Govt examining Pfizer request for indemnity for supplying Covid-19 vaccines to India

Paul rejected suggestions that the Centre was not doing enough to buy vaccines from abroad.

The government is examining Pfizer’s request seeking indemnity and liability protection for its Covid-19 vaccine.

The central government is in discussion with the global vaccine maker to bring its vaccine to India.

Dr Vinod Paul, member, health, Niti Aayog, and chair of the National Expert Group on Vaccine Administration for Covid-19, said the government was examining this request and a decision on this would be taken in the larger interest of the people and on merit.

“This is under discussion, but there is no decision as of now,” he added.

“They have requested indemnity to all the nations, including the country of origin, the US and practically every country to indemnify the liability,” Paul said at a media briefing of the ministry of health and family welfare (MoHFW) on Thursday.

Pfizer has sought indemnity and liability protection in its agreements with other countries, which gives the firm legal protection from any claims linked to any adverse event after use of its Covid-19 vaccine.

Pfizer has indicated availability of a certain volume of the Covid-19 vaccines, which can be made available starting July 2021. The company has also shown interest in making the vaccines available for India.

The government and the company are working together for the earliest possible import of the vaccine, Paul said. “We are looking at what their expectations are from the government and they are looking at what our expectations are from them,” Paul said.

He said the process was that they have to come into India and apply for licensure. There are imperative of cold chain and supply that is being looked at, he said.

The country has been reaching out to foreign vaccine manufacturers and engaging continuously with them. Multiple rounds of discussions have been held with Pfizer, J&J & Moderna so far. Vaccines are not available in free supply and buying vaccines internationally is not similar to buying ‘off the shelf’ items, he said while defending the government’s Covid-19 vaccination programme.

Paul rejected suggestions that the Centre was not doing enough to buy vaccines from abroad.

According to Paul, the government had proactively eased entry of vaccines approved by US FDA, EMA, UK’s MHRA and Japan’s PMDA, and WHO’s Emergency Use Listing into India in April so that these vaccines would not need to undergo prior bridging trials.

“The provision has now been further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries. No application of any foreign manufacturer for approval is pending with the drugs controller,” Paul said.

“Vaccines are in limited supply globally, and companies have their own priorities, game-plans and compulsions in allocating finite stocks. They also give preference to countries of their origin just as our own vaccine makers have done unhesitatingly for us,” Paul said. Vaccine producers have met the demand for vaccines in their home countries and have now started supplying to other countries, he added.