Serum Institute of India’s Chief Executive Officer Adar Poonawalla has said that he and other Covid-19 vaccine manufacturers in the country will ask the government to provide them protection against lawsuits suing them for adverse reactions experienced at the time of inoculation, reported PTI on Saturday.
This is because such matters could potentially increase fears about getting vaccinated, Poonawalla said while addressing a virtual panel on the challenges of developing a vaccine against the coronavirus, at the Carnegie India’s Global Technology Summit on Friday. He added that such punitive actions also work to “bankrupt or distract” companies that would be producing the vaccines, he said.
“We need to have the government indemnify manufacturers, especially vaccine manufacturers, against all lawsuits,” Poonawalla said. “In fact, Covax and other countries have already started talking about that.”
He said that when “frivolous” claims crop up, that are “blown out of proportion by the media”, it affects the confidence of not just the companies, but of the general public too. “And to dispel that, the government needs to step in to spread the right information,” the Serum chief said. “The government can act.”
Poonawalla gave the example of the United States, saying the country has invoked a law to indemnify vaccine manufacturers against lawsuits for severe adverse effects or “any other frivolous claims”. “This is especially important only during a pandemic,” he added. “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.”
The US government has granted vaccine makers like Pfizer and Moderna immunity from liability if something unintentionally goes wrong with their Covid-19 vaccines under the Public Readiness and Emergency Preparedness Act. The 2005 law empowers the Health and Human Services Secretary secretary to provide legal protection to companies making or distributing critical medical supplies, such as vaccines and treatments, unless there’s “willful misconduct” by the company. The protection lasts until 2024.
The Pune-based Serum Institute of India, which is the world’s largest vaccine manufacturer, has tied up with the University of Oxford and the British-Swedish company AstraZeneca to commercially produce and market this vaccine in India if and when it is approved. On December 8, the company applied for the emergency use authorisation of its vaccine.
But allegations surfaced last month concerning possible side-effects of this vaccine after a 40-year-old man had sued the Serum Institute, complaining that he had suffered serious “neurological and psychological” symptoms upon receiving the vaccine in a trial. Serum had rejected the allegation, claiming that its reputation was being “unfairly maligned”. As a result, it had sent the volunteer a legal notice of its own.
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Serum Institute’s trial has run into a controversy. Will this erode public trust in a vaccine?
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