A new study published in BMJ Global Health has revealed that over 500,000 deaths associated with antimicrobial resistance (AMR) could be averted each year with the effective use of existing vaccines and continued development of new vaccines to tackle priority pathogens. The modelling study, Global and regional burden of attributable and associated bacterial antimicrobial resistance avertable by vaccination, was carried out by the World Health Organization (WHO), the International Vaccine Institute, Korea (IVI) and the London School of Hygiene and Tropical Medicine. AMR occurs when bacteria, viruses, fungi and parasites change over time and become resistant to medicines. The condition has been declared by WHO as one of the top ten global threats to global public health, associated with around 4.95 million deaths globally per year. Science has been playing catch-up to mitigate AMR due to the strain that was faced by health systems worldwide throughout the COVID-19 pandemic. Using ...
Merck and Moderna announced Wednesday the initiation of a pivotal Phase III high-risk melanoma trial combining the companies’ mRNA-based personalized cancer vaccine with Merck’s blockbuster Keytruda checkpoint inhibitor. After a successful Phase IIb in stage III/IV melanoma patients with high risk of recurrence after surgery, Phase III is expanding the population to include stage IIb-IV patients. The study will enroll around 1,089 patients at more than 165 sites and in over 25 countries. The primary endpoint is recurrence-free survival. Secondary endpoints include distant metastasis-free survival and overall survival. Patients will receive either V940 (mRNA-4157), being co-developed and commercialized by Merck and Moderna, in combination with Keytruda or Keytruda alone for comparison. Phase IIb results shared earlier this year showed the cancer vaccine combined with Keytruda reduced risk of recurrence or death by 44% compared to Keytruda alone. Additional data in June 2023 showed the vaccine combo reduced risk of distant metastasis or death by 65% over ...
Pictured: Respiratory syncytial virus vial and syringe/iStock, Manjurul Bavarian Nordic’s portfolio has taken a hit as the company announced Saturday its respiratory syncytial virus vaccine candidate did not meet all primary endpoints in a Phase III study in older adults. While the vaccine candidate showed 59% efficacy in preventing at least two pre-defined lower respiratory tract disease (LRTD) symptoms from RSV, that number dropped to below the co-primary endpoint for severe LRTD in patients 60 and older. With the miss, Bavarian Nordic is discontinuing its RSV program. The decision also terminates its partnership with Nuance Pharma and chance for the coupled milestone payments of 195 million Danish kroner for developing and launching in select Asian markets. Bavarian Nordic CEO Paul Chaplin said in the release that the outcome was “unexpected” and will impact short-term growth expectations. However, the company said there is no impact on the financial guidance ...
The respiratory syncytial virus (RSV) vaccine arena lost a competitor on Saturday 21 July after Danish company Bavarian Nordic shelved its programme following missed endpoints in a Phase III trial. The candidate, named MVA-BN RSV, failed to meet the co-primary endpoint of severe lower respiratory tract disease (LRTD) based on at least three pre-defined symptoms, only demonstrating a 42.9% efficacy. The vaccine did, however, have a 59% efficacy in preventing at least two pre-defined LRTD symptoms. The randomised, double-blind Phase III trial (NCT05238025) involved 20,000 older adults across centres in the US and Germany. As a result of the programme termination, Bavarian Nordic has also ended its partnership with Nuance Pharma, a Chinese pharma company brought in to develop and launch the vaccine for Asian markets. Although Bavarian Nordic’s president and CEO Paul Chaplin said in a statement that the blow would impact short-term growth, ...
Pictured: Flu vaccine vials and syringe/iStock, vchal Topline data from the Phase II PENINSULA study showed that Vir Biotechnology’s investigational flu shot VIR-2482 fell short of its primary and all secondary efficacy endpoints, the biotech announced Thursday. Patients inoculated with the highest 1,200-mg dose of the vaccine candidate saw a 16% drop in influenza A-like illness as compared with placebo, an effect that did not satisfy statistical significance, according to Vir’s news release. PENINSULA defined this primary endpoint as PCR-confirmed influenza A infection with at least one respiratory and one systemic symptom. Phil Pang, Vir’s chief medical officer, called these findings “disappointing” in a statement, but nevertheless said that the company needs to conduct further analysis to “better understand these outcomes.” Vir plans to present these analyses at a future major medical congress. PENINSULA is double-blinded, randomized and placebo-controlled study with approximately 3,000 adult patients enrolled. VIR-2482 was given as a ...
Pictured: GSK headquarters office in Poland/iStock, Wirestock GSK has licensed out its Shigella vaccine candidate to LimmaTech Biologics, giving the Swiss biotech rights to further develop and eventually commercialize the quadrivalent bioconjugate investigational vaccine, the companies announced Thursday. LimmaTech is aiming to complete the Phase I/II clinical trial for this quadrivalent candidate and post data from this study within the year. The investigational Shigella shot joined GSK’s portfolio in 2015, when the pharma giant bought Swiss vaccine specialist GlycoVaxyn for $190 million. Aside from shigellosis, the disease caused by Shigella bacteria, GlycoVaxyn also handed over early-stage vaccines for pneumonia and infectious conditions caused by Pseudomonas bacteria and Staphylococcus aureus. LimmaTech spun out of this acquisition and started its operations in August of the same year. The clinical-stage biotech is focused on engineering complex carbohydrate molecules to come up with next-generation vaccine candidates. It has since signed partnerships with GSK for its Shigella and Klebsiella development programs. ...
Pfizer on Wednesday said its experimental vaccine targeting the potentially deadly bacterial disease Group B Streptococcus returned strong mid-stage clinical trial results, a promising step as the drug inches toward potential approval. Pfizer is among several drugmakers racing to develop the world’s first shot targeting Group B strep disease, which is linked to nearly 150,000 infant deaths worldwide each year, especially in lower-income countries. The Food and Drug Administration in September granted breakthrough therapy designation to Pfizer’s vaccine, which is intended to expedite the development and review of the shot. Pfizer’s single-dose shot generated antibodies that may provide infants with meaningful protection against the disease, according to the data released Wednesday from a phase two clinical trial. The jab is administered to expectant mothers, who pass vaccine-induced antibodies to their fetuses. One of the company’s vaccines targeting respiratory syncytial virus also uses that maternal vaccination method. ...
Recently, Zhejiang Pukang Biotechnology Co., Ltd. has completed the Phase IV clinical trial titled “Single-Arm, Multi-Center Evaluation of the Safety and Immunogenicity of Freeze-Dried Live Attenuated Hepatitis A Vaccine in Chinese Children Aged 18-24 Months” and received the final report. This Phase IV clinical study, involving a large sample size of 10,000 cases across multiple centers, aimed to observe the safety and immunogenicity of the freeze-dried live attenuated Hepatitis A vaccine in the real world. The study results show that after a single dose of the vaccine, the AEFI incidence rate in the 18-24 month-old children was 0.34%, with no serious AEFI reported, and an antibody seroconversion rate of 98.91%. This confirms the vaccine’s good safety and immunogenicity profile, providing richer data support for its widespread application. The freeze-dried live attenuated Hepatitis A vaccine (H2 strain), developed and produced by Zhejiang Pukang Biotechnology Co., Ltd., simulates ...
CureVac is adding fuel to its COVID-19 vaccine patent fire by asserting more claims against Pfizer and BioNTech in both its U.S. and German cases. The German mRNA specialist put a tenth patent on the table in its U.S. litigation and three more to its five in Germany, expanding the scope of the disputes. CureVac went after BioNTech in Germany last summer, starting off with four claims and adding a fifth in May. The original patents it claimed its fellow German mRNA maker stepped on related to inventions considered “essential to the design and development” of BioNTech and Pfizer’s Comirnaty, including sequence modifications and mRNA vaccine formulations, the company noted in a statement at the time. Its lawsuit doesn’t aim to stop the production and distribution of the shot but wants recognition and royalties from past and future sales. That likely puts $500 million on the line, Berenberg Capital Markets analyst Zhiqiang ...
The NHS has announced that almost a million more people (900,000) will become eligible for a shingles vaccination with the newly available vaccine, Shingrix, starting in September. The decision was made after the Joint Committee on Vaccination and Immunisation (JCVI) recommended that the Shingrix vaccine be given to a wider cohort of people after trials showed that the vaccine was highly effective and safe for people in those groups. Shingles is an infection that can occur at any age. It causes a rash that can be extremely painful and the pain can remain for many years after the rash has disappeared. Although it cannot be transmitted from other people, it develops in people who have previously been infected with chickenpox over their lifetime. Studies have shown that nine out of ten adults are already infected with the virus that causes shingles, and around one in four ...
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