SII Will Seek Protection from Government for Vaccine Makers against Unwarranted Lawsuits
NEW DELHI, Dec 20: Getting worried over legal wrangling in the event of any adverse reactions to Corona vaccine which are all set to be cleared for emergency use before undergoing the customary full trial, the Serum Institute of India chief executive Adar Poonawalla has sought for governmental protection for the vaccine makers.
“Vaccine makers need to be protected against liability for serious adverse reactions to their shots” Poonawalla said.
The Pune-headquartered company plans to propose this to the government, he said during a virtual panel discussion on the challenges to vaccine development. This is because such issues could potentially increase fear against getting vaccinated and also works to “bankrupt” or “distract” the companies making them, according to him.
“We need to have the government indemnify manufacturers, especially vaccine manufacturers, against all lawsuits. In fact, COVAX and other countries have already started talking about that,” he said.
“The government can act: the US, for example, has in fact invoked a law, to say that during a pandemic — and this is especially important only during a pandemic — to indemnify vaccine manufacturers against lawsuits for severe adverse effects or any other frivolous claims which may come about. Because, that adds to the fear and also will bankrupt vaccine manufacturers or distract them if they have to just all day just fight lawsuits and explain to the media what is happening,” he said.
According to Poonawalla, when “frivolous” claims crop up and are blown out of proportion, it affects the confidence of not just the vaccine manufacturers but also the general public waiting to be vaccinated. “Anyone may have a thought and skepticism then sort of sets in (that) definitely something can happen due to the vaccine … to dispel that, the government needs to step in (with) messaging with influencers to spread, also, the right information.” He added that this was a measure SII was “going to propose” to the Centre.
The SII CEO has genuine reasons to feel the anxiety, only recently one of the volunteers for vaccine trial based in Chennai had sent the company a legal notice for a compensation of Rs five crores claiming that its vaccine Covishield had caused him a severe neurological problem during trial.
The SII, however, rejected these claims, adding that its reputation was being “unfairly maligned”. As a result, it had sent the volunteer a reverse legal notice of its own.
The pharma firm claimed that it had alerted the apex drug regulator Central Drugs Standard Control Organisation (CDSCP), about the issue when it had occurred. CDSCO, in return, had cleared the vaccine to continue its ongoing trials.
SII is one of the firms seeking accelerated approvals for its vaccine in India besides having international deals with vaccine makers of various countries for manufacture and supply of Corona vaccine.
(Manas Dasgupta)
