Johnson & Johnson's single-dose COVID-19 vaccine gets approval for emergency use in India

Johnson & Johnson's single-dose COVID-19 vaccine has been given Emergency Use approval in India.

"India expands its vaccine basket! Johnson and Johnson’s single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines," said Health Minister Mansukh Mandaviya on August 7.

India expands its vaccine basket!

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Johnson and Johnson’s single-dose COVID-19 vaccine is given approval for Emergency Use in India.

Now India has 5 EUA vaccines.

This will further boost our nation's collective fight against #COVID19

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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— Mansukh Mandaviya (@mansukhmandviya) August 7, 2021

The US-based pharmaceutical company had applied for Emergency Use Authorisation for its jab on Friday and was granted the approval the same day by the Drugs Controller General of India (DCGI), reported news agency PTI citing a senior official.

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J&J earlier had sought approval to conduct phase-3 clinical trial of its vaccine on approximately 600 participants in two age groups---those aged 18 and below 60 years and those aged 60 years and above---to evaluate the safety, reactogenicity and immunogenicity of the jab in healthy Indian adults. However, on July 29, the firm withdrew its proposal.

A health ministry official at a recent press conference had clarified that J&J earlier applied for conducting phase-3 clinical trial of its vaccine. "The application was to undertake clinical trial and when we issued relaxed guidelines in which we said if you had approval from other regulatory bodies of other countries, then exemption would be given from clinical trials, and emergency use authorisation would be granted and trial could be continued later on, so now since they did not need it they withdrew that application," the official had said.

Also read | COVID-19 Vaccine Tracker: 49.55 lakh doses administered in India on August 6

In a bid to fast-track emergency approvals for all foreign produced coronavirus jabs, the central government had announced that COVID-19 vaccines which were approved for restricted use by regulators in the US, UK, Europe and Japan, or which were on the World Health Organisation's Emergency Use Listing, would not have to conduct bridging clinical trials in India.

With Johnson and Johnson's COVID-19 vaccine, now there are five vaccines that have been granted Emergency Use Authorisation in India. The other four are Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V, and Moderna.

(This is a developing copy. Please check back for updates)

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