Taiwan-made enterovirus vaccine could be ready for use by early 2011

Su Ih-jen,deputy head intendentof National Cheng Kung University Hospital, who also headed an EV71 vaccine research team under the National Health Research Institute (NHRI), said his team has overcome a production bottleneck and will be able to turn out an EV71 vaccine on a commercial basis in four months.

Speaking at a seminar organized by the Centers for Disease Control (CDC) under the Department of Health (DOH) , Su said the vaccine was developed with EV71-B4 subtype samples provided by the NHRI that were produced into a “seed stock” to form the basis for the vaccine.

The first phase of the clinical trial is scheduled to be launched in September after the DOH approves the program, Su said, adding that they will be carried out at National Taiwan University (NTU) Hospital and Taipei Veterans General Hospital, with 30 adults as the trial subjects.

“The main purpose of this stage of the trial is to observe the vaccine's safety and possible side effects,” Su said, adding that the second and third phases of the trial will focus on observing the vaccine's efficiacy in children.

Once the vaccine passes the human trials, Su said, production can begin in four months, if necessary. “In other words, the vaccine can be available for an immunization program in January, 2011 at the earliest,” Su said.

As EV71 has various subtypes of virus prevailing in different areas at different times, Su went on, mass production cannot begin until after the vaccine's specification has been determined.

Citing CDC statistics, Su said the number of cases of EV71 infection accounted for only about 20 percent of the total number of severe enterovirus cases reported between 2000 and 2008.

The figure indicates that children will still have a 70 percent to 80 percentchanceof contractingother types of severe enterovirus, Su said.

Against this backdrop, he asked: “How can the DOH convince local parents to get their kids vaccinated?”

In recent years, Su said, the subtypes of EV71 virus prevalent in Taiwan have been B5 and C4, while those commonly seen in other Asian countries are C5 in China, C1, C4 and C5 in Vietnam and B5 in Malaysia.

To meet the demand of local children aged under 3, Taiwan would need to produce 600,000 doses of vaccine, a number Su said is not enough to generate economy of scale.

Noting that China is also developing an EV71 vaccine, Su said Taiwan should try to use the Asia-Pacific Economic Cooperation (APEC) forum as a platform to develop a vaccine that can be effectively used in EV immunization throughout Asia.

“That way, we could produce up to 20 million doses for sale across Asia to realize economy of scale,” Su said.

Speaking on the same occasion, Huang Li-min, director of NTU Hospital's pediatric infectious disease department, said that as there are over 100 enterovirus subtypes, it will not be easy to produce a vaccine capable of preventing all those types of infection.

Moreover, Huang said, enterovirus vaccine is brand new. “It would be better to develop a vaccine on the basis of samples of a single type of virus. The issue regarding cross-protection for the various subtypes should be considered at a later stage,” he said.

For the locally developed EV71 vaccine, Huang said, the NTU Hospital will not launch a third stage of clinical trials among 5,000 to 10,000 children unless the first and second stages of test are successful.

“It will also be a challenge to persuade local parents to enroll their children in the trial,” he added.

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