The hand, foot and mouth vaccine is stored and transported for the rollout in Việt Nam. — Photos courtesy of VNVC

HÀ NỘI — Việt Nam has begun administering a vaccine against hand, foot and mouth disease caused by Enterovirus 71 (EV71) to children from two months of age, with the vaccine being rolled out nationwide through the VNVC Vaccination System.

The VNVC Vaccination System and Switzerland-based Substipharm Biologics officially launched the vaccine on Friday at nearly 300 VNVC vaccination centres across the country.

It is the first time the vaccine has been introduced in Việt Nam and Southeast Asia, according to the companies. Known as Envacgen, the vaccine was approved by the Ministry of Health in March for children aged from two months to under six years.

Dr Bạch Thị Chính, Medical Director of the VNVC Vaccination System, said hand, foot and mouth disease is caused by several different viruses. Scientists have spent decades developing vaccines against the disease, but efforts have faced challenges, particularly in achieving effective protection against EV71.

The vaccine is administered in two or three doses, depending on the child’s age when vaccination begins. It underwent Phase-3 clinical trials in Việt Nam, with results showing a high level of protection against EV71, a virus associated with a large proportion of severe cases and deaths from hand, foot and mouth disease.

A 23-month-old child receives the hand, foot and mouth disease vaccine on September 25.

According to published data, the vaccine has demonstrated 96.8 per cent efficacy rate against EV71-associated hand, foot and mouth disease. No EV71 cases were recorded among vaccinated participants in the relevant clinical study, while the vaccine also generated a strong immune response against several EV71 sub-genotypes.

The Phase 3 study involved more than 3,000 children, including a large proportion of Vietnamese children. VNVC said the vaccine demonstrated a favourable safety profile and sustained protection in follow-up studies.

The EV71 vaccine has also been administered to children in Taiwan, where more than 600,000 doses were reportedly used between August 2023 and September 2026.

According to Professor Dr Li-Min Huang, former Director of the National Taiwan University Children’s Hospital and Honorary Chairman of the Taiwan Society of Infectious Diseases, post-vaccination monitoring in Taiwan has continued to show the vaccine’s safety and effectiveness.

CEO of Substipharm Biologics Fabrice Baschiera said the company was pleased to work with VNVC to introduce the vaccine to Việt Nam, making the country the first in Southeast Asia to deploy it.

Long-awaited protection

Hand, foot and mouth disease is a common infectious disease among young children, particularly those under three years old, and has caused major outbreaks in Việt Nam.

EV71 is considered an important cause of severe disease and can lead to neurological, respiratory and cardiovascular complications, as well as death.

In 2023, Việt Nam recorded more than 181,000 cases and 31 deaths, with EV71 reportedly accounting for 82 per cent of hospitalised cases and 90.4 per cent of severe cases.

Dr Trương Hữu Khanh, Vice Chairman of the HCM City Association of Infectious Diseases and a paediatric infectious disease specialist, said paediatricians have awaited an EV71 vaccine for years, after repeated outbreaks led to increased hospitalisations and severe complications among children.

“For many years, parents have asked me when a vaccine against hand, foot and mouth disease would become available,” Khanh said.

“During each disease season, parents are worried and doctors are under pressure because some children may initially appear alert but deteriorate within just a few hours, requiring significant medical personnel, medicines and intensive care equipment. When a major outbreak occurs, the rapid increase in hospital admissions puts even greater pressure on the healthcare system. So I am very pleased that Việt Nam now has an EV71 vaccine for children,” he noted.

Dr Nguyễn An Nghĩa, Deputy Head of the Department of Infectious Diseases and Neurology at Children’s Hospital 1 in HCM City, said children with hand, foot and mouth disease can deteriorate from a mild condition to a critical state within six to eight hours.

EV71 is particularly associated with severe disease because of its ability to affect the central nervous system. Some children may show limited skin or mucosal symptoms, making the disease more difficult to distinguish from common illnesses, he said.

On the first day of the nationwide rollout, families in Hà Nội, HCM City, Đà Nẵng, Cần Thơ and other localities brought their children for vaccination. Tens of thousands of registrations were recorded at nearly 300 VNVC centres nationwide, with under-three children accounting for about 70 per cent of those seeking vaccination, according to VNVC.

Dr Chính said VNVC has worked with Substipharm Biologics for several years to bring the vaccine to Việt Nam at an early stage.

The vaccination system has prepared vaccine supply and storage facilities, trained medical staff and distributed the vaccine to its centres nationwide ahead of the peak season for hand, foot and mouth disease, she said.

“We hope families with young children will consider vaccination early so that we will no longer have to face the anxiety caused by major outbreaks or severe disease peaks like those seen in previous years,” Chính said. — VNS