Granting indemnity to Pfizer and Moderna will boost Covid-19 vaccination for not just children, but also adults, said AIIMS director Dr Randeep Guleria in an interview.
The Centre may grant indemnity from liability to Pfizer and Moderna to speed up approvals for the vaccines in India, health ministry sources indicated on Wednesday. A top official with the government has said that “there is no issue” in granting indemnity to the two giants in India and the approval will be in line with the approach taken by US and other countries administering both vaccines.
On the Government of India granting indemnity for bridging trials for Pfizer, Dr Guleria said, “It’ll help for not only children but adults also”.
“This has been done in the past too when the government gave emergency approvals to all vaccines that had been approved by agencies of US, UK or EU and WHO. Based on that, emergency approvals have already been given de-facto to vaccines with approvals from these agencies and the issue of indemnity also seems to be resolved. So, I think we will have Pfizer vaccine coming in for children and adults shortly,” the top pulmonologist said.
Responding to why norms were not eased before, Dr Guleria said, “There are two things here. First, to look at emerging data. There wasn’t enough data to be comfortable with. I am not the part of the group that decides this, but there wasn’t enough data for the vaccine to be given comfortably to Indians. There have been side-affects with European population so you have to be really careful. The first principle is you don’t want to cause more harm than good. As the vaccine rollout happened it became clear that a large number of vaccinated in UK and the US were of Indian origin and in them there were no side-effects and therefore we felt now we have enough data globally to say that we can approve the vaccines.
Amid reports that the Indian government may grant indemnity to Pfizer and Moderna to hasten the vaccination process in India, the Serum Institute of India on Thursday also asked for indemnity from liability, saying all vaccine makers, whether Indian or foreign, should be granted the same protection. The government has so far not given any manufacturer indemnity or protection against legal action for any severe side effects. As the issue gains traction, here’s what indemnity means and how it will aid the vaccination process in India.
Indemnity means protection to vaccine makers from legal proceedings, which ensures they can’t be sued in India. No other vaccine maker in India enjoys this clause. However, Pfizer and Moderna have said they will export to India only if the transaction is with the Centre and the company is protected from legal cases.
While Pfizer and Moderna have raised the demand, the Serum Institute of India on Thursday said the same protection should be provided to all vaccine makers. Pfizer and Moderna, which are among the best shots in the international market and more than 90 per cent effective, have been approved by more than 40 countries, including US and Britain.
As per Niti Ayog member VK Paul, “They have requested indemnity to all the nations, including the country of origin. We are examining this request and will take a decision in the larger interest of people and on merit. This is under discussion and there is no decision as of now.”
