The government has launched 'Mission COVID Suraksha' to help accelerate the development of approximately 5-6 vaccine candidates and ensure that these are brought closer to licensure and introduction in the market, the Department of Biotechnology said on November 25.

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The mission envisages COVID-19 vaccine development with end-to-end focus from preclinical through clinical development and manufacturing and regulatory facilitation, the DBT said. Earlier this month, the government had announced a package of Rs 900 crore for vaccines. "Government of India (GOI) announced the third stimulus package of Rs 900 crore for the Mission COVID Suraksha -- the Indian COVID-19 Vaccine Development Mission. This grant will be provided to the Department of Biotechnology (DBT) for research and development of Indian COVID-19 vaccines. "This will help accelerate development of approximately five-six vaccine candidates and ensure that these are brought closer to licensure and introduction in the market for consideration of regulatory authorities for introduction in public health systems to combat further spread of COVID infection," the DBT said.

Earlier, the DBT had announced programmes for vaccine development and other COVID-related solutions, but this mission will be dedicated purely for development of vaccines, a DBT official said. A total of 10 vaccine candidates have been supported by the DBT so far in both academia and industry. As on date, five vaccine candidates are in human trials, including the Russian Vaccine Sputnik-V, with at least three more in advanced stages of pre-clinical to enter human trials shortly.

The important objectives of the fund will be to accelerate pre-clinical and clinical development, licensure of COVID-19 vaccine candidates that are currently in clinical stages or ready to enter clinical stage of development. Its aim is to also establish clinical trial sites and strengthen the existing immunoassay laboratories, central laboratories and suitable facilities for animal studies, production facilities and other test facilities to support COVID-19 vaccine development, the DBT said. "The other important objective will be supporting development of common harmonised protocols, training, data management systems, regulatory submissions, internal and external quality management systems and accreditations," it added.

Capabilities for process development, cell line development and manufacturing of GMP (Good Manufacturing Practices) batches for animal toxicology studies and clinical trials will also be supported under the mission. A key element will be development of a suitable target product profile so that vaccines being introduced through the mission have preferred characteristics applicable for India.