Indemnity issues may hold up availability of J&J single dose vaccine

The unresolved indemnity issue is likely to hold up the availability of Johnson and Johnson’s (J&J) single dose vaccine to be manufactured by its Indian partner Biological E Limited. While the drug regulator has given a nod to Biological E to manufacture the vaccine at its plant in Telangana, its launch looks unlikely till the government resolves the indemnity issue.

“The discussions between the government and the company are ongoing and there is no conclusion yet on the indemnity issue,” said a senior government official on the condition of anonymity.

Last week, Biological E had sent three batches of the vaccine for process validation to CDL Kasauli for testing. However, this doesn’t mean that the vaccine will be launched soon. These batches cannot be used for commercial use, the same person said.

On August 18, India’s drug regulator granted permission to Biological E to manufacture the Ad26. COV2-S vaccine at its Kolt­hur plant in Telangana. Prior to this, on August 7, the drug regulator granted permission to pharmaceutical giant J&J to import its single shot Covid-19 vaccine for restricted use in India.

There’s no clarity on its launch yet. When asked, J&J’s India spokesperson said, “It is premature for us to speculate on the timing of our vaccine deliveries.”

India’s vaccination drive has been led by Serum Institute of India’s-Covishield and Bharat Biotech’s- Covaxin.

In April the government fast-tracked emergency approvals for vaccines made overseas that have been cleared by the World Health Organization or regulators in the US, Europe, Britain or Japan.

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But the US vaccine makers including Moderna and Pfizer have been insisting that the Indian government should indemnify them against lawsuits in case of adverse effects linked to their jab.

The launch of Moderna’s vaccine too got stuck over the indemnity issue.

J&J was the second foreign-made vaccine that got an approval in the country after that of Moderna.

“Johnson & Johnson is committed to facilitating global equitable access to its Covid-19 vaccine. Our teams are working around the clock to develop and broadly activate our manufacturing capabilities to supply our Covid-19 vaccine. We believe Biological E. will be an important part of our global Covid-19 vaccine supply chain network,” added the J&J India spokesperson.

J&J’s one-shot vaccine has been found to have efficacy of 85.4% against severe disease and 93.1% against hospitalisation.

Biological E did not respond to an email sent by ET.



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