No breakthrough on indemnity issue for American vaccines yet

No breakthrough on indemnity issue for American vaccines yet

“Talks are on and yes indemnity clause is also being discussed. India has put across its stand and we are in dialogue,” a senior Health Ministry official said

More than six months after the government announced it would fast-track clearances for foreign COVID-19 vaccines to India, “facilitate quicker access” and “encourage imports”, indemnity issues are still holding up the import of all American vaccines to India, including Pfizer, Johnson and Johnson (J&J) and Moderna.

With the Australia-India-Japan-U.S. Quad pressing ahead with plans to produce J&J vaccines at a facility in Hyderabad, officials indicated that the indemnity clause, required by U.S. companies to avoid legal liability for their vaccines, could mean that India will produce the vaccines only for export, and not to supply them to Indians domestically.

“Talks are on and yes indemnity clause is also being discussed. India has put across its stand and we are in dialogue,” a senior Health Ministry official said, without specifying any timeline on the issue, which has been pending since External Affairs Minister S. Jaishankar travelled to the US in May 2021 to speak about U.S. supplies of vaccines during the second wave of the Coronavirus pandemic. Subsequently, after U.S. Vice President Kamala Harris spoke to Prime Minister Narendra Modi, the U.S. offered India a batch of Moderna vaccines through the COVAX network in June.

The shipment was stopped at the last minute, however, as Indian embassy officials declined to sign indemnity clauses, explaining that no Indian manufacturer had been given a liability waiver yet.

When asked about the lack of progress, at least two of the U.S. vaccine manufacturers told The Hindu that they are still in talks with New Delhi on indemnity.

“We are in ongoing discussions with the Government of India to accelerate availability of the Johnson & Johnson COVID-19 vaccine. It is premature for us to speculate on the timing of our vaccine deliveries, ” a spokesperson for J&J told The Hindu in an email.

Under the Quad agreement that was reached between Prime Minister Narendra Modi and U.S. President Joseph Biden, America will partially fund the production of one billion J&J vaccines by the Hyderabad-based Biological E. On October 25, US, Japanese and Australian diplomats even attended a special event in Hyderabad along with MEA officials to mark a US financing arrangement for $50 million in order to expand the company’s capacity to produce COVID-19 vaccines. Biological E declined to comment on plans for the vaccine’s distribution, but a government official told The Hindu that the Quad initiative at present is only “export-oriented” as it is meant for South-East Asian countries, and any domestic Indian distribution would depend on the liability issue being resolved.

Separately, a representative for Pfizer also confirmed that indemnity talks are ongoing but there has been no breakthrough yet.

“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,” said Pfizer’s global media relations head for Asia, Roma Nair, in a written response.

“In markets that do not have the legal or legislative protections that are available in the United States, we work with governments to find mutually agreeable solutions, including contractual indemnity clauses,” Ms. Nair said, pointing to 152 countries and territories where Pfizer/BionTech have shipped more than two billion doses to this year, where the clause has been accepted.

On April 13, the Ministry of Health and Family welfare had announced that in view of the shortage of vaccines, the government would allow all vaccines that have been approved for emergency use by the U.S., European Union, U.K. and Japan or listed by the WHO to receive EUA in India, and later eased the requirements for bridging trials as well.

“This decision will facilitate quicker access to such foreign vaccines by India & would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic,” the MoHFW notification read.

MEA spokesperson Arindam Bagchi had also said that the government was “making all efforts” to augment the supply of vaccines through supplies from abroad, specifically through Pfizer, J&J and Moderna. The continuing standoff on indemnity issues, as well as on pricing and storage has meant however that not a single dose of the American vaccines has yet been shipped to India.

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