Moderna's messenger RNA (mRNA) COVID-19 vaccine is likely to arrive in India this week. Health officials expect Moderna's mRNA COVID-19 vaccine to reach hospitals by July 15 for inoculation, according to reports.
On June 29, Moderna Inc received emergency use approval from the Drugs Controller General of India (DCGI) for its mRNA COVID-19 vaccine. Moderna's vaccine became the fourth COVID-19 vaccine to get approval in India. The DCGI had also given approval to Mumbai-based drug maker Cipla to import Moderna's COVID-19 vaccine.
"This permission is for restricted use in emergency situations in the public interest. The firm has to submit 7 days' safety assessment of the vaccine in the first 100 beneficiaries before rolling out of the vaccine for further immunisation programme, according to the approval order," the DCGI had noted.
Moderna's mRNA COVID-19 has a two-dose routine. The vaccine has already been widely used in the United States and Europe. The mRNA vaccine is expected to face cost and distribution challenges in India as the jab requires cold storage.
Earlier, Moderna had informed that the US government has agreed to donate a portion of its COVID-19 vaccine doses through COVAX for the Indian government's use and has sought the approval from the Central Drugs Standard Control Organisation (CDSCO).
The Centre in April had issued detailed guidelines and proactively eased entry of foreign made COVID-19 vaccines approved by US FDA, EMA, UK's MHRA and Japan's PMDA, and WHO's Emergency Use Listing into India.
On June 1, in a bid to expedite the rollout of vaccines, the DCGI decided to waive testing of batches at CDL for foreign-manufactured vaccines. This applied to foreign developed vaccines approved by international drug regulators such as the US FDA, the UK's MHRA or the WHO.
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