Vaccine to be first introduced in Taiwan, delivering 1 million doses during the starting months of 2022
In a bid to combat rising childhood illnesses nationwide and globally, Medigen Vaccine Biologics Corp, Taiwan’s leading biotechnology firm, has reportedly announced successful completion of its phase 3 clinical trials for enterovirus 71 vaccine.
Reports have it that the firm has completed the immunogenicity data ‘unbinding’ for the vaccine last week, with the results adhering to Taiwan’s regulatory standards. The vaccine has demonstrated high efficiency against the virus which causes mouth, hand, and foot diseases in children.
Importantly, the vaccine aims to abate the risk posed by the virus, which causes one of the most prevalent infectious disease in Southeast Asian countries, China, and Taiwan; as addressed by Medigen’s CEO, Charles Chen.
Speaking of the phase 3 trials, a news report suggests that the clinical trials, which were conducted in Vietnam and Taiwan with 3,000 participants, evaluated the safety, efficiency, immunogenicity, cross protection, and consistency of the vaccine used for children below the age of six years.
Additionally, the results depicted that the antibody levels in one month, six months, and a year after two vaccine shots were relatively higher than health authorities requirements.
It was mentioned in a press release that the unblinded data demonstrated that the vaccine’s neutralizing antibody assay fits the FDA’s accelerated approval mechanism, and the company plans to file new drug applications for the vaccine post completion of the clinical trial reports.
Moreover, Medigen also plans to apply for domestic authentication by the end of this quarter or early the next quarter, giving in hopes that the vaccine would be regularly delivered and administered to the infants in the beginning of the next year.
For the uninitiated, the company plans to produce and roll out 1 million doses annually for Taiwan; while the Vietnamese market would be supplied with 3 million to 5 million doses, as the spread of virus is much more in the country.