Regulatory Pathway for the Approval of Novel Candidate Vaccine

Background The need of developing a vaccine on emergency basis to COVID-19 has captured the attention of the regulator during the recent pandemic. There is no comprehensive regulatory pathway for the development of a novel candidate provided in India. Materials and Methods The COVID-19 vaccines were developed and approved in a short duration when compared to the historical timelines. A questionnaire was sent to the manufacturers of COVID-19 vaccine and collected the information of various regulatory approvals obtained for the development of the vaccine, clinical trials conducted along with the details on their design, conduct and assessment. Results and Discussion Based on the data collected the time to approval and the innovative measures such as application of adaptive clinical trial design, comparator, rolling review by the regulator, end point, functional antibody, animal challenge study etc were tabulated. The details of the expert review were collected from the NRA website. The approval was based on the totality of evidence from all the parameters. Conclusion Based on the data obtained from the questionnaire and the gaps and best practices collected from the manufacturers an algorithm for the approval of the novel candidate vaccine during an epidemic is proposed. This algorithm if adopted, would expedite the development of Novel Candidate Vaccine in India.