WHO: New coronavirus variant seen only sporadically in Germany
The variant, known as NB.1.8.1, was first detected in January and has been classified by the WHO as a "variant under monitoring."
In Germany, the variant was first detected at the end of March and has so far only appeared sporadically, according to the country's public health agency, the Robert Koch Institute (RKI).
"No trend can be derived here; current Covid case numbers are low, and correspondingly less sequencing is being conducted," the institute stated.
University of Basel biophysicist Richard Neher said whether this variant "will establish itself [in Germany] depends on how other variants evolve. It is quite possible that NB.1.8.1 will prevail, but it is likely to be relatively insignificant."
In the most recent reporting week, which ended on June 8, the RKI recorded 698 Covid cases - a slight increase - but the institute noted this is off a very low base. Many infections are likely going undetected due to limited testing.
Slight increase in virus load in wastewater
Wastewater monitoring also showed a slight increase in SARS-CoV-2 levels over the past four weeks – albeit still at a low level.
The new NB.1.8.1 strain is derived from the XDV.1.5 lineage dominant in East Asia, according to biophysicist Neher.
The state-run Chinese news agency Xinhua, citing the National Administration of Disease Control and Prevention, reported that the new strain had become China's dominant variant by the end of May.
"The variant is increasing in frequency compared to other variants," Neher noted. NB.1.8.1 is therefore more transmissible in the sense that an infection generates more secondary infections than other strains.
No evidence of more severe cases
There is no evidence that NB.1.8.1 causes more severe illness, Chinese authorities have said. This aligns with the WHO's assessment that, despite rising case and hospitalization numbers in countries where the variant is widespread, there is currently no indication that it causes more serious illness than other circulating variants.
Covid-19 vaccines currently approved are expected to protect against severe illness caused by NB.1.8.1, the WHO said.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
40 minutes ago
- Business Wire
FDA Grants Priority Review for WINREVAIR™ (sotatercept-csrk) to Update Label Based on Results From ZENITH Trial
RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval to update the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk). In 2024, WINREVAIR was approved for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 PH) to increase exercise capacity, improve WHO* functional class (FC), and reduce the risk of clinical worsening events. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of Oct. 25, 2025. The sBLA is based on data from the Phase 3 ZENITH trial. The ZENITH trial was the first PAH Phase 3 outcome study to use a primary endpoint comprised entirely of major morbidity and mortality events. It was also the first PAH Phase 3 study stopped early by an independent data monitoring committee for overwhelming efficacy. In ZENITH, WINREVAIR demonstrated a 76% reduction in the risk of a composite of all-cause death, lung transplantation, and hospitalization for PAH ≥24 hours compared to placebo. Improvement was observed early in treatment with increasing benefit throughout the study. The safety profile of WINREVAIR in ZENITH was generally consistent with that observed in previous studies. These results were published in the New England Journal of Medicine. 'We are pleased that the FDA has accepted our sBLA for WINREVAIR and granted a priority review to consider an update to labeling for WINREVAIR to include the impressive results of ZENITH. There remains a significant unmet medical need for patients living with PAH who, despite being on background therapy, remain at higher risk of morbidity and mortality,' said Dr. Joerg Koglin, senior vice president, global clinical development, Merck Research Laboratories. 'The FDA's Priority Review designation acceptance of our sBLA reinforces our confidence in WINREVAIR for a broad range of patients and represents a critical step toward advancing the treatment of PAH.' WINREVAIR is currently approved in more than 45 countries based on the results from the STELLAR trial. *World Health Organization About ZENITH The ZENITH study (NCT04896008) is a global, double-blind, placebo-controlled clinical trial to evaluate WINREVAIR when added to maximum tolerated background PAH therapy on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours, in adult participants with WHO functional class III or IV PAH at high risk of mortality. ZENITH study inclusion criteria required Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 risk score of ≥9. The study enrolled 172 participants, who were randomized in a 1:1 ratio to either WINREVAIR plus background PAH therapy or placebo plus background PAH therapy. The primary composite outcome measure was time to first confirmed major morbidity or mortality event. Events were defined as all-cause death, lung transplantation, or PAH worsening-related hospitalization of ≥ 24 hours. Secondary outcome measures included overall survival, transplant-free survival and several additional measures. The study excluded patients with PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension as well as diagnosis of pulmonary veno-occlusive diseases, pulmonary capillary hemangiomatosis or overt signs of capillary and/or venous involvement. Participants who completed the ZENITH trial were offered the opportunity to receive WINREVAIR as part of the open-label, long-term extension study, SOTERIA (NCT04796337), consistent with that study's eligibility criteria. About WINREVAIR ™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics. WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb. Selected Safety Information for WINREVAIR in the U.S. WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required. WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm 3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required. In clinical studies, serious bleeding (eg, gastrointestinal, intracranial hemorrhage) was reported in 4% of patients taking WINREVAIR and 1% of patients taking placebo. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR if the patient is experiencing serious bleeding. WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment. Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility. The most common adverse reactions occurring in the phase 3 clinical trial (≥10% for WINREVAIR and at least 5% more than placebo) were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.2%), and erythema (13.5% vs 3.1%). Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose. About PAH Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Approximately 40,000 people in the U.S. are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( Patient Information for WINREVAIR at , and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit) at
Miami Herald
an hour ago
- Miami Herald
Feds arrest scores in $14 billion Medicare/Medicaid fraud. South Florida high on list
As always, the numbers boggle the mind. The Justice Department on Monday unveiled new healthcare fraud charges against 324 defendants nationwide, including 37 in South Florida, who were recently arrested as part of the government's annual take-down initiative. Overall, Justice Department officials said 96 doctors, nurses and pharmacists were among those arrested across all 50 states. Authorities said the defendants submitted more than $14.6 billion in falsified bills to the federal Medicare and Medicaid programs as well as to private insurers, describing the magnitude of fraud as the 'largest' in U.S. history — more than double the prior record of $6 billion. The alleged schemes, fueled by stolen identities, financial kickbacks and fabricated bills, continue to plague the medical equipment, genetic testing and painkiller sectors, among others. READ MORE: Kendall companies and doctors pay $810,000 to settle Medicare fraud charges In a statement, Attorney General Pam Bondi described the array of defendants as 'criminal actors who prey upon our most vulnerable citizens and steal from hardworking American taxpayers.' Agents with the FBI and Health and Human Services seized more than $245 million in cash, luxury vehicles, cryptocurrency and other assets nationwide, authorities said during a news conference in Washington on Monday. But while that number may seem huge, it pales next to the government's losses to healthcare fraud every year, according to experts. South Florida, often described as the capital of fraud, continues to be among the hardest-hit regions in the country. For all of its resources committed to fighting the schemes, including data analytics, the federal Medicare and Medicaid programs for the elderly and indigent continue to lose untold sums to fraud, waste and abuse because they routinely pay bills quickly — leaving law enforcement to chase after offenders who cheat the system after payments land in their pockets. Authorities say the Centers for Medicare and Medicaid Services has reduced the rate of 'improper payments' — a combination of 'fraud, waste and abuse' — to 7.46% for the 2022 fiscal year compared with 9.51% in fiscal year 2017, the latest comparisons available. But the federal agency has never publicly disclosed the total amount of improper payments that should not have been made or were made in the wrong amount. Experts estimate that CMS, with an annual budget of $850 billion funded with payroll taxes, loses tens of billions yearly as a result of improper payments. Here are a few South Florida cases filed by the U.S. Attorney's Office in Miami during the national take-down: ▪ Dave Sudarshan Singh, 37, of Pembroke Pines, was charged on Thursday with conspiracy to commit healthcare and money laundering for submitting false claims to Medicare for over-the-counter COVID-19 tests — tests that beneficiaries, including some who were deceased, had not requested. An indictment accused Singh and others of using his business, MDP Products and Services, Inc., to file over $14.1 million in bogus claims to Medicare between 2022 and 2023. Medicare, in turn, paid Singh's business about $13 million for the over-the-counter tests, which did not qualify for reimbursements, prosecutors said. His arraignment is pending. ▪ Lazaro Delgado, 59, of Miami, was charged last week with conspiracy to commit health care fraud, alleging he and others submitted false Medicare and Medicaid bills for orthotic braces on behalf of unsuspecting beneficiaries. Prosecutors said Delgado acted as an intermediary to place a nominal owner as the head of Hucel Custom Med Inc., while other co-conspirators coordinated the phony claims for durable medical equipment products that the beneficiaries did not need. In 2022, Hucel fraudulently billed Medicare/Medicaid for about $9 million worth of orthotic braces and received government reimbursements of $1.8 million. His arraignment is pending. ▪ Marlen Veliz Rios, 58, of Hialeah, owner of Loves Community Health Mental Health Inc., was charged last week with health care fraud and conspiracy to commit money laundering. An indictment accused Veliz Rios of scheming with others to bill more than $15.3 million worth of wound care and skin graft products on behalf of Medicare beneficiaries who never did not need them or receive them. As a result, Medicare paid her company about $10 million. Further, the indictment accused Veliz Rios of transferring the money from Loves' bank account to shell companies under her control and then to others in the alleged laundering scheme. As part of the probe, federal agents have seized $4.6 million from her various accounts, prosecutors said. Her arraignment is pending.
Axios
an hour ago
- Axios
Moderna's flu-COVID combo shot will test RFK Jr.'s vaccine regulators
Moderna is preparing to test Health Secretary Robert F. Kennedy Jr.'s tougher vaccine policies with a combination flu-COVID shot. The question is whether it gets approved for both viruses. Why it matters: The company this week reported positive late-stage safety and efficacy results for a flu shot called mRNA-1010 that would provide the basis for the combo jab. That poses a quandary for regulators, who could treat it like another seasonal flu shot for the general population or apply heightened scrutiny and require additional studies, the way they've done for new COVID boosters. What they're saying: Moderna indicated it would cover its bets and pursue a dual track for approval after showing the flu shot jab was 26.6% more effective than a standard-dose flu vaccine in adults 50 and older. "We will engage with regulators on next steps, both as a potential standalone flu product and for ... our flu/COVID combination vaccine candidate," a Moderna spokesperson said in an email. The intrigue: Food and Drug Administration commissioner Marty Makary and his top vaccine regulator, Vinay Prasad, have said flu shots should be widely recommended for all age groups. But they've limited COVID vaccine to certain age groups or high-risk individuals. Top Health and Human Services officials have cast serious suspicions on mRNA platforms like Moderna's; Prasad has even suggested COVID vaccine risks may outweigh benefits in low-risk populations, Endpoints reported. Moderna has already run afoul of the new vaccine regime. HHS in May canceled a nearly $600 million award to the company to develop an mRNA vaccine for bird flu in humans, killing one of the Biden administration's final pandemic preparedness efforts. Zoom in: Financial analysts say the combo jab will yield important clues about how the FDA will handle such vaccines. Wall Street is less interested in the flu shot alone than the combination vaccine and how it ultimately gets treated by regulators, Mani Foroohar of Leerink Partners told Axios. "Will this combo be a real opportunity? How will that opportunity play out in a less forgiving regulatory environment?" he said. "And how will that play out in an environment where you have certainly senior leadership at HHS, plausibly at [the Centers for Disease Control and Prevention] ... which is quite skeptical on the value and differentiation of mRNA vaccines writ large?" Between the lines: Analysts said they expect both products will be available for the 2027 respiratory illness season. "That said, we acknowledge ongoing vaccine policy-related uncertainty via HHS/[the Advisory Committee on Immunization Practices]," Goldman Sachs wrote in a note. Earlier this year, the FDA stipulated it would require additional placebo-controlled studies before it approves mRNA vaccines in younger, healthier individuals. "This is specifically written for COVID-19 vaccines, but it remains to be seen how far-reaching to other vaccine targets this guidance framework will be," William Blair wrote in an analyst note. What to watch: This is not just a Washington parlor game. Moderna's facing headwinds after slashing its projected sales earlier this year. It's also facing uncertainty around the future of its closely watched cytomegalovirus, or CMV, vaccine.
