New Delhi: Moderna, an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts, has requested approval for its COVID vaccine in India, and Mumbai-based pharma major Cipla has applied for permission to import and sell it in the country, reports said quoting sources.
As per a report published in NDTV, Moderna expects clearance from the Drug Controller General of India (DCGI) soon.
Cipla, in its application to the drug regulator, refers to a recent move 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.
As per the Moderna, the US government has agreed to donate a certain number of doses of its vaccine through COVAX to India.
The vaccine is said to be 90 per cent effective against COVID and has fragments of the genetic material known as messenger RNA. It also works by giving cells temporary instructions to make the coronavirus spike protein. The protein is found on the surface of the COVID virus.
In a recent statement, Pfizer CEO Albert Bourla had said that the company’s vaccine may soon be available in India as the process of its approval is in the “final stages”.
“Pfizer is now in the final stages to get approval for COVID vaccine in India. I hope very soon we will finalize an agreement with the government,” Bourla had said.
The rollout of foreign vaccines has been stalled over the condition that India waives indemnity from liability in case of an adverse effect, the report said.