Roundup: First Approved Nasal-Spray Flu Vaccine for Self-Use; and More News

FDA Approves First Nasal-Spray Flu Vaccine for At-Home Use, But Prescription Required

The U.S. Food and Drug Administration (FDA) has approved FluMist for “self- or caregiver-administration” – meaning that the nasal-spray flu vaccine can be self-administered at home with a prescription.

The vaccine is approved for the prevention of influenza disease caused by virus subtypes A and B in individuals 2 through 49 years of age. FluMist is sprayed into the nose and was initially approved in 2003 for use in a healthcare setting. It’s approval for home use or self-administration is expected to encourage more “needle-shy” kids and adults to get vaccinated, the FDA anticipates.

A prescription is still required to receive the newly approved FluMist for home use, the FDA said. Consult with your doctor if you have any questions. It isn’t expected to become available until next year. “The vaccine may be administered by a healthcare provider in a healthcare setting (including a pharmacy) or it may be administered by the vaccine recipient or a caregiver who is 18 years of age or older,” states the FDA.

The vaccine manufacturer plans to make the nasal spray vaccine for home use available through a third-party online pharmacy, states the FDA. Those who choose this option will “complete a screening and eligibility assessment” when they order FluMist. 

“Approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families,” states Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

According to the U.S. Centers for Disease Control and Prevention (CDC), flu has resulted in about 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalizations and 4,900 to 51,000 deaths annually between 2010 and 2023. Several FDA-approved vaccines are available each flu season to prevent influenza.

Higher Levels of Mental, Emotional Well-Being Linked to Lower Risk of Heart Health Issues

People with high levels of mental or emotional well-being were linked to a significantly reduced risk of cardiovascular problems, according to a study published in the Journal of the American Heart Association.

In one of the largest studies to date connecting mental or emotional status to physical health, researchers focused on data from more than 121,000 participants in the UK Biobank, a large database in the United Kingdom widely used in clinical studies.

The study also found that higher mental well-being was associated with healthier lifestyles – including being more active, eating more fruits and vegetables, getting enough sleep and not smoking – which helped lower levels of inflammation.

“Because increased inflammation has been linked to a higher risk of cardiovascular disease, the researchers also looked at markers for inflammation in the blood and at genetic markers related to well-being,” states a news release from the American Heart Association (AHA) on the study.

Using a statistical model which adjusted for variations in age, sex, ethnicity, high blood pressure, diabetes and more, the risk for heart attack fell 21 percent and the risk of stroke dropped 14 percent with each increase in a person's well-being score, the AHA stated.

The findings could help healthcare providers better understand the significant impact that mental and emotional health has on physical health, particularly cardiovascular health, researchers said. Researchers caution that cardiovascular disease is caused by multiple factors beyond well-being.

"While we expected well-being to influence cardiovascular health, the extent to which lifestyle factors like physical activity, diet and smoking mediated this relationship was remarkable," said the study’s senior author Wen Sun, M.D., deputy director of the Stroke Center at the First Affiliated Hospital of the University of Science and Technology of China.

Global Deaths from Antibiotic-Resistant ‘Superbugs’ Estimated to Surge 70% by 2050

Infections of drug-resistant “superbugs” are projected to kill nearly 40 million people over the next 25 years around the world, increasing by almost 70 percent by 2050 compared to 2022, a new global analysis estimates.

Superbugs – strains of bacteria or pathogens that have become resistant to antibiotics, making them much more difficult to treat – have been a rising threat to global health for many years. Authors of the study, published in The Lancet journal, is considered the first in-depth analysis of the global health threats posed by the superbugs – also known as antimicrobial resistance (AMR). 

More than one million people died from AMR globally each year between 1990 and 2021. Over the period, AMR deaths among children aged under five declined by 50 percent, while those among people aged 70 and older increased by more than 80 percent, states a news release on the study.

“Statistical modelling was used to produce estimates of deaths directly from AMR and those in which AMR played a role,” states the news release. “Estimates were also produced for scenarios in which healthcare quality and access to antibiotics improve in the future and drug development targets Gram-negative bacteria.”

The future death rate AMR will be highest in South Asia – which includes countries such as India, Pakistan, and Bangladesh – where a total of 11.8 million deaths directly due to AMR are forecast between 2025 and 2050. Deaths from AMR will also be high in other parts of southern and eastern Asia and sub-Saharan Africa, the study found.

“Antimicrobial medicines are one of the cornerstones of modern healthcare, and increasing resistance to them is a major cause for concern. These findings highlight that AMR has been a significant global health threat for decades and that this threat is growing. Understanding how trends in AMR deaths have changed over time, and how they are likely to shift in future, is vital to make informed decisions to help save lives,” said study author Mohsen Naghavi, M.D., leader of the AMR Research Team at the Institute of Health Metrics (IHME), University of Washington in Seattle.