(Reuters) -Inovio Pharmaceuticals Inc said on Thursday it would start a large study for its experimental COVID-19 vaccine in the next few weeks, after the drugmaker received authorization from Brazil’s regulatory agency.
The company is currently working on importing the vaccine to Brazil and expects dosing of trial participants to begin in September, Chief Executive Officer Joseph Kim told Reuters.
Inovio started developing its COVID-19 DNA vaccine, INO-4800, last year but fell behind rivals after the U.S. Food and Drug Administration (FDA) put the Phase 3 portion of its mid-to-late stage trial on hold for more information on the vaccine delivery device.
The FDA’s decision was followed by the U.S. government pulling funding for the late-stage part of the study due to vaccines being available in the country.
Inovio then decided to conduct the Phase 3 portion of the trial outside the United States in partnership with China’s Advaccine Biopharmaceuticals, with initial trials planned in Asia, Latin America and Africa where vaccination rates are low.
The company expects regulatory authorization for its trial in several countries in the next two weeks.
Kim said the vaccine had shown strong responses to variants of concern, including Delta, in a study of clinical samples and he expects it to demonstrate efficacy against the Delta variant in the global trial.
Two clinical trials testing booster doses of INO-4800 with CoronaVac, an inactivated COVID-19 vaccine developed by Sinovac, are expected to start this fall in China.
INO-4800 can play a greater role as a potential booster vaccine in people who have already received other vaccines, Kim said.
The trial in Brazil will evaluate the efficacy of INO-4800 in people 18 years of age and older and the company plans to conduct separate trials in younger population.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Vinay Dwivedi)
