New Delhi: US pharma giant Johnson & Johnson has said it is in talks with the Modi government to start clinical trials for its single-shot Covid-19 vaccine in India.
The company has informed the Central Drugs Standard Control Organisation (CDSCO), the Indian drug regulator, about its plan to start “bridging clinical trials” soon.
The move will help India ramp up the vaccination drive amid the rising number of Covid cases in the country.
“We are in discussions with the Government of India with the objective of starting a bridging clinical study of our Janssen COVID-19 vaccine candidate in India, subject to local regulatory approvals,” J&J’s spokesperson told ThePrint via an email.
“At Johnson & Johnson, we remain fully focused on bringing a safe and effective COVID-19 vaccine to people around the world, if authorized for use by local health authorities,” the spokesperson said.
A bridging trial is a supplementary trial performed in a new region or country to get more clinical data on efficacy, safety, and dose regimen. It can be done on over approximately 1,000 participants.
Johnson & Johnson Covid vaccine can be shipped and stored at standard refrigeration temperatures.
A senior official at CDSCO also confirmed that the company has reached out to the regulator and will submit the protocol of the trial before the expert panel, in the coming weeks.
“The process for clearance of bridging trials would be the same as given to Dr. Reddy’s for Sputnik vaccine and Serum Institute of India (SII) for AstraZeneca-Oxford University vaccine,” he said requesting anonymity.
Good news for India
India is currently using two Covid vaccines — Covishield, developed by Oxford University and AstraZeneca, and Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
As Covid cases surge in India, the addition of more vaccines will help the government to expand the vaccination drive across age groups.
Shekhar Mande, director-general of the Council of Scientific and Industrial Research (CSIR), India’s apex scientific research organisation, had earlier told ThePrint that India should find ways to bring Johnson & Johnson to India.
“J&J’s single-shot vaccine looks quite exciting,” he had said, adding that the country needs more options to conclude the vaccination drive faster.
The Covid-19 curve shows that the cases in the country are rising much faster this time, despite the fact the spread of the disease is much better understood now. In the last 24 hours, India has recorded around 1,30,000 cases and 780 deaths.
(Edited by Neha Mahajan)