Viet Nam has suspended the use of a Hepatitis B vaccine manufactured by global leader LG group (the Republic of Korea ), after three newborn babies suddenly died after being administered with the vaccine.
The Health Ministry has immediately halted the use of the vaccine nation-wide while they ascertain the causes of the infants' deaths.
Since the vaccine is distributed through the World Health Organisation (WHO) channels, the agency is embarrassed and says it will investigate the deaths.
Hepatitis B is a serious disease caused by a virus that attacks the liver. The virus, which is called hepatitis B virus (HBV), can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death.
Hepatitis B vaccine is available for all age groups to prevent hepatitis B virus infection. Dr. Do Si Hien, Chairman of Vietnam's National Vaccination Programme, said that between April 23 and May 7, a total of four infants went into shock after being given the vaccine. According to statistics, usually only one case of Hepatitis B vaccine shock is found for every one million people vaccinated against the disease, he added.
According to Hien, children under 12 months of age have been vaccinated against Hepatitis B under the national vaccination programme since 1997, with the programme expanding to all regions of the country by 2003. With close to 1.5 million children being vaccinated annually, Hepatitis B vaccine has been used on millions of Vietnamese children to date.
Hien urged parents to remain calm, saying that these were extremely unusual cases that related to only two batches of Hepatitis B vaccine manufactured by LG. The WHO said it supports, as a precautionary measure, the nationwide temporary suspension of the drug produced by South Korea's LG Life Sciences and distributed in Vietnam through a UN system.
The global health body has also "recommended the temporary suspension of the distribution and use of specific lots of the Euvax B vaccine produced by LG because of these recent reports," said WHO spokesperson Dida Connor.
Drugs from the same lots had been shipped to 24 countries, but no other adverse reactions had been reported to date from any of them, she said.
WHO will send a team of international experts to Vietnam as early as this week to investigate the cases, said Connor.
"WHO, Unicef and the government are taking this very seriously," she said. "We're making all efforts to ensure a full, prompt investigation.
"This doesn't mean that we have any information that is conclusive about the potential cause of this at this stage. WHO will send out further advice pending the outcome of this investigation."
Connor said the LG vaccine had been used for some years and that WHO had received no reports of deaths or serious reactions from any other countries.