Cipla gets DCGI nod to import Moderna vaccine; no commercial deal yet

1st mRNA vax part of US-India pact; no commercial deal yet

India on Tuesday approved a fourth Covid-19 vaccine--Moderna’s mRNA-1273. With this, the government has cleared the path for importing Covid vaccines approved by international regulators, without bridging clinical studies. The vaccine will be made available through a tie-up with Mumbai-headquartered Cipla.

Cipla is supporting Moderna with the regulatory approval for import the vaccines to be donated to India, a company spokesperson said. ‘’At this stage, there is no definitive agreement on commercial supplies,’’ the spokesperson added.   

The vaccine developed by Cambridge (Massachusetts)-based Moderna Inc has demonstrated 94.1 per cent efficacy. This will be the first mRNA vaccine to get an emergency approval in India. Unlike other types of vaccines which put inactivated germ into a body to trigger an immune response, mRNA teaches cells to make protein for the purpose.

US vaccine makers Pfizer and Moderna had sought indemnity against serious adverse events following vaccination as a pre-condition for India presence. This is an immunity they have secured in other countries where they supply doses. This matter is under consideration, said V K Paul, member (health), NITI Aayog.

Paul confirmed that Moderna’s application for emergency use authorization of its vaccine through its Indian partner has been granted approval by the Drugs Controller General of India (DCGI).

“This potentially opens up a clear likelihood of this vaccine being imported into India in the near future. There must be other formalities that have to be followed but a very important licensure has been given,” Paul said.

On the issue of indemnity, Paul said, “Indemnity issue is being addressed and being taken up for examination. Their consideration is being examined.”

Meanwhile, sources indicate that Cipla is interested to import around 50 million doses of the Moderna vaccine. It is not clear how soon the supplies will begin, but sources add that much of this could be in 2022.

Apart from Cipla, US major Moderna was in discussions with other Indian firms too for partnership.

In May, the Indian regulator had released guidelines for import of Covid19 vaccines and cleared the way for private sector or state governments to import. The guidelines said that the importer or authorized agents of the foreign manufacturers would need to obtain three key permissions or licences from the Central Drugs Standard Control Organisation (CDSCO).

These include a new drug permission under the New Drugs and Clinical Trials Rules, 2019; import registration permission under the Drugs Rules, 1945 and a basic import licence under the Drugs Rules, 1945.

Once the import licence is obtained, ‘’the importer or the authorized agent can import the vaccine and any private sector entity can procure the vaccine from them as per the national guidelines,’’ the drug regulator had said.

All  imports will have to be based on the health ministry vaccination guidelines which came into effect from May 1.

The two-dose Moderna vaccine, to be given 28-days apart, has shown an efficacy of 94.1 per cent in protecting against Covid19. This efficacy rate kicks in 14 days after the first dose. It is already approved in 40 countries including the US, Japan, Singapore, UK, Italy, Spain, Canada, Germany etc.

Storage for the medium term for Moderna vaccine is in the range of -25 to -15 degree Celsius.  An unopened vial can be stored in a normal cold chain for 30 days in -2 to -8 degrees.

The government is also hopeful that the Moderna vaccine would be manufactured in India as well in future. The other international vaccine Sputnik V is being manufactured in India too. ‘’We hope that they (Moderna) should produce on Indian soil,” Paul said.

The two India-made vaccines being administered currently are Covishield and Covaxin.

“Our efforts to get other international vaccines such as Pfizer and Johnson & Johnson are also on. We are also looking to increase availability and production of our own vaccines,” Paul said.

Referring to import of Moderna vaccine, he said this was only a regulatory clearance. “Let us wait to see how this opportunity would be used in accessing vaccines into our country.”

On the issue of Pfizer’s vaccine, Paul said that multiple sessions had been held with the pharma major. “Inputs are going back and forth. We are waiting to hear from them after an intensive meeting last week,” Paul said.