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Ishita Roy

FDA Greenlights Nucala as New Treatment for COPD

FDA approves Nucala as add-on therapy for COPD with high eosinophils, offering new hope by reducing flare-ups in patients unresponsive to inhaled treatments.

The U.S. Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) that remains inadequately controlled despite existing therapies. The approval offers new hope to patients whose symptoms persist despite being on inhaled triple therapy.

According to the World Health Organization (WHO), COPD is a common, preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities. It typically results from significant exposure to noxious particles or gases.

<ul><li>Chronic cough</li><li>Shortness of breath</li><li>Wheezing</li><li>Chest tightness</li><li>Excess mucus production</li></ul>

Causes of COPD range from long-term smoking and air pollution exposure to occupational dusts and fumes. Genetics and respiratory infections in early life can also contribute.

COPD is progressive and often worsens over time, severely impacting quality of life. One of the most critical challenges in managing the condition is reducing exacerbations—flare-ups that may require hospitalization or emergency treatment.

Nucala is the only approved biologic that has been specifically studied in COPD patients with an eosinophilic phenotype defined by a blood eosinophil count (BEC) of ≥150 cells/μL. This is important because up to 70% of U.S. COPD patients who are not adequately managed on inhaled triple therapy fall into this category.

Biologics like Nucala work by targeting specific pathways in the immune system. Mepolizumab, the active ingredient in Nucala, is an anti-IL-5 monoclonal antibody that reduces eosinophilic inflammation—a key contributor to COPD exacerbations in certain patients.

The FDA’s approval of Nucala is based on results from two large Phase 3 clinical trials, MATINEE and METREX, which evaluated its use alongside optimal inhaled therapy. Both were randomized, double-blind, and placebo-controlled.

In the MATINEE trial, involving 804 patients with a BEC ≥300 cells/μL, Nucala showed:

A significant reduction in moderate or severe exacerbations: 0.80 vs 1.01 events/year (rate ratio, 0.79).

A 35% decrease in emergency visits or hospitalizations for COPD exacerbations (rate ratio, 0.65).

The METREX trial produced similar outcomes. Patients on Nucala had:

Fewer moderate or severe exacerbations: 1.40 vs 1.71 events/year (rate ratio, 0.82).

Adverse events were comparable between the Nucala and placebo groups, suggesting a favorable safety profile.

“COPD isn't just a disease, it's a relentless cycle,” said Dr. Jean Wright, CEO of the COPD Foundation. “Even with current therapies, managing exacerbations remains a daily battle. Biologics like mepolizumab offer new hope.”

The FDA approval was granted to GSK, the pharmaceutical company that developed Nucala. With this decision, clinicians now have a novel option for patients with eosinophilic COPD who are still struggling despite standard treatment.

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The U.S. Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) that remains inadequately controlled despite existing therapies. The approval offers new hope to patients whose symptoms persist despite being on inhaled triple therapy.What is COPD?According to the World Health Organization (WHO), COPD is a common, preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities. It typically results from significant exposure to noxious particles or gases.Symptoms of COPD include:Chronic coughShortness of breathWheezingChest tightnessExcess mucus productionCauses of COPD range from long-term smoking and air pollution exposure to occupational dusts and fumes. Genetics and respiratory infections in early life can also contribute.COPD is progressive and often worsens over time, severely impacting quality of life. One of the most critical challenges in managing the condition is reducing exacerbations—flare-ups that may require hospitalization or emergency treatment.Why Nucala MattersNucala is the only approved biologic that has been specifically studied in COPD patients with an eosinophilic phenotype defined by a blood eosinophil count (BEC) of ≥150 cells/μL. This is important because up to 70% of U.S. COPD patients who are not adequately managed on inhaled triple therapy fall into this category.Biologics like Nucala work by targeting specific pathways in the immune system. Mepolizumab, the active ingredient in Nucala, is an anti-IL-5 monoclonal antibody that reduces eosinophilic inflammation—a key contributor to COPD exacerbations in certain patients.Clinical Trial EvidenceThe FDA’s approval of Nucala is based on results from two large Phase 3 clinical trials, MATINEE and METREX, which evaluated its use alongside optimal inhaled therapy. Both were randomized, double-blind, and placebo-controlled.In the MATINEE trial, involving 804 patients with a BEC ≥300 cells/μL, Nucala showed:A significant reduction in moderate or severe exacerbations: 0.80 vs 1.01 events/year (rate ratio, 0.79).A 35% decrease in emergency visits or hospitalizations for COPD exacerbations (rate ratio, 0.65).The METREX trial produced similar outcomes. Patients on Nucala had:Fewer moderate or severe exacerbations: 1.40 vs 1.71 events/year (rate ratio, 0.82).Adverse events were comparable between the Nucala and placebo groups, suggesting a favorable safety profile.A New Era for COPD Management“COPD isn't just a disease, it's a relentless cycle,” said Dr. Jean Wright, CEO of the COPD Foundation. “Even with current therapies, managing exacerbations remains a daily battle. Biologics like mepolizumab offer new hope.”The FDA approval was granted to GSK, the pharmaceutical company that developed Nucala. With this decision, clinicians now have a novel option for patients with eosinophilic COPD who are still struggling despite standard treatment.

fda greenlights nucala as new treatment for copd

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New Delhi is witnessing a modest increase in COVID-19 cases, with 23 active infections reported as of May 22, Health Minister Dr. Pankaj Singh confirmed on Friday. Emphasizing that there is no reason to panic, Singh said all patients are currently stable. “Two to three patients are admitted to private hospitals while the others are being monitored. We will verify if these patients are residents of Delhi or from outside. The strain is similar to influenza,” he noted.

The minister also reassured the public about the state’s preparedness. “We’ve had conversations with medical superintendents. Eight senior officials are visiting hospitals daily to ensure everything is in order. Our hospitals are equipped with oxygen, oximeters, and essential medical supplies,” Singh added.

In line with this, the Delhi health department has instructed all private and government hospitals to ensure the availability of beds, oxygen, essential medicines, and vaccines. An advisory will be issued shortly to provide further guidance.

<h4>Omicron Sub-Variants Fuel Regional and Global Spike</h4>

The rise in COVID-19 cases in Delhi and other Indian states comes after a spike was observed in several Asian countries. Health authorities have attributed the increase to Omicron-related sub-variants—primarily LF.7 and NB.1.8—descendants of the JN.1 variant, which in turn evolved from the BA.2.86 (Pirola) strain.

These sub-lineages are known for their high transmissibility but relatively mild symptoms. Despite the rise, experts maintain that the current wave is manageable and no immediate threat of severe disease has been identified.

In an internal order, Delhi’s health department directed all hospitals to ensure critical equipment like ventilators, BiPAP machines, and oxygen concentrators are functional. Staff are being asked to undergo refresher training, and all hospitals must report Influenza-like Illness (ILI) and Severe Acute Respiratory Illness (SARI) cases daily on the Integrated Health Information Platform (IHIP).

Additionally, 5% of ILI cases and 100% of SARI cases must undergo COVID-19 testing, in accordance with ICMR guidelines. Positive samples are to be sent to Lok Nayak Hospital for genome sequencing to detect any emerging variants.

<h4>Neighboring States And Others Also Report Mild Cases</h4>

Haryana: Two mild COVID-19 cases were reported in Gurgaon—a 62-year-old man and a 31-year-old woman who had recently travelled from Mumbai. Both are in home isolation. Meanwhile, a 28-year-old security guard from Faridabad tested positive at Delhi’s Safdarjung Hospital. None had a travel history abroad or known contact with infected persons. Health officials emphasized that these are isolated, mild cases and do not indicate a severe outbreak.

Maharashtra: The state has reported 95 new COVID-19 cases in Mumbai this month, with a total of 106 since January. At least 16 patients are hospitalized, mostly shifted to Seven Hills Hospital from KEM Hospital. Pune, although not reporting any active cases currently, has reserved 50 beds at Naidu Hospital as a precautionary step.

Tamil Nadu: In Chennai and Puducherry, health officials are seeing a shift in viral diagnosis, where fevers initially linked to influenza are now being identified as COVID-19. Public Health Director Dr. TS Selvavinayagam has urged caution in crowded places but reassured the public not to panic.

Karnataka: The state currently has 16 active COVID-19 cases, confirmed by Health Minister Dinesh Gundu Rao.

Gujarat: Seven new cases were reported in Ahmedabad in a single day—a sharp spike for a city that has averaged one case per month over the past year. All patients are in home isolation, and their samples have been sent for genomic sequencing. Officials say the infections are from the JN.1 variant and are mild in nature.

Singapore and Hong Kong are witnessing a noticeable surge in COVID-19 cases, primarily driven by LF.7 and NB.1.8 sub-variants. Singapore’s Ministry of Health has urged citizens to get vaccinated, especially those who haven’t received their initial doses. Hong Kong has reached its highest case numbers in over a year and is encouraging mask-wearing and crowd avoidance.

Unlike earlier variants, the current wave presents some slightly different symptoms. While cough and sore throat remain common, additional symptoms include nausea, vomiting, brain fog, and conjunctivitis. Most cases are mild, but health authorities advise individuals to monitor symptoms and seek medical attention if needed.

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New Delhi is witnessing a modest increase in COVID-19 cases, with 23 active infections reported as of May 22, Health Minister Dr. Pankaj Singh confirmed on Friday. Emphasizing that there is no reason to panic, Singh said all patients are currently stable. “Two to three patients are admitted to private hospitals while the others are being monitored. We will verify if these patients are residents of Delhi or from outside. The strain is similar to influenza,” he noted.The minister also reassured the public about the state’s preparedness. “We’ve had conversations with medical superintendents. Eight senior officials are visiting hospitals daily to ensure everything is in order. Our hospitals are equipped with oxygen, oximeters, and essential medical supplies,” Singh added.In line with this, the Delhi health department has instructed all private and government hospitals to ensure the availability of beds, oxygen, essential medicines, and vaccines. An advisory will be issued shortly to provide further guidance.Omicron Sub-Variants Fuel Regional and Global SpikeThe rise in COVID-19 cases in Delhi and other Indian states comes after a spike was observed in several Asian countries. Health authorities have attributed the increase to Omicron-related sub-variants—primarily LF.7 and NB.1.8—descendants of the JN.1 variant, which in turn evolved from the BA.2.86 (Pirola) strain.These sub-lineages are known for their high transmissibility but relatively mild symptoms. Despite the rise, experts maintain that the current wave is manageable and no immediate threat of severe disease has been identified.Advisory To HospitalsIn an internal order, Delhi’s health department directed all hospitals to ensure critical equipment like ventilators, BiPAP machines, and oxygen concentrators are functional. Staff are being asked to undergo refresher training, and all hospitals must report Influenza-like Illness (ILI) and Severe Acute Respiratory Illness (SARI) cases daily on the Integrated Health Information Platform (IHIP).Additionally, 5% of ILI cases and 100% of SARI cases must undergo COVID-19 testing, in accordance with ICMR guidelines. Positive samples are to be sent to Lok Nayak Hospital for genome sequencing to detect any emerging variants.Neighboring States And Others Also Report Mild CasesHaryana: Two mild COVID-19 cases were reported in Gurgaon—a 62-year-old man and a 31-year-old woman who had recently travelled from Mumbai. Both are in home isolation. Meanwhile, a 28-year-old security guard from Faridabad tested positive at Delhi’s Safdarjung Hospital. None had a travel history abroad or known contact with infected persons. Health officials emphasized that these are isolated, mild cases and do not indicate a severe outbreak.Maharashtra: The state has reported 95 new COVID-19 cases in Mumbai this month, with a total of 106 since January. At least 16 patients are hospitalized, mostly shifted to Seven Hills Hospital from KEM Hospital. Pune, although not reporting any active cases currently, has reserved 50 beds at Naidu Hospital as a precautionary step.Tamil Nadu: In Chennai and Puducherry, health officials are seeing a shift in viral diagnosis, where fevers initially linked to influenza are now being identified as COVID-19. Public Health Director Dr. TS Selvavinayagam has urged caution in crowded places but reassured the public not to panic.Karnataka: The state currently has 16 active COVID-19 cases, confirmed by Health Minister Dinesh Gundu Rao.Gujarat: Seven new cases were reported in Ahmedabad in a single day—a sharp spike for a city that has averaged one case per month over the past year. All patients are in home isolation, and their samples have been sent for genomic sequencing. Officials say the infections are from the JN.1 variant and are mild in nature.International SpikeSingapore and Hong Kong are witnessing a noticeable surge in COVID-19 cases, primarily driven by LF.7 and NB.1.8 sub-variants. Singapore’s Ministry of Health has urged citizens to get vaccinated, especially those who haven’t received their initial doses. Hong Kong has reached its highest case numbers in over a year and is encouraging mask-wearing and crowd avoidance.What Are the Current Symptoms?Unlike earlier variants, the current wave presents some slightly different symptoms. While cough and sore throat remain common, additional symptoms include nausea, vomiting, brain fog, and conjunctivitis. Most cases are mild, but health authorities advise individuals to monitor symptoms and seek medical attention if needed.

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Baby Food Pouches Recalled Due To Elevated Lead Levels

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While in the cases of listeria and other food-related diseases, products are recalled. In another news, supermarket chain Publix has issued a recall for its Greenwise Pear, Kiwi, Spinach &amp; Pea Baby Food pouches after routine product testing detected elevated levels of lead, federal health officials announced. The affected items were sold across eight states in more than 1,400 Publix stores.

The 4-ounce baby food pouches, manufactured by Bowman Andros—a French company with a production facility in Mount Jackson, Virginia—were voluntarily recalled by Publix on May 9. However, the recall wasn’t listed on the U.S. Food and Drug Administration (FDA) website until late Thursday.

Testing by North Carolina officials—the same team that first discovered a widespread 2023 lead contamination in applesauce pouches—detected 13.4 parts per billion (ppb) of lead in the product. This exceeds the FDA's recommended limit of 10 ppb for food consumed by infants and young children.

While no health issues have been reported in connection with this product, Publix has removed all possibly contaminated pouches from store shelves. Customers are encouraged to return them for a full refund.

This is the second recall in two months involving baby food pouches due to lead contamination. In March, Target recalled over 25,000 units of its Good &amp; Gather Baby Pea, Zucchini, Kale &amp; Thyme Vegetable Puree for the same reason.

North Carolina continues to partner with the FDA to conduct routine food safety testing. The state played a key role in the 2023 lead poisoning investigation involving WanaBana Apple Cinnamon Fruit Puree, which was linked to over 500 cases of illness across 44 states. Those pouches contained lead levels up to 2,000 times the FDA’s safety limit and were found to contain chromium as well.

The Centers for Disease Control and Prevention (CDC) led the response during that outbreak, identifying 566 confirmed, probable, or suspected cases. However, the CDC’s childhood lead poisoning prevention program was cut in April during federal budget reductions under the Trump administration. A CDC spokesperson confirmed the agency is aware of the Publix recall but has not been asked to investigate.

According to the CDC, no level of lead exposure is safe, especially for children. Lead can cause serious neurological and developmental damage, including learning disabilities and delayed growth.

The American Academy of Pediatrics notes that heavy metals like lead can enter food through soil, water, air, or industrial contamination, making rigorous safety checks critical for baby food products.

Recently, to ensure that baby foods are produced ensuring the safety procedures, the US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) have now begun a comprehensive review of the nutritional value of infant formula. This program by the agencies is dubbed as Operation Stork Speed.

This operation aims to review the nutrient content of infant formula. How will it be done? The agencies will increase testing for heavy metals and contaminants in the formula. The agencies will also encourage companies to develop new formulas, and clarify ways to better inform consumers about their ingredients.

The individual nutrient requirements for infant formula are already reviewed at regular intervals, however, this will be the first comprehensive review since 1998.

As part of Operation Stork Speed, the FDA has issued a Request for Information (RFI) to solicit public input on the nutritional composition of infant formula. 

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While in the cases of listeria and other food-related diseases, products are recalled. In another news, supermarket chain Publix has issued a recall for its Greenwise Pear, Kiwi, Spinach & Pea Baby Food pouches after routine product testing detected elevated levels of lead, federal health officials announced. The affected items were sold across eight states in more than 1,400 Publix stores.What Prompted the Recall?The 4-ounce baby food pouches, manufactured by Bowman Andros—a French company with a production facility in Mount Jackson, Virginia—were voluntarily recalled by Publix on May 9. However, the recall wasn’t listed on the U.S. Food and Drug Administration (FDA) website until late Thursday.Testing by North Carolina officials—the same team that first discovered a widespread 2023 lead contamination in applesauce pouches—detected 13.4 parts per billion (ppb) of lead in the product. This exceeds the FDA's recommended limit of 10 ppb for food consumed by infants and young children.No Reported Illnesses YetWhile no health issues have been reported in connection with this product, Publix has removed all possibly contaminated pouches from store shelves. Customers are encouraged to return them for a full refund.This is the second recall in two months involving baby food pouches due to lead contamination. In March, Target recalled over 25,000 units of its Good & Gather Baby Pea, Zucchini, Kale & Thyme Vegetable Puree for the same reason.A Wider ConcernNorth Carolina continues to partner with the FDA to conduct routine food safety testing. The state played a key role in the 2023 lead poisoning investigation involving WanaBana Apple Cinnamon Fruit Puree, which was linked to over 500 cases of illness across 44 states. Those pouches contained lead levels up to 2,000 times the FDA’s safety limit and were found to contain chromium as well.The Centers for Disease Control and Prevention (CDC) led the response during that outbreak, identifying 566 confirmed, probable, or suspected cases. However, the CDC’s childhood lead poisoning prevention program was cut in April during federal budget reductions under the Trump administration. A CDC spokesperson confirmed the agency is aware of the Publix recall but has not been asked to investigate.Why Lead Is DangerousAccording to the CDC, no level of lead exposure is safe, especially for children. Lead can cause serious neurological and developmental damage, including learning disabilities and delayed growth.The American Academy of Pediatrics notes that heavy metals like lead can enter food through soil, water, air, or industrial contamination, making rigorous safety checks critical for baby food products.Recently, to ensure that baby foods are produced ensuring the safety procedures, the US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) have now begun a comprehensive review of the nutritional value of infant formula. This program by the agencies is dubbed as Operation Stork Speed.This operation aims to review the nutrient content of infant formula. How will it be done? The agencies will increase testing for heavy metals and contaminants in the formula. The agencies will also encourage companies to develop new formulas, and clarify ways to better inform consumers about their ingredients.The individual nutrient requirements for infant formula are already reviewed at regular intervals, however, this will be the first comprehensive review since 1998.As part of Operation Stork Speed, the FDA has issued a Request for Information (RFI) to solicit public input on the nutritional composition of infant formula. 

baby food pouches recalled due to elevated lead levels

Riya Baibhawi

New COVID-19 variant known as NB.1.8.1 is drawing global attention, particularly among public health officials in the United States. Although this variant has been circulating in the US since late March, there is currently no indication of a significant increase in infections. This comes as there has been a resurgence of coronavirus across the world.

According to the most recent data, the positivity rate for COVID swabs, which reflects the proportion of tests returning positive, has actually declined by 12 per cent in the latest week of available figures. This decline suggests that while the new variant is present, it has not triggered a broader surge in cases.

The US Centres for Disease Control and Prevention (CDC) receives data on emerging variants through a traveler-based surveillance program at select airports. Operated in partnership with biotechnology firm Ginkgo Bioworks, the initiative allows international travellers to voluntarily provide nasal swabs and complete a brief health survey. The samples are then screened for a range of infectious diseases, including Covid-19.

Between April 22 and May 12, several cases of the NB.1.8.1 variant were identified through this program. Although the numbers remain low, experts are keeping a close watch on the strain due to its rapid spread in parts of Asia and its growing dominance in China.

Taiwan is one country seeing a marked impact from the variant. The island recently reported over 19,000 healthcare visits for COVID-related symptoms in a single week. Local health authorities confirmed that NB.1.8.1 is now the dominant strain circulating in the country. Early laboratory studies from China suggest that the NB.1.8.1 variant may have enhanced ability to bind to human cells, which could potentially make it more infectious than previous strains.

Public health officials in Hong Kong have responded to the variant's emergence by advising high-risk individuals to wear masks in public places and urging all residents to use face coverings while on public transportation or in crowded areas.

In the US, the Food and Drug Administration (FDA) recently convened a meeting to assess potential updates to COVID-19 vaccines. While the current vaccines are designed to protect against the JN.1 variant and its offshoots, NB.1.8.1 was discussed during the session due to its international spread and evolving characteristics.

The dominant variant in the US remains LP.8.1, a descendant of JN.1. However, only one strain — known as XFC — has shown noticeable growth in the country so far, according to updates shared by the CDC and FDA during the meeting. Although NB.1.8.1 has yet to cause widespread concern domestically, health experts continue to monitor its trajectory. Vigilance remains key, particularly as global travel increases and variants can quickly cross borders. 

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New COVID-19 variant known as NB.1.8.1 is drawing global attention, particularly among public health officials in the United States. Although this variant has been circulating in the US since late March, there is currently no indication of a significant increase in infections. This comes as there has been a resurgence of coronavirus across the world. According to the most recent data, the positivity rate for COVID swabs, which reflects the proportion of tests returning positive, has actually declined by 12 per cent in the latest week of available figures. This decline suggests that while the new variant is present, it has not triggered a broader surge in cases.The US Centres for Disease Control and Prevention (CDC) receives data on emerging variants through a traveler-based surveillance program at select airports. Operated in partnership with biotechnology firm Ginkgo Bioworks, the initiative allows international travellers to voluntarily provide nasal swabs and complete a brief health survey. The samples are then screened for a range of infectious diseases, including Covid-19.Between April 22 and May 12, several cases of the NB.1.8.1 variant were identified through this program. Although the numbers remain low, experts are keeping a close watch on the strain due to its rapid spread in parts of Asia and its growing dominance in China.Taiwan is one country seeing a marked impact from the variant. The island recently reported over 19,000 healthcare visits for COVID-related symptoms in a single week. Local health authorities confirmed that NB.1.8.1 is now the dominant strain circulating in the country. Early laboratory studies from China suggest that the NB.1.8.1 variant may have enhanced ability to bind to human cells, which could potentially make it more infectious than previous strains.Public health officials in Hong Kong have responded to the variant's emergence by advising high-risk individuals to wear masks in public places and urging all residents to use face coverings while on public transportation or in crowded areas.In the US, the Food and Drug Administration (FDA) recently convened a meeting to assess potential updates to COVID-19 vaccines. While the current vaccines are designed to protect against the JN.1 variant and its offshoots, NB.1.8.1 was discussed during the session due to its international spread and evolving characteristics.The dominant variant in the US remains LP.8.1, a descendant of JN.1. However, only one strain — known as XFC — has shown noticeable growth in the country so far, according to updates shared by the CDC and FDA during the meeting. Although NB.1.8.1 has yet to cause widespread concern domestically, health experts continue to monitor its trajectory. Vigilance remains key, particularly as global travel increases and variants can quickly cross borders. 

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FDA Greenlights Nucala as New Treatment for COPD

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23 New Covid Cases In Delhi, Health Minister Issues Advisory

Baby Food Pouches Recalled Due To Elevated Lead Levels

New COVID Variant NB.1.8.1 Has Been Circulating Across US Since March, Officials Confirm

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Staying Socially Active May Be Key To Longer Living

These 3 Habits Could Be A Game Changer For Your Weight Goals

23 New Covid Cases In Delhi, Health Minister Issues Advisory