Randeep Guleria, who is heading the All India Institute of Medical Sciences (AIIMS) stated on Friday that the vaccine developed by pharmaceutical company Pfizer is expected to be available soon in India both for adults, as well as children, according to a report published in News18’s website. Talks are on with the Union government to roll out five crore doses between July and October 2021.
Guleria said that emergency approvals have been granted to vaccines in the past based on approvals given by regulatory agencies of foreign countries and the World Health Organization (WHO).
“Based on that, emergency approvals have already been given de-facto to vaccines with approvals from these agencies,” Guleria said.
Last month, the Food and Drug Administration in the United States of America had expanded emergency authorisation given to the pfizer vaccine for those in the group of 12-15
Meanwhile, Guleria added that the matter of Pfizer’s demand for indemnity “also seems to be resolved”, according to News 8 reports. 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.
Guleria said that the Pfizer was not given a green signal earlier because data on side effects was still pending which could not have been given easily to Indians. “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.
Earlier, Dr VK Paul, head of India’s Covid-19 Task Force, had said that the union government was inspecting Pfizer’s request. He added that decisions will be taken “in the larger interest of people and on merits”.
Source: News 18National, News