WHO suggests Vietnam bring back Quinvaxem despite deaths

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A baby being vaccinated in Hanoi. Photo by Ngoc Thang

The World Health Organization (WHO) has advised Vietnam to resume its use of the pentavalent vaccine Quinvaxem after WHO tests revealed no problems with the vaccine which had been alleged to be connected to a recent series of deaths.

Officials from the Health Ministry's Preventive Health Department, which is in charge of overlooking the quality of vaccines in the country, agreed to resume using Quinvaxem at a meeting on June 19. The ministry will ask the Prime Minister for approval.

Nguyen Van Binh, head of the department, said samples of doses of the vaccine connected to the deaths were tested by the British National Institute for Biomedical Standards and Controls and results showed they met quality standards established by WHO.

Quinvaxem, a liquid drug which has been pre-qualified by WHO, is distributed in Vietnam by the Berna Biotech Korea Corporation and given to babies from two months old, three times over two months, to immunize them against diphtheria, tetanus, whooping cough, hepatitis B, and Hib (Haemophilus influenza type b).

It costs VND77,000 a dose and has been pushed to low-income countries since it was introduced globally in 2006 by the Netherlands-based biopharmaceutical company Crucell.

As part of a program run by the Global Alliance for Vaccines and Immunization through the nonprofit organization UNICEF, Vietnam has imported 13 million shots and administered more than 11 million for free since June 2010 with no major problems until nine infants died over six months between last November and this March.

The fatalities began with two infants from the northern province of Thanh Hoa and the Central Highlands province of Lam Dong, before three boys died in the neighboring province of Nghe An in December. One death was reported in Hanoi and one in Ho Chi Minh City.

The victims, who died on the same day or a few days after they were given the shot, suffered from various symptoms including fever, vomiting and widespread bruising.

Previously, the ministry had planned to suspend the use of the vaccine for up to three months for testing.

Doctors said a three-month interval would not affect babies' immunity and parents would be able to consult doctors if their children began the regimen before the suspension took effect.

Before and after the halt, many worried parents elected to have their children given an acellular five-in-one shot, which is made from purified antigens with less risks than whole-cell preparations found in the whooping cough component of Quinvaxem.

The purified shot, produced in Belgium and the US, has always been available in Vietnam, but costs VND500,000 (US$24) a shot.

Nguyen Tran Hien, chairman of the National Extended Vaccination Program, said in a Tuoi Tre report that Quinvaxem is a more affordable choice for Vietnam, and that it has proven effective over time.

The vaccine has helped reduce diphtheria infections in Vietnam by 410 times and whooping cough by 841 times.

Hien said after Quinvaxem is reintroduced, "people will have to accept that related complications will continue to occur."

Around 22,000 infants younger than one year old die every year in Vietnam, many of those for unknown reasons, and those babies who died after being given Quinvaxem are not exceptions, he said.

He also promised that health agencies would work harder to investigate the causes of any deaths that occur among infants after being given Quinvaxem, now that the vaccine itself has been deemed safe.

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