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Bharat Biotech on Thursday said it has partnered with GSK plc for the development of a vaccine for Shigellosis, a severe form of bacterial diarrhoea. The altSonflex1-2-3 vaccine candidate, developed by GSK and now advancing through a strategic collaboration with Bharat Biotech, represents one of the most advanced Shigella vaccine candidates globally, the company said in a statement. With no licensed Shigella vaccine currently available and rising antimicrobial resistance, this candidate stands out for its broad serotype coverage, innovative Generalized Modules for Membrane Antigens (GMMA)-based platform, and robust early clinical results, it added. "With no approved vaccine currently available and antimicrobial resistance on the rise, there is an urgent need for scalable, science-backed solutions focused on low and middle-income countries," Bharat Biotech Executive Chairman Krishna Ella said. As part of this agreement, Bharat Biotech will lead the further development of ...
Bharat Biotech International Ltd on Wednesday said its oral Cholera Vaccine Hillchol has successfully completed phase III clinical trials. The vaccine maker, in a press release, said it has demonstrated against both Ogawa and Inaba serotypes, proving non-inferior in healthy Indian adults and children, supporting its potential as an effective OCV. Ogawa and Inaba are two serotypes of Vibrio cholerae O1, a bacterial species that causes cholera. The findings of a double-blind, randomized phase III clinical trial evaluating the safety, immunogenicity, non-inferiority, and lot-to-lot consistency of the Hillchol oral cholera vaccine, compared to a comparator vaccine, were recently published in a journal. The study involved 1,800 participants, ranging from infants to adults, across 10 clinical sites in India, the release said. The participants were divided into three age groups: adults over 18 years, children aged 5 to under 18 years, and infants aged 1 to under 5 years. They were randomi
Bharat Biotech on Wednesday announced a collaboration with Alopexx Inc for development and commercialisation of the latter's broad-spectrum anti-microbial vaccine in India and other low income countries. As part of the collaboration, the companies will co-develop and commercialise the vaccine -- AV0328, in India and other licensed territories, Bharat Biotech said in a statement. Alopexx would be entitled to a one-time upfront payment and milestone payments, as well as royalties on future sales of AV0328 in the licensed territories, it added. "Our goal is to develop solutions to reduce anti-microbial resistance through vaccination. This collaboration aligns with our mission to provide safe, affordable, and high-quality vaccines to combat infectious diseases globally," Bharat Biotech Executive Chairman Krishna Ella said. Alopexx CEO Daniel Vlock said, this collaboration brings the company one step closer to addressing the critical need for affordable, broad-spectrum antimicrobial ..
Bharat Biotech on Thursday asserted that its Covid-19 vaccine Covaxin is safe and devoid of any side-effects amid AstraZeneca's admission that Covishield could cause complications in rare cases. In a statement, the company stated that Covaxin was developed with a single-minded focus on safety first, followed by efficacy. The vaccine was evaluated in more than 27,000 subjects as part of its licensure process, Bharat Biotech stated. It was licensed under restricted use in clinical trial mode, where detailed safety reporting was carried out for several hundred thousand subjects, it noted. The vaccine was also evaluated by the Union Ministry of Health, it said. Besides, safety monitoring (pharmacovigilance) was continued throughout the product life cycle of Covaxin, it stated. All the above studies and safety follow-up activities have demonstrated an excellent safety record for Covaxin without any vaccine-associated incidents of blood clots, thrombocytopenia, TTS, VITT, pericarditis,