Global Vaccine Alliance GAVI to Buy 500,000 Doses of Mpox Vaccine
The global vaccine alliance Gavi will buy 500,000 doses of mpox vaccine to battle outbreaks of the disease in African countries, the organization said on Wednesday.
The vaccine doses — manufactured by the Danish company Bavarian Nordic — will be available this year, Gavi said, without giving any specific dates.
Gavi said the full costs, including the transportation, delivery and administration of the doses, amounting to $50 million, would be covered by the group’s First Response Fund, a new financial mechanism created in June 2024.
Since the beginning of the year, there have been over 25,000 confirmed mpox cases and 723 related deaths, the vast majority in Congo, and the World Health Organization declared it a global health emergency.
The U.S. Should Follow California’s Lead on Banning Toxic Chemicals in IV Bags and Tubes
In 2017, at the age of 42, Susan Whitehead was diagnosed with an early form of breast cancer after discovering a lump in her breast.
She embarked on a challenging path of treatment, including a recurrence with stage 2 cancer four years later.
Susan underwent two lumpectomies, a mastectomy, radiation, and chemotherapy.
Throughout this process, she was steadfast in her resolve to seek the best possible care, which included demanding a controversial full-body scan that led to an unexpected discovery: She also had thyroid cancer.
The diagnosis marked the beginning of a journey that would not only test her resilience, but also lead to a shocking discovery about the potential risks associated with IVs used to administer chemotherapy:
The plastic used to make the bags and tubing often contain a toxic chemical known as Di(2-ethylhexyl) phthlate, or DEHP.
Superbugs Due to Antibiotic Resistance Could Kill 39 Million People by 2050, Large Study Finds
Resistance to antibiotics has led to one million worldwide deaths each year since 1990, for a total of 36 million.
It is expected to cause more than 39 million more fatalities by 2050 — three per minute.
That’s according to a large study led by the Global Research on Antimicrobial Resistance (GRAM) Project, a partnership between the University of Oxford and the Institute for Health Metrics and Evaluation (IHME) at the University of Washington.
After analyzing 520 million health records, the researchers provided future estimates for 22 pathogens, 84 pathogen-drug combinations and 11 infectious syndromes across 204 countries and territories, according to a GRAM press release.
Tested in Africa, Used in America
At the recent annual International AIDS Conference, a startling presentation about the newest wonder drug in HIV prevention brought a raucous standing ovation.
Lenacapavir, a novel drug given as an injection under the skin every six months, was 100% successful in preventing HIV in adolescent girls and young women in two countries in Africa.
It felt to many like a generational moment.
After years of failed vaccine trials, this was something nearly as valuable — a shot given twice yearly that substantially prevents HIV infections.
That the drug was so beneficial in young women in Africa made the finding particularly monumental.
But some of us in the public health community are now starting to wonder what all the cheering was about.
Although the scientific results were impeccable, the process for translating those results into action for young women in Africa has been left to our imaginations. And if history is any guide, this could be a nightmare.
GSK Touts Co-Administration Data for RSV, Shingles Vaccines as Narrowed CDC Guidance Threatens Sales
This summer, GSK cut its yearly vaccine sales projection on the back of a narrowed recommendation for adult respiratory syncytial virus (RSV) vaccines from the Centers for Disease Control and Prevention.
With sales of its flagship shingles vaccine Shingrix separately faltering, new data on co-administration of the two adult vaccines could provide a new way for the company to promote the jabs.
The company studied co-administration of its RSV vaccine Arexvy and Shingrix in a phase 3 study of 530 adults age 50 years and older.
When the shots were given during the same doctor’s visit, the company recorded non-inferior immune responses compared with separate administration of the shots during different doctor’s visits.
Those who received the vaccines separately took Shingrix on the first visit and went back for their first dose of Arexvy on day 31.
Both groups experienced the same adverse events related to vaccine administration such as pain at the injection site, fatigue and muscle pain. The duration of those events were “comparable” across both trial groups, GSK reported.
Eye Drop Company in FDA’s Sights Once Again
The FDA has sent another letter — this time a warning letter — to a company that it previously flagged for marketing amniotic fluid eye drops.
In a letter to Carl Harrell, MD, CEO of Regenerative Processing Plant in Palm Harbor, Florida, the agency said the company’s Regener-Eyes Pro and Regener-Eyes Lite products were unapproved new drugs because they make claims about treating dry eyes.
FDA also said the facility violated several current good manufacturing practices (CGMPs), including not validating its aseptic practices and not having adequate environmental monitoring in aseptic areas.
Two years ago, Harrell received an FDA untitled letter over a version of its Regener-Eyes product that contained amniotic fluid.
The agency sent a subsequent safety communication about other eye drops — including StimulEyes — that were made with amniotic fluid.
