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U.S. Kids’ HPV Vaccination Rate Has Stalled
U.S. News & World Report reported:
For the first time in a decade, the rate at which American adolescents received the human papillomavirus (HPV) vaccine has not increased, new data show.
A new report says uptake of the vaccine by adolescents had risen steadily since 2013. But an analysis of 2022 data found that “for the first time since 2013, HPV vaccination initiation did not increase among adolescents aged 13 to 17 years,” according to a team led by agency researcher Cassandra Pingali.
The data comes from an annual federal survey of U.S. households.
As has long been the case, kids not covered by any form of insurance continued to have the lowest rate of vaccination in 2022 — just over 39% of uninsured kids who turned 13 in 2022 had gotten vaccinated, the report found. Paying out of pocket can prove expensive for families: According to Merck, which makes the HPV vaccine Gardasil, the shots cost about $268 per dose.
Biden Administration Investing up to $24 Million for Cancer-Fighting mRNA Tech
The Biden administration’s new biomedical research agency said Wednesday it is investing up to $24 million to develop mRNA platforms that can train the immune system to more effectively fight cancer and other diseases.
The research will be led by a team at Emory University in Atlanta. The project will be funded through the administration’s Advanced Research Projects Agency for Health (ARPA-H), a new agency charged with funding high-risk, high-reward research.
The project is paired with President Biden’s “cancer moonshot,” which aims to cut the cancer death rate in half by 2047.
ARPA-H was launched last year with an initial $1 billion in funding. Biden earlier this year called for up to $2.5 billion for the agency in his fiscal 2024 budget.
Opioid-Maker Mallinckrodt’s Bankruptcy Will Cut Nearly $1 Billion From Settlement
Drug manufacturer Mallinckrodt Pharmaceuticals plans to file for bankruptcy, the company said Wednesday, under a plan that would allow it to pay nearly $1 billion less to a trust as part of a settlement of claims that it helped fuel the nation’s opioid crisis.
One of the largest makers of opioid pain pills in the United States, Mallinckrodt emerged from its first Chapter 11 bankruptcy last year while agreeing to pay $1.7 billion as part of a national settlement to help cities and states ease the addiction and overdose crisis.
The company had made its first payment of $450 million but had been unable to make a second $200 million payment due in June.
According to a filing with the Securities and Exchange Commission on Wednesday, the company and its creditors agreed that Mallinckrodt would enter bankruptcy under a restructuring agreement calling for the “permanent elimination” of the opioid settlement payments, except for a final $250 million payment.
Cities and states sued Mallinckrodt as part of historic litigation against drug manufacturers, distributors, pharmacies and other companies involved with opioids. Plaintiffs have said companies ignored red flags that pain pills were highly addictive and being diverted to the black market — fueling an addiction crisis that still rages today.
Similac Special Care Lawsuit Alleges Infant Formula Caused Premature Baby to Die From Severe Intestinal Disease
An Indiana mother has filed a lawsuit against Similac manufacturers, Abbott Laboratories, alleging that the popular infant formula caused a painful and deadly case of necrotizing enterocolitis (NEC), which triggered severe intestinal disease and the need for multiple surgeries, which ultimately caused the baby to die in “excruciating” pain.
The complaint was brought late last month in the U.S. District Court for the Northern District of Illinois by Jayona Jones, who is pursuing damages on behalf of herself and her deceased minor child, identified with the initials K.J.
Jones now joins other families of preterm infants nationwide who are pursuing a Similac NEC lawsuit against Abbott Laboratories. A number of similar claims are also being pursued against Mead Johnson over problems linked to their competing cow’s milk product, Enfamil, alleging that the companies have withheld information about the risks premature babies may face from the infant formula.
FDA Warns Against Using Contaminated Eyedrops Sold Online
The Food and Drug Administration is urging people to stop using certain brands of eyedrops found to have fungal and bacterial contamination.
The drops in question are Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops-Eye Repair. Both are sold online but are considered illegal because they contain an ingredient called methylsulfonylmethane, or MSM.
The chemical is sometimes used to try to treat arthritis. It is not approved for use in eyedrops, although there are unproven claims online that it can be used for a range of eye problems, including dryness and floaters.
Dr. Berne’s MSM drops, according to the FDA, were contaminated with a type of bacterium called Bacillus, and a type of fungus called Exophiala. The LightEyez drops contained three kinds of bacterial contamination: Pseudomonas, Mycobacterium, Mycolicibacterium and Methylorubrum, the agency said.
J&J’s Janssen to Close Part of Its Vaccine Division — Telegraaf
Johnson & Johnson‘s (JNJ.N) Janssen division, which helped to develop its single-dose COVID-19 vaccine, will close much of its vaccine research and development operations in the Netherlands, the newspaper De Telegraaf reported.
In an emailed response on Wednesday, Johnson & Johnson confirmed plans to exit some of its vaccine research and development programs, which it said it had initially disclosed in its 2023 second-quarter results.
J&J said during second-quarter earnings in July it would cease development of vaccines for respiratory syncytial virus (RSV), hepatitis, and HIV. It said on Wednesday it is continuing work on a vaccine against E.coli bacterial infections.
The Janssen COVID-19 vaccine did not perform as well as the company hoped in high-income countries due in part to worries about blood clots as a rare side effect. In June 2023, the FDA revoked emergency-use authorization for the vaccine at Janssen’s request.
FDA Warns Amazon, Walmart and Others Over Unapproved Drug Products
The FDA has issued six warning letters, including to retail giants Amazon and Walmart, for selling unapproved products online that target a skin condition common in children.
The warnings, posted Tuesday to the agency’s website, require the companies to respond within 15 days with evidence that they are no longer selling the products or that their sale doesn’t violate FDA rules. The FDA says non-compliance could prompt the agency to take further action.
The FDA wants a number of products labeled as treating molluscum contagiosum, a viral skin infection that results in small itchy bumps on the skin, taken off the market.
Pfizer Cuts Enrollment for Lyme Disease Trial After CRO Debacle
After complications with the CRO behind Pfizer‘s Lyme disease shot, vaccine R&D chief Annaliesa Anderson, Ph.D, says that much fewer than the planned 18,000 participants will be recruited.
The new enrollment expectations for the phase 3 VLA15 program follow a dramatic back-and-forth between Pfizer and a contract research organization, Care Access — owned by Reify Health.
Pfizer alleged in February that due to breaches of Good Clinical Practice half of the enrolled patients to date would be removed. Care Access CEO Ahmad Namvargolian said in a LinkedIn post that his company disagreed with the decision. Endpoints News subsequently reported that Pfizer had ended work with Care Access.
The trial originally got underway in August 2022 with an overall enrollment goal of 18,000 healthy people who live in areas with endemic Lyme disease and lead lifestyles that put them at increased risk of being bitten by ticks. An initial 6,000 people were supposed to be enrolled to ensure a read-out by the second quarter of this year.
