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

Johnson & Johnson’s (J&J) single-dose Covid-19 vaccine was on Saturday granted approval for emergency use in India. “India expands its vaccine basket. Johnson and Johnson’s single-dose Covid-19 vaccine is given approval for Emergency Use in India,” health minister Mansukh Mandaviya tweeted on Saturday. This is the fifth Covid-19 vaccine to be given emergency use approval in India and would further boost the nation’s collective fight against Covid-19, the minister said.

J&J had a week ago withdrawn its application for carrying out phase-3 clinical trials in India for its vaccine. This was after the Indian government waived this requirement for vaccines that had approvals from regulatory bodies in the US, UK, Europe and Japan. This was done to fast-track the vaccine approval process in the country and accelerate vaccination.

The country already has four vaccines approved so far, including Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V and Moderna, making J&J the fifth one. Moderna is yet to launch their vaccine in India. In India, J&J have a tie up with Biological E for technology transfer and manufacturing the Covid-19 vaccine in India.

J&J had been given emergency use authorisation by the US FDA in February this year. J&H also has Conditional Marketing Authorisation Application from the European Commission and got an Emergency Use Listing from the World Health Organization for its Covid-19 vaccine.

This single vaccine has been developed by the Janssen Pharmaceutical Companies of J&J. The J&J Covid-19 single-dose vaccine has to be stored at 2-8°C. According to J&J, their single-shot Covid-19 vaccine had demonstrated strong neutralising antibody activity against the rapidly spreading Delta variant . This variant is dominant in India. Their data showed that the durability of the immune response lasted through at least eight months. Overall the vaccine had an efficacy of 85% against severe and critical Covid-19 disease.

The country on Saturday crossed the 50-crore mark in vaccination administration. There were 38,628 daily new cases reported in the country taking the active case load to 4.12 lakh cases with a daily case positivity rate of 2.21%.