificant or nonexistent.
SVB, which worked with nearly half of all venture-backed tech and healthcare companies in the United States before it was taken over by the government, has a Chinese joint venture, which was set up in 2012 and targeted the country’s tech elite.
The SPD Silicon Valley Bank, which was owned 50-50 owned by SVB and local partner Shanghai Pudong Development Bank, said Saturday that its operations were “sound.”
“The bank has a standardized corporate governance structure and an independent balance sheet,” it said in a statement. “As China’s first technology bank, SPD Silicon Valley Bank is committed to serving Chinese science and technology companies, and has always had sound operations in accordance with Chinese laws and regulations.”
It’s unclear what will happen to SVB’s ownership of the joint venture.
SVB Financial Group, the parent company of SVB, also has two business consulting firms and one financial services firm in mainland China, according to corporate database Tianyancha.
Concerns about the failure of SVB have spread around the world, as investors fretted about the broader risks to the global banking sector and any potential spillover effect.
In an extraordinary move to restore confidence in America’s banking system, the Biden administration on Sunday guaranteed that customers of SVB and Signature Bank, which was closed by regulators, will have access to all their money.
That action appears to have appeased global markets, with US futures rallying in response and some Asian markets paring earlier losses.
In China, at least a dozen firms have issued statements since SVB collapsed trying to pacify investors or clients, saying that their exposure to the lender was limited. Most were biotech companies.
BeiGene, one of China’s largest cancer-focused drug companies, said Monday it had more than $175 million uninsured cash deposits at SVB, which represents approximately 3.9% of its cash, cash equivalents and short-term investments.
“The company does not expect the recent developments with SVB to significantly impact its operations,” it said.
Zai Lab, a pharmaceutical firm, announced that its cash deposits at SVB were “immaterial” at about $23 million.
The closure of SVB “will not have an impact” on the company’s ability to meet its operating expenses and capital expenditure requirements, including payroll, it said.
Other companies that publicly assured investors included Andon Health, Sirnaomics, Everest Medicines, Broncus Medical, Jacobio Pharmaceuticals, Brii Biosciences, CStone Pharmaceuticals, Genor Biopharma and CANbridge Pharmaceuticals.
Mobile ad tech firm Mobvista and wealth management firm Noah Holdings said their cash holdings at SVB were “minimal” or “immaterial.”
Popular selfie app Meitu said it hadn’t held any bank accounts at SVB since 2020. It issued a statement “to avoid any potential public misunderstanding.”
Ascletis Pharma, MicroPort NeuroTech, Antengene Corp, and Suzhou Basecare Medical Corporation also denied they had any deposits or business dealings with SVB.
Pan Shiyi, co-founder and former chairman of Soho China, a major Beijing-based property developer, denied he had any money at SVB after reports went viral on social media that he had lost billions of yuan.
“We never opened an account with Silicon Valley Bank, nor placed a deposit,” he said late Sunday on his Weibo account.
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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:
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.
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.
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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.
The Alzheimer’s Association, in a statement Wednesday, said it was “appalled” by CMS’ decision.
“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.
Join CNBC’s Healthy Returns on March 29th, where we’ll convene a virtual gathering of CEOs, scientists, investors and innovators in the health care space to reflect on the progress made today to reinvent the future of medicine. Plus, we’ll have an exclusive rundown of the best investment opportunities in biopharma, health-tech and managed care. Learn more and register today: http://bit.ly/3DUNbRo
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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.
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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.
Coronavirus update: MarketWatch’s daily roundup has been curating and reporting all the latest developments every weekday since the coronavirus pandemic began
Other COVID-19 news you should know about:
• 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,
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.
Here’s what the numbers say:
The global tally of confirmed COVID-19 cases topped 671.3 million on Monday, while the death toll rose above 6.83 million, according to data aggregated by Johns Hopkins University.
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.
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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 WHO is now prioritizing four omicron descendent lineages, including XBB.1.5, which is dominant in the U.S., according to data from the Centers for Disease Control and Prevention.
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.
Coronavirus update: MarketWatch’s daily roundup has been curating and reporting all the latest developments every weekday since the coronavirus pandemic began
Other COVID-19 news you should know about:
• Quest Diagnostics Inc.
DGX,
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.
Here’s what the numbers say:
The global tally of confirmed COVID-19 cases topped 671.1 million on Monday, while the death toll rose above 6.83 million, according to data aggregated by Johns Hopkins University.
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.
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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.
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The initial version of this story had incorrect price changes for 2023. It is now updated with information as of the market close on Jan. 31.
Investors staged a January rally, with solid gains for the S&P 500 and an even better showing for technology stocks that led the dismal downward action in 2022.
This…
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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…
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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.
That was the message Monday from WHO Director-General Tedros Adhanom Ghebreyesus at the agency’s annual executive board meeting. He said that the world is in a far better state today than it was a year ago, when the omicron wave was at its peak.
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.
Coronavirus update: MarketWatch’s daily roundup has been curating and reporting all the latest developments every weekday since the coronavirus pandemic began
Other COVID-19 news you should know about:
• 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.
• 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.
Here’s what the numbers say:
The global tally of confirmed COVID-19 cases topped 670.4 million on Monday, while the death toll rose above 6.82 million, according to data aggregated by Johns Hopkins University.
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.
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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.
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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,
or Moderna
MRNA,
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.
Coronavirus update: MarketWatch’s daily roundup has been curating and reporting all the latest developments every weekday since the coronavirus pandemic began
Other COVID-19 news you should know about:
• 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.”
• 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.
Here’s what the numbers say:
The global tally of confirmed COVID-19 cases topped 669.9 million Wednesday, while the death toll rose above 6.82 million, according to data aggregated by Johns Hopkins University.
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.
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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.
On…
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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.
The subvariant is pulling further ahead of BQ.1.1 and BQ.1, the former dominant strains of the coronavirus that causes COVID, according to the data from the Centers for Disease Control and Prevention.
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.
Coronavirus Update: MarketWatch’s daily roundup has been curating and reporting all the latest developments every weekday since the coronavirus pandemic began
Other COVID-19 news you should know about:
• 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.
Read also: Moderna is the latest company to produce a promising RSV vaccine
• 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.
• CureVac’s
CVAC,
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.
Here’s what the numbers say:
The global tally of confirmed cases of COVID-19 topped 668.3 million on Thursday, while the death toll rose above 6.73 million, according to data aggregated by Johns Hopkins University.
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.
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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.
Coronavirus Update: MarketWatch’s daily roundup has been curating and reporting all the latest developments every weekday since the coronavirus pandemic began
Other COVID-19 news you should know about:
• 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.
• 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,
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.
Here’s what the numbers say:
The global tally of confirmed cases of COVID-19 topped 668 million on Thursday, while the death toll rose above 6.73 million, according to data aggregated by Johns Hopkins University.
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.
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Steve Weiss, chief investment officer and managing partner of Short Hills Capital Partners LLC, joins ‘Closing Bell Overtime’ to discuss Goldman Sachs’ earnings miss, the environmental factors impacting the company’s margins and Moderna’s RSV vaccine news.
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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 of fatality numbers on Saturday came after weeks of complaints that China was not keeping experts abreast of what was happening.
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.
See also: China reports first population drop in decades as birthrates plunge
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.
Coronavirus Update: MarketWatch’s daily roundup has been curating and reporting all the latest developments every weekday since the coronavirus pandemic began
Other COVID-19 news you should know about:
• 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,
BNTX,
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,
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.
• 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.
Here’s what the numbers say:
The global tally of confirmed cases of COVID-19 topped 667.3 million on Tuesday, while the death toll rose above 6.7 million, according to data aggregated by Johns Hopkins University.
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.
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Nearly two years after biotechnology stocks began to tumble, executives at small and midsize companies in the space are finally accepting that share prices aren’t bouncing back anytime soon.
With reality setting in, it’s a buyer’s market for companies looking for acquisitions and partnerships, according to many of the pharmaceutical and medical technology executives who gathered at this year’s
J.P. Morgan
healthcare investor conference, which wrapped up in San Francisco on Thursday.
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