Vietnam health agencies declare vaccine safe despite seven deaths

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One of the three babies that suffered complications after they received Quinvaxem shots in the central province of Binh Dinh on December 25, 2012, but were fortunate to survive.

At least seven babies, six of them boys, have died in Vietnam after receiving pentavalent vaccine Quinvaxem since November, but health officials maintain that there is no evidence it should be recalled.

Over the weekend, an unidentified baby of two months old in the southern province of Kien Giang became the latest victim of the vaccine.

Experts with the Health Ministry in charge of vaccination reactions said at a meeting on January 9 that health agencies have found no problems with the vaccine's quality.

"There's no evidence that the preservation, transportation, or the provision of the vaccine was involved in the complications," Dr Nguyen Van Binh, head of the ministry's Preventive Health Department, told local media at the meeting.

He said the vaccine has been tested and used following biopharmaceutical standards of Vietnam and the World Health Organization.

Three boys of three months old died in the central province of Nghe An between one and ten days after receiving the vaccination on December 7.

On January 5, a 3-month-old baby boy in Hanoi died one day after being given the vaccination. His parents said the baby was normal before the shot, and that he'd had no problems after his two previous vaccinations.

All victims suffered from various symptoms including fevers, vomiting and bruise marks around their bodies.

While assuring its safety, the Health Ministry is concerned about a worried public not sending their children for vaccination any more, Dr Nguyen Tran Hien, head of the National Institute of Hygiene and Epideomology and chairman of the National Extended Vaccination Program, told Nguoi Lao Dong on January 7.

He said the ministry has asked the WHO to have another independent agency test the batch used in Nghe An, which made many headlines due to the number of fatalities, and asked the producer, Berna Biotech Korea Corporation of South Korea, to review production and distribution of the vaccine in Vietnam.

According to Hien, the batch includes 400,000 doses and more than 200,000 have been used in the northern region.

"It's hard to say that the problems are with the vaccine when hundreds of other children are healthy after taking it," he said.

He added all the victims in Nghe An died at home and the exact cause of their deaths remained unknown.

On December 25, three babies two months old in the south central province of Binh Dinh also had to be rushed to hospital hours after they received Quinvaxem shots in the morning. They had high fever, bruise marks and convulsions, but they were luckier as they survived.

A Tuoi Tre report said two other babies died after receiving Quinvaxem vaccinations in November in the northern province of Thanh Hoa and the Central Highlands province of Lam Dong. But local health authorities there have also said that tests found the vaccine was of proper quality.

All the batches involved in the deaths would be suspended until official confirmation from the WHO regarding their safety, authorities in Hanoi and Binh Dinh have announced.

Quinvaxem, listed as a prequalified medicine by the WHO, has been distributed in Vietnam since June 2010 as part of a program run by the Global Alliance for Vaccines and Immunization through the UNICEF. The fully liquid drug immunizes children from five diseases diphtheria, tetanus, pertussis or whooping cough, hepatitis B, and Hib (Haemophilus influenzae type b).

Vietnam has used 13 million doses of the vaccine for children between two and four months old, according to figures from the Health Ministry.

The country previously used DPT, another combination vaccine that protects children from diphtheria, tetanus, and pertussis.

Hien said the rate of complications from DPT is 1.03 per a million children, and the death rate is 0.6 per million, while corresponding rates for Quinvaxem are 0.69 and 0.17 per million.

"The rates are all under the death threshold of the WHO for vaccines 1 per one million," he said.

Combination vaccines aim to facilitate protection from multiple life-threatening infectious diseases. But global researchers have expressed concern about the possibility of severe reactions arising from combining components, even though they have been used and tested safe independently.

Quinvaxem was the first fully liquid pentavalent vaccine brought to the market, launched in 2006 by the Netherlands-based biopharmaceutical company Crucell.

According to the Vaccine Resistance Movement, the vaccine has been responsible for deaths of at least five children in Sri Lanka, eight in Bhutan and at least three in Pakistan during a couple years after it was launched.

It cites an IANS (Indo-Asian News Service) report on an article in the British Medical Journal in which a group of pediatricians, professors, health activists and a former Indian health secretary, cautions against the introduction of the five-in-one vaccine that combines antigens against five diseases in a single shot.

"Our article describes how the World Health Organization, in an elaborate cover-up, changed its own criteria for classifying adverse effects to say the vaccine was not responsible for the deaths in Sri Lanka," Jacob Puliyel, head of pediatrics at St. Stephen's Hospital in Delhi and key author, is quoted as saying.

But Hien said Quinvaxem is an affordable one for Vietnam. It costs around VND77,000 (over three US dollars) a dose, which was supported by the Global Alliance for Vaccines and Immunization, while new alternatives produced in the US and Belgium cost ten times more.

South Korea and many developed countries have been using the latest version of the vaccine.

Crucell says on its website that since the launch of Quinvaxem in 2006, over 200 million doses have been delivered to developing countries. "Most were low-income countries supplied through Unicef and the Pan American Health Organization."

However, the authors of the British Medical Journal article point out that the pentavalent vaccine was withdrawn in Sri Lanka in April 2008 after 25 serious adverse reactions that included five deaths and Bhutan stopped its use within two months of introduction in July 2009 after eight deaths.

The IANS report said Bhutan has "so far resisted pressure from WHO to restart immunization, but Sri Lanka reintroduced the vaccine this year after a WHO expert panel, which investigated the events, declared that the vaccine was "˜unlikely' to have caused the deaths.

"The panel, however, could not conclusively attribute the deaths to any other cause," it said.

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