Serum Institute asks for Indemnity, says “Same rules for all”: Sources

Serum Institute asks for Indemnity, says

After Pfizer and Moderna, Covishield-maker Serum Institute of India (SII) has asked for indemnity from liability, according to sources. 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,” Serum sources said today.

“Serum is hoping that rules should be same for everyone,” the sources added.

The Serum Institute produces Covishield – the Indian name for Oxford-AstraZeneca’s shot – and is involved in trials for three new anti-Covid vaccines.

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.

Yesterday, Health Ministry sources said other countries have granted this concession and “there is no problem” in granting indemnity or legal protection from any claims linked to the use of a company’s COVID-19 vaccine.

“If these companies have applied for Emergency Use Authorisation in India then we are ready to give them indemnity,” the sources said.

“It is expected that they will be granted indemnity against legal proceedings along the lines of what has been allowed in other countries for Pfizer and Moderna,” they added.

Countries like the US have granted indemnity from liability to these 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.

Sources say Pfizer’s demand for sovereign indemnity is a tough call; no other vaccine manufacturer has secured this so far.

“Pfizer continues to remain engaged with the government of India towards making its COVID-19 vaccine available for use in the government immunisation program in the country. As these discussions are ongoing, we are unable to share any additional details at this time,” a Pfizer spokesperson said on Wednesday.

“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 and we are looking at what their expectations from the government are and they are looking at what our expectations from them are,” VK Paul, the head of the National Expert Group on Vaccine Administration had said last month.

“They have requested indemnity to all the nations including the country of origin. We are examining this request and will take a decision in the larger interest of people and on merits,” Dr Paul had said.