In an important development that could increase vaccine availability in India, Johnson & Johnson, the only manufacturer with a single-dose Covid-19 vaccine, has informed the Indian regulator that it will soon begin bridging clinical trials in the country. According to government sources, J&J will soon begin trials that will pave the way for its vaccine to be marketed in India. “Johnson & Johnson has informed the CDSCO (Central Drugs Standard Control Organization) that they will apply for approval to perform clinical bridging trials in India very soon.”
India is looking to increase vaccine doses, due to the high demand caused by the country’s second coronavirus outbreak, with many states reporting that stocks are running low. A bridging trial is a clinical trial in which the regulator requests that the company enroll a limited number of patients (around 1,000) in order to only determine the safety and immunogenicity of a vaccine. The effectiveness of a vaccine, which has already been proven in another clinical study, doesn’t have to be tested in the bridging trial. J&J’s bridging trial will be identical to Dr Reddy’s for the Russian vaccine Sputnik V and the Serum Institute of India’s for the AstraZeneca-Oxford vaccine.
J&J has partnered with Biological E in India to extend the manufacturing capabilities of its vaccine candidate. The Covid vaccine, developed by J&J’s Janssen Pharmaceutical Companies, received Emergency Use Authorization from the US regulators in February. The approval was based on data from a Phase 3 ensemble trial, which showed that the vaccine was 85 % effective in preventing serious disease across all regions tested — and 66 % to 72 % effective in preventing “moderate to severe” Covid — and that it provided protection against Covid-related hospitalisation and death starting 28 days after vaccination.
The company began distributing the single-shot vaccine toward the end of March, shortly after the United States announced a plan to vaccinate its entire adult population. Johnson & Johnson’s vaccine was granted emergency use authorization by the US Food and Drug Administration on February 27, and was added to the World Health Organization’s emergency use list, the following month. The approval was based on a trial conducted in the United States, South Africa, and Mexico. It had an overall efficacy of 66.3 % and a US efficacy of 74.4 %.
The Union Health Ministry recently confirmed that clinical trials for covid-19 vaccines for children are currently underway. “In the United States, Pfizer, Janssen, and Moderna are currently conducting trials in children 12 and older, with the aim of going lower. In the United Kingdom, Astra Zeneca is testing the vaccine on children aged 6 to 17. Novavax intends to conduct research on young children. Covaxin must apply interim efficacy data from adults to obtain approval for the trial in adolescents, but I believe they had a few children over the age of 12 in their phase 2 study,” said Dr Gagandeep Kang, vice-chair of the Coalition for Epidemic Preparedness Innovations (CEPI), a global non-profit assisting in vaccine production for the covid-19 pandemic, and professor at the Christian Medical College (CMC), Vellore, Tamil Nadu.
