Johnson and Johnson (J&J) has submitted an application to the Drugs Controller General of India (DCGI) seeking permission to conduct a local bridging study of its single-dose Janssen COVID-19 vaccine in India, according to news reports. The multinational pharma has also sought permission for an import licence.
As of now, India has two vaccines for its citizens: Oxford/Astrazeneca vaccine COVISHIELD manufactured by Serum Institute in India. Besides this, there is the indigenously developed COVAXIN by Bharat Biotech. A third vaccine approved by the Indian drug regulator is Sputnik V which is developed in Russia. It will be imported and sold in India by Dr Reddy's Laboratories.
According to sources, Johnson & Johnson had applied on April 12 in the Global Clinical Trial Division through the Sugam online portal, instead of applying to the biological division which deals with vaccines and other biologicals. 'Due to the technicalities involved, Johnson & Johnson has resubmitted its application on Monday,' a source said.
Johnson & Johnson's vaccine is a single-dose jab, whereas the three vaccines cleared by India so far are of doubles doses. It can be stored for up to three months in a temperature between 2 and 8 degrees Celsius.
J&J’s single dose vaccine has been approved by USFDA in February. A bridge trial of a single dose vaccine like J&J's takes about two months, according to a report in Moneycontrol. The US paused the vaccination rollout, as it is investigating the link between the vaccine and a few cases of rare blood clots observed in people who are vaccinated with J&J jabs.
Last week, the central government decided to fast-track emergency approvals for all foreign produced coronavirus jabs that have been given a similar nod by the World Health Organization or regulators in the United States, Europe, Britain or Japan.
Such vaccines will be given emergency use approval mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial under the provisions of the New Drugs and Clinical Trials Rules 2019, the health ministry had said.