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Johnson & Johnson says in talks with Indian government for trial of single-dose vaccine

The U.S. drugs and healthcare giant's vaccine is currently approved for use in the United States, the European Union and other nations including Thailand and South Africa.

April 09, 2021 / 03:02 PM IST
Johnson and Johnson

Johnson and Johnson

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

The U.S. drugs and healthcare giant's vaccine is currently approved for use in the United States, the European Union and other nations 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 said 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) saying it would "very shortly apply for permission to conduct clinical bridging trials in India".

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

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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"We are in discussions with the (government) with the objective of starting 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 indicated 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 firm Biological E Ltd to contract-manufacture its vaccine.

India currently has two approved 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 straight day on Friday, increasing by more than 130,000, while daily deaths hit their highest in five months.
Reuters
first published: Apr 9, 2021 11:28 am

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