CDSCO Panel Rejects Phase II Data for Reliance's RelCoVax COVID-19 Booster Over Immunogenicity Gap

The objective of the trial was to assess whether RelCoVax® could elicit an immune response comparable to Corbevax® when administered as a heterologous booster.

However, after a detailed deliberation, the SEC found that the vaccine did not meet the primary immunogenicity endpoint. As a result, the SEC concluded that RelCoVax® failed to demonstrate non-inferiority when compared to the reference vaccine and thus did not recommend the trial results for further regulatory consideration. It observed that;

"Immunogenicity results of the test vaccine did not meet the primary objective of the study as compared with the reference vaccine. The lower bound of 95% CI of difference in proportion of seroconversion rate in test v/s reference group did not meet the non-inferiority criteria of -10% as defined in the protocol. Hence, the vaccine did not demonstrate non-inferiority with the comparator vaccine."