National Taiwan University (NTU) Children’s Hospital superintendent Huang Li-min (黃立民) yesterday said a development team he led has successfully completed a phase 3 clinical trial for an enterovirus A71 vaccine in infants aged two months to six years.
The study has been published in the Lancet medical journal, he said, adding that the vaccine might be approved by the Food and Drug Administration by the end of the year.
With an efficacy rate of 96.8 percent, the vaccine is a significant improvement over one developed in China that can only be used on infants over six months of age, Huang said.
Photo: Yang Yuan-ting, Taipei Times
A large outbreak of enterovirus in 1998 struck Taiwan, resulting in tens of thousands of children being infected. There were 400 severe cases and 78 deaths.
Enterovirus 71 (EV71), which caused the 1998 epidemic, causes severe symptoms and can be deadly, affecting young children’s nervous systems, potentially causing brain stem encephalitis or paralysis.
The international, multi-central, double-blinded phase 3 trials were conducted with 3,061 participants ranging from two months old to six years old, who were divided into three groups: infants aged two months to six months; children aged six months to two years; and children aged two years to six years, Huang said.
The first two groups received three doses while the final group received two.
The results showed that 100 percent of the participants who received Taiwan’s enterovirus A71 vaccine did not develop an infection.
In comparison, 22 participants in the placebo groups developed an enterovirus infection; 11 with EV71 B5 subgenotype and 10 with EV71 C4 subgenotype, showing that the vaccine developed using the B4 subgenotype offered good protection.
None of the participants had adverse reactions after receiving the vaccine, which can also be administered with other children’s vaccines, the study showed.
NTU Hospital pediatrician Chang Luan-yin (張鑾英), who participated in the research, said that although the vaccine is highly effective, full vaccination coverage is likely needed to prevent the virus from spreading.
The team is to track whether antibodies remain in vaccinated participants when they reach age five, Huang said.
Children over the age of five have mature immune systems that protect against severe symptoms with enterovirus infections, he said.
For children under the age of two months, researchers might investigate whether vaccinating a pregnant woman could provide antibodies to a fetus, Huang said.
If the vaccine is approved, the self-paid price could be between NT$2,000 and NT$3,000, he added.
Palauan President Surangel Whipps Jr arrived in Taiwan last night to kick off his first visit to the country since beginning his second term earlier this year. After arriving at Taoyuan International Airport at around 6:30 pm, Whipps and his delegation were welcomed by Minister of Foreign Affairs Lin Chia-lung (林佳龍). Speaking to gathered media, the Palauan leader said he was excited and honored to be back in Taiwan on his first state visit to Taiwan since he was sworn in this January. Among those traveling with Whipps is Minister of State Gustav N. Aitaro, Public Infrastructure
President William Lai (賴清德) yesterday thanked Palau for its continued support of Taiwan's international participation, as Taipei was once again excluded from the World Health Assembly (WHA) currently taking place in Switzerland. "Palau has never stopped voicing support for Taiwan" in the UN General Assembly, the WHO and other UN-affiliated agencies, Lai said during a bilateral meeting with visiting Palau President Surangel Whipps Jr. "We have been profoundly touched by these endorsements," Lai said, praising the Pacific island nation's firm support as "courageous." Lai's remarks came as Taiwan was excluded for the ninth consecutive year from the WHA, which is being held in
RESOLUTIONS DEBATE: Taiwan’s allies said that UN and WHA resolutions cited by China and other nations ‘do not determine Taiwan’s participation in WHO activities’ A proposal to invite Taiwan to this year’s World Health Assembly (WHA) was rejected on Monday, resulting in Taipei’s absence from the annual meeting for a ninth consecutive year, although partners spoke up for Taiwan’s participation at the first day of the meeting. The first agenda item after the opening was a “two-on-two debate” on a proposal to invite Taiwan to participate at the WHA as an observer. Similar to previous years, two countries made statements in favor of the proposal, while two others expressed their opposition. Philippine Secretary of Health Teodoro Herbosa, president of the 78th WHA, accepted the WHA General Committee’s
At least three people died and more than a dozen were injured yesterday afternoon when a vehicle struck a group of pedestrians in New Taipei City’s Sansia District (三峽). The incident happened at about 4pm when a car rammed into pedestrians at an intersection near Bei Da Elementary School. Witnesses said the sedan, being driven at a high speed, ran a red light, knocking scooters out of the way and hitting students crossing the road before careening into a median near the intersection of Guocheng and Guoguang streets. The incident resulted in three deaths and 13 injuries, including the driver, a 78-year-old man
RSS