Latest infant deaths force Vietnam parents to rethink vaccination

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Health Minister criticized for tardy, "˜indifferent' response to fatalities following administration of Hepatitis B vaccine

Nguyen Dinh Dao, 35, (2nd, L) cries as he stands outside the morgue while an autopsy is performed on his newborn son at the Huong Hoa General Hospital in Quang Tri Province. Dao's son and two other newborns died on July 20 after they were given hepatitis B vaccine shots. Photo: Nguyen Phuc

Le Thu Thao expects to give birth to her second child in the coming weeks and she is wondering whether she will give the baby the usual vaccinations.

"I am really worried, after all the incidents. I am also worried about the risks of skipping the vaccinations," said the resident of Hanoi's Cau Giay District.

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The incidents that Thao is talking about include the deaths of four infants over the weekend after being administered a locally-made Hepatitis B vaccine. The deaths are being investigated.

The United Nations and World Health Organization maintain that the benefits of vaccination far outweigh the risk, and that "adverse events" are extremely rare.

In April-May 2007, three newborns died after getting Hepatitis B vaccine shots made by Korean firm LG.

Investigations found the baby in HCMC died of reactive shock against the vaccine. Three more babies in HCMC had the same shock but were saved.

The 2007 deaths were attributed to "extreme anaphylactic shock" - a fatal allergic response to a foreign substance. Subsequent tests found the vaccine met relevant quality requirements.

Observers say that the failure of Health Minister Nguyen Thi Kim Tien, a doctor and former director of the Pasteur Institute in HCMC, to respond swiftly to the deaths following contradictory comments from health experts could see parents refusing to have their babies vaccinated. This could compromise the national extended vaccination program, they add.

On July 20, three newborns at the Huong Hoa General Hospital in Quang Tri Province turned blue and had breathing difficulties 30 minutes after getting their Hepatitis B shots. They were rushed to the emergency ward, but doctors could not save them.

A day later, another infant in Binh Thuan Province died after taking the same vaccine, produced by the Company for Vaccine and Biological No 1 that belongs to the Health Ministry. 

Lack of empathy

Although the ministry sent a team to Quang Tri to investigate the deaths and the Drug Administration of Vietnam has suspended the use of the two vaccine batches involved, Tien has been criticized for her response or the lack of it. 

On July 21, Tien arrived in Quang Tri, but on another mission. She neither visited the families of the three babies nor commented on the case.

Local media reported she attended a groundbreaking ceremony for the construction of a bell tower at the Gio Linh war martyrs cemetery and burned incense at the Truong Son war martyrs cemetery.

In an interview with the Kien Thuc online newspaper, lawmaker Le Nhu Tien said minister Tien should have visited and expressed condolences to the families of the babies.

For her part, the minister told the Kham Pha online newspaper on Wednesday that she had a meeting with the Quang Tri People's Committee on other matters and she couldn't visit the families because of her busy schedule.

"The Health Ministry sent a working delegate to Quang Tri to visit [the families]. I couldn't do so in person," she said.

She said both her ministry and Ministry of Public Security are conducting independent investigations of the deaths and there would be "no concealment" on the issue.

At the historic first ever confidence vote held by the national parliament last month on senior government officials,  Tien had received the fourth highest number of "low confidence" votes.

During her visit to Quang Tri, Tien refused to comment on the deaths of the three babies and said her ministry's delegate would investigate and respond to the media.

A Sai Gon Tiep Thi editorial on July 24, said the response was tantamount to showing "the utmost indifference possible."

While it would take time to identify the actual cause of the deaths, the minister should have at least expressed sympathy for the families and reassured the citizens on vaccinating children, the newspaper said.

"Four infants dying after being vaccinated for Hepatitis B is a heavy blow to the country's vaccination program"¦ The parents are really confused and frightened," it said.

Overanxious parents

On July 24, health minister Tien announced that the practice of administering Hepatitis B vaccine to infants within 24 hours of birth will remain unchanged.

Meanwhile, there have been contrasting recommendations from experts.

Trinh Quan Huan, a senior expert with the health ministry, said the vaccine should only be administered to children born to mothers with Hepatitis B.

"The infants are fragile and cannot resist several factors if they have undetected congenital diseases," he was quoted by the Tuoi Tre (Youth) newspaper as saying.

Nguyen Dinh Bang, former director of the National Institute for Control of Vaccine and Biologicals, also backed Huan's opinion, the paper said.

On the other hand, Nguyen Huy Du, Maternal and Neonatal Specialist with UNICEF Vietnam, said the rate of adverse events following immunization is well within the rates the UN would expect to see.

"It's very important to remember that about 1.7 million children under one year old are vaccinated with 8 essential childhood vaccines in Vietnam each year, and even though one case is still too many, adverse events following immunization still remain exceedingly rare," he said.

According to a joint WHO-UNICEF statement, effective vaccines against Hepatitis B have been available for more than 25 years and have been shown to be safe and highly protective against the disease. It has also said that the recommendation to vaccinate infants against Hepatitis B within the first 24 hours after birth is based on the best available international evidence, and is a recommended strategy to prevent infection with the disease.

The statement said that such incidents are very rare, but they generate a great deal of media coverage, which can cause a great deal of concern among parents.

"Whilst one such incident is still one too many, it's important to remember that immunization is generally safe, and provides vital lifesaving protection for children," it said.

But doctors and other experts have agreed that the health ministry's handling of the case continues to undermine the confidence parents have in the national vaccination program, which has already been marred by several scandals, ranging from administering inadequate doses to expired vaccines.

In June, the health ministry placed a nationwide moratorium on the use of Quinvaxem vaccines in response to the deaths of nine babies in the previous, during which time many other babies suffered from several complications after receiving the five-in-one shot.

The ministry had previously maintained there were no problems with the vaccine, but issued the moratorium after the fatalities climbed to nine between last November and March 26. The WHO has since said it found no problems with the controversial vaccine and urged the Vietnamese government to resume its use. The proposal is awaiting approval from the Prime Minister.

According to the health ministry, the percentage of children taking the Hepatitis B vaccine had drastically decreased to 20-25 percent from the previous 90 percent following several deaths of newborns in 2007 after taking the shot.

After much effort, the percentage had increased to 80 percent recently.

Following the latest incident, many people have said they would wait for the investigation's findings before having their babies vaccinated. Others have said they will not have their babies vaccinated or that they no longer trust vaccines made in Vietnam.

Although other batches of the Hepatitis B vaccine produced by the Company for Vaccine and Biological No 1 are still being used, many parents have shifted to imported products which are more expensive.

Dr. Nguyen Thi Tu Anh of the Hung Vuong Hospital in HCMC said many parents have shifted to using the foreign Hepatitis vaccines of Euvax B and Engerix B for between VND50,000 and VND80,000.

The Mekong Hospital in HCMC also saw more parents having their newborns administered with foreign vaccines over the past days. 

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By Vietweek Staff, Thanh Nien News (The story can be found in the July 26th issue of our print edition Vietweek)

* AN DIEN contributed to this report

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