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Vaccine suspended for testing

Update: May, 16/2013 - 09:28

The use of a multi-purpose vaccine has been temporarily halted. Director of the National Expanded Programme on Immunisation Nguyen Tran Hien explains the reasons to the Vietnam News Agency.

What are the reasons behind this move?

After thoroughly analysing reports on the negative reactions of children exposed to the vaccine, the Ministry of Health (MOH) decided to temporarily halt its use. This is for the safety of the children while we wait for evidence over the vaccine's safety. It is not because of a problem with the quality of the vaccine. So far I can say that the Professional Consultants' Council of Viet Nam, the WHO and UNICEF have all agreed there is no link between the recent side effects and the transportation, storage and injection of the vaccine.

Vaccine Quinvaxem was first introduced to Viet Nam in June 2010 by the Global

Alliance for Vaccine and Immunisation (GAVI) through UNICEF, following stringent testing by the WHO. After it was imported to Viet Nam it was once again subjected to tests by the MOH on its safety and quality as well as to clinical trial in stage 2 and stage 3 on Vietnamese children.

According to the WHO, the vaccine has been used in more than 90 countries for more than 400 million doses. So far, there is no evidence showing that the vaccine failed to meet standards.

However, for the safety of the children, while waiting for the test results from an independent WHO laboratory on the quality of the vaccine, the MOH decided to suspend use. It is expected by the end of June, when all the information about the safety of the vaccine has been received from the WHO, the MOH will announce its final decision.

The temporary halt is a normal practice in the EPI worldwide. I feel confident saying our EPI in the past 25 years has been a success. In that period of time, we have temporarily stopped use of some lots of vaccine Quinvaxem several times due to reports of side effects on vaccinated children.

Has the EPI come up with a replacement vaccine?

As part of the decision, the MOH has ordered a ban of the vaccine for about two months and has not suggested an alternative vaccine. Meanwhile, the MOH has worked closely with the WHO in the hope of reaching an early conclusion regarding the safety of the Quinvaxem vaccine. There are several possible outcomes. One is that there is no evidence on the link between the vaccine and these side effect cases, meaning the MOH will again green light use of the vaccine. If there is evidence of a link, Viet Nam will use other vaccines instead - three in one (diphtheria, whooping cough and tetanus) and one shot of hepatitis B without Hib. I should say that no vaccine is 100 per cent safe and a two months gap between shots during the EPI will have no negative impact on the effectiveness of the vaccines.

What are your recommendations for mothers?

The first message I want to say is they should have total confidence in the health sector.

Vietnamese health workers are doing all they can to sustain the successes of the EPI over the past 25 years.

For mothers, please monitor closely your child's health following the shots and report immediately to the health workers any abnormal symptons displayed by your child. When you take your child to the vaccination site, please take with you their vaccination book and inform the health worker of your child's medical records, ranging from birth date to all diseases, particularly any reactions to previous vaccination shots.

After getting the shot, the child needs to be monitored for 30 minutes in the vaccination site and then 48 hours at home. If the child has a fever of over 39 degree Celsius and has convulsions or difficult breathing, take your child to the nearest health centre immediately.

During the suspension of the Quinvaxem vaccine, mothers should continue to give other type of vaccinations to their children in the EPI, such as vaccines against hepatitis B (right at birth), TB, measles, polio and the DPT for the 4th shot. — VNS

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