Taiwanese company to seek FDA approval of new drug for enterovirus vaccine
Taipei, June 20 (ANC) Medigen Vaccine Biologics Corp. announced on Sunday that it will soon seek the Food and Drug Administration of Taiwan and other countries for approval of a new drug for its enterovirus 71 (EV71) vaccine, as it has successfully completed phase III . clinical tests.
At a press conference, Medigen said results from Phase III clinical trials, which were released earlier today, showed the EV71 vaccine met Taiwan‘s standards for safety and efficacy for the submission of a new drug request.
In the Phase III trials, no one who received the vaccine contracted the EV71 virus two and a half years later, while in the placebo group there were 22 infections, Medigen said. These results indicate that the vaccine is 100% effective, he said.
Meanwhile, another batch of results from the Phase III trial, which was released in April, showed positive antibodies in 99.5% of participants, based on a “neutralizing antibody titer” of 1:32, a month after receiving two shots of the EV71 vaccine, Medigen said.
An antibody titer reflects the concentration of specific antibodies in the blood that recognize a certain agent.
In the trial, antibodies were found in 99.5% of participants, when blood samples were diluted to 1:32 parts, the company said. The current standard set by the government of Taiwan for a vaccine to gain approval is 90%.
Six months after participants received two injections of EV71 vaccine, the positive antibody prevalence, or seroprotection rate, was 97.9%, well above the government standard of 70%, and this rate s’ is maintained for a full year, Medigen said.
Based on these positive results, the company will submit its Phase III clinical trial reports to Taiwan’s FDA, seeking approval for a new drug, in the third quarter of this year, the CEO of Medigen, Charles Chen (陳燦堅).
According to Medigen, a total of 3,049 people in Taiwan and Vietnam have participated in multiregional Phase III clinical trials for its EV71 vaccine candidate.
It was a randomized, double-blind trial, and participants were divided into three age groups – 2 to 6 months, 6 months to 2 years and 2 to 6 years, the Taiwanese company said.
According to Medigen, EV71 is one of the most common infectious diseases in Taiwan, China and Southeast Asia, but there are only three vaccines against it, all made in China.
Chen said Medigen is not only targeting Taiwan, but also the huge ASEAN market, where millions of babies are born every year.
Enterovirus infections are common in children under 5, with more than 90 percent of all severe cases occurring in this age group, and the death rate from the disease can reach 25.7 percent.
The main symptoms are fever, red blisters on the hands, feet and mouth, and canker sores.
Severe cases can lead to acute flaccid paralysis, aseptic meningitis, encephalitis, pulmonary edema and heart failure, according to Medigen.
There are currently no drugs for enterovirus infections, only supportive therapies such as fluid intake, bed rest and antipyretic treatments, the company said.
Another Taiwanese vaccine maker, Enimmune, has also developed an EV71 vaccine and is awaiting approval from Taiwan’s FDA for its new drug application, which was submitted in May 2020.