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DCGI might soon give ‘emergency use’ approval to Moderna’s Covid-19 vaccine for adults above 18 years: Sources

The Drugs Controller General of India is likely to approve Moderna’s Covid-19 vaccine contender soon for emergency use in people aged 18 and above, according to sources privy to the development.

Moderna had earlier sought regulatory approval for its Covid-19 vaccine in India.

Moderna has further informed that the United States government has agreed to donate a certain number of its vaccine doses through the global initiative of COVAX to India and has sought approval from the Central Drugs Standard Control Organisation (CDSCO) for the same.

Mumbai-based pharmaceutical company Cipla, on behalf of the US vaccine maker, has applied for the import and marketing authorisation of the jabs.

Sources have informed news agency PTI that an approval is likely on the cards as the Central Drugs Standard Control Organisation of India is in favour of that.

Cipla had on Monday filed an application seeking permission to import Moderna’s Covid-19 vaccine referring to DCGI notices dated April 15 and June 1 stating that “if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorisation without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme”.

Reports earlier claimed that the Centre had agreed to purchase vaccines from Moderna and Pfizer only if they are offered at a special price.

Earlier this month, sources in the Union Health Ministry revealed that the central government is likely to provide indemnity against legal proceedings to the foreign coronavirus vaccine manufacturers along the lines of the permission granted by some countries.

 

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