Bad news for those waiting for the US pharma giant Johnson & Johnson’s single-shot Covid-19 vaccine ‘Janssen’ in India. The top drug regulator, Drugs Controller General of India (DCGI), said on Monday that the pharma major had withdrawn its proposal seeking accelerated approval of its vaccine in the country. It didn’t give additional details.
So far, four vaccines have been given Emergency Use Authorisation (EUA) in India — Covishield, Covaxin, Sputnik V and Moderna.
In mid-July, Dr VK Paul, Niti Aayog member (health), had said, “We are in talks with Johnson & Johnson regarding their single-dose vaccine.” He had added, “As per the plan, this vaccine will also be produced in Hyderabad’s Bio E.”
The US-based Johnson & Johnson had sought approval in April to conduct a bridging clinical study of its Janssen Covid-19 vaccine candidate in India.
It was reported earlier that a few thousand doses of Johnson & Johnson’s vaccine could arrive in India in July.
The US FDA authorised Johnson & Johnson’s viral vector Covid-19 vaccine for emergency use in February 2021. However, weeks after its authorisation, the vaccine was linked to a rare but serious blood-clotting disorder.
According to the World Health Organization (WHO), the Johnson & Johnson vaccine’s efficacy was 66.3 per cent for mild to moderate Covid-19 and 76.3 per cent for severe to critical infection. Additionally, it provides 100 per cent protection from hospitalisation for Covid 28 days after vaccination.
Johnson & Johnson has said its single-shot vaccine showed strong promise against the Delta variant and other emerging strains.