DCGI gives approval to Cipla to import Moderna’s COVID-19 vaccine for emergency use

After Bharat Biotech-developed Covaxin, Serum Institute’s Covishield and Sputnik V of Russia, India is set to use the fourth vaccine of COVID-19 in the country following Drugs Controller General of India’s (DCGI) approval of Mumbai-based pharmaceutical company Cipla to import COVID-19 vaccine of Moderna for emergency use in India.

On June 29, Cipla had filed an application seeking permission for the import of the COVID-19 vaccine developed by Moderna referring to DCGI notices of dates 15th April and 1st June allowed market authorization with no bridging trials as well as assessment of safety data of first hundred beneficiaries that was approved by the United States Food and Drug Administration (USFDA) for Emergency Use Authorization (EUA).

In addition, Moderna had informed that the government of US has agreed to donate a portion of Moderna’s COVID-19 vaccine doses through COVAX to the Indian government. It had submitted the dossiers through an e-mail and said, “This correspondence is to request the CDSCO (Central Drugs Standard Control Organization) to open a file for approval of these urgently needed vaccines.”

The method used by Moderna’s COVID-19 vaccine codenamed mRNA-1273 is its reliance on messenger RNA (mRNA) to programme cells to generate immunity to the coronavirus.

The vaccine will be administered to individuals above the age of 18 years. Children as well as adolescents below 18 years of age are not covered under the vaccination programme yet.

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