With the regulatory approval, J&J moves a step closer to supplying the first single-dose Covid-19 vaccine dose to the country
J&J Covid-19 vaccine authorised in India. (Credit: Pete Linforth from Pixabay.)
Johnson & Johnson (J&J) has received the regulatory authorisation for its single-dose Covid-19 vaccine, developed by its subsidiary Janssen, for emergency use in India.
Last Friday, the US drugmaker has applied for the emergency use approval of its single-shot vaccine in India, and received the approval on the next day, Reuters reported.
With the regulatory approval, J&J moves a step closer to supplying the first single-dose Covid-19 vaccine dose to the country.
However, the company has not given any commitment to the delivery of vaccine doses.
According to the Reuters report, J&J would distribute its Covid-19 vaccine in India through a supply agreement with Biological E Limited, a local vaccine maker based in Hyderabad.
The company told Reuters in an email: “While we look forward to meeting our delivery commitments it is premature for us to speculate on the timing of our vaccine deliveries.”
“This decision was based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial. This is an important step forward in accelerating availability of our Covid-19 vaccine to help end the pandemic,” the company said.
The approval was based on the Phase 3 ENSEMBLE trial, which showed that the single-shot vaccine was 85% effective in preventing severe disease across all regions studied.
It also underlined that the vaccine showed protection against Covid-19 related hospitalisation and death, after 28 days from the vaccination.
Indian health authorities have previously approved the use of vaccines developed by AstraZeneca, Bharat Biotech, Russia’s Gamaleya Institute and Moderna.
The approval of the J&J vaccine candidate marks the fifth vaccine to be approved in India, while another US company Pfizer has yet to seek permission for use of its vaccine in India.
Furthermore, Moderna is in talks with the Indian government to sort out issues over imports of the vaccine and indemnity.
Moderna has collaborated with Indian drugmaker Cipla as its local distribution partner.