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Escherichia coli (E. coli) is a harmful bacteria that poses a severe threat to newborns, causing neonatal sepsis infections that can be life-threatening. Given the underdeveloped immune systems of newborns, they are particularly vulnerable to such infections.
The risk of death from neonatal sepsis increases by 7.6% every hour a treatment is delayed.
However, there is currently no vaccine available for pregnant women to prevent this medical issue.
In an attempt to fill this void, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has taken an assertive stance by announcing $467k funding for GlyProVac to develop a maternal vaccine (GPV02) that targets E. coli.
This strategic move will help combat this bacterial species and save the lives of many newborns at risk of these severe infections.
GPV02 uses a selected bacterial protein, naturally decorated with small sugar molecules, to trigger an immune response for protection. This approach differs from previous attempts to develop protein-based bacterial vaccines since it involves specific natural sugar modifications previously undiscovered.
GlyProVac uses BEMAP technology to ensure that GPV02 correctly imitates E. coli, thus preparing the immune system to recognize the bacterium when an infection occurs.
Erin Duffy, Ph.D., R&D Chief of CARB-X, commented in a press release on February 29, 2024, "Because newborns at risk for neonatal sepsis are too young to be immunized, the vaccine would be administered to expectant mothers and target bacteria that cause neonatal bloodstream infections in babies."
"The vaccinated mothers would pass antibodies on to their babies in utero and through breastmilk after birth to strengthen their newborns' immune systems, helping them ward off infections."
The BARNARDS study estimated that 2.5 million neonates or infants in the first month of life die annually of sepsis, with the most significant burden in low- and middle-income countries. Since neonatal sepsis progresses rapidly, it requires immediate treatment with IV fluids and antibiotics.
GlyProVac is a research and development company from the University of Southern Denmark in Odense committed to reducing bacterial infections and antimicrobial resistance worldwide.
CytoDyn Inc., a biotechnology company developing leronlimab, a CCR5 antagonist, announced that the U.S. Food and Drug Administration (FDA) has lifted its clinical hold on leronlimab.
According to a press release on February 29, 2024, the Company is now free to proceed with its proposed HIV clinical trial exploring leronlimab and its effects on chronic inflammation.
The FDA placed a partial clinical hold on the Company's HIV program on March 30, 2022.
CytoDyn's CEO, Dr. Jacob Lalezari, commented, "CytoDyn is grateful for the FDA's guidance on our (HIV) protocol, and we are excited to open a new chapter in the development of leronlimab as a therapy that provides clinical benefit by modulating chronic inflammation."
Leronlimab is a humanized monoclonal antibody that is a once-a-week subcutaneous injection that can also be administered intravenously.
However, it is not a traditional HIV vaccine candidate.
It is a competitive rather than allosteric inhibitor of the CCR5 receptor. This mechanism of action of binding competitively to the CCR5 receptor differentiates leronlimab from all other CCR5 antagonists.
The CCR5 receptor is a protein located on the surface of various cells, including white blood cells, stellate cells that produce scar tissue in the liver, and cells that undergo malignant transformation. It is the predominant co-receptor needed for certain strains of HIV to infect healthy T-cells.
The CCR5 receptor serves as a receptor for chemical attractants called chemokines. Chemokines are the key orchestrators of leukocyte trafficking by attracting immune cells to the sites of inflammation.
For HIV, leronlimab is a viral-entry inhibitor, protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells.
Dr. Lalezari plans to host a webcast on Tuesday, March 5, 2024, to provide a Company update. The update will include discussing the Company's clinical trial goals and expectations, upcoming publications, and overall development strategy.
The global measles outbreak continued to impact people in England during late February 2024. Over the past decade, the uptake levels of childhood vaccines offered in England have been falling across all vaccines, including measles.
Data show more than 3.4 million children in England are either unprotected or not fully protected and at risk of catching completely preventable diseases.
According to the UK Health Security Agency, 69 additional laboratory-confirmed measles cases have been confirmed in England since one week ago.
As of March 1, 2024, the total number of measles cases confirmed since October 2023 is now 650.
Sixty-three percent (410 of 650) of these measles cases have been in the West Midlands, 15% in London, and 7% in Yorkshire and The Humber. The remaining cases were reported in other regions of England.
To change the trajectory of this measles outbreak, the UKHSA is launching a Childhood Immunisations national marketing campaign on March 4, 2024.
Professor Dame Jenny Harries, Chief Executive of UKHSA, said in a media release, "We need an urgent reversal of the decline in the uptake of childhood vaccinations to protect our communities. Through this campaign, we particularly appeal to parents to check their children's vaccination status and book appointments if their children have missed any immunizations."
"The ongoing measles outbreak we are seeing is a reminder of the very present threat."
"Unless uptake improves, we will start to see the diseases vaccines protect against re-emerging and causing more serious illness."
The UKHSA is co-ordinating its national marketing campaign with an operational measles, mumps, and rubella (MMR) catch-up campaign to counter this decline.
Areas with low uptake will be a focus for support and parents of children aged six to 11 years will be contacted directly and urged to make an appointment with their child's GP practice for any missed MMR vaccines.
In 2023, two million texts, emails, and letters were sent to parents and carers of 1-5-year-olds who were unvaccinated, and thanks to those efforts, 165,000 doses of MMR vaccine were delivered.
A new survey published in the journal Vaccine revealed about 68% of parents in high- and emerging-incidence states would vaccinate their children against Lyme disease.
With Lyme disease vaccines approaching approval, there appears to be significant consumer demand in some U.S. states.
Announced on February 28, 2024, this survey found addressing safety concerns important, and a healthcare provider recommendation could also encourage those unsure or unwilling to be vaccinated.
Given the slight preference for monoclonal antibody passive immunization over-vaccination, particularly in rural areas, access to both may increase Lyme disease prevention.
Initially developed by Valneva SE, the VLA15 Lyme disease vaccine candidate development program was granted Fast Track designation by the U.S. Food and Drug Administration in 2017.
The journal The Lancet Infectious Diseases published results from a Jully 2023 study that concluded Valneva's novel multivalent Lyme vaccine candidate was safe and immunogenic.
VLA15 is currently in advanced phase 3 clinical study.
The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend that individuals aged 65 and older receive an additional dose of 2023-2024 Formula COVID-19 vaccine four months after receiving the last dose.
According to a Novavax Inc. press release on February 28, 2024, while today's recommendation focuses on protection for older adults at increased risk of COVID-19, information shared at this ACIP meeting also reinforces the ongoing benefit of vaccination for all eligible.
Data from clinical trials continue to show broad long-lived neutralization responses to currently circulating forward-drift variants, including JN.1 and JN.4, for Novavax's protein-based non-mRNA COVID-19 vaccine while maintaining a favorable side effect profile.
Peer-reviewed real-world effectiveness data that shows the immune responses seen in our trials translate into COVID-19 prevention in the real world is being published.
Those interested in a non-mRNA protein-based vaccine should ask their pharmacists about the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) at major retail pharmacies nationwide, including, but not limited to, Albertsons, CVS Pharmacy and Rite Aid.
Vaccine doses can also be located at us.novavaxcovidvaccine.com or vaccines.gov.
Novavax's Nuvaxovid™ XBB.1.5 is one of 13 COVID-19 vaccines the World Health Organization listed as of early 2024.
The Advisory Committee on Immunization Practices (ACIP) is scheduled to review this draft agenda today at 8 AM EST. This two-day ACIP meeting includes digital access; no registration is required to watch the webcasts.
On the agenda, vaccines to be discussed include COVID-19, Chikyngyna, Influenza, Polio and others.
As previously announced, the ACIP has undergone significant member changes in 2024.
The ACIP develops recommendations for U.S. immunizations, including ages when vaccines should be given, number of doses, time between doses, and precautions and contraindications.
Recent ACIP meeting recommendations are available at this link.
These recommendations are subject to the approval of the U.S. Centers for Disease Control and Prevention director, Dr. Mandy Krauthamer Cohen.
