
Hand, foot, and mouth disease (HFMD) is a common illness in children under 5 years old, but anyone can get it. It is usually not serious, but it is very contagious. While there is no vaccine available in the United States, China has developed the world's first vaccine against enterovirus 71, a dangerous virus that can cause HFMD. This vaccine provides almost complete protection against enterovirus 71, which is a major cause of neurologic damage and has resulted in thousands of deaths in China.
| Characteristics | Values |
|---|---|
| Is there a vaccine for hand, foot, and mouth disease? | There is no vaccine for hand, foot, and mouth disease in the United States. However, China produced the world's first vaccine against enterovirus 71, a virus that causes hand, foot, and mouth disease, in 2015. |
| Effectiveness of the vaccine | The vaccine has been shown to be 97% effective in preventing enterovirus 71 disease with only mild and temporary fever as the most common reaction. |
| Availability | The vaccine is available in China and Thailand. |
| Suitability | The vaccine is suitable for children from 6 months to 5 years old. |
| Dosage | Two doses of the vaccine are required, administered intramuscularly with a one-month interval between them. |
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What You'll Learn

There is no vaccine for HFMD in the US
Hand, foot, and mouth disease (HFMD) is a common illness in children under 5 years old, but it can affect anyone. The illness is usually not serious, but it is highly contagious. HFMD usually causes fever, mouth sores, and skin rashes. It can spread quickly in schools and daycare centers.
Currently, there is no vaccine available in the United States to protect against the viruses that cause HFMD. While there are no specific treatments, the disease usually resolves on its own within 7 to 10 days with minimal or no medical intervention. To manage the illness, individuals can take over-the-counter medications to relieve fever and pain caused by mouth sores. It is important to avoid giving aspirin to children. Additionally, preventing dehydration is crucial.
In contrast, China has made significant progress in developing a vaccine for HFMD. In 2015, China produced the world's first vaccine against enterovirus 71 (EV71), a dangerous virus that can cause HFMD. This vaccine provides almost complete protection against EV71, which is a leading cause of neurological damage and deaths in Chinese children. The EV71 vaccine is administered in two doses, given intramuscularly with a one-month interval, and is suitable for children from 6 months to 5 years old.
While the EV71 vaccine is a major breakthrough, it is important to note that HFMD can be caused by other enteroviruses, such as coxsackievirus A16 (CV-A16). The EV71 vaccine does not protect against infections caused by other enteroviruses. As a result, there is still a need to develop multivalent vaccines that can provide protection against multiple strains of the virus.
To prevent the spread of HFMD in the absence of a vaccine in the US, it is important to practice good hygiene. This includes frequent handwashing, cleaning, and disinfecting surfaces and shared items, and avoiding close contact with infected individuals. Teaching children proper handwashing techniques is especially important in controlling the spread of the disease.
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China licensed the world's first vaccine in 2015
Hand, foot, and mouth disease (HFMD) is a common illness in children under five years old, but it can affect anyone. It is usually not serious, but it is highly contagious. HFMD is characterised by fever, mouth sores, and skin rashes. While there is no specific treatment, most people recover within 7 to 10 days without medical intervention.
In 2015, China licensed the world's first vaccine against enterovirus 71 (EV-A71), a dangerous virus that can cause hand, foot, and mouth disease. This was a significant breakthrough as there was no previous treatment for EV-A71-induced hand, foot, and mouth disease, which can be severe and even fatal in young children. Dr Bernhard Schwartländer, WHO Representative in China, emphasised the importance of this development, stating that the vaccine provides "almost complete protection" against EV-A71, a leading cause of neurological damage and thousands of child deaths in China.
The vaccine, manufactured by the Institute of Medical Biology, Chinese Academy of Medical Science, in Kunming, Yunnan province, is an inactivated (killed) vaccine administered by injection. To ensure full protection, two doses are required, with a one-month interval between them. The first dose can be given as early as six months of age, safeguarding infants and young children who are most vulnerable to complications and death from EV-A71.
A large clinical trial involving over 12,000 children demonstrated the vaccine's impressive efficacy, showing it to be 97% effective in preventing EV-A71-induced hand, foot, and mouth disease. Mild and temporary fever was the most common reaction to the vaccine, which is typical for vaccines of this nature. This vaccine specifically targets EV-A71 and does not protect against hand, foot, and mouth disease caused by other enteroviruses, such as Coxsackievirus A16.
Following the introduction of the two-dose EV-A71 vaccination in Guangzhou, China, in 2016, studies assessed its effectiveness in preventing hand, foot, and mouth disease. The results suggested that the vaccine effectively prevented HFMD, particularly in children aged three years and above. However, the evidence for the effectiveness of the monovalent Enterovirus 71 (EV71) vaccine against HFMD is still uncertain.
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The EV71 vaccine is 97% effective
Hand, foot, and mouth disease (HFMD) is a highly contagious illness that is common in children under 5 years old but can affect anyone. It is typically not severe, and most people recover within 7 to 10 days without medical intervention. However, in some cases, HFMD can lead to serious neurological complications and even death, especially when caused by the enterovirus 71 (EV71) strain.
The EV71 strain of the virus has emerged as a significant health threat, particularly in the Asia-Pacific region, with severe outbreaks reported in multiple countries. In 2015, China produced the world's first vaccine specifically targeting EV71, which can cause severe neurological damage and has resulted in thousands of childhood deaths in the country. This vaccine is an inactivated (killed) vaccine administered through injection, providing almost complete protection against EV71.
The development and licensing of the EV71 vaccine are crucial because there was previously no specific treatment for EV71 disease. Clinical trials involving over 12,000 children in China have shown that the vaccine is 97% effective at preventing EV71 infection. This high level of effectiveness means that the vaccine has the potential to significantly reduce the incidence of EV71-related illness and death, not just in China but also globally.
The EV71 vaccine regimen consists of two doses, given intramuscularly with a one-month interval between them. The first dose can be administered as early as 6 months of age, offering protection to infants and young children who are most vulnerable to severe complications and death from EV71 disease. While mild and temporary fever was observed as a common reaction to the vaccine, no serious side effects were reported during the clinical trials.
The availability of the EV71 vaccine is a significant advancement in the fight against hand, foot, and mouth disease, especially in regions where EV71 is prevalent. However, it is important to note that the vaccine does not protect against other strains of the virus that cause HFMD, such as coxsackievirus A16 (CV-A16). Therefore, ongoing research and development of multivalent vaccines targeting multiple strains of the virus are crucial to providing comprehensive protection against HFMD.
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The EV71 vaccine is suitable for children from 6 months to 5 years old
Hand, foot, and mouth disease (HFMD) is a common illness in children under 5 years old, but anyone can get it. The illness is usually not serious, but it is very contagious. HFMD is caused by enterovirus 71 (EV71) and coxackievirus A16 (CV-A16), with EV71 accounting for the majority of severe and fatal cases.
Currently, there is no vaccine in the United States to protect against the viruses that cause HFMD. However, in 2016, the B-EV71 vaccine was licensed for children aged 6-35 months by the former China Food and Drug Administration. This vaccine has shown good safety, immunogenicity, and efficacy in this age group.
The B-EV71 vaccine has also been proven safe and immunologically effective in children aged 36-71 months, who are still susceptible to EV71 infection. This was demonstrated in a double-blind, randomized, controlled, non-inferiority phase III clinical trial. Therefore, the EV71 vaccine is suitable for children from 6 months to 5 years old, with potential benefits for those up to 71 months old.
Further exploration is needed for the B-EV71 vaccine application in older children, and to assess the persistence of vaccine-induced immunities. However, the available evidence suggests that the EV71 vaccine is a promising intervention to prevent HFMD, especially among children aged 3 years and above.
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The need for a bivalent EV71/CVA16 vaccine
Hand, foot, and mouth disease (HFMD) is a highly contagious viral infection that is common in children under 5 years old, but anyone can get it. It is usually not serious, and most people recover within 7 to 10 days without medical treatment. However, in some cases, HFMD can cause severe neurological complications and even lead to death.
Enterovirus 71 (EV71) and coxackievirus A16 (CVA16) are the two predominant causes of HFMD epidemics worldwide. EV71, in particular, has emerged as a major neurovirulent virus responsible for severe neurological complications and fatal outcomes. The recurrence of outbreaks associated with high morbidity and mortality has prompted the World Health Organization to declare HFMD a rising menace in Asia.
Currently, there is no vaccine in the United States to protect against the viruses that cause HFMD. However, there is a monovalent EV71 vaccine available in China, and studies have shown that it is effective in preventing HFMD. Despite this, the evidence for the effectiveness of the monovalent EV71 vaccine against HFMD remains unknown.
In summary, the development of a bivalent EV71/CVA16 vaccine is crucial to effectively prevent HFMD, reduce the burden of this disease, and protect individuals, especially children, from severe neurological complications and fatal outcomes associated with EV71 and CVA16 infections.
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Frequently asked questions
There is no vaccine for hand, foot, and mouth disease in the United States. However, China licensed the world's first vaccine against enterovirus 71, a dangerous virus that can cause hand, foot, and mouth disease, in 2015. This vaccine is manufactured by the Institute of Medical Biology, Chinese Academy of Medical Science, in Kunming, Yunnan province.
The enterovirus 71 vaccine is suitable for children from 6 months to 5 years old. It is administered in two doses, with a one-month interval between them. The first dose can be given at 6 months, protecting infants and young children who are at the greatest risk of complications and death from the disease.
A large clinical trial of over 12,000 children showed that the vaccine is 97% effective at preventing enterovirus 71 disease. It is important to note that this vaccine only provides protection against hand, foot, and mouth disease caused by enterovirus 71 infection and not against other enteroviruses, such as Coxsackievirus A16. While the vaccine is generally safe, there is a small chance of mild and temporary side effects, such as fever.











































