J&J's single-dose COVID-19 vaccine given approval for emergency use in India

New Delhi: Johnson & Johnson's single-dose vaccine against the coronavirus disease (Covid-19) was on Saturday granted approval for emergency use in India. The American pharmaceuticals company had applied to the Central Drug Standard Control Organisation (CDSCO) on August 5 seeking emergency use approval for its single-shot vaccine.

In a statement issued on Saturday, the company said, "We are pleased to let you know that on 7th August 2021, the Government of India issued Emergency Use Authorization (EUA) for the Johnson & Johnson Covid-19 single-dose vaccine in India."

The CDSCO approval comes as an important milestone for India. With an eye on a potential third wave of the pandemic, the central government has now granted EUA to a total of five Covid-19 vaccines.

India has so far administered the Covishield, Covaxin, and Sputnik V vaccines. Mumbai-based pharmaceuticals company Cipla has also been granted approval to import the Moderna vaccine, which has shown 95 per cent efficacy against the coronavirus disease. With the latest approval of Johnson & Johnson's candidate, India has now paved the way for the single-dose vaccine to be available for people of the country.

Johnson & Johnson made the EUA submission based on "topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial," a company statement said. The trials showed that the single-dose Covid-19 vaccine was 85 per cent effective in preventing severe cases of coronavirus disease across all the regions that were studied.

Moreover, the vaccine also demonstrated protection against Covid-19 related hospitalisation and death, beginning 28 days after vaccination. "This is an important step forward in accelerating the availability of our Covid-19 vaccine to help end the pandemic,” read the statement issued by Johnson & Johnson.