Medigen Vaccine Biologics Corp’s (高端疫苗) phase 3 clinical trials for an enterovirus 71 vaccine completed the immunogenicity data “unblinding” on Saturday, with the results meeting Taiwan’s regulatory standard, the company said yesterday.
The vaccine has a high efficacy against the virus, which can cause hand, foot and mouth disease, Medigen said in a Taiwan Stock Exchange filing.
The trial results showed that antibody levels one month, six months and one year after two vaccine shots were higher than health authorities’ requirements, the company said.
Photo: Chen Yung-chi, Taipei Times
“The unblinded data showed the vaccine’s neutralizing antibody assay has qualified the Food and Drug Administration’s accelerated approval mechanism, and Medigen plans to file new drug applications for the vaccine after completing the clinical trial reports,” it said.
The phase 3 trials — conducted in Taiwan and Vietnam with 3,000 participants — evaluated the efficacy, safety, immunogenicity, cross protection and lot-to-lot consistency of the vaccine used for children under six years old.
The vaccine aims to reduce the risk posed by the virus, which causes one of the most prevalent infectious diseases in Taiwan, China and Southeast Asia, Medigen chief executive officer Charles Chen (陳燦堅) told a news conference at the Taipei Exchange yesterday.
The company plans to apply for local approval at the end of this quarter or early next quarter, Chen said, adding that he hopes that the vaccine would be regularly administered starting next year.
Medigen plans to produce 1 million doses annually for the domestic market, where the drug would be introduced first, Chen said.
For the Vietnamese market, 3 million to 5 million doses would be produced, as the virus is more widespread there, he said.
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