Vietnam halts use of Quinvaxem after 9 babies die in 6 months

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A dose from this Quinvaxem batch was administered to 4-month-old boy Dinh Ngo Ngoc Vuong Anh in Da Lat on March 15, a day before he died. Photo courtesy of Tuoi Tre

Vietnam's health ministry placed a nationwide moratorium on the use of Quinvaxem vaccines Saturday, in response to the deaths of nine babies in the last six months, with many others suffering from complications after receiving the five-in-one shot.

Previously, the ministry had maintained there were no problems with the vaccine, but came to the decision after the fatalities climbed to nine between last November and March 26.

Nguyen Viet Hung, deputy head of the ministry's Pharmaceutical Management Department, said the halt was ordered in the interests of public safety.

The department also notified the vaccine's distributor, the Berna Biotech Korea Corporation, of the halt and asked local health departments to implement the order in their areas.

Quinvaxem is given to babies from two months old, three times every one month, to immunize them against diphtheria, tetanus, whooping cough, hepatitis B, and Hib (Haemophilus influenza type b).

Vietnam has been administering around 4.5 million Quinvaxem shots to 1.5 million children every year.

The liquid drug, pre-qualified by the World Health Organization (WHO), has been distributed in Vietnam for free since June 2010 as part of a program run by the Global Alliance for Vaccines and Immunization through the nonprofit organization UNICEF.

Various symptoms including fevers, vomiting and widespread bruising were reported among the victims, including one in Hanoi.

All the questionable batches were suspended right after the deaths. But the Health Ministry and WHO have both vouched for the vaccine's quality, distribution, preservation and administration, at least after the seventh death.

Local health officials said there were problems in previous years, though less severe, as complications arose from more than 20 of 42 batches imported so far.

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Nguyen Tran Hien, chairman of the National Extended Vaccination Program of the National Institute of Hygiene and Epidemiology, said ten such cases of complications were reported in 2011, without any fatal cases.

But two deaths were reported in November 2012, in the northern province of Thanh Hoa and the Central Highlands province of Lam Dong. Three 3-month-old boys died in the neighboring province of Nghe An last December.

Hien told Tuoi Tre that while there is no evidence proving the vaccine was responsible for the deaths, nine deaths in six months were enough to render it suspect.

The ministry is yet to instruct medical centers on which drug they should use instead of Quinvaxem.

The pharmaceutical department said they can use single hepatitis B and Hib shots and the three-in-one shots for diphtheria, tetanus, whooping cough. 

However, Nguyen Nhat Cam, director of the Hanoi Preventive Health Center, said the three-in-one shots are only prescribed to children over 18-months-old.

Cam said the five diseases are all dangerous and the ministry should not leave local children unprotected for long.

Health officials said the government can find alternative vaccines of better quality.

Quinvaxem was introduced globally in 2006 by the Netherlands-based biopharmaceutical company Crucell. It has been pushed to low-income countries, as it costs around VND77,000 (nearly four US dollars) a dose, ten times cheaper than new alternatives produced in the US and Belgium.

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