On August 7th, Janssen became the sixth vaccination to get the Indian government's Emergency Use Approval (EUA). The CDSCO clearance represents a pivotal point for India. Here's what you need to know about the vaccine and what makes it different from its counterparts? 

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India has already achieved a major milestone by delivering 50 million vaccine doses as part of a national immunisation campaign. But, in anticipation of a possible third wave of the pandemic, the central government has already given EUA to a total of 5 COVID-19 vaccines in India - Covishield, Covaxin, Sputnik V, Moderna, and Janssen. The single-dose COVID-19 vaccine from Johnson & Johnson was authorised in India on August 7th. The American firm of pharmaceuticals requested emergency use clearance for their single-shot vaccination to the Central Drug Standard Control Organization (CDSCO).

The central government proclaimed that COVID-19 vaccines that were authorised for confined use by regulatory agencies in the US, UK, Europe, and Japan, or that were on the World Health Organization's Emergency Use Listing, would not be needed to undertake bridging clinical trials in India, in order to expedite emergency approvals for all foreign-produced coronavirus vaccines.

The EUA application is based on topline safety and quality information from the ENSEMBLE Phase 3 clinical trial, which displayed that a single-shot vaccine was 85 per cent beneficial in controlling severe disease throughout all regions studied, as well as prevention against COVID-19-related hospitalisation and death, starting 28 days after vaccination.

What is the mechanism of the Jansen vaccine?

The adenovirus provides the information that tells cells to produce the spike protein after the vaccination reaches your body. Your immune system responds by producing antibodies to target the spike protein, ensuring that if you are subsequently subjected to COVID-19, your body is prepared to resist it.

The vaccine is more lasting because of the inclusion of DNA, and it may be kept refrigerated for up to 3 months. mRNA vaccines from Pfizer-BioNTech and Moderna vaccines, on the other hand, must be kept extremely cold and utilised very quickly.

Is it both harmless and efficient?

A federal commission examined the Johnson & Johnson data and identified no major safety issues, allowing it to be approved. Fever and discomfort at the injection site were common adverse effects for individuals who were vaccinated in the study, although these usually went away within a few days. These are the same responses that individuals who got the Pfizer-BioNTech and Moderna vaccinations had.

In a clinical study in the United States, the Johnson & Johnson vaccine was shown to be 72 percent effective against mild to severe COVID-19 infections. It was less successful in Latin America (66%) and South Africa (57%) owing to the presence of more readily transmissible coronavirus strains in those nations at the time.

At 28 days following immunisation, the Johnson & Johnson vaccine was 85 per cent effective in preventing severe cases of COVID-19 in all areas where it was studied. After day 49 of the trials, no instances of serious illness were recorded.

The study did not involve any children or pregnant women, as it did with the other approved vaccinations. The Johnson & Johnson vaccination is only available to individuals over the age of 18.

Minor setback?

The federal authorities halted the delivery of the Johnson & Johnson vaccination on April 13 to look into a few cases of individuals developing blood clots after getting the vaccine. After two weeks following immunisation, all of the instances surfaced.

After reviewing the facts on the incidents, federal health authorities decided that the vaccine's advantages exceeded the risks, and they allowed the vaccine's usage to be continued 10 days afterwards.

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author is a practising super specialist from New Delhi.