Johnson and Johnson says in talks with Indian government for preliminary of single-portion vaccine

Johnson and Johnson says in talks with Indian government for preliminary of single-portion vaccine


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  • Source: Reuters

  • Date: 09 Apr,2021

Johnson & Johnson is in talks with India’s government to start a clinical trial of its single-dose COVID-19 vaccine in the country, the company said on Friday.

The U.S. drugs and health care giant’s vaccine is currently approved for use in the USA, the European Union and other countries including Thailand and South Africa.

The news comes as some parts of India face a shortage of vaccine supplies just as the country of 1.3 billion battles a second wave of COVID-19 infections. India’s government, however, has stated there is no shortage of shots.

The Indian Express newspaper reported earlier on Friday that J&J had sent a letter to India’s Central Drugs Standard Control Organisation (CDSCO) stating it would”very soon apply for permission to conduct clinical bridging trials in India”.

The CDSCO did not immediately respond to Reuters request for comment.

“We are in talks with the (government) with the aim of beginning a bridging clinical study of our Janssen COVID-19 vaccine candidate in India, subject to local regulatory approvals,” a local J&J representative said via email.

A bridging study tests the safety and immunogenicity of a vaccine, and India has suggested that any vaccine maker must conduct such a trial for a shot to be considered for its immunisation programme.

Separately, J&J has a deal with Indian company Biological E Ltd to contract-manufacture its vaccine.

India now has two accepted vaccines in use, one developed by Oxford University and AstraZeneca and the other, a shot from local player Bharat Biotech.

There are other vaccine candidates in trials in India including Russia’s Sputnik-V and a shot developed by Cadila Healthcare Ltd..

COVID-19 infections in India rose by a record number for a third consecutive day on Friday, increasing by over 130,000, while daily deaths hit their highest in five months.

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