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Home / News / India /  Covid vaccine: Central govt may grant indemnity to Pfizer and Moderna

The Indian government is expected to grant vaccine manufacturers Pfizer and Moderna a concessional request of legal protection from any claims linked to the use of their Covid-19 vaccines in India, reported ANI.

Quoting government sources, the news agency said that like other countries, the Indian government will also grant indemnity to the companies if they apply for Emergency Use Authorisation (EUA).

In another development that would speed up approvals, the Drug Controller General of India (DCGI) has waived the requirement of testing every batch of foreign-made Covid-19 vaccines by the Central Drugs Laboratory, Kasauli and post-launch bridging trials for such firms.

The decision came in the backdrop of Pfizer and Cipla putting forth similar demands during negotiations to supply imported vaccines to India.

The apex drug controller has said that the vaccines that are already approved by US FDA, EMA, UK MHRA, PMDA Japan or listed in WHO Emergency Use Listing will not need to undergo a post-approval bridging clinical trial.

"Testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of the country of origin," it said.

Earlier, vaccines that had completed clinical studies outside the country were required to carry out "bridging trials" or limited clinical trials on the Indian population to know how the drug works on people of Indian origin.

Tensions over indemnity

Although Pfizer has obtained legal protection in several countries, including Britain and the United States, India has not given any manufacturer of a Covid-19 vaccine indemnity against the costs of compensation for any severe side effects.

Due to this, the central government and Pfizer were at loggerhead over the vaccine manufacturer's demands.

"The whole problem with Pfizer is the indemnity bond. Why should we sign it?" a government source was earlier quoted as saying by news agency 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.

Recently, NITI Aayog Member (Health) VK Paul said that the government is examining Pfizer's request and will make a decision in the larger interest of people and on merit.

"Yes we are engaged with Pfizer and they have indicated the availability of a certain amount of vaccine in the coming months, possibly starting in July," Paul said at a press conference.

"We are looking at what their expectations are from the government and they are looking at what our expectations are from them. That's the process in which this will move. Because they will have to come to India and apply for licensure in India, that's one path and there are imperatives of cold chain and supply," he added.

Efficacy of jabs

Seeking a fast-track approval for its Covid-19 vaccine, Pfizer has told Indian authorities that its jab has shown "high effectiveness" against the SARS-CoV-2 variant prevalent in India and on people of Indian ethnicity or nationality.

The company said it is suitable for everyone aged 12 years or above and can be stored for a month at 2-8 degrees.


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