BCG vaccine(Max Planck Institute For Infection Biology)

The vaccine candidate VPM1002 shows its safety in a study with HIV- and non-HIV-exposed newborns. No other infectious disease has killed more people than tuberculosis. Currently, only one vaccine is available to prevent severe courses: Bacillus Calmette Guérin (BCG). However, it is not equally effective against all types of tuberculosis. Especially infants and immunocompromised patients are therefore in urgent need for more effective tuberculosis vaccines. A clinical trial in South Africa has now shown that the new vaccine candidate VPM1002, developed by Max Planck researcher Stefan H.E. Kaufmann and his team, is equally safe for newborns with and without HIV exposure and has fewer side effects compared to BCG. At least 20 million people worldwide suffer from tuberculosis, according to World Health Organization (WHO), with 10 million new cases every year and about 1.5 million deaths annually. The disease is caused by mycobacteria, which predominantly affect the lungs, but can also infect any other organ. Tuberculosis is particularly common in low income countries. Here, the WHO recommends that newborns be immunized against it as soon as possible. First used 100 years ago, the BCG vaccine against the disease contains attenuated pathogens of cattle tuberculosis. "We know that BCG can prevent so-called tuberculous meningitis and miliary tuberculosis in infants with a 75 to 86 percent effectiveness rate. But this is not the case for the most common form of the disease, pulmonary tuberculosis, in all age groups. Here, BCG is only insufficiently effective," explains Kaufmann, Emeritus Director at the Max Planck Institute for Multidisciplinary Sciences in Göttingen and the Max Planck Institute for Infection Biology in Berlin. Since the 1990s, the infection biologist and his team have been working on an improved next-generation vaccine, called VPM1002. To achieve this, the researchers genetically modified the attenuated BCG vaccine strain so that immune cells can better recognize the pathogens. "We developed VPM1002 in no small part to combine increased safety with improved efficacy for immunocompromised children," the Max Planck researcher reports. Vaccine candidate VPM1002 is safe The group of immunocompromised children includes, for example, HIV-exposed infants born to HIV-positive mothers. In a clinical trial in South Africa, an international research consortium including Kaufmann has now compared VPM1002 with BCG in HIV-exposed and non-HIV-exposed newborns. The study examined both the safety and the immune response induced -- called immunogenicity -- associated with the formation of immune cells and immunostimulatory proteins. The conclusion of the study: VPM1002 is safe in both HIV-exposed and non-HIV-exposed newborns, has fewer side effects than BCG, and elicits a similar immune response. In the randomized phase II double-blind study in South Africa, 416 eligible newborns were randomly selected and vaccinated before day 12 of life. 312 of them received VPM1002, and 104 received the BCG vaccine. As the study showed, VPM1002 triggered fewer vaccine-related adverse reactions than BCG. This was true for reactions occurring at the injection site, such as scarring and abscess formation, as well as enlargement of lymph nodes. This finding is important because local and regional reactions after vaccination are among the limitations of the BCG vaccine, Kaufmann points out. Newborns with or without HIV exposure showed similar immunogenicity with both vaccines. However, starting at six weeks of age, the BCG-triggered immune response was greater than in even younger infants. Phase III study investigates protection "Studies such as those described here examine a vaccine's immunogenicity, but not its protection. For the latter, we have already developed a larger phase III clinical trial and have successfully enrolled mothers with their newborns to participate. Now the clock is ticking," Kaufmann said. The infectious biologist expects initial results showing whether VPM1002 can provide comparable or better protection than existing BCG vaccines in about three years. In addition, the VPM1002 vaccine is currently evaluated in adults in two other phase III clinical trials in India for protection against tuberculosis. These trials are expected to be completed in 2023 and 2024, respectively. The Max Planck Society licensed the VPM1002 vaccine to the company Vakzine Projekt Management (VPM) in 2004. Starting in 2012, the company continued to develop the vaccine in collaboration with the Serum Institute of India, one of the world's largest vaccine manufacturers. "Serum Institute of India is giving access to a unique solution for tuberculosis elimination by detect-treat-prevent strategy. VPM1002 is a unique component of this strategy, and it will help in preventing infection and disease. The ongoing phase III trial is one of the key trials in order to strengthen our scientific rationale. Pleased to see that we have completed recruitment of all infants in such an important trial," said Umesh Shaligram, Executive Director R&D of Serum Institute of India.

Health Canada releases VERITY-BCG™ bladder cancer treatment for distribution TORONTO, Sept. 9, 2021 /CNW/ - Verity Pharmaceuticals Inc. is pleased to announce that it has received approval to begin distributing VERITY-BCG™ (Bacillus Calmette-Guérin [BCG]: Strain Russian BCG-I). This approval means that hospitals and clinics across Canada will no longer see shortages of this critical drug. "Our patient community has faced the stress of realizing that there has been a shortage of BCG, which has resulted in a drug rationing approach at many institutions across Canada," said Ferg Devins, Survivor and Volunteer Chair of Bladder Cancer Canada. "This announcement is truly a relief for all of us who have faced uncertainty resulting from this long term shortage. We are delighted that Health Canada has finally approved another supplier of BCG in Canada. It will greatly improve patient care," added Devins. Bacillus Calmette-Guérin (BCG) is a proven immunotherapy of choice for bladder cancer. It is used as first-line intravesical therapy following tumor resection of non–muscle-invasive bladder cancer. Several large pharmaceutical manufacturers of BCG announced shortages within the last decade or stopped production altogether, leading to a worldwide scarcity of the treatment. Verity partnered with Serum Institute of India, which manufactures BCG. Serum Institute is the world's largest manufacturer of vaccines. "Increasing global usage and demand of BCG has resulted in a limited and erratic supply for decades and Canada has had just one supplier since 2016," said Howard Glase, Chief Executive Officer, Verity Pharma. "With the addition of VERITY-BCG to the Canadian healthcare system, Canada becomes the first country in the western world to solve the BCG shortage crisis. VERITY-BCG is an example of our expertise in supplying life-saving therapeutic options to help fulfill unmet patient needs." Bladder Cancer Canada states that bladder cancer is the fifth most common cancer in Canada and that almost 12,000 people will be diagnosed with bladder cancer this year alone. "BCG is a proven and effective adjunct to transurethral resection (TUR) and the gold standard of care," said Dr. Alexandre Zlotta, Department of Surgery, Division of Urology, University of Toronto. "It is used to help keep the cancer from coming back and potentially becoming life-threatening. It is also the best known immuno-oncological agent, used the last three decades. However, in the last years, BCG shortages were leading to rationing and dose reduction of this crucial bladder cancer drug with unfortunate impact on outcomes. Patients had delayed or sometimes even cancelled treatments. With the availability of VERITY-BCG, Canada's multi-year BCG drug shortage will be a thing of the past as Canadian patients will now have full access to this well-established, safe and efficacious therapy. It will also foster further scientific studies and research." Amit Thatte, Director of Serum Institute Inc, said the facility supplies BCG for bladder cancer instillations to more than 21 countries around the world. "As the manufacturer of the product, we are very pleased to partner with Verity Pharma for the approval and supply of Verity BCG to Canada." he said. "Serum Institute is the world's largest vaccine manufacturer by number of doses produced and sold globally and we take great pride in delivering a safe, efficacious, high-quality product to all of our partners. Our world-class research and production facilities are continuously upgraded to ensure compliance with all regulations and have been accredited by the World Health Organization. We are very happy to have our partnership with Verity Pharma and look forward to providing this life-saving therapy to Canada for years to come." Ajay Bisaria, High Commissioner of India to Canada, welcomed the announcement. "India is proud to support this effort to resolve the shortage of BCG in Canada," he said. "With more than 60 percent of global vaccine manufacturing capacity, India believes in vaccine internationalism. This collaboration between the Serum Institute of India and Verity Pharma is a clear demonstration of our commitment to global health." About VERITY-BCG™ VERITY-BCG™ is an adjuvant therapy after transurethral resection (TUR) of a primary or relapsing superficial papillary urothelial cell carcinoma of the bladder stage Ta (grade 2 or 3) or T1 (grade 1, 2, or 3), without concomitant carcinoma in situ. It is only recommended for stage Ta grade 1 papillary tumors, when there is judged to be a high risk (>50%) of tumor recurrence. More information is available here: Contact information for HCP questions: Email: medinfo@veritypharma.com Phone: 1-800-977-9778 About Verity Pharmaceuticals Inc. Founded in Canada and owned by Canadians, and with a head office in Mississauga, Ontario, Verity Pharmaceuticals is a specialty pharmaceutical company focused on providing therapeutically relevant agents to the Canadian healthcare community. Our mission is to provide access to prescription products that are in short supply or have not yet been made available in Canada. Verity Pharmaceuticals works with best-in-class global pharmaceutical manufacturing partners to ensure that product quality and availability is a constant deliverable. We are also committed to supporting programs, initiatives and organizations that help improve health, expand research opportunities, and promote education within the Canadian healthcare community. Visit: SOURCE Verity