The Drugs Controller General of India (DCGI) allowed Indian pharmaceutical Cipla to import the Moderna mRNA Covid-19 vaccine on Tuesday making it the fourth vaccine that will be available to Indians.
Cipla will not have to conduct a bridging clinical trial as per the rules shared by the Ministry on June 1, 2021. Vaccines approved by the US Food and Drug Administration, the Pharmaceuticals and Medical Devices (PMDA) of Japan, the European Medicines Agency (EMA), or the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom are exempt from conducting trials as per the new notification.
While Dr. Vinod Paul, member of Niti Aayog did not elaborate about the deal and doses in the weekly Ministry COVID-19 press conference, Cipla later in the evening released its official statement saying that they are only importing the vaccines that US is donating to India.
"Cipla Limited is supporting Moderna, Inc. with the regulatory approval and importation of vaccines to be donated to India. At this stage, there is no definitive agreement on commercial supplies," read the statement.
Cipla will be expected to perform a seven-day safety assessment through a thorough follow up of the first 100 recipients of the Moderna vaccine. Positive efficacy, immunogenicity, and safety results among these recipients will then be followed by the vaccine receiving approval to be administered to all the citizens of the country.
Moderna vaccine has been approved as a New Drug Permission for Restricted Used under the New Drugs and Clinical Trial Rules , 2019 under Drugs and Cosmetics Act, 1940.
Moderna: Storage And Efficacy
Moderna's Covid-19 vaccine mRNA-1273, sold under the brand name 'Spikevax' in the United States, was developed by the pharmaceutical company in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) in the US.
Moderna's mRNA vaccine was found to be over 90 per cent effective against SARS-CoV-2. With a requirement of storage between -25ºC and -15ºC, Cipla will have to make special arrangements to ensure that the vaccine can survive in India's climate.
Paul added that while Cipla will now be importing ready to inject vaccines, it may later try for its production. PTI reported that Cipla was willing to pay over $1 billion as advance to the US major for importing about 50 million doses.
(Note: This story has been updated with Cipla's official statement)