After Pfizer and Sputnik, Moderna is the latest to join the list of foreign covid vaccines to take emergency approval in India. The US-based jab-maker sought the drug controller’s nod in releasing its vaccine for administration here while Cipla, the Mumbai-based pharmaceutical giant stepped forward to ask for its import and sale authorization.
According to sources, Moderna expects to receive a green signal from the Drug Controller General of India (DCGI) soon. The country can also expect the vaccine to be available in the market shortly as officials are inclined towards clearing Moderna for the EU.
In its application to the DCGI, Cipla referred to the drug regulator’s notices dates April 15 and June 1 where it mentioned that if the USFDA has given EUA, the vaccine can be given authorization for marketing without bridging trials. However, the safety assessment data of the first 100 beneficiaries should be submitted prior to the mass immunization programme, the document read.
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Moderna, which is said to be 90 per cent effective against covid-19, said the US government is willing to donate a part of its vaccine doses through COVAX to India that can be used soon after its approval.
It has a similar functioning mechanism like Pfizer as Moderna is an mRNA-based vaccine. It has fragments of messenger RNA, a genetic material, that works to fight against the severity of covid. The vaccine sends temporary instructions to the human body cells to produce coronavirus spike protein. This protein is found on the surface area of coronavirus.
As for Pfizer, the drug-maker had applied for EUA weeks ago. Its CEO Albert Bourla said recently that their vaccine is expected to be released in India for administration soon as its approval process has reached the “final stage”.
Speaking about the same, Mr Bourla had said, “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.”
Pfizer’s approval was halted after foreign vaccines sought indemnity, protection from legal issues if their jab produces an adverse effect in any person’s body. The SII had demanded similar protection for Covishield if it gets granted to foreign vaccines.
