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Pfizer Inc. today announced data from a Phase 2 clinical study investigating its hexavalent capsular polysaccharide (CPS) conjugate Group B Streptococcus (GBS) vaccine candidate, GBS6.
This vaccine candidate is being developed for maternal administration to protect infants against invasive GBS disease.
In stage two of the three-part study, GBS6 generated robust maternal antibody responses against the six GBS CPS serotypes included in the vaccine, and these antibodies were efficiently transferred to infants at ratios of ~0.4-1.3 depending on the GBS6 group.
Based on a parallel natural history study conducted in South Africa, the Phase 2 study immunogenicity data suggest that GBS6 may offer meaningful protection against invasive GBS disease in newborns and young infants.
The results were published in an Original Article in The New England Journal of Medicine on July 20, 2023, and will inform a planned Phase 3 clinical development program.
“Group B Streptococcus can cause potentially devastating diseases in infants, including sepsis, pneumonia, and meningitis. Annually, there are nearly 400,000 cases of infant disease and approximately 138,000 stillbirths and infant deaths worldwide due to GBS,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a press release on July 19, 2023.
“Building on decades of expertise and knowledge in vaccines, we are committed to helping protect newborns and young infants through maternal immunization.”
The U.S. CDC says bacteria called group B Streptococcus cause GBS disease.
GBS bacteria commonly live in people’s gastrointestinal and genital tracts. The genital tract is the part of the body involved in reproduction and includes the vagina in women.
Sometimes the bacteria invade the body and cause certain infections, which are known as GBS disease.
The Texas Department of State Health Services (DHSHS) today announced that no-cost health clinics will be available for residents of South Texas next week.
Operation Border Health Preparedness (OBHP) will operate in the Rio Grand Valley from July 24-28, 2023.
OBHP services will include immunizations for children and adults, medical exams, student sports physicals, health and diabetes screenings, dental and vision exams, and prescription glasses from a mobile lab.
In 2022, OBHP provided 30,031 health services to about 6,400 patients.
“Operation Border Health Preparedness allows DSHS and its partners to develop and refine their emergency response actions while also providing no-cost healthcare options for many South Texas residents who may face challenges receiving health care,” said DSHS Commissioner Jennifer Shuford, MD, MPH, in a media statement on July 20, 2023.
“For some (Texas) residents, this may be their only time to visit with a doctor this year.”
Services vary by location, so the public can visit dshs.texas.gov/obhp2023 or call 2-1-1 to confirm which services are offered at a specific Texas location.
Vir Biotechnology, Inc. today announced that the Phase 2 clinical trial (PENINSULA) evaluating VIR-2482 for preventing symptomatic influenza A illness did not meet primary or secondary efficacy endpoints.
In participants who received the highest dose of the investigational hemagglutinin-targeting monoclonal antibody (mAb) VIR-2482 (1,200 mg), a non-statistically significant reduction of approximately 16% in influenza A protocol-defined illness was observed.
And participants who received the highest dose showed an approximately 57% reduction in symptomatic influenza A illness when defined according to U.S. CDC influenza-like-illness criteria, which was one of two secondary endpoints.
VIR-2482 was generally well tolerated, and no safety signals were identified.
“We are grateful to all who participated in this trial, and we remain committed to the pursuit of novel therapies that have the potential to address some of the world’s most serious infectious diseases,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer, in a press release issued on July 2023.
The PENINSULA trial has been supported in whole or in part with federal funds from the Department of Health and Human Services, the Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority.
As of July 20, 2023, about 95 million influenza vaccines were being distributed in the U.S. The U.S. CDC recommends an annual flu shot for most people, which is offered at most health clinics and community pharmacies in the U.S.
The Lancet Global Health published an early-release study funded by Unitaid that estimated preventive tuberculosis (TB) treatments offered to people with HIV/AIDS (PLWHA) and household contacts of newly diagnosed TB patients could save nearly 850,000 lives by 2035.
People living in close contact with a person with TB disease are at highest risk of infection, accounting for a significant percentage of the 10.6 million new TB infections yearly.
These researchers wrote on July 18, 2023, that the costs of scaling up a TB preventive treatment (TPT) program, including TPT drugs and investigation to rule out active disease, are a major barrier to implementing TPT guidelines and allocating resources.
This study found implementing short-course TPT is likely cost-effective for people living with HIV/AIDS, including child and adult contacts in most countries.
Between 2023 and 2035, scaling up TPT prevented 0.9 (95% uncertainty interval) people from developing TB and 0.13 (0·05–0·27) TB deaths per 100 PLWHA at an incremental cost of $15 per PLWHA.
“The imperative for TB prevention is clear,” said Vincent Bretin, Director of Results at Unitaid, in a related press release.
“This cost-effectiveness analysis proves that preemptively reaching all at-risk individuals – even when it requires the logistical hurdles of going into communities to find those who may not be actively seeking care – is not just ethically sound. It is a smart investment capable of making an enormous impact on the fight to end TB worldwide.”
Previous studies found deploying the 100-year-old BCG vaccine with children offered ample protection against TB and would save billions in healthcare costs.
As of July 2023, over 14 types of BCG vaccines are in use globally. In the U.S., the BCG vaccine is considered for people who meet specific criteria.
Since the beginning of 2023, dengue outbreaks of significant magnitude have been recorded in the WHO Region of the Americas, with close to three million suspected and confirmed cases of dengue reported as of July 19, 2023.
This total surpassed the 2.8 million cases of dengue registered for the entire year of 2022.
The WHO has assessed the risk of dengue as high at the regional level since all four dengue virus serotypes are present in the Region of the Americas.
One example of these dengue outbreaks is Costa Rica.
As of EW #25, there have been 2,712 reported dengue cases, which is 16% higher compared to the same period in 2022 and 19% higher compared to the average of the last five years.
Almost half of the world’s population, about 4 billion people, live in areas with a risk of dengue. Dengue is often a leading cause of illness in areas with risk, says the U.S. CDC.
In the U.S., Florida continues to report both locally-acquired and travel-related dengue cases in July 2023.
Symptoms can be mild or severe for people who get sick with dengue. However, severe dengue can be life-threatening within a few hours and often requires care at a hospital.
Dengue viruses are spread to people through the bite of an infected Aedes mosquito.
The WHO does not recommend travel restrictions for countries in the Americas experiencing dengue epidemics based on the currently available information.
From a disease prevention perspective, two approved dengue vaccines (Qdenga and Dengvaxia) are available in certain countries in 2023.
VBI Vaccines Inc. today announced that the PreHevbri® vaccine is now available in the Netherlands and Belgium for active immunization against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults.
It is the only approved 3-antigen hepatitis B vaccine for adults in the Netherlands and Belgium.
As part of the partnership announced in September 2022, PreHevbri is available through France-based Valneva SE's commercial infrastructure and distribution networks.
PreHevbri (PreHevbrio™, Sci-B-Vac®) can be expected that hepatitis D will also be prevented by immunization with PreHevbri as hepatitis D does not occur without hepatitis B infection.
Jeff Baxter, President and CEO of VBI, commented in a press release on July 19, 2023, "Over the next several months, we expect to continue to expand global access to PreHevbri with additional market launches as we work to make an impact in the fight against hepatitis B worldwide."
This HBV vaccine is currently available in the U.S., Europe, the U.K., and Israel.
Hepatitis B is one of the world's most significant infectious disease threats, with more than 290 million people infected globally. It is the leading cause of liver disease, about 25%, and is tough to cure, says the U.S. CDC.
Furthermore, women with hepatitis B can transmit the virus to their newborns during birth. If not vaccinated, 90% of infants infected with HBV at birth will progress to chronic HBV infections.
Emergex Vaccines Holding Limited today announced the successful completion of naNO-COVID, a Phase I clinical trial investigating the safety and reactogenicity of CoronaTcP™ in healthy volunteers.
CoronaTcP is Emergex's multi-target T cell-priming set-point product, designed to be broadly effective against diseases caused by betacoronaviruses, including SARS-CoV-1 and SARS-CoV-2 variants.
Cellular analyses demonstrated that CoronaTcP (two doses administered at Day 0 and 21) was able to activate virus-specific CD8+ T cells, with a significant increase in frequencies of CoronaTcP-specific CD8+ CD137+ CD69+ cells following in vitro antigenic stimulation in both low and high dose CoronaTcP groups at Day 35 post-treatment.
Significant changes were also observed for several virus-specific CD8+ memory subsets.
Professor Thomas Rademacher, Co-Founder and Chief Executive Officer of Emergex, said in a press release on July 19, 2023, Demonstrating that our platform has an acceptable safety profile and successfully mobilizes specific T cells that may elicit broad and long-term immune memory, validates our approach."
"By improving T cell-based immunity, we can enhance any previous immune status. We are delighted that this first assessment of treatment against infectious diseases for clinical use, based solely on a T cell response, was successful."
Overall, Phase I trial data validate Emergex's T cell-based approach to protection against RNA viruses and confirm the platform's potential using this innovative technology, supporting the investigation of other T cell-priming immune set-point candidates from the same platform.
In secondary immunogenicity analyses, several participants seroconverted during the trial (due to exposure to SARS-CoV-2) but had mild symptoms, confirming that CoronaTcP does not worsen an acute episode of COVID-19.
The naNO-COVID trial was a Phase I double-blind, randomized, base particle-controlled, single-center study designed to evaluate the safety and reactogenicity of two intradermal injections of an anti-Betacoronavirus candidate.
