All India Institute of Medical Sciences chief Randeep Guleria has said that the coronavirus vaccine developed by pharmaceutical company Pfizer is expected to be available soon in India for adults, as well as children, News18 reported on Friday. The company is in talks with the Centre to roll out five crore doses between July and October this year.
In an interview to the news channel, Guleria said that emergency approvals have been granted to vaccines in the past based on clearances given by regulatory agencies of foreign countries and the World Health Organization.
“Based on that, emergency approvals have already been given de-facto to vaccines with approvals from these agencies,” Guleria said. “So, I think we will have Pfizer vaccine coming in for children and adults shortly.”
Last month, the Food and Drug Administration in the United States had expanded emergency authorisation given to the Pfizer vaccine for those in the age group of 12-15.
Meanwhile, Guleria added that the matter of Pfizer’s demand for indemnity “also seems to be resolved”, News18 reported. Reports said this was a key condition put forth by pharmaceutical companies Pfizer and Moderna for supplying doses to India. Pfizer has obtained indemnity in several countries where its vaccine is already in use, including the US.
Indemnity provides protection to vaccine makers against legal proceedings and costs of compensation for severe side effects among those who receive the shots.
In his interview, Guleria said that the norm was not eased earlier as data on side effects was still emerging. “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,” Guleria told News18. “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.”
He said that the roll out in US and the United Kingdom without any significant cases of side effects will help in granting indemnity.
On Thursday, Serum Institute of India chief Adar Poonawalla also sought indemnity from liability. The Indian drug regulator has so far not granted indemnity against the costs of compensation for severe side effects to the manufacturers of any of the three Covid-19 vaccines which have received emergency use authorisation.
Last month, Dr VK Paul, head of India’s Covid-19 Task Force, had said that the government was examining Pfizer’s request. He added that decisions will be taken “in the larger interest of people and on merits”.
The government has, however, waived the requirement to conduct post-launch bridging trials for foreign-made coronavirus vaccines, in a move that is expected to bolster the availability of shots. The Drugs Controller General of India has also done away with the mandatory testing of every batch of such vaccines at the Central Drugs Laboratory in Kasauli.