New Delhi: The central government should indemnify vaccine manufacturers against lawsuits alleging side-effects, Adar Poonawalla, chief executive officer of Pune-based Serum Institute of India (SII) said Friday.
Speaking at the Global Technology Summit 2020 organised by Carnegie India, Poonawalla said, the government can intervene and protect the vaccine manufacturers from “frivolous claims.”
“Govt should indemnify vaccine manufacturers against all the lawsuits. Infact, COVAX and other countries are already talking about it,” he said in a reply to a question by session’s moderator Kiran Mazumdar-Shaw, Chairperson of Biocon, on how the government should handle the concerns related to side-effects of vaccines and misinformation.
“When frivolous claims of adverse events come up, they are being blown out of proportion. The US has already evoked a similar law to indemnify the manufacturers during the pandemic,” Poonawalla said.
Poonawalla’s firm SII had received a legal notice from a Chennai-based participant seeking compensation of Rs 5 crore alleging side-effects from its leading vaccine candidate Covishield.
The vaccine, Covishield, is being developed by the University of Oxford and drugmaker AstraZeneca.
The Serum Institute of India has a tie-up with Swedish-British pharma giant for manufacturing billion doses of the vaccine. Covishield is among the frontrunners in the race to develop an effective vaccine against Covid-19.
Poonawalla added, “Apart from creating unnecessary fear in mind of people against the vaccines…the manufacturers will go bankrupt (due to such legal notices). They also distract the manufacturers as they keep on explaining to the media what has happened.”
He was speaking as part of a panel titled The Challenges of Developing a Covid19 vaccine. Dr Soumya Swaminathan, chief scientist at the World Health Organization (WHO) and John Nkengasong, director, Africa Centres for Disease Control and Prevention were the other panellists.
‘Monitor safety of the vaccines but also efficacy’
Swaminathan said, “the countries must put in place mechanisms for monitoring the safety of the vaccines but also for monitoring the effectiveness of these vaccines.”
She explained that the criteria for vaccine to be declared efficacious was decided by the group of regulators, clinical trialists and statisticians after which it was set at 50 per cent efficacy benchmark, with lower bound not below 30%.
“Luckily, so far we have seen few vaccines that have met the benchmark of 50 per cent efficacy, in the interim results. That’s very good news. It also forms the criteria for emergency authorisation listing.”
However, for collecting safety data, the WHO has shortened the period from 12-24 months (under normal clinical trials) to two months, due to the pandemic.
“Majority of serious adverse events (from taking vaccine shots) occur in the first 6-8 weeks and some can happen later. Also, when a larger number of people are being vaccinated, rare side effects can also be seen,” she said.
‘Equitable access to vaccines’
“We used global solidarity and cooperation to conquer a pandemic rapidly. It is absolutely clear in my mind that we can’t win the war against Covid pandemic without a speedy distribution of vaccines across the world,” said John Nkengasong.
“From where I see, we can only be on the right side of history by doing the difficult thing which is to make sure that we all have equitable access to the vaccines,” he said.
ThePrint is a digital partner with Carnegie India for the Global Technology Summit 2020.