J&J Applies to India’s Drug Controller for Phase-3 Vaccine Trials

The Quint
·2 min read

Pharma giant Johnson and Johnson has applied to India’s Central Drugs Standard Control Organisation to conduct phase-3 clinical trials of its single-dose COVID-19 vaccine in India as well as for import licences, reported NDTV quoting sources

The application comes on the heels of the Centre fast-tracking emergency approvals for all foreign-produced COVID-19 vaccines that have been approved by other accredited health regulators, like WHO, in the United States, the UK, Europe and Japan.

According to the Union Health Ministry, foreign vaccines will be given emergency-use approval mandating the requirement of post-approval parallel bridging clinical trials at place of local clinical trials under the provisions of the New Drugs and Clinical Trials Rules, 2019.

According to the NDTV report, Johnson & Johnson had applied for approval on 12 April in the Global Clinical Trial Division through the Sugam online portal, instead of applying to the biological division, which deals with vaccines and other biologicals.

The other three vaccines approved in India are Oxford/AstraZeneca vaccine Covishield, by Serum Institute of India , Bharat Biotech’s Covaxin and Russia’s Sputnik V.

The Johnson & Johnson vaccine was proven to be 72 percent effective in preventing moderate and severe forms of COVID-19 in the United States, the company said. The vaccine, however, was found to be 85 percent effective in preventing severe forms of the disease across all regions studied 28 days after vaccination in all adults.

Johnson & Johnson’s vaccine is a single-dose jab, whereas the three vaccines cleared by India so far require two doses.

The Centre on Monday, 19 April, announced the decision to permit everyone above 18 years of age to be vaccinated from 1 May. The decision came after Prime Minister Narendra Modi chaired a meeting with leaders from the pharmaceutical industry.

. Read more on India by The Quint.J&J Applies to India’s Drug Controller for Phase-3 Vaccine TrialsMourinho Sacked by Tottenham Hotspur After 17 Months in Charge . Read more on India by The Quint.