Vaccine makers need to be protected against liability for serious adverse reactions to their shots during a pandemic scenario, said Adar Poonawalla, Serum Institute of India (SII) CEO, on Friday.
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 during Carnegie India’s Global Technology Summit.
“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 anti-vaxxers, but the general public too. “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 statements come in the backdrop of an issue raised by one of the volunteers who had taken SII’s ‘Covishield’ as part of mid- to late-stage clinical trials to test the safety and immunogenicity of the Covid-19 vaccine in India. The volunteer had sent SII a notice seeking Rs 5 crore in compensation, alleging that the vaccine had caused a severe neurological issue.
SII, however, rejected these claims, adding that its reputation was being “unfairly maligned”. As a result, it had reportedly sent the volunteer a 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, as per PTI.
SII is one of the firms seeking accelerated approvals for its vaccine in India. It is also one of the firms that has a tie up to supply Covishield to the COVAX facility led by Gavi, The Vaccine Alliance, in collaboration with CEPI and WHO. The collaboration on Friday announced additional deals to access Covid-19 vaccines for 190 countries. This includes an advance purchase agreement with AstraZeneca for 170 million doses of the vaccine it developed with the University of Oxford. SII’s Covishield is based on this vaccine.
“These deals are in addition to existing agreements COVAX has with the Serum Institute of India (SII) for 200 million doses — with options for up to 900 million doses more — of either the AstraZeneca/Oxford or Novavax candidates, as well as a statement of intent for 200 million doses of the Sanofi/GSK vaccine candidate,” stated COVAX in a release.