India close to deal with Pfizer on vaccines as indemnity talks advance: Report

The government is reportedly angling for conditional legal indemnity for Pfizer, other drug makers

India may soon close in on a deal with American pharmaceutical giant Pfizer as it irons out issues of indemnity to arm itself with another vaccine to check the spread of the fatal coronavirus. The government has been at the receiving end of global criticism for its unpreparedness in dealing with the second Covid-19 wave and running critically low stock of vaccines.

Government officials said the Centre was in advanced talks with Pfizer and was leaning towards granting conditional immunity to Pfizer and other companies, The Economic Times reported.

Conditional immunity could fast-track emergency use approval for the vaccine in the country but not let it completely off the hook legally, especially in cases where the vaccine might cause serious complications for people on certain medication or with existing medical conditions, the business daily quoted top government officials as saying.

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Pfizer had applied for emergency use authorisation for its vaccine in December but withdrew after it ran up against the Indian government’s insistence on bridging trials— clinical trials in an India-specific context. India scrapped this requirement last month amid a surge in cases and low vaccine stocks, allowing automatic approval to any vaccine with regulatory permission in the United Kingdom, United States, European Union and Canada.

More recently, in a Health Ministry briefing, the government further said that vaccines or Covid-19 drugs that receive approval from the WHO or FDA will be granted import licenses at the earliest.

Earlier this month, Pfizer CEO Albert Bourla had said the company was in talks with the Indian government for the vaccine’s expedited approval in the country, even offering the vaccine at a not-for-profit price. The major sticking point in the discussions has reportedly been the indemnity clause that would shield Pfizer from legal liability related to the vaccine’s effects. Domestic vaccine makers Serum Institute and Bharat Biotech have not been afforded indemnity for their vaccines.

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If the talks are successful, Pfizer would initially import vaccines into India and then explore domestic manufacturing, ET reported.

DH could not independently verify this report.

Opinion on the effectiveness of mRNA-based vaccines like Pfizer is so far inconclusive. The European Medicines Agency (EMA) said last week that mRNA-based jabs were showing encouraging efficacy against the variant that originated in India, while the World Health Organisation has hinted that mRNA vaccines were slightly less effective against the variant, though it left the door open for data from real-world studies.