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Investigations over, reports awaited

25 January, 2009 - The World Health Organisation (WHO) has finally identified two laboratories in France and Thailand to quality test the samples of the pentavalent vaccine that the health ministry suspended four months ago after nine babies that received the vaccine died.
The testing of samples say public health officials is one of the most important and the final step in the investigation process, that would help confirm whether the vaccine had any role in the deaths of the nine infants.

The labs identified are the division of biological products, department of medical sciences in Bangkok and the Agence Française de Sécurité Sanitaire de Produits de Santé (AFSSAPS), Direction des Laboratoires et des Contrôles, Unité de Contrôle des Médicaments Immunologiques in France.

Public health director, Dr Ugen Dophu, said the testing of samples is an important part of the investigation. “The review of the patient’s history and the testing of the cerebrospinal fluid are equally important, but this would test the quality of the vaccines,” he said.

With the laboratories identified for testing, the investigation part, said Dr Ugen Dophu, is over. “Now we have to wait for the reports from the experts and the laboratories to confirm if the vaccine was or wasn’t responsible,” he said.

The investigation process began on October 29 with the arrival of an expert team from the WHO. The expert team, in their preliminary findings had categorised eight of the deaths as coincidental and linked only one to the vaccine. The health ministry suspended the use of pentavalent vaccine on October 23, after four deaths were reported.

According to the WHO letter, which was sent to the health ministry, on January 22, the drug regulatory authority (DRA) should send 85 vials to the Bangkok laboratory and 30 to France on February 1. The sample vaccines should be packed and sealed in the presence of officials from UNICEF, WHO and other health officials on January 31.

Health officials said the results would be known in about a month’s time. Meanwhile, the health ministry is yet to receive reports from the three experts, to whom the case history of the nine infants was sent, and from the lab in U.S., where the cerebrospinal fluid (CSF) was sent for testing.