J&J’s single-dose Covid vaccine gets emergency use nod in India

Johnson & Johnson’s single-dose Covid-19 vaccine has received emergency use approval in India, becoming the fifth jab against the virus to get such a clearance in the country. However, there is uncertainty over starting of supplies as issues around indemnity against legal liabilities in case of severe adverse events are yet to be resolved.

“As of now, the government is not inclined to give indemnity to foreign manufacturers. We have our own manufacturers and vaccines, there is no reason why we should be arm-twisted,” a senior official said. The government hopes that ongoing talks with foreign vaccine manufacturers will lead to a fruitful resolution. J&J trails Pfizer and Moderna in the US and may be keen to enter India market.

The government expects supplies to start around September if talks go through with the company, the official said. The initial supplies could be 3-5 crore doses a month.

It is unclear whether J&J has reached an agreement with the government over legal concerns though. It will supply the vaccine through a pact with Indian vaccine maker Biological E.

The US firm said it is too early to indicate a timeline for supplies. “While we look forward to meeting our delivery commitments, it is premature for us to speculate on the timing of our vaccine deliveries,” J&J said in a statement.

“At this time, the company is only negotiating with government bodies and supranational organisations (e.g., European Commission, African Union, Gavi/COVAX) at a central level for vaccine procurement or purchase. We are not working with or through third parties for vaccine access during the current emergency pandemic period,” it said.

Currently, no individuals or private companies are authorised to offer, advertise, distribute or sell the Janssen Covid-19 vaccine on behalf of J&J, either directly or indirectly, the company said.

Sources said Biological E can start local manufacturing and supply of J&J’s vaccine in India only if the American company agrees to follow the legal compensation norms of the country.

Considering that J&J is third to Pfizer and Moderna’s vaccines in America, India may come across as a lucrative market. The fact that India too is looking at ramping up its vaccination drive coverage may also make it more viable for J&J. There is an in-principle visibility of around 5 crore doses per month given by the company, official sources said. Indian health authorities have so far approved the use of vaccines developed by AstraZeneca (Covishield), Bharat Biotech (Covaxin), Russia’s Gamaleya Institute (Sputnik V) and Moderna.

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