Pharmaceutical company Pfizer will supply its coronavirus vaccine only through government channel in India, reported The Indian Express on Thursday.
This means that the vaccine of the United States-based company may not be available through private hospitals unless the central or state governments sell doses to these medical facilities, according to the newspaper.
“Pfizer remains committed to continuing our engagement with the government towards making the Pfizer and BioNTech vaccine available for use in the government’s immunisation programme in the country,” a company spokesperson told The Indian Express.
India had on Monday opened up its inoculation distribution strategy, allowing companies to sell vaccines directly to states and private companies.
Pfizer’s stand, however, was clear before the Centre’s decision to allow sale to private players. “During this pandemic phase, Pfizer will prioritise supporting governments in their immunisation programs and supply the Covid-19 vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval,” the company spokesperson had told The Print before Centre’s decision to expand vaccinations to include all adults.
The pharmaceutical company had submitted an application to the Drugs Controller General of India for restricted use permission of its Covid-19 vaccine to India on December 4. It had then received emergency use authorisation in the United Kingdom.
Although Pfizer had not conducted local trials in India, provisions under Clinical Trial Rules, 2019, allowed it to seek approval without conducting the tests. It was permitted as the vaccine had received approval from a foreign drug regulator recognised by the Central Drugs Standard Control Organization.
However, the company had announced on February 5 that it was withdrawing its application after an expert body under India’s drug regulator had raised safety concerns. It asked the US-based company to conduct local trials to prove the safety of the vaccine, developed with Biotechnology company BioNTech, on the Indian population.
Unidentified officials had told The Print that Pfizer’s withdrawal was because India did not sign indemnity bonds as asked by the pharmaceutical company. Indemnity bonds are the legal bonds that protect the company from being sued in case the vaccine causes any side-effects.
As India is now reporting an alarming surge in coronavirus cases, the Centre announced on February 13 its decision to fast-tracked emergency approvals for foreign-produced vaccines that have been cleared in other countries. VK Paul, NITI Aayog member and chairperson of the National Expert Committee on Vaccine Administration, then invited international vaccine manufacturers, including Pfizer, to come to India as early as possible.
Meanwhile, India on Thursday reported a record-breaking 3,14,835 new coronavirus cases, taking the total number of infections to 1,59,30,965 since the pandemic broke out in January 2020. This is also the highest ever single-day rise in cases reported by any country so far. With 2,104 deaths, the toll rose to 1,84,657.
This is the eighth consecutive day the country has recorded over 2 lakh coronavirus cases.