Cipla had referred to the government’s decision to waive bridging trials for foreign vaccines if it is cleared for emergency use in countries like the US and if the safety assessment data of the first 100 beneficiaries is submitted before mass rollout.
Pharma major Cipla has been cleared to import Moderna’s Covid vaccine for restricted emergency use in India.
Cipla, in its application to the drug regulator, had referred to the government’s decision to waive bridging trials for foreign vaccines if it is cleared for emergency use in countries like the US and if the safety assessment data of the first 100 beneficiaries is submitted before mass rollout.
Moderna is said to be 90 per cent effective against Covid.
Like Pfizer, Moderna is an mRNA vaccine that has fragments of the genetic material known as messenger RNA.
The vaccine works by giving cells temporary instructions to make the coronavirus spike protein. The protein is found on the surface of the COVID-19 virus.
“Pfizer is now in the final stages to get approval for COVID-19 vaccine in India. I hope very soon we will finalise an agreement with the government,” Mr Bourla had said.
The rollout of foreign vaccines has been stalled over their condition that India waives indemnity from liability in case of an adverse effect.
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