Covid-19 pandemic: Serum Institute seeks indemnity for jab again

In talks with RDIF to manufacture Sputnik V in India

Pune-based vaccine maker Serum Institute of India (SII) has sought indemnity from the government of India from any claims linked to the use of their Covid-19 vaccines, according to sources. Meanwhile, the company is also in discussions with the Russian Direct Investment Fund (RDIF) to manufacture Sputnik V vaccine in India.
 
SII sources said the company was hoping that if legal protection or indemnity is given to foreign vaccine makers, the same would be applicable for all. SII had sought indemnity for Covishield, the AstraZeneca vaccine before it launched the same in India.
 
SII Chief Executive Adar Poonawalla had then indicated that legal indemnity was required to ensure that the vaccination drive could be completed smoothly. In an interview in January, Poonawalla had said an indemnity clause during the period of the pandemic would ensure the vaccination drive did not halt if there was an injunction.
 
SII is selling the AstraZeneca vaccine named Covishield in India. It is also manufacturing the Novavax Covid-19 vaccine and would bring the same to the Indian market. Besides, the company has two more Covid-19 vaccines in its pipeline — Spy Biotech and Codagenix candidates.
 
No indemnity, however, was given to SII or Bharat Biotech when the nationwide Covid-19 vaccination drive was rolled out. Legal experts had pointed out at that time that by making the vaccination drive voluntary, the government has built in a concept of ‘implied consent’ or that one understands the risks and benefits.

 
However, after foreign vaccine makers like Pfizer and Moderna insisted on indemnity, the government is now giving this a serious thought. Reports suggest the Centre is likely to allow indemnity to these foreign vaccine makers. This would mean that by default, the same would extend to the Indian vaccine makers, too. Bharat Biotech and Zydus Cadila did not wish to respond on the matter.
 
“Most developed economies have opted for a ‘no-fault vaccine injury compensation scheme’, where a claim can be filed against the government by anyone who has received the vaccine and has been injured as a result, provided that the claim is filed within an agreed period,” said Sidharrth Shankar, Partner, J Sagar Associates.
 
He said some countries like Australia agreed on the inclusion of an indemnity provision, where an aggrieved person will have to file a legal action against the vaccine maker, and the government will foot the bill in case the action is successful. “Most European economies have only agreed to be liable for claims which exceed a pre-agreed limit. In such cases, the vaccine maker bears the risk as well. While the Indian government can go ahead with the approach followed by other countries, it will raise demands from other manufacturers,” Shankar said.
 
Meanwhile, SII is in discussions with RDIF to make the Sputnik V vaccine at Pune, sources claimed. Discussions are on to decide on the number of doses SII can make. The company did not wish to comment. RDIF has tied up with several Indian manufacturers to make over 850 million doses of Sputnik V. SII has begun initial discussions with the regulator.
 
SII is now making around 70 million doses per month of Covishield and has also started production of Covovax, the Novavax vaccine. It aims to make 100 million doses a month of Covishield from July onwards.
 
A source indicated that SII has the capacity to manufacture Sputnik V. It has been readying plants for its pipeline products. Some capacity from that could be used to make Sputnik V.
 
Recently, the firm had sought a Rs 3,000 crore grant from the Centre to allocate more capacities to make Covishield. It had said if it has to sacrifice some more capacity to make Covishield, then at least the cost of machinery and equipment should be given.