New Delhi: Drugs Controller General of India (DCGI) has given Cipla approval to import Moderna’s COVID-19 vaccine for restricted emergency use in the country. Moderna’s COVID-19 vaccine will be the fourth vaccine to be administered to Indians after Bharat Biotech’s Covaxin, Serum’s Covishield and Russian vaccine Sputnik V.
The vaccine will be administered to beneficiaries above 18 years of age. Children below 18 years are yet to be covered under the vaccination programme, Business Today reported.
Niti Aayog (Health) member Dr VK Paul confirmed the development at the health briefing on Tuesday, saying an application received from Moderna through an Indian partner has received emergency use authorisation.
“This opens up likelihood of the vaccine being imported in near future. This is the fourth vaccine,” he said, adding, “This is only the regulatory approval given. Indemnity issue is being examined.”
The pharma company had filed an application on Monday seeking the regulator’s nod to import the Moderna vaccine to India.
Cipla filed the application after the DCGI notices on April 15 and June 1 allowed marketing authorisation without bridging trials and assessment of safety data of the first 100 beneficiaries to vaccine manufacturers that was approved by the US FDA for emergency use.
Moreover, the US government has also agreed to donate a portion of Moderna vaccines to the Indian government through COVAX. The company had sought approval from the Central Drugs Standard Control Organisation (CDSCO) for the vaccine.
Vaccine manufacturers like Moderna and Pfizer had sought legal indemnity in India to exempt themselves from adverse effects suffered by beneficiaries after the dosage.