China News Service, May 5. According to Taiwan's "Central News Agency", Taiwan successfully developed a vaccine for enterovirus 71. The National Taiwan University Hospital presided over the third phase of clinical trials and confirmed that it has protective power and is safe to administer. Obtain a license to inoculate 2 to 3 doses for children aged 2 months to 6 years old, which is expected to prevent infection.
National Taiwan University Hospital held a press conference to share the cross-border Phase III clinical trial hosted by National Taiwan University Hospital and successfully developed an emerging vaccine with manufacturers to effectively prevent severe enterovirus type 71 in infants and young children. The research was published in The Lancet on April 12 this year. .
Huang Limin, director of the National Taiwan University Children's Hospital, said that as far as he knows, this is the first time that the first to third phases of vaccine development have been independently completed in Taiwan.
According to reports, there are at least 96 types of enteroviruses. Children under the age of 5 are a high-risk group for enterovirus infection complicated by severe illness, and they are also an age group with a high mortality rate. The most common types of severe illness are type 71 and type D68.
Enterovirus 71 is one of the pathogens that cause hand, foot and mouth disease in infants and young children. It can invade the nervous system of infants and young children and cause brainstem encephalitis, resulting in non-psychogenetic pulmonary edema and acute limb weakness, which may cause death or permanent paralysis of patients.
The research team of National Taiwan University Hospital has joined the second phase clinical trial of enterovirus 71 vaccine since 2014. Huang Limin served as the chief moderator of the trial and completed the third phase clinical trial study of the vaccine. After 2 to 3 doses of the vaccine, all the subjects in the vaccine group were not infected with enterovirus 71, compared with 22 cases in the placebo group during the follow-up period.
Huang Limin said that the efficacy of the vaccine in the trial was as high as 100%, and the statistical model estimated it was as high as 96.8%.
Among the 22 confirmed cases in the placebo group, 11 cases belonged to the B5 genotype of enterovirus 71, and 10 cases belonged to the C4 genotype. protection.
Huang Limin mentioned that considering that enterovirus 71 may also infect children under 6 months old, in order to provide early protection for children, the vaccine developed in Taiwan will reduce the vaccination age to 2 month old infants. Tests have proved its safety. Common side effects are: Pain, restlessness, and fever at the injection site with no serious side effects.
In response to the persistence of vaccine efficacy, Huang Limin said that long-term follow-up is currently underway, and blood will be drawn every year to confirm antibodies until the subject is 5 years old. The enterovirus 71 vaccine is different from the adult vaccine, and the effect only needs to be maintained until the age of 5. Immunization Before the system is mature, as long as children under the age of 5 are not easily infected, it will reduce community transmission, indirectly protect children over 6 years old, and avoid sporadic severe cases.
Zhang Luanying, the chief physician of the Department of Infectious Diseases of National Taiwan University Hospital, said that enterovirus 71 poses a more serious threat to children than new coronary pneumonia. Even survival may be accompanied by lifelong sequelae. Because enterovirus 71 is highly contagious, the infection rate of children transmitted by households is almost as high as 80% to 90%, even if you wash your hands frequently, you may still be infected. Prevention is better than cure. We are happy to see vaccines marketed quickly.