Pharmaceutical giant Johnson & Johnson is in talks with the Indian government to start early-stage clinical trials of its single-dose coronavirus vaccine in the country, NDTV reported on Friday.
“We are in discussions with the government of India with the objective of starting a bridging clinical study of our Janssen Covid-19 vaccine candidate in India, subject to local regulatory approvals,” the company said in a statement. A bridging study tests the safety and immunogenicity of a vaccine, which is necessary for approval in India.
Johnson and Johnson added that it was committed to delivering a safe and effective vaccine to people around the world. The company has sent a letter to the Central Drugs Standard Control Organisation and said that it will apply for permission to conduct trials, The Indian Express reported, citing sources.
The development comes at a time when several states, including Maharashtra, Andhra Pradesh and Chhattisgarh, are reporting a severe shortage of vaccine doses as India grapples with a second wave of the pandemic. The government has, however, consistently maintained that there are no shortages. Union Health Minister Harsh Vardhan has blamed states for trying to “divert attention from their poor vaccination efforts by just continuously shifting the goalposts”.
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In large clinical trials, the American drugmaker’s single-dose vaccine was 72% effective at preventing all Covid-19 and 86% effective at preventing severe cases of the disease. Researchers found the Johnson & Johnson vaccine to be slightly less effective at preventing all illness in South Africa with overall 64% efficacy. It was still 82% effective at preventing severe disease. A report by the Food and Drug Administration indicates that the vaccine protects against other variants from Britain and Brazil too.
Johnson & Johnson’s vaccine is currently approved for use in the United States, the European Union and other countries such as Thailand and South Africa.
India’s drug regulator has authorised the emergency use of a vaccine developed by Oxford University and AstraZeneca and another shot from biotechnology company Bharat Biotech. Russia’s Sputnik-V and a shot developed by Cadila Healthcare Limited are also being tested in trials.
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