Moderna vaccine soon to be jabbed in India for emergency use says DCGI, Cipla applies for import
The Drugs Controller General of India (DCGI) is likely to approve the American Covid-19 vaccine Moderna soon for emergency use on those aged 18 and above, PTI reported on Tuesday.
The news agency reported that pharmaceutical company Cipla has applied for the import and marketing authorisation of the Moderna's inoculation, once it gets regulatory approval.
Moderna has also informed that the US government would be donating a certain number of doses of covid-19 vaccine to India through COVAX, a programme by GAVI and WHO to ensure equitable distribution of Covid-19 vaccines globally, for which it has sought approval from the Central Drugs Standard Control Organisation (CDSCO).
The approval is likely to come as early as possible, CDSCO is in favour of doing so, PTI reported.
Cipla, a medicine company, filed an application seeking permission for import of Moderna Covid-19 vaccine on Monday. It referred to DCGI notices dated April 15 and June 1, which state that if the vaccine is approved by the USFDA for Emergency Use Approval, the vaccine can be granted marketing authorization without a bridging trial and the assessment of safety data of first 100 beneficiaries of moderna vaccine shall be submitted before rolling out in the immunization programme.
Earlier in May, Cipla had requested the government of india for indemnification and exemptions from price capping, bridging trials and basic customs duty, while stating that it is close to committing over 1-billion USD as advance to the US major Moderna's single dose vaccine.
Meanwhile, Pfizer CEO Albert Bourla said on June 22 that the Pfizer Covid vaccine is now in final stages to get approval for it's final use in India. I hope very soon we will finalize an agreement with the Union government,' he said, news agency ANI reported.
India has scrapped local trials of vaccines for “well-established” foreign coronavirus vaccines in order to accelerate the vaccination drive in the nation.