WHO to probe Quinvaxem deaths in Vietnam

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A baby is vaccinated in Hanoi. Photo by Ngoc Thang

The World Health Organization will check the quality of the Quinvaxem vaccine used in Vietnam to help decide whether or not to resume using the pentavalent vaccine.

In a belated action taken after nine infants died over six months (last November to this March) after they were given the vaccine, the Vietnam Health Ministry halted the use of the vaccine on May 3. Many other babies between two and four months hold, the age at which the vaccine is administered, developed complications. 

Deputy health minister Nguyen Thanh Long said once the WHO presents its conclusions after investigating the issue, the ministry will take a decision on whether to use the vaccine again or not, and which drug to use as a replacement.

Quinvaxem is pre-qualified by WHO and distributed in Vietnam by the Berna Biotech Korea Corporation. It 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 imported 13 million shots and administered more than 11 million 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 fever, vomiting and widespread bruising were reported among the babies that died, including one in Hanoi and one in Ho Chi Minh City. Some babies died the day after the shot, some a few days later.

Long said the ministry is considering alternatives between giving children single hepatitis B and Hib shots combined with the locally-produced three-in-one shots diphtheria, tetanus, whooping cough, or giving the children the acellular five-in-one shot which is prepared from purified antigenic components of cell-free microorganisms, carrying less risk than whole-cell preparations like in Quinvaxem's whooping cough component.

The new vaccine, produced in Belgium and the US, has been administered upon parents' demands at the price of VND500,000 (US$24) a shot. Quinvaxem costs VND77,000 a dose and thus has been pushed to low-income countries since it was introduced globally in 2006 by the Netherlands-based biopharmaceutical company Crucell.

The ministry estimated that if the country switches to providing the quality vaccine, it will have to increase the annual vaccination budget to around VND800 billion ($38.26 million).

Doctors in Hanoi said more parents have been seeking the acellular shots for their children after use of the other was halted.

Medical centers have received many calls from parents who are not confident about the new vaccine. They are also worried about the impact on their children's immunity if their vaccination is delayed.

Long said the investigation can take a couple months but that is not long enough to put the children at risk of being infected.

Tran Phu Manh Sieu, director of the Ho Chi Minh City Preventive Health Center, said parents will need to consult doctors about the need of an extra dose if the ban on the vaccine lengthens the time taken between two shots.

"A delay of one month late will cause no problem, but more than that will need an extra dose," Sieu said.

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