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India says Johnson & Johnson withdraws proposal for speedy COVID-19 vaccine approval

The U.S.-based company had said in April it was seeking an approval to conduct a bridging clinical study of its Janssen COVID-19 vaccine candidate in India. Trials in the United States at that time were paused on reports of rare blood clots.

August 02, 2021 / 02:38 PM IST
Johnson & Johnson. | Representative Image (PC-Reuters)

Johnson & Johnson. | Representative Image (PC-Reuters)

India's drug regulator said on Monday that Johnson & Johnson withdrew its proposal seeking accelerated approval of its COVID-19 vaccine in the country, without giving additional details.

The U.S.-based company had said in April it was seeking an approval to conduct a bridging clinical study of its Janssen COVID-19 vaccine candidate in India. Trials in the United States at that time were paused on reports of rare blood clots.

The drugmaker's withdrawal comes as India tackles legal challenges with manufacturers over indemnity issues, with its junior health minister saying last week that a team had been formed to engage with vaccine makers.

"This team is in continuous dialogue with Pfizer, Moderna and Johnson & Johnson to discuss and address various issues including the issue of indemnity," Bharati Pravin Pawar had said.

Johnson & Johnson and the Central Drugs Standard Control Organisation (CDSCO) did not immediately respond to Reuters' requests for comments on why the company withdrew its application.

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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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As of July 31, Johnson & Johnson is yet to request a full approval for its shot with the U.S. FDA, while Pfizer Inc , BioNTech SE, and Moderna Inc have already sought full approval of their vaccines with the FDA.

In India, the drug regulator had given emergency use authorisation to Moderna's vaccine in June.
Reuters
first published: Aug 2, 2021 02:39 pm

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