India has last month approved the import of US pharmaceutical major Moderna’s mRNA technology-based COVID-19 vaccine. The Drugs Controller General of India (DCGI) has granted permission to Mumbai-based pharmaceutical firm Cipla to import Moderna’s COVID-19 vaccine, making it the fourth vaccine in the country to be given the Emergency Use Authorisation (EUA).
Meanwhile, discussions regarding granting indemnity to Moderna have been initiated but no reply has come from the company, Dr. VK Paul, Member-Health, Niti Aayog told news agency ANI on Tuesday.
"Talks initiated, no reply has come from them. We're waiting for the process. Negotiations are on with positive mind. We're in the process of trying to clinch it but there's a back & forth as it's a negotiated process," he said.
What is indemnity?
Granting indemnity to the vaccine manufacturing companies means that they cannot be sued in those countries on account of adverse effects due to vaccination. However, the Indian drug regulator has so far not granted indemnity to any of the three Covid-19 vaccines which are currently available in the country— Covishield, Covaxin and Sputnik V.
In the United States, Pfizer and Moderna have been granted indemnity. According to an Indian Express report, the vaccine makers have been protected until 2024 from lawsuits arising out of any unintentional medical complications as a result of vaccination against COVID-19.
Moderna has already received emergency (or other conditional, interim or provisional) authorisation for use of its COVID-19 vaccine from health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO).
According to WHO, the Moderna vaccine has shown to have an efficacy of approximately 94.1 per cent in protecting against COVID-19, starting 14 days after the first dose.