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First Children Vaccinated in New Clinical Study Seeking to Expand the Indication for Bavarian Nordic’s Mpox Vaccine
Bavarian Nordic A/S announced today the initiation of a clinical study of the mpox/smallpox vaccine in children two to 11 years of age.
The first children have now been vaccinated in the study, which is currently enrolling in the Democratic Republic of Congo with plans also to include sites in Uganda. A total of 460 individuals are expected to participate in the study, which will compare the safety and immunogenicity of the vaccine between children aged two to 11 years of age to adults. The study (NCT06549530) is partially funded by the Coalition for Epidemic Preparedness Innovations.
Results from this study could support an extension of the current approval of MVA-BN to include children from two years of age and older.
Last month, the World Health Organization prequalified the vaccine for adolescents 12 to 17 years of age, adopting the recent approval from the European Medicines Agency for this age group.
GSK Cuts Vaccine Sales Outlook Amid U.S. Weakness
GSK cut its full-year vaccine sales outlook after key shots for respiratory syncytial virus and shingles missed expectations in the third quarter due to weak U.S. demand.
The British pharmaceutical giant said vaccine demand was lower than anticipated in the third quarter as U.S. health authorities gave priority to COVID-19 jabs, a setback for the company’s efforts to bolster its vaccines business.
As a result, GSK now expects vaccine sales to fall this year rather than increase as previously forecast, even though guidance for sales and core earnings at the group level was confirmed. The move sent shares in GSK down as much as 4% and prompted some analysts to question whether a weak vaccine performance could put the group’s mid-term sales targets at risk.
Under-Vaccinated Ethnic Minority Groups in UK at Higher Risk of Covid
People from ethnic minority groups in the U.K. are twice as likely to be under-vaccinated against COVID-19 compared with individuals who have a white British background.
That is the striking finding of a study carried out by scientists at Health Data Research UK (HDR UK), which indicates that people from these groups are more likely to need hospital treatment or risk death from COVID-19 because they lack full protection against the disease.
“The results are very clear,” said Prof Angela Wood, of the HDR UK and Cambridge University. “Using data for 67 million people from England, Scotland and Wales, we found that only about 40% of those of white backgrounds had not had their full COVID-19 vaccinations by the beginning of this year, while 80% of individuals from some ethnic groups were under-vaccinated. It is a really striking difference.”
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Metformin Use Shown to Induce Vitamin B12 Deficiency in Diabetics
Metformin remains the most commonly prescribed oral medication for managing Type 2 diabetes due to its effectiveness in controlling blood glucose levels. However, emerging research indicates a significant concern regarding vitamin B12 deficiency, particularly with long-term metformin use.
This deficiency is associated with several serious health complications, including neurological problems such as peripheral neuropathy and hematological issues like anemia, both of which negatively impact quality of life.
The prevalence of Type 2 diabetes is escalating globally, posing a significant public health challenge. Factors contributing to this rise include increasing obesity rates, sedentary lifestyles and an aging population. Metformin is a conventional first-line treatment for managing Type 2 diabetes.
However, long-term use of metformin is linked to reduced absorption of vitamin B12. This vitamin is crucial for nerve function and the production of red blood cells. Deficiency leads to serious health issues, including peripheral neuropathy and megaloblastic anemia, significantly impairing the quality of life for diabetic patients.
These findings underscore the necessity for regular monitoring of vitamin B12 levels in individuals undergoing metformin therapy to prevent potential adverse effects.
Pfizer Rides Paxlovid Sales Growth to Better-Than-Expected Third Quarter
A boost from COVID-19 treatment sales helped push Pfizer to a better-than-expected third quarter and higher forecast for the year.
Demand for the drugmaker’s Paxlovid treatment spurred by the latest COVID-19 wave and a U.S. national stockpile delivery led to $2.7 billion in sales for the drug, Pfizer said Tuesday. The company also cited sales growth from several other drugs, as total revenue climbed 31% to $17.7 billion in the recently completed quarter. Adjusted earnings totaled $1.06 per share. Analysts expect earnings of 61 cents per share in the third quarter on $14.92 billion in revenue, according to FactSet. Pfizer shares climbed in early trading.
The drugmaker said it made a one-time delivery of a million Paxlovid treatment courses to the U.S. Strategic National Stockpile in the third quarter. Pfizer also saw sales of its COVID-19 vaccine Comirnaty grow 9% to $1.4 billion.
