Latest news with #BiomedicalAdvancedResearchandDevelopmentAuthority
India Today
2 days ago
- Health
- India Today
US cancels $766 million pandemic flu vaccine support to Moderna
The Trump administration has withdrawn $766 million in funding previously allocated to Moderna Inc. for the development of a vaccine against potential pandemic flu, including bird H5N1 highly pathogenic H5N1 virus has caused widespread destruction in several countries, resulting in the loss of millions of animals. In the US, the virus claimed its first human life in January 2025, following exposure to infected announced on Wednesday that the US Department of Health and Human Services had rescinded the funds, which were awarded in July 2024 and again in January 2025, to support the development and procurement of its experimental vaccine. The funding had been provided through the Biomedical Advanced Research and Development Authority (BARDA), a program designed to support medical countermeasures for potential public health investigational vaccine, mRNA-1018, uses the same mRNA technology that enabled the rapid development and deployment of Covid-19 the setback, the company shared promising interim results from its early-stage clinical trial that targeted H5 bird flu virus involving 300 healthy adults. The vaccine showed a strong immune response and a favourable safety profile."While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis," Moderna said in a move comes amid growing skepticism within the administration toward mRNA vaccine platforms. Health Secretary Robert F. Kennedy Jr. has publicly questioned their safety, despite extensive real-world data showing that mRNA vaccines are safe and have saved millions of lives, according to an Associated Press report. Despite the setback, the company shared promising interim results from its early-stage clinical trial involving 300 healthy adults. () Bird flu, which initially spread through wild birds, has now spilled over into cattle in the US, infecting hundreds of animals across at least 17 states. As of May 28, more than 173 million poultry have been affected. At least 70 human infections have been reported, mostly mild, with one death so remain concerned that continued viral mutations could make H5N1 more dangerous or capable of human-to-human transmission, raising fears of a future had received $176 million in July 2024 and $590 million in January 2025 to support vaccine development. The latter amount was intended to fund a large-scale trial that could have evaluated the vaccine's effectiveness against potential pandemic strains, including this year, a report in The Lancet by the Global Virus Network (GVN) urged governments to ramp up virus surveillance, improve farm biosecurity, and prepare for the possibility of human-to-human spread."H5N1 is no longer just a bird flu, it has already jumped to dairy cows and humans. The virus' ability to infect both animals and humans, combined with recent genetic changes, underscores the importance of proactive surveillance," said Dr. Sten Vermund, Chief Medical Officer of the current public health risk remains low, the US Centers for Disease Control and Prevention (CDC) is closely monitoring the agency is working with state health departments to track individuals exposed to infected animals and is using existing flu surveillance systems to monitor for signs of H5 infections in Reel
Axios
3 days ago
- Health
- Axios
HHS cancels Moderna's $590M bird flu vaccine award
The Trump administration canceled a nearly $600 million award to Moderna to develop an mRNA vaccine for bird flu in humans, the company announced Wednesda y. Why it matters: It ends one of the remaining Biden-era efforts aimed at creating vaccines for pandemic preparedness. But the company said it would explore alternatives for further developing and manufacturing the shot. Driving the news: Moderna reported positive early stage data on the mRNA vaccine, saying clinical testing in roughly 300 adults was found to be generally well-tolerated. Participants achieved 98% immunity within three weeks of the second dose of the vaccine, the company said. "While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program," Moderna CEO Stéphane Bancel said in a statement. "These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats." Details: The funds awarded in January from the Biomedical Advanced Research and Development Authority were aimed at creating a line of defense against H5N1 in peoplethat matches the strains circulating in cows and birds.
CNN
14-04-2025
- Health
- CNN
Millions of women get painful UTIs that keep coming back. A new kind of antibiotic may help break the cycle
The US Food and Drug Administration has approved a new type of antibiotic to treat urinary tract infections. The pill, gepotidacin, will be sold under the brand name Blujepa and is expected to be available in the second half of 2025. Blujepa is approved to treat females 12 and older with uncomplicated urinary tract infections, or UTIs. About half of all women will experience a UTI at some point in their lives, and about 30% will have a UTI that comes back after treatment, drugmaker GSK said. Recurrent UTIs have become a bigger problem as the bacteria that cause them have become more resistant to the antibiotics available to treat them. Blujepa is the first new type of oral antibiotic to treat UTIs to gain approval in more than 20 years. Its development was funded in part by grants from the US government's Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency. Dr. Tony Wood, chief scientific officer of GSK, said in a statement that Blujepa's approval is 'a crucial milestone.' 'We are proud to have developed Blujepa, the first in a new class of oral antibiotics for [uncomplicated UTIs] in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments,' the statement said. Other antibiotics have recently been approved for UTIs, although they fit into existing drug classes. Pivya, a type of penicillin, was approved in April 2024 to treat uncomplicated UTIs, and Orlynvah was approved in December 2024 to treat uncomplicated UTIs in women who have limited or no other antibiotic treatment options. Blujepa is what's known as a triazaacenaphthylene antibiotic and it's the first of its kind. UTIs are the cause of roughly 8 million emergency room visits and 100,000 hospitalizations in the US each year, GSK said. They strike women more often than men. Blujepa works by interfering with two enzymes that bacteria need to copy themselves. Because its mechanism of action is targeted, it may cut down on the possibility that bacteria will become resistant to it, Wood said Monday during a call with reporters. In clinical trials with more than 3,000 women and teen girls, the drug - a pill taken twice daily - performed as well as or better than nitrofurantoin, the frontline antibiotic which is currently used to treat UTIs. Its main side effects were diarrhea, which affected 16% of patients in the clinical trial, and nausea, which affected 9% of participants. Most of these events were considered mild. Symptoms of UTIs include frequent urination that is painful or burns, bloody urine, low stomach cramps and the need to urinate even after having just gone.
CNN
25-03-2025
- Health
- CNN
Millions of women get painful UTIs that keep coming back. A new kind of antibiotic may help break the cycle
The US Food and Drug Administration has approved a new type of antibiotic to treat urinary tract infections. The pill, gepotidacin, will be sold under the brand name Blujepa and is expected to be available in the second half of 2025. Blujepa is approved to treat females 12 and older with uncomplicated urinary tract infections, or UTIs. About half of all women will experience a UTI at some point in their lives, and about 30% will have a UTI that comes back after treatment, drugmaker GSK said. Recurrent UTIs have become a bigger problem as the bacteria that cause them have become more resistant to the antibiotics available to treat them. Blujepa is the first new type of oral antibiotic to treat UTIs to gain approval in more than 20 years. Its development was funded in part by grants from the US government's Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency. Dr. Tony Wood, chief scientific officer of GSK, said in a statement that Blujepa's approval is 'a crucial milestone.' 'We are proud to have developed Blujepa, the first in a new class of oral antibiotics for [uncomplicated UTIs] in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments,' the statement said. Other antibiotics have recently been approved for UTIs, although they fit into existing drug classes. Pivya, a type of penicillin, was approved in April 2024 to treat uncomplicated UTIs, and Orlynvah was approved in December 2024 to treat uncomplicated UTIs in women who have limited or no other antibiotic treatment options. Blujepa is what's known as a triazaacenaphthylene antibiotic and it's the first of its kind. UTIs are the cause of roughly 8 million emergency room visits and 100,000 hospitalizations in the US each year, GSK said. They strike women more often than men. Blujepa works by interfering with two enzymes that bacteria need to copy themselves. Because its mechanism of action is targeted, it may cut down on the possibility that bacteria will become resistant to it, Wood said Monday during a call with reporters. In clinical trials with more than 3,000 women and teen girls, the drug - a pill taken twice daily - performed as well as or better than nitrofurantoin, the frontline antibiotic which is currently used to treat UTIs. Its main side effects were diarrhea, which affected 16% of patients in the clinical trial, and nausea, which affected 9% of participants. Most of these events were considered mild. Symptoms of UTIs include frequent urination that is painful or burns, bloody urine, low stomach cramps and the need to urinate even after having just gone.
CNN
25-03-2025
- Health
- CNN
FDA approves a new kind of oral antibiotic to treat urinary tract infections
The US Food and Drug Administration has approved a new type of antibiotic to treat urinary tract infections. The pill, gepotidacin, will be sold under the brand name Blujepa and is expected to be available in the second half of 2025. Blujepa is approved to treat females 12 and older with uncomplicated urinary tract infections, or UTIs. About half of all women will experience a UTI at some point in their lives, and about 30% will have a UTI that comes back after treatment, drugmaker GSK said. Recurrent UTIs have become a bigger problem as the bacteria that cause them have become more resistant to the antibiotics available to treat them. Blujepa is the first new type of oral antibiotic to treat UTIs to gain approval in more than 20 years. Its development was funded in part by grants from the US government's Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency. Dr. Tony Wood, chief scientific officer of GSK, said in a statement that Blujepa's approval is 'a crucial milestone.' 'We are proud to have developed Blujepa, the first in a new class of oral antibiotics for [uncomplicated UTIs] in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments,' the statement said. Other antibiotics have recently been approved for UTIs, although they fit into existing drug classes. Pivya, a type of penicillin, was approved in April 2024 to treat uncomplicated UTIs, and Orlynvah was approved in December 2024 to treat uncomplicated UTIs in women who have limited or no other antibiotic treatment options. Blujepa is what's known as a triazaacenaphthylene antibiotic and it's the first of its kind. UTIs are the cause of roughly 8 million emergency room visits and 100,000 hospitalizations in the US each year, GSK said. They strike women more often than men. Blujepa works by interfering with two enzymes that bacteria need to copy themselves. Because its mechanism of action is targeted, it may cut down on the possibility that bacteria will become resistant to it, Wood said Monday during a call with reporters. In clinical trials with more than 3,000 women and teen girls, the drug - a pill taken twice daily - performed as well as or better than nitrofurantoin, the frontline antibiotic which is currently used to treat UTIs. Its main side effects were diarrhea, which affected 16% of patients in the clinical trial, and nausea, which affected 9% of participants. Most of these events were considered mild. Symptoms of UTIs include frequent urination that is painful or burns, bloody urine, low stomach cramps and the need to urinate even after having just gone.
