New Delhi: Multinational pharma giant Johnson & Johnson has applied to India’s drug regulator Central Drugs Standard Control Organisation (CDSCO) seeking a nod to conduct the phase-3 clinical trial of its single-dose Covid-19 vaccine in India as well as import licence.
Sources said the company has sought an early meeting of the subject expert committee on COVID-19 of the CDSCO to take a decision on its application, PTI reported.
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 dealing with vaccines and other biological, sources said, adding the company has resubmitted its application on Monday due to the technicalities involved.
Johnson & Johnson’s vaccine is a single-dose jab whereas the three vaccines cleared so far by India are of doubles doses.
Two vaccines -- Oxford/Astrazeneca vaccine Covishield manufactured by Serum Institute in India and indigenously developed Covaxin by Bharat Biotech -- are being administered so far in India. The Indian drug regulator has also approved a third vaccine Sputnik V, which is developed in Russia and to be imported and sold in India by Dr Reddy's Laboratories.
Earlier last week, Prime Minister Narendra Modi-led government had decided to fast-track emergency approvals for all foreign produced coronavirus jabs that have been given a similar nod by the World Health Organization (WHO) or regulators in the United States, Europe, Britain or Japan.
Meanwhile, the government today announced a liberalised and accelerated phase three strategy of Covid-19 vaccination stating everyone above the age of 18 years will now be administered the vaccine from May 1.
The government also allowed the state governments, private hospitals and industrial establishments to procure the doses directly from manufacturers as efforts to defeat the pandemic.
(With Agency Inputs)