Biological E Limited (BE) announced that the CDSCO approved the Phase 3 infants clinical trial data and recommended for manufacture of its 14-valent paediatric vaccine against Streptococcus pneumoniae infection in single-dose and multidose presentations.
Hyderabad: Bharat Biotech International announced that its Covaxin has received emergency use approval in children aged between 6 and 12 years. It had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity Covaxin in healthy children and adolescents in the 2-18 age group. The clinical trials conducted in the paediatric […]
New Delhi: Amid the ongoing resurgence of new Covid-19 cases in the country, an expert panel of the Central Drugs Standard Control Organisation has approved two new vaccines and one anti-viral drug for restricted use in emergency situation. The CDSCO has granted the Emergency Use Authorization (EUA) to COVOVAX, developed by the Serum Institute of […]
Hyderabad: Explaining its 28 days open vial policy, Hyderabad-based Bharat Biotech on Monday stated that healthcare workers do not have to worry about opening Covaxin’s vial and its wastage. This means that an open Covaxin vial can be used up to 28 days post opening and would not go waste if there are no people […]
Hyderabad: The shelf life of Hyderabad-based Bharat Biotech’s Covid-19 vaccine, Covaxin, has been extended to 12 months from the present nine months by the Central Drugs Standard Control Organisation (CDSCO). “The CDSCO has approved the extension of shelf life of Covaxin up to 12 months, from the date of manufacture. This approval of shelf life […]
For vaccines to result in actual vaccination of people, highly coordinated efforts are required from international supply chains, manufacturers, regulators and State and Central government agencies, says Bharat Biotech
While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. Covaxin has generated excellent safety data with robust immune responses
The development came after the UK became the first country in the world to approve a coronavirus vaccine developed by Oxford University and AstraZeneca, even as it battled the new highly contagious variant of the coronavirus.