Taiwan-made enterovirus vaccine clears trial, could hit market soon

Taipei, April 11 (CNA) Taiwan-based Medigen Vaccine Biologics Corp. (MVC) on Sunday announced positive trial results for its enterovirus 71 (EV71) virus vaccine and expressed hope the vaccine could hit the market in Taiwan next year.

At a press event, MVC spokesman Leo Lee (李思賢) said the results of the Phase III clinical trial of the EV71 vaccine, released publicly on Saturday, showed that the vaccine has met Taiwanese standards for filing a new drug application.

The Phase III multi-region clinical trial for the EV71 Vaccine had a total enrollment of 3,061 people combined in Taiwan and Vietnam.

This randomized, double-blind, placebo-controlled trial was conducted on infants and children in three age brackets -- 2-to 6-months-old; 6-months to 2-years-old; and 2-to 5-years-old.

The results showed that positive antibodies were found among 99.5 percent of clinical trial participants based on a "neutralizing antibody titer" of 1:32, a month after the participants received two EV71 vaccine shots.

An antibody titer reflects the concentration of specific antibodies in the blood that recognize a certain agent.

In MVC's trial, antibodies were present in 99.5 percent of participants even when one part of each blood sample was diluted to 32 parts of the diluent solution.

Taiwan's government sets the standard at 90 percent.

Positive antibody prevalence was seen at a 97.9 percent rate six months after participants received two EV71 vaccine shots, well above the 70 percent government standard.

There is no standard in Taiwan to measure the effectiveness of a vaccine one year or more after the vaccine has been given.

Based on these results, the company will soon file a new drug application with Taiwan's Food and Drug Administration, said MVC CEO Charles Chen (陳燦堅) at the same press event.

If everything goes well, the new vaccine will hit the market in Taiwan next year, Chen said.

According to MVC, the EV71 virus is one of the most prevalent infectious diseases in Taiwan, China and Southeast Asia, but only three Chinese vaccine makers currently offer a vaccine against it.

Chen said the company is eyeing the huge ASEAN market for the new vaccine and said that if it gets approval for its product in that region it could produce about 3 million to 5 million doses of the vaccine annually.

Enterovirus infections are commonly found in children under 5, with more than 90 percent of all severe cases occurring in that age group, and the disease's mortality rate can hit as high as 25.7 percent.

The main symptoms include fever, red blisters on the hands, feet and mouth, canker sores, and herpangina. Severe cases may result in acute flaccid paralysis, aseptic meningitis, encephalitis, pulmonary edema, even cardiopulmonary failures, according to MVC.

There are currently no medications for enterovirus infections, only supportive therapies such as taking fluids, resting in bed, and taking medicine to keep fevers down.