J&J seeks India's nod for phase 3 trial of its one-shot vaccine after GoI's liberalisation

Amid the exponential surge in COVID-19 cases, multinational pharma giant Johnson & Johnson has now applied to India's drug regulator, seeking permission to conduct phase-3 clinical trials of its single-dose COVID vaccine in India as well as an import license. Sources have said that Johnson & Johnson has sought an early meeting of the subject expert committee on COVID-19 of the Central Drugs Standard Control Organisation (SCSCO) to take a decision on its application. 

This latest update comes after the Government of India on Monday evening announced that all above 18 years of age can be vaccinated against the Coronavirus. Earlier, in the last week, the Centre had decided to fast-track emergency approvals for all foreign-produced COVID vaccine jabs that have been given a similar nod by the World Health Organisation or regulators in the United States, Europe, Britain or Japan. 

J&J seeks India's permission to conduct phase-3 trials of its COVID vaccine

The J&J vaccine can be stored for up to three months at a temperature between 2 and 8 degrees Celsius. A source said, "Due to the technicalities involved, Johnson & Johnson has resubmitted its application on Monday." Johnson & Johnson's vaccine is a single-dose jab, whereas the three vaccines cleared by India so 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, while a third vaccine Sputnik V -- developed in Russia and to be imported and sold in India by Dr Reddy's Laboratories -- has also been approved by the Indian drug regulator.

"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.

Vaccination against Coronavirus opened up for 18+

In a massive push to ramp up vaccination, the Centre on Monday has liberalised its vaccination strategy allowing all adults over the age of 18 to get the vaccination from May 1. Currently, only those above 45 are allowed to get vaccine doses. India has administered 12,42,64,553 doses till date across India with 10,80,34,647 receiving the first dose.

After a discussion between PM Modi and pharmaceutical manufacturers, the Centre has decided that all stakeholders will be given the flexibility to customise to local needs. Moreover, everyone above the age of 18 to be eligible to get a vaccine against Covid-19 and vaccine manufacturers will be incentivized to further scale up their production, as well as attract new national and international players. Vaccine manufacturers have been empowered to release up to 50% of their supply to State Govts. and in the open market at a pre-declared price.

(Image: AP)