New Delhi: In a major development, India's apex drug regulator Drug Controller General of India (DCGI) has given emergency use authorisation (EUA) to Moderna on Tuesday for using its Covid-19 vaccine in India. The Indian government is also considering giving indemnity to the US-based pharmaceutical company after it pressed for the same. "With the approval of emergency use authorisation to Moderna, we have got four vaccines at present Covishield, Covaxin, SputnikV and Moderna. We will now have to see how can we use this regulatory approval," said Dr VK Paul, chairman of the national task force on the Covid-19 vaccine.
He said that there is no need for any more bridging study of Moderna on Indian soil. In fact, the Indian authorities have recently released a guideline stating that any vaccine approved by US FDA and already in use in other countries need not go for any more study in India. "We will keep a watch on the first 100 people who get doses of such vaccines for our reference," said Dr Paul who is also a Niti Aayog member. When asked about the issue of indemnity as demanded by Moderna, Dr Paul said that the indemnity issue is under consideration. "This issue is being addressed and it's being taken up for exemption," said Dr Paul.
Read:| Moderna gets emergency use authorisation of its vaccine in India: Dr VK Paul
It may be mentioned here that both Moderna and Pfizer have been asking for indemnity from the Indian Government before it comes into the country. Once indemnity is granted, the vaccine manufacturers will get protection against a loss or any other financial stress. It's a safeguard for the company against all legal cases for many severe side effects. Earlier, Indian vaccine manufacturer, Serum Institute of India (SII), has also asked for indemnity.
Read:| Moderna seeks regulatory approval for its COVID-19 vaccine
Dr Paul said that talks are on with Pfizer also to bring its vaccines in India. "At present, we will get ready to use vaccines from Moderna but later on we will try to produce Moderna vaccine in India," said Dr Paul. He said that Indian Pharma giant Cipla has come to an understanding with Moderna to bring their vaccines to the Indian market. Moderna is one of the much-hailed vaccines for high efficacy with 94.1 per cent effective at preventing symptomatic Covid-19.
Read:| Indemnity to vaccine manufacturers is logical: Expert
"Moderna has seven months storage capacity under -25 to -50° temperature. An unopened vial of Moderna can be kept in 2-8° temperature for 30 days," said Dr Paul. With this approval, India is planning to boost up its vaccination strategy as the government aims to administer 1 crore doses every day from mid-July.
