IND Submitted To Begin Unvaccinated Patient and Booster Study Ocugen has submitted an IND to begin a Phase 3 study testing Covaxin (BBV152) as a vaccine for COVID-19. The study will enroll unvaccinated patients and those vaccinated at least six months prior to determine if immune responses in US patients are comparable with those seen in the Phase 3 conducted in India. If successful, we expect the data to be submitted for marketing approval.Study Design Patients will be randomized to receive two doses of either Covaxin or placebo 28 days apart. The primary endpoint will compare blood-based samples taken from the US study with samples from patients in the Phase 3 Bharat biotech trial. The secondary endpoints test the vaccine’s immunogenic profile, safety, and tolerability. The company hopes to complete the study during H1 2022.Covaxin Uses Traditional Vaccine Technology Covaxin is a whole-virion inactivated COVID-19 vaccine made with classical methods and vero cell manufacturing platform that has been used to produce anti-viral vaccines, such as polio vaccine, for many years. It does not use the newer messenger RNA technologies or stem cell technologies. We believe this should address concerns that have led to avoidance of the current vaccines.Filing Is A Milestone Toward Approval We see the filing of the IND as a positive step toward Covaxin approval. As the environment for COVID-19 changes, the requirements for approval have moved toward more standard vaccination requirements and away from emergency use approvals. We see this as a positive that should maintain high-standards of safety for large-scale vaccination of healthy people.Conclusion: The filing of the IND is an important step that can provide data for FDA approval and marketing claims. We reiterate our Outperform rating and $15 price target. Read More >>