India on Tuesday approved a fourth Covid-19 vaccine, and its first mRNA vaccine, Moderna’s mRNA-1273, thereby clearing the path for importing foreign regulator-approved Covid vaccines to India without bridging clinical studies. Moderna vaccine which has 94.1 percent efficacy will be available here through its Indian partner Cipla.
Cipla did not respond till the time of going to press.
US vaccine makers Pfizer and Moderna had sought indemnity against serious adverse events following vaccination, an immunity they enjoy in other countries where they supply. 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 Pauls 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 mn 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 licenses from the 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 license under the Drugs Rules, 1945.
Once the import license 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 take place based on the guidelines on the Health Ministry’s Liberalized Pricing and Accelerated National Covid-19 Vaccination Strategy with effect from May 1.
The two dose Moderna vaccine given 28-days apart, has shown an efficacy of 94.1 percent in protecting against Covid-19, starting 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.
Government is also hopeful that the Moderna vaccine would be manufactured in India as well in the future. “The other international vaccine Sputnik V which is being manufactured in India and Moderna is coming in a ready to inject form. We hope that they should produce on Indian soil,” Paul said.
There are four vaccines with such licensure in India, including Covishield, Covaxin and Sputnik. “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.
He said this is only the 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 have been held with Pfizer. “Inputs are going back and forth. We are waiting to hear from them after an intensive meeting last week,” Paul said.
On whether this was a commercial deal or a country to country agreement Paul said “Today it is important that a regulatory step has been taken and opens up pathway for imports. Let us see how this will be used for importing vaccines into the country,” he said.
Source : The Hindu Businessline
