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The government is yet to decide on providing indemnity to Serum Institute of India (SII) and Bharat Biotech International, and the purchase pacts with the two vaccine makers do not include the provision, three people aware of the development said.

Both Serum Institute and Bharat Biotech had requested indemnity in case there are health complications after the vaccination. An indemnity is a form of insurance for legal claims made by vaccine beneficiaries if they have serious adverse events (SAEs) after receiving a dose. If the indemnity is granted, the government will be liable to pay compensation to the affected people.

“We have discussed indemnity with several companies, including Serum and Bharat Biotech, and also the regulator and other stakeholders, but have not yet decided on the matter," one of the people cited above, a government official, said.

The government on Monday signed two separate purchase agreements for a total of 16.5 million doses from the two companies.

Pune-based Serum Institute will supply 11 million doses of Covishield, a version of the vaccine developed by AstraZeneca Plc and the University of Oxford, to the government at 200 per dose, health secretary Rajesh Bhushan said on Tuesday. Bharat Biotech will provide 1.65 million doses of its Covaxin shot free of cost and another 3.85 million doses at 295 per shot, Bhushan said. The average cost for procurement of Covaxin for the doses is 206.

As of 4pm on Tuesday, 5.47 million doses of vaccines had been delivered, primarily from Serum Institute, Bhushan said, adding that the rest will be delivered by Thursday.

Serum Institute chief executive Adar Poonawalla had sought the indemnity clause following a 5-crore legal notice sent by a trial participant in November after he suffered a serious neurological dysfunction. An industry official aware of the discussions, one of the three people cited above, said on condition of anonymity that the government is waiting for data on whether adverse events are observed after the mass immunization programme starts on Saturday.

Bharat Biotech has also faced multiple issues during clinical trials of Covaxin. One of the participants in Nagpur suffered from viral pneumonitis, which required hospitalization during the phase 1 trial in August, while another in Bhopal died after the first dose in the phase 3 trial last month. The company said both cases were unrelated to the vaccine.

In a controversial move, Bharat Biotech received emergency licensure from the Drugs Controller General of India V.G. Somani last week even though the company was yet to provide efficacy results from its phase 3 trials—an important criterion for providing clearance to any vaccine. The regulator authorized the use of the vaccine in “clinical trial mode," based on the expectation that the shot would provide immunity against the new mutant strain of the virus discovered in the UK. As part of its authorization in “clinical trial mode", the firm has to provide a detailed protocol for roll-out and informed consent has to be taken from each of the vaccine beneficiaries. Bharat Biotech did not immediately respond to queries seeking comment.

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