Permitted for restricted use; vaccine is the fourth to be available in India; talks with Pfizer and J&J continue
Moderna’s Covid vaccine has been granted permission for restricted use in India. The Drugs Controller General of India on Tuesday approved application from Cipla, which is partnering with Moderna, to import the vaccines for restricted use in the country. The mRNA vaccine was cleared by India on Tuesday. VK Paul, member, healthy, Niti Aayog, said the emergency use authorisation is now in operation and the country’s vaccine basket is now richer by this addition, and the vaccination programme will gain further momentum for larger coverage of the population.
Cipla had filed the application on June 28 seeking permission to import the Moderna’s vaccine. According to Paul, Moderna is coming to India in a ready-to-inject form and will not undergo any bridging study. The Moderna vaccine has approval from the USFDA for EUA so it has got a marketing authorisation without bridging trials. They would only have to share data of first 100 beneficiaries of vaccines before rolling it out as part of the immunisation programme.
Paul said this was only the regulatory clearance given and further details on modalities of import of vaccines were being worked out and it could be through the donation route or through commercial deal between the companies. The indemnity issue was being addressed and under consideration Paul said.
After Covishied, Covaxin and Sputnik, this will be the fourth Covid vaccine to be available in India. This is the first international vaccine to be given emergency use authorisation and the government will be continuing talks with Pfizer and Johnson vaccines, Paul said. He also hoped that Moderna would start manufacturing this vaccine in India in future and it becomes a Made-in-India vaccine.
This will be a two-dose vaccine with a 28-day interval between two doses. It needs to be stored at -20 degrees. It has a seven-month shelf life. Unopened vials can be kept in a normal cold chain at 2-8 degree for 30 days. The Moderna vaccine has been shown to have an efficacy of approximately 94.1% in protecting against Covid-19, starting 14 days after the first dose.
Moderna has supplied 217 million doses of the mRNA vaccine to the US government and has commitment to supply a total of 500 million doses to the US. The European Commission has ordered 460 million doses from Moderna. It has got Emergency Use Listing from the World Health Organisation (WHO). The vaccine has been administered in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand, Brunei, Paraguay, Japan, South Korea and Botswana. For now, Moderna is donating these vaccine doses to India through the US government as part of their commitments to the COVAX platform.