3 babies in Nghe An province of Viet Nam die and vaccines questioned

News about: Vietnam

Date: Thu 21 Dec 2012
Source: VietNamNet Bridge [edited]

The Ministry of Health on 20 Dec 2012 asked the World Health Organization (WHO) and the manufacturer to verify the safety of the Quinvaxem and polio vaccines, after 3 babies in Nghe An province died after vaccination.

The Preventive Medicine Agency has directed the National Institute of Hygiene and Epidemiology, the National Children's Hospital in collaboration with the Nghe An Department of Health, to investigate the 3 deaths.

Nghe An has also stopped using the batches of Quinvaxem vaccine and polio [vaccine] which were injected into the 3 children, and sent vaccine samples to the National Institute for Vaccine and Medical Products Inspection to test.

According to the Preventive Medicine Agency, there is no evidence of the relevance of vaccines and immunization services to these deaths. The storage and transportation of the vaccines observed the regulations. The immunization staff was trained in accordance with the rules.

On 7 Dec 2012, 2 3-month-old babies in Chau Quang commune, Quy Hop district, Nghe An province, were vaccinated with Quinvaxem vaccine dose one, and took oral polio vaccine for the 1st time at the local health station. One of them died 34 hours after vaccination, showing nothing unusual. The remaining baby had fever in the evening, reduced fever in the next day. On 10 Dec 2012 (66 hours after the injection), the baby died. The 3rd baby was injected with the vaccine on 10 Dec 2012, in Dong Hop commune, and died on 12 Dec 2012 (38 hours after the injection).

There are 2 types of "5 in 1" vaccines. One is called Quinvaxem, from South Korea, preventing at the same time 5 diseases including diphtheria, pertussis, tetanus, Hib [_Haemophilus influenzae_ type B], and hepatitis [B]. This is the vaccine used in the expanded program on immunization. The 2nd type is the Pentaxim vaccine from France, to prevent diphtheria, pertussis, tetanus, polio, and Hib.  [Byline: Thu Ha]
[The newswire reports the suspension of Quinvaxem, a vaccine for diphtheria, pertussis, tetanus, Hib, hepatitis B, and polio vaccine after these vaccines were suspected to be related to the deaths of 3 babies in the province of Nghe An. According to other newswires, local authorities also suspect that Quinvaxem caused more than 30 cases of [adverse] reaction.

In recent years, the quality of vaccines has become a public concern in Viet Nam. In November 2012, the Viet Nam Drug Administration announced the recall of Typhim Vi typhoid vaccine manufactured by Sanofi Pasteur after the vaccine was found to be too weak.

In October 2012, GlaxoSmithKline ordered a recall of certain batches of Infanrix Hexa, a vaccine which is given to children in 3 doses (at 3, 5, and 11 months) for diphtheria, tetanus, polio, hepatitis B, _H. influenzae_ type B, and whooping cough, in 20 countries around the world including Viet Nam, for a possible risk of contamination with a bacterium (_Bacillus cereus_).

For a map of Viet Nam with provinces, see <http://www.vietbando.com/maps/#&amp;t=0&amp;st=0&amp;l=6&amp;kv=17.6440220,107.237548>. For the interactive HealthMap/ProMED-mail map with direct links to other outbreaks in Viet Nam and surrounding countries reported on ProMED-mail and PRO/MBDS, see <http://healthmap.org/r/4CmM>. - ProMed Mod.QCN]

[An infant death is always a disconcerting event, and when it occurs temporally associated with receipt of a vaccine there is the fear that there has been a failure in vaccine safety, jeopardizing the infant population. Vaccine safety failures lead to lack of confidence in the vaccines, further jeopardizing the infant and child population as the community refuses vaccinations based on fear of the adverse events that have occurred.

In principle the vaccines in use in most countries are WHO-approved vaccines produced by manufacturers with known good manufacturing practices. That being said, there are always concerns of release of "bad lots" of vaccines where there has been a problem in the manufacturing process that went undetected prior to release. Another problem that has been observed in some areas is contamination of a vaccine vial that occurs locally either during reconstitution of a lyophilized (freeze-dried) vaccine that is mixed with a diluent prior to administration of the vaccine, or the vaccine vial is contaminated prior to administration of the vaccine. In the case of Quinvaxem, the vaccine is not lyophilized so problems with diluent addition should not be an issue here. More information on the findings of the investigation would be greatly appreciated. - ProMed Mod.MPP]

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Source: ProMed Newsgroup Date: 27-Dec-2012 18:07:45