India and Pfizer at impasse over vaccine indemnity demand -sources

NEW DELHI/NEW YORK (Reuters) – Pfizer and the Indian government are at loggerheads over a demand by the U.S. drugmaker for legal protection from any claims linked to the use of its COVID-19 vaccine in one of the world’s biggest markets, two sources told Reuters.

India has not given any manufacturer of a COVID-19 vaccine indemnity against the costs of compensation for any severe side effects, which is a condition Pfizer has obtained in many countries where its shots have already been widely rolled out, including Britain and the United States.

“The whole problem with Pfizer is the indemnity bond. Why should we sign it?” an Indian government source with direct knowledge of the matter told Reuters.

“If something happens, a patient dies, we will not be able to question them (Pfizer). If somebody challenges in a court of law, the central government will be responsible for everything, not the company,” the source added.

Pfizer and India’s health ministry did not reply to Reuters requests for comment on Friday.

The second source said Pfizer was not going to change its position on the indemnity issue.

Both sources declined to be named as they were not authorized to talk to the media.

LOCAL TRIAL

India, which is facing a shortage of shots as coronavirus cases soar, pledged last month to fast-track approvals for overseas vaccine makers including Pfizer, Moderna and Johnson and Johnson.

However, none have since sought permission from India’s drug regulator to sell their vaccine in the country, which has a population of 1.35 billion.

The second source said that the other issue being discussed between Pfizer and New Delhi was the Indian government’s insistence on a local trial for any vaccine approval.

Pfizer withdrew its application for emergency use authorization for the vaccine developed with Germany’s BioNTech in February after India insisted on such a trial.

But three other shots on sale in India, developed by AstraZeneca, Russia’s Sputnik V and Bharat Biotech in collaboration with state-run Indian Council of Medical Research, have completed the small-scale safety trials.

Albert Bourla, Pfizer’s chief executive said on May 4 that he was hopeful that the government would change its policy of local trials and that a path to delivering the drugmaker’s shots in India could be found.

A third source told Reuters that India’s foreign minister would visit the United States this month or in early June to try and address Pfizer’s concerns and ease exports of vaccine raw materials to India.

The Indian foreign ministry did not immediately respond to a request for comment.

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