Despite nod foreign Covid vaccines likely to be delayed over indemnity clause

India is not keen to ‘bow down’ to demands related to indemnity against legal liabilities in case any vaccine recipient develops severe adverse reactions post inoculation.

Even as foreign Covid-19 vaccines get the Indian regulator’s nod, actual availability may be still some time away.

Sources claim that India is not keen to ‘bow down’ to demands related to indemnity against legal liabilities in case any vaccine recipient develops severe adverse reactions post inoculation.

“Talks are on with foreign vaccine makers. However, there is a general consensus that if indemnity is given, then it will be for all vaccine players, not just a handful,” said a senior government official who added that no final decision has been taken on the matter yet.

US vaccine makers including Pfizer, Moderna have sought indemnity against adverse side effects following vaccination. One source in the government pointed out that indemnity sought in the ‘current form’ may not be granted, and India has proposed some changes in the clauses.

“There are enough options available before India now, and supplies are expected to increase from September-October onwards. Unless there is a shortage or a crisis of vaccines, foreign vaccines may not play a critical role in India’s immunisation mission as only small volumes are expected from them initially,” the source cited above said.

On Saturday US pharma major Johnson & Johnson’s (J&J) viral vector single dose vaccine got the nod from the Drugs Controller General of India (DCGI).

The company, however, did not comment on timelines around availability. A J&J spokesperson said: “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 will supply the vaccine through a contract manufacturing contract with Indian vaccine maker Biological E. Sources claim that talks are on between Indian government and J&J on matters related to indemnity. Supplies will start once the talks are productive. Biological E is expected to make 500 mn doses for J&J. However, how much of this will be available for India is not yet known.

J&J is only negotiating with government bodies and supranational organizations (like European Commission, African Union etc) at a central level for vaccine procurement or purchase. It is not working with or through third parties for vaccine access during the current emergency pandemic period, the company has noted on its website.

India expects vaccine makers to agree to local compensation norms, one industry source said.

Approvals are expected for Zydus Cadila’s ZyCoV-D, Biological E’s own vaccine Corbevax and also the Novavax vaccine manufactured by Serum Institute of India (SII) Covovax between August to October. This would significantly increase the availability of Covid19 vaccines, and dependence on imports would be reduced.

So far talks between Indian government and Pfizer and Moderna are on to come to a mutually acceptable contract terms.

Earlier in June a Pfizer spokesperson had indicated to Business Standard that Pfizer seeks indemnity and liability protections in all of our agreements, including the COVAX facility.

“We seek the same kind of indemnity and liability protections in all of the countries that have asked to purchase our vaccine, consistent with the local applicable laws to create the appropriate risk protection for all involved,” the spokesperson had said.

Industry sources feel that unless there is visibility of higher volumes from players like Pfizer or Moderna, India is unlikely to give in to the indemnity demands.

Pfizer has also indicated that it has offered to provide the Covid19 vaccines at a ‘not for profit’ price for India. “Currently, as our discussions with the Government of India are ongoing and confidential, we cannot provide further details,” the company had said earlier.