Johnson & Johnson seeks approval for phase-3 trial of its single-shot COVID vaccine in India, import license

Multinational pharma giants Johnson & Johnson have applied to India’s drug regulator to seek approval for a phase-3 clinical trial of its single-dose COVID-19 vaccine in India as well as an import license.

He said that the company has demanded an early meeting of the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) to decide on its application.

It comes close to the heels of the central government last week deciding fast-track emergency approvals for all foreign-produced coronavirus jabs, which the World Health Organization or regulators in the United States, Europe, Britain or Japan A similar permission has been granted by.

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The Health Ministry had said that such vaccines would be approved for emergency use, mandating the need for post-clearance parallel braiding clinical trials after local clinical trials were conducted under the provisions of the New Drugs and Clinical Trial Rules 2019.

According to sources, Johnson & Johnson applied to the Global Clinical Trial Division on 12 April through the facilitated online portal, instead of applying to the biological division that deals with vaccines and other biologicals.
A source said, “Due to the technicalities involved, Johnson & Johnson has re-issued its application on Monday.”

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The J&J vaccine can be stored at temperatures between 2 and 8 ° C for up to three months.
The Johnson & Johnson vaccine is a single-dose jab, while the three vaccines that India has cleaned so far are doubles.

So far, the Oxford / AstraZeneca vaccine COVISHIELD – in COVAXIN manufactured indigenously and developed indigenously by Bharat Biotech in India – is being administered in India, while a third vaccine, Kutnik V – is being developed and imported and sold in Russia. . Dr. In India by Reddy’s laboratories – also approved by the Indian drug regulator.

Meanwhile, the government on Monday has decided to expand its vaccination campaign, which allows all people over the age of 18 to be vaccinated from May 1, and direct state governments, private hospitals and industrial establishments directly from manufacturers. Allows for dosage to be taken.

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