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Government Must Protect Vaccine Manufacturers Against Lawsuits: Adar Poonawalla From IBS


Manufacturers of vaccines against coronavirus disease (Covid-19) should be protected from liability in the event of serious adverse reactions or other claims to their vaccines during a pandemic, said the executive director of the Serum Institute of India (SII). ), Adar Poonawalla. Poonawalla, who made the remarks during a virtual roundtable on the challenges to vaccine development, said this is because these issues could increase fear of getting vaccinated and also the “bankrupt or distracted” companies that make these vaccines. He said his company plans to propose this to the government.

“We need the government to indemnify manufacturers, especially vaccine manufacturers, against all lawsuits. In fact, COVAX and other countries have already started talking about it, ”he said at Carnegie India’s Global Technology Summit on Friday. “This is especially important only during a pandemic to indemnify vaccine manufacturers against serious adverse effects lawsuits or any other frivolous claims that may come up because that adds to fear (about vaccines),” he added.

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The government, Poonawalla said, should enact a law as it would help companies focus on developing and manufacturing the vaccines rather than having to tackle legal issues. “The government can act. The United States, 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 serious adverse effects lawsuits or any other frivolous claims that may arise. Because that increases fear and will also ruin vaccine manufacturers or distract them if they have to fight all day with lawsuits and explain to the media what is happening, “he said.

Poonawalla said that when “frivolous” claims come up and are exaggerated, it affects the confidence of not only those opposed to vaccination, but also the general public. “Anyone can have a thought and skepticism and then it is established in (that) definitely something can happen because of the vaccine … to dispel that, the government must intervene (with) messages with influencers to spread, also, the correct information , ”Said the CEO of the Pune-based SII.

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His comments came after one of the participants, who had taken Covishield from IBS as part of intermediate to late stage clinical trials to test the safety and immunogenicity of the Covid-19 vaccine in India, sent IBS a legal notice requesting Rs 5 crore in compensation. The participant had claimed that the vaccine had caused serious neurological side effects. The SII, however, dismissed the charges as “malicious and ill-conceived” and threatened to sue the participant for more than 100 million rupees, according to reports.

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IBS, the world’s largest vaccine manufacturer, had applied for approval for the vaccine from the University of Oxford-AstraZeneca on December 6. The Oxford-AstraZeneca vaccine has been shown to be 62% effective when volunteers received two full doses of the vaccine, but 90% higher. % when the first was a medium dose, based on interim results from trials in the UK and Brazil. In India, IBS is conducting trials of the vaccine, which is also producing one billion doses of the injection.

The Central Drug Control Organization (CDSCO) expert committee has sought additional safety and efficacy data from IBS and Bharat Biotech for its coronavirus disease (Covid-19) vaccine, after deliberating on their requests to obtain authorization for injections.

Hindustan Times