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Pregnant Women and Older People in England Offered RSV Vaccine on NHS
Pregnant women and older people across England will be routinely vaccinated against the respiratory syncytial virus (RSV) for the first time, the National Health Service (NHS) has said.
From Sept. 1 the (NHS) will vaccinate pregnant women from 28 weeks onwards and adults turning 75. Adults aged 75 to 79 will be offered a catch up vaccine to make sure they are protected.
Previous studies have shown that giving pregnant women the RSV vaccine reduces the risk of babies experiencing severe lung infections in the first six months of life by about 70%.
The RSV vaccine has been approved by the medicines regulators in the U.K., as advised by the Joint Committee on Vaccination and Immunization.
FDA OKs Updated Novavax COVID Shot
The U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for an updated Novavax COVID-19 vaccine to protect against hospitalization and death from circulating variants.
The protein-based shot represents a non-mRNA option for the 2024-2025 season, and follows the agency’s recent approvals and authorizations of the updated Moderna (Spikevax) and Pfizer-BioNTech (Comirnaty) vaccines.
Unlike the mRNA vaccines which target the KP.2 strain of SARS-CoV-2, the monovalent protein-based vaccine targets the JN.1 strain. As of Aug. 31, variants KP.3.1.1, KP.2.3, KP.3, and LB.1 have the highest prevalence in the U.S., according to the CDC’s COVID Data Tracker.
The FDA assessed manufacturing and nonclinical data to support the change to the 2024-2025 formula, the agency said. The updated vaccine is manufactured using a similar process as previous formulas of this vaccine.
The FDA determined that the updated vaccine met the statutory criteria for issuance of an EUA, including that the known and potential benefits of the vaccine outweigh its known and potential risks in individuals ages 12 years and older.
New Research Could Ease Concerns Over Suicide Risk of Obesity Drugs
Regulators in the U.S. and Europe recently determined that a popular group of drugs for weight loss and diabetes don’t heighten the risk of suicide.
Still, in an editorial that accompanied two JAMA studies, experts urged “continued vigilance” to ensure GLP-1 drugs don’t worsen problems in people with preexisting mental health conditions.
New data published in the Journal of the American Medical Association on Tuesday appear to back up those assessments, though researchers cautioned that there’s still more work to be done.
The findings come from a pair of large, retrospective evaluations. One reviewed the effects of a so-called GLP-1 drug or another diabetes medication on the risk of suicide or other mental health problems in nearly 300,000 people in Sweden and Denmark.
The other looked at the incidence of suicidal thoughts or depression symptoms in 3,600 study volunteers who received the obesity drug Wegovy or a placebo in studies Novo Nordisk ran to secure regulatory approval.
New Trend of Pharma Selling Directly to Consumers Raises Questions
Enabling patients to order prescription medications directly from the drug maker is an emerging trend exemplified by the launch this year of two online platforms, LillyDirect and PfizerForAll, by Eli Lilly and Pfizer, respectively.
Other pharmaceutical companies may follow suit. While these initiatives facilitate patient access to certain products, they also raise (ethical) questions concerning the possible disruption of established patient-physician relationships and the potential for conflicts of interest.
The drug maker Eli Lilly launched a site called LillyDirect in January that allows patients with diabetes, obesity and migraine to connect to telehealth providers and in-person referrals who can prescribe medications, which are then filled by third-party pharmacy dispensing services, such as Truepill or Amazon Pharmacy, and in the case of Lilly products delivered to the patients’ homes.
Pfizer unveiled a similarly designed digital portal at the end of August, intended to connect patients to a range of healthcare services and products.
At Major Cardiology Conference, Wegovy’s the Word
All the research going into the weight loss drug amounts to a significant scientific pursuit, but there’s a business case behind it, too.
When Europe’s largest cardiology conference opened here this past Friday, one of the first sessions centered entirely on a single drug.
It cut the risk of complications from a common form of heart failure, researchers reported. It helped improve the structure of the heart as well as its function. It even saved the lives of people with COVID-19 — a respiratory infection of all things.
“Now on to something entirely different,” Richard Pratley, a diabetes specialist at AdventHealth in Orlando, told the standing-room-only crowd as he introduced a trial of the drug in kidney disease.
Childhood HIV Vaccination Strategy Shows Promise in Study
Research at Weill Cornell Medicine suggests that childhood immunization against human immunodeficiency virus (HIV) could one day provide protection before the risk of contracting this potentially fatal infection dramatically increases in adolescence.
The study, published Aug. 30 in Science Immunology, demonstrated that a series of six vaccinations containing a modified protein from the surface of HIV particles stimulated initial steps of a potent immune response in young nonhuman primates.
This difficult-to-achieve response represents an important step toward providing full and potentially lifelong protection against the virus, the researchers say.
Immunizing young children, rather than adults, makes sense because risk factors for HIV infection rise steeply when adolescents become sexually active, according to senior author Dr. Sallie Permar, the Nancy C. Paduano Professor in Pediatrics and chair of the Department of Pediatrics at Weill Cornell Medicine.
Evidence also suggests that the immune systems of infants and children generally mount more effective responses to the virus than those of adults. Said Permar, “One of the advancements we’ve made is to demonstrate that an HIV vaccine could be delivered on a schedule similar to routine vaccines already given to babies and children.”
Fentanyl Vaccine Heads for Clinical Trials, With Goal of Saving Lives
A fentanyl vaccine developed by researchers at the University of Houston is expected to head to clinical trials sometime in the middle of next year, with the hope of being a groundbreaking solution to a deadly crisis.
The vaccine, which has shown success in animal studies, is designed to stop the highly addictive opioid from entering the brain and causing an overdose.
Biopharmaceutical startup Ovax acquired the license to produce and test the vaccine in Nov. 2023 and raised over $10 million toward that effort by June.
“We’re all incredibly excited,” said Collin Gage, the start-up’s co-founder and chief executive officer. He added that his company is starting at “ground zero,” but he is confident it will one day have a fentanyl vaccine available to the public.
That day may be a long time from now. While public health emergencies, like the COVID-19 pandemic, can accelerate a vaccine’s development, testing a new vaccine can take anywhere from five to 10 years—sometimes longer.
Measles Cases Are up and Childhood Vaccinations Are Down
For about three weeks in 2000, there were zero measles cases in the U.S.. It was declared eradicated.
Fast forward to 2024, and measles cases are surging, especially in Oregon where the state is facing the worst outbreak since the early 1990s.
This is happening as the Centers for Disease Control and Prevention reports that the vaccination rate among kindergartners is dropping, and more and more parents are seeking exemptions to school vaccine requirements.
People are vaccinating their children at lower and lower rates.
COVID Vaccine Distrust Growing Among Americans, Survey Finds: ‘Should Be a Personal Choice’
A growing number of Americans are skeptical of vaccines for COVID-19 and other infectious diseases, according to the most recent national health survey by the Annenberg Public Policy Center at the University of Pennsylvania.
More than a quarter of respondents (28%) said they believe the COVID-19 vaccines have contributed to thousands of deaths, according to a press release. This is an increase from 22% in June 2021.
Meanwhile, 22% of respondents said they are under the assumption that it is safer to contract COVID than it would be to get vaccinated — an increase from 10% in April 2021.
Also, 15% of Americans said they believe the vaccine “changes people’s DNA,” up from 8% since the last survey.
The survey gathered input from nearly 1,500 U.S. adults.
GlaxoSmithKline Pharma Gets Big Income Tax Refund
Global healthcare company GlaxoSmithKline Pharmaceuticals Ltd on Sept. 3 said it has received an income tax refund of ₹222.23 crore for the assessment year 2022-23, following an order issued by the Income Tax Department.
“This is to inform that the Company has received an Income Tax Order from the Income Tax Department under Section 143(3) for Assessment Year 2022-23, issuing income tax refund of Rs INR 222.23 cr (including interest),” according to a stock exchange filing.
GlaxoSmithKline Pharmaceuticals reported a 37.8% year-on-year jump in net profit at ₹182.3 crore for the first quarter that ended June 30. In the corresponding quarter, GlaxoSmithKline posted a net profit of ₹132.3 crore, the company said in a regulatory filing.
