Cipla Cleared to Import Moderna for Emergency Use in India: Centre
The Moderna jab is the fourth vaccine to be give Emergency Use Authorisation (EUA) in the country.
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:
"This permission is for restricted use in emergency situations in public interest. The firm has to submit 7 days safety assessment of the vaccine in first 100 beneficiaries before rolling out of vaccine for further immunisation programme, according to the approval order."
Cipla had applied for the import and marketing rights of the United States-manufactured vaccine on Monday.
According to ANI, speaking on the marketing rights of the vaccine, the company said in a statement on Tuesday, "Cipla Limited is supporting Moderna with the regulatory approval and importation of vaccines to be donated to India. At this stage, there is no definitive agreement on commercial supplies."
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.
More About Moderna
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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