Medigen Vaccine Biologics Corp’s (高端疫苗) board of directors yesterday approved a proposal to conduct a phase 3 clinical trial of its COVID-19 vaccine in Europe, it said yesterday.
The final stage of human tests, if approved by the European Medicines Agency (EMA), would mark a big milestone in the COVID-19 vaccine development of Medigen, which has so far completed phase 1 and 2 clinical trials in Taiwan and is conducting a small phase 3 clinical trial in Paraguay.
Medigen in July consulted the EMA about conducting clinicial trials of its vaccine and it received a “positive response” from the agency, the company said in a statement.
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The EMA advised the company to conduct a phase 3 clinical trial directly in Europe instead of phase 1 or phase 2 trials, as the European regulator took into account that Medigen had completed earlier-stage human tests of the vaccine in Taiwan, company spokesman Leo Lee (李思賢) told by telephone.
The company is to finalize its design for the protocols of the phase 3 clinical trial in the near term and would apply to the EMA for permission to go ahead with it.
Although Medigen had researched how a third shot would bolster immunity by giving tens of participants in Taiwan a third dose, the company would still give two doses to those enrolled in its phase 3 trial in Europe, Lee said.
The number of participants in the clinical trial in Europe is expected to be 4,000 or fewer, and the trial would be conducted in multiple locations in multiple countries in Europe, it said.
“If everything goes smoothly, the clinical trial would begin in November and yield preliminary results in the first quarter next year,” Lee said.
It is possible that Medigen would be able to conduct an immunobridging study to compare the levels of antibodies in people who have received a Medigen vaccine against those who have been given one of the vaccines approved in Europe, the company said.
So far, the EMA has approved four COVID-19 vaccines for use in Europe: Pfizer-BioNTech, Moderna, AstraZeneca and Johnson & Johnson; the first two are developed by the messenger RNA technology while the latter two are adenovirus-based vaccines, the EMA’s Web site showed.
Medigen’s vaccine is a protein-subunit vaccine, developed by the recombinant technology; the vaccine comprises recombinant spike protein of SARS-CoV-2 as the antigen to help a person’s body recognize the real virus if the person becomes infected, company data showed.
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