Pfizer says its engagement with the government of India is on while reports claim that the government may grant indemnity to the drug-maker. (REUTERS)

Explained: What is indemnity for vaccine makers? What Pfizer, Govt say about it

An agreement with Pfizer is likely to come to fruition soon as consultations regarding indemnity and other issues are going on.

By hindustantimes.com | Edited by Poulomi Ghosh

PUBLISHED ON JUN 02, 2021 06:37 PM IST

Amid reports that the Indian government may grant indemnity to Pfizer and Moderna so that they export their vaccines to India, Pfizer on Wednesday said consultations with the Indian government is going on and the US pharma company will not be able to divulge more details at this point.

"Pfizer continues to remain engaged with the Government of India towards making its COVID-19 vaccine available for use in the Government immunisation programme in the country. As these discussions are ongoing, we are unable to share any additional details at this time," a Pfizer spokesperson told ANI.

What is indemnity?

Indemnity is protection to vaccine-makers from legal proceedings, which means that they can't be sued in India. No other vaccine maker in India enjoys this clause. But Pfizer said it will export to India only if the transaction is with the central government and the company will be protected from legal cases.

Can GOI grant indemnity to Pfizer?

Since no vaccine maker in India has this immunity, others may also raise the demand if the government of India grants indemnity to Pfizer and Moderna. Pfizer has indemnity in all the countries it has exported its vaccines. So the government of India can extend indemnity on the lines of what other countries did, reports said.

Foreign-approved vaccines no longer need bridging trials in India: DCGI

"They have requested indemnity to all the nations, including the country of origin. We are examining this request and will take a decision in the larger interest of people and on merit. This is under discussion and there is no decision as of now," Niti Aayog (health) member VK Paul said in May. While reports on Wednesday indicated progress on that front and a likely development that the government is expected to extend the indemnity to Pfizer, the final decision has not been yet taken.

'Be assured, everyone will get Covid-19 vaccine', says Union minister

Waiver for foreign vaccines

Vaccines which have been approved by the appropriate agencies in the United States, the United Kingdom, Japan will not require bridging trials in India, the Drug Controller General of India has said. vaccines listed in the emergency use listing of the World Health Organization too are exempt from the bridging trials, it said. Earlier, foreign vaccines needed to undergo specific trial in India so that the effect on the Indian population could be understood. For example, Dr Reddy's Laboratories conducted a trial for Sputnik V in India.

Pfizer has indicated that it has five crore vaccine doses which it can send to India in several phases — one crore in July, one crore in August, two crore in September and 1 crore in October. Moderna, on the other hand, said it won't be able to supply vaccines to India this year even if an agreement is reached as it does not have surplus stock.

(With agency inputs)

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