Serum Institute Joins Pfizer & Moderna Seeking Liability Protection. Here's Why It's Important

The Serum Institute of India, (SII) the Pune-based manufacturer of the Oxford-AstraZeneca COVID-19 vaccine which is marketed in India as Covishield has reportedly sought protection against liabilities over any adverse effects from the vaccine.

The development came after reports that the government is discussing possible legal protection to foreign vaccine manufacturers Pfizer and Moderna over their COVID-19 jabs in India.

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What SII wants

¡°If foreign vaccine makers are given indemnity protection, then all vaccine firms in the country, not just the SII, must be given the same. We are hoping the same rules apply to everyone," an SII source told ANI.

Earlier, Pfizer which agreed to start supply COVID-19 vaccines to India as early as July had sought an indemnity bond that will exempt it from legal claims in case there are any adverse effects from the vaccine.

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Another COVID-19 vaccine maker Moderna, which is still in the early stage of negotiations has also sought similar protection against liabilities from the Indian government.

SII CEO Adar Poonawala had last year advocated for indemnity for all vaccine manufacturers.

"We need to have the government indemnify manufacturers, especially vaccine manufacturers, against all lawsuits... Frivolous claims come up and you see in the media something being blown out of proportion. The government needs to step in with the right messaging," he had said.

What government says

NITI Aayog Member (Health) Dr VK Paul had said on May 27 that the government is still examining the American pharma company's request for indemnity.

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"We are examining this request and will make a decision in the larger interest of people and on merit. This is under discussion and there is no decision as of now," he had said.

No company in India's vaccination history has ever paid indemnity and the government, which is the biggest user of vaccines, has also not done it, Dr Nirmal K Ganguly, former ICMR chief had said on Wednesday.

In fact liability protection has been a major issue for foreign vaccine makers to supply the doses to India.

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Earlier, when states were trying to import COVID-19 vaccines on their own, Pfizer, Moderna refused to sell Covid vaccines directly to them as the companies said they will only deal with the central government.

Along with the payment, liability protection was one the reasons for this decision as states can't guarantee this.

Legal challenges

Recently, a man from Lucknow had filed a case against SII alleging that no antibodies were formed in his body after receiving the first dose of Covishield.

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The complainant, Pratap Chandra, stated that after listening to a press briefing of ICMR where it was mentioned that antibodies in sufficient quantities are formed in the body against the virus after taking the first dose, he got an antibody test to determine the level of antibodies formed in his body.

Chandra was administered the first dose on April 8 and got the test done on May 25.

While this was a one-off case, in the early stages of clinical trials there was a more serious incident.

In November 2020, a Chennai man who was a participant in the Covishield vaccine trials had sought Rs. 5 crore compensation for allegedly suffering from serious 'neurological' side-effects after taking the experimental doses.