The Serum Institute of India has sought indemnity from liability or legal protection from the government for any severe side effects of its coronavirus vaccine, NDTV reported on Thursday. Reports said this was a key condition put forth by pharmaceutical companies Pfizer and Moderna for supplying doses to India.
The Adar Poonawalla-led company, which manufactures Covishield, has told the government that all vaccine makers, whether Indian or foreign, should be granted the same protection. “Serum is hoping that rules should be same for everyone,” a source told NDTV.
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.
An unidentified top official told News18 that “there is no problem” in granting indemnity to Pfizer and Moderna. The approval, the official added, will be in line with the approach taken by the United States and other countries in administering vaccines of the pharma giants.
Pfizer has obtained indemnity in several countries where its vaccine is already in use, including the US. The company cannot be sued for compensation if there are any adverse effects from its Covid shot.
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”.
Pfizer is in talks with the Centre to roll out five crore doses between July and October this year. It was the first company to seek emergency use authorisation for its vaccine in India late last year. But it withdrew its application in February after the drugs regulator asked for a local safety study for the vaccine.
The government has now 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.
The announcement comes at a time when the Narendra Modi government is trying to allay concerns about shortages of vaccine and ward off allegations of mishandling of the inoculation drive. Health experts have warned that India needs to increase its current pace of vaccination to reduce the impact of subsequent waves of the pandemic.
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