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U.S. FDA Accepts AstraZeneca’s Self-Administered Flu Vaccine for Review
AstraZeneca (AZN.L) said on Tuesday the U.S. Food and Drug Administration (FDA) has accepted for review the company’s application seeking approval for patients or caregivers to administer its nasal flu vaccine.
If approved, the vaccine — branded as FluMist Quadrivalent — could become the first self-administered flu vaccine that does not necessitate a healthcare practitioner for administration. FluMist was first approved by the FDA in 2003.
The company said it expects the FDA to decide on the vaccine by the first quarter of 2024, adding that it expects the vaccine to be made available for self-administration in the United States during the 2024-2025 flu season if approved.
The supplemental application is based on data from a usability study which confirmed that individuals over 18 years of age could self-administer or administer FluMist to eligible patients from 2 to 49 years of age when given instructions for use without any additional guidance, AstraZeneca said.
COVID Shots May Slightly Raise Stroke Risk in the Oldest Recipients
The COVID vaccines made by Pfizer-BioNTech and Moderna may be linked to a slight increase in the risk of stroke when administered along with a high-dose flu vaccine, according to a new analysis by the Food and Drug Administration.
The high-dose flu vaccine is usually given to older people, and the risk association is clearest in adults aged 85 and older. But that increase, if real, seems very small, and it is possible that the risk may stem from the flu vaccine alone.
A separate analysis by the agency points to a small increase in the incidence of seizures after COVID vaccinations in children ages 2 to 5. The papers were posted online last week, and have not yet been vetted for publication in a scientific journal. Experts in vaccine safety said the studies were well done.
Although the findings do not warrant a change to vaccine recommendations, they are suggestive enough to merit further study, the experts said.
Both studies are based on observational data, which cannot identify cause and effect. The agency is planning to study the occurrence of seizures in children after vaccination “using a more robust design,” said Cherie Duvall-Jones, a spokeswoman for the FDA.
First Shot Administered in Moderna’s Combo COVID/Flu Vaccine Final Stage Trial
U.S. News & World Report reported:
Moderna on Tuesday announced that its combination shot for flu and COVID-19 is the first candidate to make it to late-stage trial.
The first participant has been dosed in the trial, which is expected to enroll about 8,000 people in the Northern Hemisphere, the company said on Tuesday. About half of the participants will be ages 65 and older, while the other half will be ages 50 to 64.
The shots won’t be available for this respiratory virus season, as Moderna said it is targeting regulatory approval for the shot in 2025.
Moderna earlier this month announced positive data from its earlier studies of the combo shot, finding that it produced an immune response similar to or greater than licensed flu shots and Moderna’s bivalent COVID-19 shot.
Shortage of Shots That Protect Babies Against RSV Prompts CDC Alert
U.S. News & World Report reported:
Demand for a new shot that protects babies against respiratory syncytial virus (RSV) has outpaced supply, prompting U.S. health officials to recommend the doses be saved for high-risk infants.
In an alert posted Monday afternoon, the U.S. Centers for Disease Control and Prevention said nirsevimab (Beyfortus) should be reserved for infants with underlying health conditions and those younger than 6 months old.
“We are going to protect some children from RSV this year. We’re not going to be able to protect as many as we’d hoped, and that’s frustrating,” Dr. Buddy Creech, a pediatrician at Vanderbilt and president of the Pediatric Infectious Disease Society, told CNN.
Babies ages 8 to 19 months old should not receive Beyfortus because they are eligible for an older medication known as palivizumab (Synagis), CNN reported. Unlike Beyfortus, which protects babies for 6 months with a single dose, Synagis has to be given once a month through the RSV season.
‘On Track’: 3% of Americans Have Gotten the New COVID Shot, but the CDC Director Remains Confident
The Biden administration’s campaign to convince Americans to get an annual COVID shot is off to a very slow start. Even so, the nation’s top disease-fighting official says the U.S. remains “on track” to hit last year’s uptake levels, which crested at just 17% of the U.S. population.
So far, 12 million people, or about 3.6% of the population, have gotten the shot in the five weeks since it hit pharmacy shelves — though reporting lags mean it’s likely a bit higher, Centers for Disease Control and Prevention Director Mandy Cohen said.
More people, by far — 16 million — have gotten their annual flu vaccine, Cohen said, attributing the difference to long-held routines.
Cohen is in the middle of a national tour promoting vaccination targeting elderly people at most risk from COVID, as well as underserved communities. She’s also meeting with lawmakers on Capitol Hill, including House Republicans who have criticized the agency, as part of her efforts to rebuild trust in the CDC.
Addiction Treatment for Kids and Teenagers Lags Far Behind Demand
An alarming rise in overdose deaths among children and teenagers is colliding with an inadequate pediatric mental health system — including a lack of addiction treatment.
Why it matters: Limited treatment options and coverage gaps mean that many kids aren’t getting needed care that could help prevent them from developing a deeper and potentially deadly addiction. By the numbers: Pediatric opioid deaths began to spike with the rise in fentanyl availability in the mid-2010s.
Median monthly overdose deaths among adolescents ages 10-19 increased by 109% between the second half of 2019 and the second half of 2021, according to Centers for Disease Control and Prevention data from last year. Deaths involving illicitly manufactured fentanyl increased by 182%.
The big picture: Opioid misuse is only one factor in a growing mental health crisis among children that was exacerbated by the pandemic, prompting children’s health advocacy organizations to declare a national state of emergency two years ago.
Officials Say Narcan Is Now Stocked in NYC Public High Schools, but Some Principals Say They Haven’t Received It Yet
The opioid crisis is a new challenge for schools this fall. As fentanyl fears remain high among teens, New York City Public Schools officials say Narcan, the medicine used to reverse opioid overdoses, is now stocked in its high schools. CBS New York has been following the opioid crisis and the push to get Narcan in schools.
According to the Centers for Disease Control, fentanyl-related adolescent overdose deaths nearly tripled from 2019-21. In New York City, health data shows fentanyl was involved in 81% of all overdoses last year. Doctors say naloxone or Narcan instantly reverses overdoses. The Food and Drug Administration approved the nasal spray for use without a prescription.
CBS New York revealed back in February that most high schools across the state, including on Long Island, were stocked with the lifesaving spray, except New York City Public Schools.
This academic year, as education leaders grapple with how to approach the grim drug crisis, CBS New York has learned Narcan is finally in city public high schools. Still, it’s unclear if it’s in all 571 high schools. Some principals told CBS New York they don’t have their supply yet.
Indivior to Pay $385 Million to End Final Suboxone Monopoly Lawsuits
Indivior (INDV.L) on Monday agreed to pay $385 million to settle lawsuits in the U.S. brought by drug wholesalers on claims it illegally suppressed generic competition for its opioid addiction treatment Suboxone.
The company’s London-listed shares closed 5% higher as the latest settlement marks the end of long-running litigation relating to Suboxone.
Indivior in June agreed to pay $102.5 million to settle related claims by dozens of U.S. states. In August, it agreed to pay $30 million to settle a similar class action lawsuit by health plans.
