India opens doors for import of Moderna, its fourth vaccine

Cipla gets DCGI nod to market US-made vax

Tribune News Service

New Delhi, June 29

India on Tuesday licensed its fourth Covid-19 vaccine for restricted emergency use at home with the drugs regulator approving Cipla’s request for import of US pharma major Moderna’s jabs.

Moderna will be the first internationally manufactured ready-to-inject shot to enter the Indian market once the import formalities are concluded. India has earlier licensed Covaxin, Covishield (both made in India) and the Russian Sputnik V for restricted emergency use.

With the Centre already having waived all requirements for local clinical trials for foreign jabs approved by reputed regulators, Moderna would not need to conduct any bridging studies at home.

Only the first 100 persons who receive the shot would have to be watched for adverse events.

Unlike Sputnik V which is being produced in India, Moderna will only be imported although the government is hoping Moderna would consider manufacturing in India.

Member, NITI Aayog, VK Paul said the regulatory approval had opened the pathway for import of Moderna but did not put a timeline to the availability of the shots in the domestic market.

“Today’s development opens up the clear likelihood and possibility of Moderna being imported in India. Formalities would be there but an important licence has been given and our vaccine basket is richer today,” Paul said.

The government said efforts to invite other internationally developed vaccines to come to India continued to ensure a rising momentum towards coverage.

Asked about indemnity from legal costs for foreign developers, including Moderna and Pfizer have sought, Paul said, “That is under consideration and is being addressed. We have held multiple discussions with Pfizer and are going through agreements needed for such an arrangement to be exercised. We had an intensive meeting with Pfizer last week and are awaiting feedback from their end.”

Asked when Moderna would enter India, Paul said: “Let’s wait and see how today’s opportunity will be used for importing Moderna into India”.

Moderna had reported over 94.5 per cent efficacy in late-stage trials.

Its long-term storage will require a cold chain storage at -20°C. Unopened vaccine vials can be stored between 2 and 8°C for 30 days at vaccination centres.