US-based vaccine maker Moderna has approached the Indian drug regulator seeking emergency use authorization for its COVID-19 vaccine in India. Media reports suggest that the vaccine maker may soon get the nod from the Drug Controller General of India (DCGI) for the administration of its vaccine for people above 18 years.
Notably, Indian pharmaceutical major Cipla has also filed an application with DCGI seeking permission to import Moderna’s COVID-19 vaccine in India and market the jabs. The Indian drug major has applied on June 28 asserting that the US food and drug administration has already granted emergency use authorization for Moderna’s jab.
Cipla has said that since the vaccine has been granted emergency use authorization by the USFDA, it can be granted marketing authorization without a bridging trial. It has also said that the assessment of safety data of the first 100 beneficiaries of vaccines will be submitted before rolling out the immunization drive.
Moderna has also informed that the US government has agreed to donate a certain number of doses of the Moderna COVID-19 vaccine through COVAX to the Government of India for use and has sought approval from the Central Drugs Standard Control Organisation (CDSCO) for these vaccines.
India’s vaccination drive
The Indian drug regulator has so far approved three COVID-19 vaccines for emergency use in India—Covishield, Covaxin and Sputnik-V. Many other Indian vaccines candidates are also likely to seek a nod from the drug regulator for emergency use authorization. This apart, US-based vaccine maker Pfizer has also sought permission for emergency use authorization.
India’s immunization drive started in January and has gradually picked up pace as the threat of a third wave of the pandemic looms large. The ministry also informed that over 32.90 crore COVID-19 jabs have been administered so far. Of it, over 52.76 lakh people were vaccinated on Monday.
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