Sources say that the company is in talks with Indian authorities for permission to import the vaccine and for legal protection against any product liability claims arising out of unexpected serious adverse events
On August 6, global healthcare major Johnson & Johnson said it has applied for Emergency Use Authorization (EUA) of its single-dose COVID-19 vaccine in India. (File image of J&J COVID-19 vaccine)
Johnson & Johnson (J&J) said it cannot give a definitive timeline at this stage for the availability of its single-shot COVID-19 vaccine in India, as there are other pending permissions and issues to be addressed.
“While we look forward to meeting our delivery commitments it is premature for us to speculate on the timing of our vaccine deliveries,” Johnson & Johnson spokesperson told Moneycontrol.
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The spokesperson said the US drug major was looking forward to concluding its discussions with the Government of India to accelerate availability of the vaccine.
Sources told Moneycontrol that J&J is engaged with Indian government on getting permission to import the vaccine along with securing indemnity or legal protection against any product liability claims arising out of unexpected serious adverse events
J&J’s vaccine received emergency use authorization (EUA) from the Drug Controller General of India (DCGI), to prevent COVID-19 in individuals 18 years of age and older.
The approval was based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial of the vaccine, which demonstrated that the 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.
J&J applied for EUA of its single-dose COVID-19 vaccine to the Government of India.
Partnership with Biological E is ongoing
J&J said its ongoing partnership with Biological E to manufacture the vaccine locally is progressing, despite the latter being busy developing its own vaccine candidate in collaboration with Baylor College of Medicine in Houston and U.S.-based Dynavax Technologies Corp. That vaccine is undergoing late-stage testing in India.
Biological E in the past has indicated that it can produce 600 million doses of J&J vaccine at its facilities, and the tech transfer process is underway.
“Biological E will be an important part of our global supply chain network, helping to supply our Johnson & Johnson COVID-19 vaccine through the extensive collaborations and partnerships we have with governments, health authorities and organisations such as Gavi and the COVAX Facility,” J&J spokesperson said.
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Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
