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At a time when some vaccine makers are seeking legal indemnity against lawsuits arising from any adverse events of the Covid-19 vaccines developed by them during the pandemic, drug major Zydus Cadila has exuded confidence on the efficacy of its vaccine and ruled out a requirement for such protection.
Striking a markedly different note to the prevailing sentiment among vaccine-makers, the Chairman of Zydus Cadila Group, Pankaj R Patel, told BusinessLine, “We at Zydus will be testing our vaccine ZyCoV-D thoroughly before we roll it out to the public and so we do not see any challenges thereafter. So, no, I don’t think we need to look at a legal indemnity angle."
The Gujarat-based company's plasmid DNA vaccine - ZyCoV-D - is set for advanced Phase III trials in 30,000 volunteers, the largest in the country. Patel rules out the need for legal indemnity as the company trusts the extensive tests conducted before administering the vaccine to the public.
Earlier this week Serum Institute of India and Bharat Biotech were given restricted emergency use approval for their Covid-19 vaccines in India. And with India set to to begin a mass vaccination programme for Covid-19, there are concerns being raised on the possible legal complications that could arise from any adverse reaction to the beneficiaries after vaccination. A situation made tricky since one of the two vaccines that have been given restricted use approval is in a "clinical trial mode".
The indemnity issue comes in the backdrop of a Rs 5-crore legal notice by a trial participant to SII after the participant suffered serious neurological dysfunction following a trial shot of Covishield. SII has, however, rejected the charges. In the UK, global major Pfizer has been granted legal indemnity during the pandemic period, while the US, too, has enacted a law giving protection to vaccine makers from legal disputes.
Caution against anxiety
From the data for its Phase I/II clinical trials - conducted in over 1,000 healthy adult volunteers - Zydus Cadila informed that its vaccine was found to be safe, well tolerated and had triggered a good immune response. Trials on a greater number of volunteers gives more meaningful data, thereby, ensuring safety of the vaccine.
In an earlier interview to BusinessLine, Patel had cautioned against anxiety and haste in arriving at a vaccine. "People will have to learn to have a little patience," he had said while going for phase-I/II trials. Zydus Cadila is moving into phase-III trials about seven months after the start of the clinical trials for ZyCov-D. "We have to pass through this process, otherwise we can't have a product in the market," Patel had said in July.