New Delhi: Moderna has requested approval for its Covid vaccine in India and Mumbai-based pharma major Cipla has applied for permission to import and sell it within the country, consistent with sources.
Moderna expects clearance from the Drug Controller General of India (DCGI) soon, sources say.
Cipla, in its application to the drug regulator, refers to a recent move to waive bridging trials for foreign vaccines if it’s cleared for emergency use in countries just like the US and if the security assessment data of the primary 100 beneficiaries is submitted before mass rollout.
Moderna has also said the United States government has agreed to donate a particular number of doses of its vaccine through COVAX to India.
Moderna is claimed to be 90 per cent effective against Covid.
Like Pfizer, Moderna is an mRNA vaccine that has fragments of the genetic material referred to as messenger RNA .
The vaccine works by giving cells temporary instructions to form the coronavirus spike protein. The protein is found on the surface of the COVID-19 virus.
Recently, Pfizer CEO Albert Bourla had said that the company’s vaccine may soon be available in India because the process of its approval is within the “final stages”.
Pfizer is now within the final stages to urge approval for COVID-19 vaccine in India. I hope very soon we’ll finalise an agreement with the govt ,” Mr Bourla had said.
The rollout of foreign vaccines has been stalled over their condition that India waives indemnity from liability just in case of an adverse effect.