India's drug regulator may soon grant restricted emergency use authorisation for Moderna's COVID-19 vaccine, official sources told PTI on Tuesday. 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. Moderna is an mRNA vaccine which was granted approval by the World Health Organisation for emergency use on April 30.
According to the sources, an approval is likely to come anytime as the CDSCO is in favour of doing so. Cipla filed an application on Monday seeking permission for import of Moderna 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 authorization without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme.
The World Health Organisation has said that the Moderna vaccine has been shown to have an efficacy of approximately 94.1 per cent in protecting against COVID-19, starting 14 days after the first dose. The WHO Strategic Advisory Group of Experts (SAGE) has recommended the use of the Moderna mRNA-1273 vaccine at a schedule of two doses (100 µg, 0.5 ml each) 28 days apart. If necessary, the interval between the doses may be extended to 42 days. WHO has also added that based on the evidence so far, the new variants of coronavirus, including the Alpha and Beta variants, do not alter the effectiveness of the Moderna mRNA vaccine.
Earlier in May, it was reported that Cipla has shown interest in procuring 5 crore doses from Moderna and has requested confirmation from the Union government in respect of stability in regulatory requirements and policy regime. The Health Ministry had also been asked to take an early decision on Cipla's request regarding support required by them for procurement of Moderna vaccines.
With PTI inputs