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COVID-19 Vaccine | Johnson & Johnson to conduct bridging trails in India, awaiting DGCI nod: Report

This comes even as NEGVAC Chairman VK Paul on May 13 said that drugmakers such as J&J are “welcome to apply for import license” and approval will be given “in two days”.

May 14, 2021 / 09:05 AM IST
Johnson & Johnson: The magazine has listed the company as

Johnson & Johnson: The magazine has listed the company as "Delivering a one-dose vaccine". (Image: Reuters)

Johnson & Johnson is awaiting approval from the Drugs Controller General of India (DCGI) for bridging trials of its one-dose COVID-19 vaccine.

In a statement to the Economic Times, J&J said that it has submitted an application to the DCGI requesting approval to “conduct a bridging clinical study of our single-dose Janssen COVID-19 vaccine candidate in India to comply with local regulations,” J&J said in an emailed statement to ET.

The report noted that it is unclear why J&J is pushing through with a bridging trail when India has said that it will allow easy access and regulatory clearances to US Food and Drugs Administration (FDA) or European Union (EU) approved vaccines

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National Expert Group on Vaccine Administration Committee (NEGVAC) Chairman VK Paul on May 13 said that drugmakers such as J&J are “welcome to apply for import license” and approval will be given “in two days”.

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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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Besides its one-jab offering, the US pharma giant has also partnered with Hyderabad-based Biological E to manufacture its vaccine for global supply, but apart from the announcement in August 2020, no indication of timeline has emerged, the report added.

Sources told the paper that Biological E “may have prioritised its own vaccine candidate over J&J’s, besides the US maker’s advance commitments to other countries also having “pushed India to the back of the queue”.

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Moneycontrol News
first published: May 14, 2021 09:05 am

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