Foreign vaccine companies must conduct a bridging trial in India before launching their products in the country. Even if the vaccines are approved outside India, foreign companies must conduct phase-3 trials with Indian volunteers. Moderna received funding in January 2020 from the Coalition for Epidemic Preparedness Innovations (CEPI), which is part of the COVAX facility of the World Health Organization, to develop its mRNA vaccine against the Covid-19 virus. The COVAX facility aims to equitably distribute 2 billion Covid-19 vaccine doses in low-and middle-income countries including India by the end of 2021.
Moderna will also supply its vaccine to these countries. Exploratory talks have started between Tata Medical & Diagnostics and Moderna and concrete plans will be finalised once government approvals for private sector participation come in, top officials said. Moderna, based in Cambridge, Massachusetts, and Tata Sons did not respond to emailed queries from ET.
Tata Medical & Diagnostics was set up in June last year in the midst of the pandemic and is keen to tap the country’s Covid-19-led health requirements in the devices and formulations space, officials said. “The requirement for vaccines in India will be huge and the Tata Group has a strong brand equity in the country to gain people’s trust and confidence by following approved guidelines for vaccines,” a top group official said.
Private companies are waiting for directions from the government on the kind of role they can play in the nation’s vaccination programme, one of the largest globally. Companies in the country with international tie-ups for testing and supplying Covid-19 vaccines include Serum Institute of India for the vaccine developed by the University of Oxford and AstraZeneca; Dr Reddy’s Laboratories for Russia’s Sputnik V vaccine, and Biological E for Johnson & Johnson’s candidate. Domestic companies working to develop or manufacture vaccine formulations include Bharat Biotech, Zydus Cadila and Hetero Biopharma. Tata Medical & Diagnostics started in the Covid-19 space by signing up with the Institute of Genomics and Integrative Biology, CSIR’s constituent lab, for licensing of knowhow for a rapid diagnosis test to be deployed as early as end of May.
Moderna has no separate tieup with Indian manufacturers yet and its first supply commitments are to governments that pre-ordered vaccines. The US company’s vaccine has been approved for use in countries including the US, Canada and the UK. Moderna uses the same mRNA technology as US drug maker Pfizer, although it requires a storage temperature of -25 degrees Celsius compared with -70 degrees C for the Pfizer product. India has not signed advance purchase agreements with global or domestic vaccine makers.