Ocugen reports ‘positive’ data from Phase 2/3 trial of COVAXIN

Ocugen announced positive results from the Phase 2/3, observer-blind, immuno-bridging and broadening study of its COVID-19 vaccine candidate, COVAXIN, a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades. COVAXIN, an inactivated virus vaccine adjuvanted with TLR7/8 agonist, has been demonstrated in clinical trials to generate a broader immune response against the whole virus covering important antigens such as S-protein, RBD, and N-protein; whereas currently approved vaccines in the U.S. target only S-protein antigen. Additionally, in contrast to other inactivated vaccines, clinical trials have demonstrated that TLR7/8 agonist adjuvant in COVAXIN generates a Th1-biased immune response that induces robust long-term memory B- and T-cell responses. This study enrolled 419 U.S. adult participants that were randomized 1:1 to receive two doses of COVAXIN or placebo, 28 days apart. Blinded safety results and preliminary unblinded immunogenicity results are available through Day 56, one month following the second vaccination. Immunogenicity results from COVAXIN-vaccinated participants in the U.S. were compared with results in COVAXIN-vaccinated participants in the Bharat Biotech International Limited-sponsored Phase 3 study in India . Approximately 24% of tested participants in the U.S. were vaccine-naive while all participants in the Bharat Biotech Phase 3 study were vaccine-naive. Immune responses were adjusted for differences between the U.S. and Indian cohorts in baseline neutralizing antibody, body mass index, gender, and age. Both co-primary immunogenicity endpoints were met, with the 95% confidence interval for the propensity score-adjusted geometric mean titer ratio well above the non-inferiority limit of 0.667 and the 95% CI for the propensity score-adjusted difference in seroconversion rates well above the non-inferiority limit of -10%. Blinded safety data are also available for one month following vaccination. There were no deaths, related potential immune mediated medical conditions, or related adverse events of special interest. There were also no cases of myocarditis, pericarditis, thrombotic events, or Guillain-Barre syndrome. Thirty medically attended adverse events in 18 subjects and two serious adverse events in one subject were reported, and all were considered unrelated to vaccination.