US pharma major Johnson & Johnson will begin clinical trials of its single-shot vaccine in India soon
The pharma major has written a letter to the Indian regulator Central Drugs Standard Control Organisation(CDSCO) mentioning that the company would soon be seeking its permission to begin the bridging clinical trials in India.
In a crucial development US pharma major Johnson & Johnson’s Coronavirus vaccine will soon be starting clinical trials in India and start its production after the completion of clinical trials. The arrival of another Coronavirus vaccine could bring huge relief as the country is struggling with the unprecedented rise in the number of Coronavirus cases in the country during the second wave. With many states ramping up vaccination, the shortfall of vaccine doses could also emerge as a new challenge. Johnson & Johnson according to an Indian Express report has expressed its intent to the Indian regulator to start the bridging clinical trials in India. The pharma major has written a letter to the Indian regulator Central Drugs Standard Control Organisation(CDSCO) mentioning that the company would soon be seeking its permission to begin the bridging clinical trials in India.
What distinguishes a bridging clinical trial from a full-fledged clinical trial of the vaccine is the small number of participants who are administered the vaccine to establish its safety and immunogenicity. Since the Johnson & Johnson’s vaccine has already been approved by the US regulator, a small bridging trial on about 1,000 participants would be enough before it is given the approval to manufacture the vaccine in India. The bridging trial for the J&J’s vaccine is expected to pan out on similar lines as that being conducted of the Russian Covid19 vaccine Sputnik V by Dr Reddy’s and the trial conducted by Serum for the Oxford University-AstraZeneca Coronavirus vaccine.
According to The Indian Express report, Johnson & Johnson has tied up with the Indian company Biological E to conduct the vaccine trials and later set off the vaccine manufacturing. The Johnson & Johnson vaccine was given emergency approval by the US regulator in February after the clinical data showed the vaccine efficacy of about 85% in preventing the severity of the disease. The vaccine had also shown effectiveness in preventing hospitalisation and mortality of Covid-19 patients. One of the other most important advantages of the Johnson & Johnson vaccine is the fact that it is a single-dose vaccine and could be administered more effectively and quickly among the large uncovered population of the country.