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The Drugs Controller General of India (DCGI) granted permission to Mumbai-based pharmaceutical firm Cipla to import Moderna COVID-19 vaccine for restricted emergency use in India, Dr VK Paul announced in a press meet on Tuesday, 29 June. The Moderna vaccine will be administered in two doses, Dr VK Paul further said.
Also, it is the fourth vaccine to be given Emergency Use Authorisation (EUA) in the country after Covaxin, Covishield and Sputnik.
An official told PTI:
Cipla had applied for the import and marketing rights of the United States-manufactured vaccine on Monday.
The Mumbai-based company referred to DCGI notices dated 15 April and 1 June, which declared that if a vaccine is approved by the US Food and Drug Administration (USFDA) for EUA, then it may be made available without a post-approval bridging trial and the testing of every batch of the vaccine by Central Drugs Laboratory.
In May, Cipla had reportedly already indicated an interest in procuring five crore Moderna doses from next year and had urged confirmation from the Union government over stable regulatory requirements and policies.
The modern vaccine is the second US-based mRNA vaccine, besides Pfizer, to be granted emergency use authorisation.
mRNA vaccines are based on a new vaccine technology that make us of the pathogen's genetic code to elicit a strong immune response, Quint Fit reported.
The moderna vaccine has undergone the review of the European Medicines Agency and it meets the World Health Organization's (WHO) criteria for safety and efficacy.
Although the vaccine has only been granted emergency authorisation for those above the age of 18, the biotechnology firm had announce that its vaccine was found to be "highly effective" in adolescents aged between 12 and 17.
(With inputs from PTI and ANI)
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