INDIA’S...

Apart from the J&J vaccine, the four other Covid-19 shots approved for emergency use in India are Bharat Biotech’s Covaxin, Serum Institute of India’s Covishield, the Russianmade Sputnik V, and the Moderna vaccine.

“While we look forward to meeting our delivery commitments, it is premature for us to speculate on the timing of our vaccine deliveries,” the company told Reuters.

The J&J vaccine, which has shown 66-72% efficacy in different trials, has been approved by regulators in the US, UK, Europe and the World Health Organization. The company in May applied for a permission to carry out bridging trials – smaller clinical trials that are meant to assess if the findings are similar to larger trials carried out elsewhere. But it withdrew the request last week and filed for emergency approval directly, making use of a change in policy in India that allows coronavirus vaccine makers to do so if they have received approvals by certain regulators around the world.

In a statement issued on Saturday, the American pharma major said: “We are pleased to announce 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, to prevent COVID-19 in individuals 18 years of age and older.”

“This decision was based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated our single-shot vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination. This is an important step forward in accelerating availability of our COVID-19 vaccine to help end the pandemic,” the company said.

The company applied for the grant of emergency use authorisation to the central drugs standard control organisation (CDSCO) on Thursday.

“On 5th August 2021 Johnson & Johnson Pvt. Ltd applied for Emergency Use Authorization (EUA) of its single-dose COVID-19 vaccine to the Government of India. This is an important milestone that paves the way to bringing our single-dose COVID-19 vaccine to the people of India, and the rest of the world, through a collaboration with Biological E. Limited,” the company’s India spokesperson said on Friday.

The vaccine is developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent the viral infection in individuals 18 years of age and older.

Experts have welcomed the approval.

“Yes, single dose vaccine works better; we may need a booster later, but it’s a great addition,” said Dr Gagandeep Kang, the country’s senior vaccine expert, from Christian Medical College, Vellore (Tamil Nadu).

In April this year, the government announced that Covid-19 vaccines cleared for use in western countries and Japan will get fast-track approval in India, throwing open the market for possible imports of Pfizer, Moderna and J&J doses.

The accelerated approval applies to doses authorised by the US’s Food and Drug Administration (FDA), the UK’s Medicines and Healthcare products

Regulatory Agency (MHRA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) Japan or by WHO.

The US FDA authorised J&J vaccine for emergency use in February 2021.

(With inputs from Reuters)