Bharat Biotech's US partner Ocugen, a Pennsylvania-based biopharmaceutical company, announced that it has submitted an Investigational New Drug application (IND) with the US Food and Drug Administration (FDA) to evaluate the Covid-19 vaccine candidate, Covaxin outside the United States.
Covaxin is yet to be approved by the WHO for emergency use listing of the vaccine.
Covaxin is 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.
With more than 100 million doses having been manufactured, Covaxin is currently being administered under emergency use authorizations in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries.
The Phase 3 trial proposed in the IND is designed to establish whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in a demographically representative, healthy adult population in the U.S. who either have not been vaccinated for Covid-19 or who already received two doses of an mRNA vaccine at least six months earlier.
“We are very excited to take this next step in the development of Covaxin, which we hope will bring us closer to introducing a different type of Covid-19 vaccine to the American public,” said Dr. Shankar Musunuri, Chairman of the Board, CEO, and Co-Founder of Ocugen.
“We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population.”
If the study is allowed to proceed, Ocugen’s Phase 3 immuno-bridging study, will seek to enroll several hundred healthy adults in the U.S. Subjects will be randomized to receive either two doses of Covaxin or placebo, 28 days apart. The study will help evaluate safety and tolerability of the vaccine in the US population.
Ocugen hopes to complete the study during H1 2022.
The Phase 3 study conducted in India by Bharat Biotech, involved 25,798 participants receiving two doses of Covaxin or placebo, 28 days apart.
Results of the trial found 93.4% efficacy against severe Covid-19 disease, 77.8% efficacy against symptomatic Covid-19 and 63.6% efficacy against asymptomatic disease.
A sub-analysis of the Phase 3 study examined the presence of infections by variants of the original coronavirus strain. Overall, 90% of infections showed the presence of a variant, with 59% of those being the Delta variant. The sub-analysis revealed Covaxin-treated patients experienced 65.2% efficacy against the Delta variant.
Adverse events reported in the trial included pain, erythema, induration, swelling, headache, pyrexia, fatigue, chills, myalgia, arthralgia, nausea and vomiting.
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