Enimmune Corp (安特羅生技) plans to apply to the Taiwan Food and Drug Administration for marketing approval for its enterovirus 71 (EV-71) vaccine next quarter after the treatment passed an interim analysis yesterday.
If approved, it would be the nation’s first vaccine for EV-71, which is a common pathogen that causes polio-like syndromes, and mostly infects infants and children aged five and younger.
Although the firm has developed three EV-71 vaccines in China, the latest treatment would have an advantage in the home market, as it is designed to act against genotype B4 of EV-71, which is more widespread in Taiwan and Vietnam, while Chinese vaccines target genotype C4, Enimmune general manager Vic Chang (張哲瑋) told the Taipei Times by telephone.
The interim analysis was conducted by the firm’s independent data monitoring committee comprised of external experts, Chang said.
The experts monitored vaccinated test subjects for at least six months to see if they developed any allergic reactions, but none of them had severe reactions to the vaccine, barring some mild side-effects, such as inflamed skin, he said.
The overall seroprotection rate for the subjects who were given a single dose in the phase-III clinical trial was about 90 percent, higher than the regulatory minimum, Chang added.
“That means that our vaccines had good efficacy,” Chang added.
Enimmune, a subsidiary of Adimmune Corp (國光生技), has over the past decade focused on researching and developing the EV-71 vaccine.
The firm said that it completed a phase-III randomized, double-blind and placebo-controlled trial in April last year with a 1,266 subjects.
Given that there is no medication for EV-71 infection in Taiwan except for supportive therapies, the vaccine would likely qualify to apply to the agency’s accelerated approval mechanism, in which review would be sped up for treatments that satisfy unmet medical needs and greatly advance treatment, Chang said.
“If everything goes smoothly, we anticipate gaining approval in the fourth quarter. Adimmune would help us manufacture the vaccines,” Chang said.
The government is also expected to consider including the vaccine in the National Health Insurance system, he added.
Meanwhile, Medigen Vaccine Biologics Corp (高端疫苗) said that it would conduct an interim analysis of its EV-71 vaccine later this year after enrolling 3,000 subjects for a phase-III trial in December last year, spokesman Leo Lee (李思賢) said.
“We concentrate on developing the world’s first EV-71 vaccine for protecting children two months to six months old, given all existing EV-71 vaccines would be administered to children older than six months,” Lee said.
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