Sources say after Pfizer and Moderna, SII seeks indemnity from liability


Pune-based Serum Institute of India (SII), which manufactures Covishield, has also sought indemnity from liability, expressing the hope that rules would be the same for everyone, said sources.

This comes as the Centre is favourably considering granting indemnity against legal proceedings to foreign vaccine makers Pfizer and Moderna prior to their rollout in India.

“All vaccine makers, whether Indian or foreign, should be granted the same protection,” the Adar Poonawalla-led company has reportedly told the government.

“Not just Serum Institute of India (SII), all the vaccine companies should get indemnity protection against liabilities if foreign companies are granted it,” it further said.

It is learnt that Serum is hoping that rules should be same for everyone.

The Serum Institute produces Covishield (the Indian name for the AstraZeneca-Oxford jab) and is involved in trials for three new anti-Covid vaccines.

Besides Oxford-AstraZeneca’s Covishield vaccine and Novovax’s Covovax, the SII has also applied to the Drug Controller General of India (DCGI) to manufacture the Russian ‘Sputnik V’ Covid-19 vaccine in India. ‘Sputnik V’ is currently being imported by Dr Reddy’s Laboratories.

According to reports, the Centre is apparently considering granting indemnity to vaccine manufacturing companies if they applied for Emergency Use Authorisation (EUA). Till date, no Indian vaccine company has ever paid indemnity and neither has the Central government, the biggest vaccine user, done so.

Advanced trials are on for Covovax being developed in collaboration with the pharma company Novovax. Codagenix, a single-dose nasal vaccine, is in phase 1/2 trials in the UK. The third, SpyBiotech, is a novel virus-like particle vaccine, which is also in trials.

The government has so far not given any manufacturer indemnity or protection against legal action for any severe side effects.

This is a key condition put forth by foreign vaccine-makers Pfizer and Moderna for supplying to India.

Countries like the US have granted indemnity from liability to Covid vaccine manufacturing companies for the possibility of something going wrong with their vaccines. They cannot be sued for compensation if there are any adverse effects from the shot.

Dr V.K. Paul, the head of the National Expert Group on Vaccine Administration, had said last month that the government is engaged with Pfizer and they have indicated the availability of a certain amount of vaccine in the coming months, possibly starting in July.

“We are looking at what their expectations from the government are and they are looking at what our expectations from them are,” Paul said, adding they have requested indemnity to all the nations including the country of origin.

The NITI Ayog member (Health) also said that the government is also examining the request and will take a decision in the larger interest of people and on merits.

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