Johnson & Johnson applies for Emergency Use Authorisation of its one-shot vaccine in India

Johnson & Johnson, the single-dose COVID-19 vaccine maker from the US has applied for Emergency Use Authorisation of its jab in India. According to Johnson & Johnson India spokesperson, the company had on August 5 applied for the Emergency Use Authorisation of its single-dose vaccine with the Government of India.

The one-shot vaccine is developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. "We look forward to concluding our discussions with the government of India to accelerate the availability of our COVID-19 vaccine to help end the pandemic," the company statement said.

The Emergency Use Authorisation submission is based on its efficacy and safety data from the Phase 3 clinical trial, which demonstrated that the single-shot vaccine was 85.4% effective in preventing severe disease across all regions studied. It also showed protection of 93.1% against COVID-19 related hospitalisation and death, 28 days from vaccination.

The US FDA authorised Johnson & Johnson's single-dose COVID-19 vaccine for emergency use in February 2021. Now, the single-shot vaccine is approved in several countries of the world.

If J&J's vaccine gets approval in India, it will be the third foreign-made vaccine to be approved in the country, after Moderna and Sputnik V.

However, both Moderna and Pfizer are entangled in the issue of legal indemnity as both these companies have sought this legal cover in India. According to the latest developments, Pfizer has not got the emergency use approval and Moderna has got the approval but is stuck with the indemnity issue. 

Advantage of J&J vaccine

The vaccine is based on the SARS-CoV-2 virus's genetic instructions for building the spike protein that it uses to enter human cells.

Unlike the Pfizer-BioNTech and Moderna vaccines, which store the instructions in single-stranded RNA, the J&J vaccine uses double-stranded DNA.

The J&J vaccine is adenovirus-based, which is a more rugged type than the mRNA vaccines from Pfizer and Moderna.

DNA is not as fragile as RNA, and the adenovirus's tough protein coat helps protect the genetic material inside.

As a result, the J&J vaccine can be refrigerated for up to three months at 2-8 Degree Celcius.

Unlike Pfizer, Moderna, Oxford-AstraZeneca and even the Bharat Biotech (Covaxin) vaccine, the J&J vaccine is given as a single dose.