The China Food and Drug Administration (CFDA) licensed the world’s first vaccine against enterovirus 71, a dangerous virus that can cause Hand, Foot and Mouth Disease. This is a major breakthrough as there is currently no treatment for Hand, Foot and Mouth Disease caused by enterovirus 71 (‘enterovirus 71 disease’) – which can cause serious illness and death in young children.
“This is great news for China’s children – because this vaccine provides almost complete protection against enterovirus 71 disease. This disease is a major cause of neurologic damage in children, which has caused thousands of deaths of children in China over the years,” said Dr Bernhard Schwartländer, WHO Representative in China.
Most cases of Hand, Foot and Mouth Disease occur in children under 10 years of age – usually beginning with a fever, poor appetite, and sore throat, followed by the development of painful sores in the mouth. While most cases of Hand Foot and Mouth Disease do not develop beyond these symptoms, enterovirus 71 disease may progress to meningitis or encephalitis (potentially life-threatening infections of the nervous system and brain) – both very serious neurological disorders which can cause death.
Enterovirus 71 disease has become a major, emerging infectious disease in Asia. It often occurs in outbreaks, as is currently being seen in Hong Kong Special Administrative Region.
“There is no specific treatment for enterovirus 71 disease, which is what makes the development and licensing of this vaccine so important: by preventing children from getting this dangerous disease in the first place, this new vaccine has the potential to greatly reduce suffering and death from enterovirus 71 disease in China – and hopefully one day, the rest of the world,” Dr Schwartländer said.
“China’s scientists can be very proud of having produced the world’s first vaccine to protect against enterovirus 71 disease. It shows the increasingly important role China is playing in global health through innovation in vaccine development and production,” Dr Schwartländer explained.
“Parents of young children in China can be thankful that they can now protect their little ones from being infected by this nasty, and potentially life-threatening, disease,” concluded Dr Schwartländer.
Note to editors: information about Enterovirus 71 vaccine
The new vaccine is manufactured by the Institute of Medical Biology, Chinese Academy of Medical Science, in Kunming, Yunnan province.
Enterovirus 71 vaccine is an inactivated (killed) vaccine that is administered by injection. Two doses, separated by one month are needed for full protection. The first dose can be given at 6 months of age, allowing protection of infants and young children, who are at greatest risk of complication and death from EV71 disease.
A large clinical trial of over 12,000 children showed that the vaccine is 97% effective at preventing enterovirus 71 disease. No serious side effects were seen, and the most common reaction to the vaccine is mild, temporary fever – not unusual for vaccines of this nature.
The vaccine will be available on the private vaccine market in China (that is, it is not on the list of vaccines provided free by the Government).
The CFDA and the National Health and Family Planning Commission will monitor the safety and impact of enterovirus 71 vaccine, as they do for all vaccines that are used in China.