Govt must protect vaccine makers against lawsuits: SII’s Adar Poonawalla

Manufacturers of vaccines against the coronavirus disease (Covid-19) must be protected against liability in case there is any serious adverse reactions or other claims to their shots during a pandemic, Serum Institute of India (SII) chief executive officer Adar Poonawalla has said. Poonawalla, who made the comments during a virtual panel discussion on the challenges to vaccine development, said it is because such issues could potentially increase fear against getting vaccinated and also “bankrupt or distract” companies making these shots. He said his company plans to propose this to the government.

“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 on Friday during Carnegie India’s Global Technology Summit. “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 (about vaccines),” he added.

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The government, Poonawalla said, should bring a law as it would help companies focus on developing and manufacturing the vaccines rather than having to address legal issues. “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.

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Poonawalla said that when “frivolous” claims crop up and are blown out of proportion, it affects the confidence of not just people opposed to vaccination but the general public too. “Anyone may have a thought and scepticism 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,” the CEO of the Pune-based SII said.

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His comments came after one of the participants, 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, sent SII a legal notice seeking Rs 5 crore in compensation. The participant had alleged that the vaccine had caused severe neurological side-effects. SII, however, rejected the charges as “malicious and misconceived” and threatened to sue the participant in excess of Rs 100 crore, according to reports.

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SII, the world’s largest vaccine manufacturer, had requested approval for the Oxford University-AstraZeneca vaccine, on December 6. The Oxford-AstraZeneca vaccine has shown the efficacy of 62% when volunteers were given two full doses of the vaccine, but a higher 90% when the first was a half-strength dose, according to interim results from trials in the United Kingdom and Brazil. In India, the vaccine’s trials are being carried out by SII, which is also producing a billion doses of the shot.

The expert committee of the Central Drugs Standard Control Organisation (CDSCO) has sought additional safety and efficacy data from SII and Bharat Biotech for their coronavirus disease (Covid-19) vaccine, after deliberating upon their applications seeking authorisation for the shots