Multinational pharma large Johnson & Johnson has utilized to India’s drug regulator in search of permission to conduct phase-3 medical trial of its single-dose COVID-19 vaccine in India in addition to import licence, sources mentioned.
They mentioned the corporate has sought an early assembly of the topic professional committee on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) to take a choice on its utility.
This comes near the heels of the central authorities final week deciding to fast-track emergency approvals for all international produced coronavirus jabs which have been given the same nod by the World Health Organization or regulators within the United States, Europe, Britain or Japan.
Such vaccines will probably be given emergency use approval mandating the requirement of post-approval parallel bridging medical trial instead of conduct of native medical trial underneath the provisions of the New Drugs and Clinical Trials Rules 2019, the well being ministry had mentioned.
According to sources, Johnson & Johnson had utilized on April 12 within the Global Clinical Trial Division by means of the Sugam on-line portal, as a substitute of making use of to the organic division which offers with vaccines and different biologicals.
“Due to the technicalities concerned, Johnson & Johnson has resubmitted its utility on Monday,” a supply mentioned.
The J&J vaccine could be saved for as much as three months in a temperature between 2 and eight levels Celsius.
Johnson & Johnson’s vaccine is a single-dose jab, whereas the three vaccines cleared by India thus far are of doubles doses.
So far, two vaccines — Oxford/Astrazeneca vaccine COVISHIELD manufactured by Serum Institute in India and indigenously developed COVAXIN by Bharat Biotech — are being administered in India, whereas a 3rd vaccine Sputnik V — developed in Russia and to be imported and bought in India by Dr Reddy’s Laboratories — has additionally been accredited by the Indian drug regulator.
The authorities, in the meantime, on Monday determined to broaden its vaccination drive by permitting everybody above 18 years of age eligible to be vaccinated from May 1 and permitted state governments, personal hospitals and industrial institutions to obtain the doses straight from producers.