With bridging trials on foreign vaccines not required during the pandemic period, the stage is set for the Centre’s final call on providing indemnity to foreign vaccine-makers against litigation that may involve their products.

US companies such as Pfizer and Moderna are believed to have sought indemnity for their vaccines if they get green-lighted for mass use. Domestic vaccines makers like Serum Institute of India had sought similar protection, but had been declined.

Vaccine programme

The Centre’s more liberal approach follows its expanded vaccination programme launched last month that opened inoculation to everyone over 18 years. This makes it necessary to have many more vaccine suppliers.

While the companies did not comment on the indemnity issue, Sidharrth Shankar, equity partner at law firm J Sagar Associates, said clinical trial rules had become flexible for a while, given the pandemic. And, given the urgent need for vaccines, approvals were being given based on data generated in other countries and companies did not want to be entangled in litigation, as their products get rolled-out for mass use. Supreme Court lawyer Vishal Tiwari explained that indemnity means an assurance from the government that the company will not be held legally liable for the cost of compensation or any side-effects after use of vaccine. Pfizer is asking the government to sign an indemnity bond, which means in case of any negative outcome like death or a side-effect on using its vaccine, the company will not be held responsible.

A representative with a vaccine-maker said companies would be liable only if there were quality or manufacturing flaws. The Centre’s decision on indemnity would benefit local vaccine-makers such as Serum Institute, Bharat Biotech and Zydus Cadila. Public health experts, though, are uncomfortable with the development and are seeking more clarity.

Covaxin scale-up

Even as the country looks at foreign sources, it is also working on a domestic scale-up of vaccines, with the Maharashtra PSU Haffkine Biopharma readying to manufacture 22.8 crore doses of Covaxin through a technology transfer arrangement with Bharat Biotech.

With ₹159-croreaid from the Centre and the State, production will start at Haffkine’s Parel complex in central Mumbai, a note from the Ministry of Science and Technology said. Sandeep Rathod, Managing Director of Haffkine, said, ‘We have been given a timeline of eight months and the work is being executed on a war footing. The vaccine production process involves two stages — drug substance and final product.

For production of the drug substance we, need to build a Bio Safety Level 3 (BSL 3) facility, while Haffkine already has the Fill Finish facility.”

Centre ‘must buy vaccine‘

In a related development on vaccines for the people, Odisha Chief Minister Naveen Patnaik added his voice to the growing demand that the Centre should procure vaccines for States.

In a letter to his counterparts, Patnaik said Covid-19 vaccines required by the States should be procured by the Centre and vaccine procurement cannot be made into a battle among the States.

The execution of the vaccination programme, however, should be decentralised and States should be allowed the flexibility to determine their own mechanisms to ensure universal vaccination, Patnaik wrote.

On Wednesday, India reported 1,32,788 Covid-19 cases with 3,207 deaths in the last 24 hours. The declining trend in daily coronavirus infections continues, and this is the sixth consecutive day when the country reported less than two lakh cases.

On the vaccination front, a total of 21.85 crore vaccines have been administered so far, with 23,97,191 vaccine doses given in the last 24 hours.

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