Public Health

European Medicines Agency begins safety review of Hexavac

Last Updated: 2005-02-18 15:10:12 -0400 (Reuters Health)

LONDON (Agence de Presse Medicale for Reuters Health) - A second safety review of Aventis Pasteur MSD's Hexavac paediatric vaccine was announced on Thursday by the European Medicines Agency (EMEA).

In a statement the agency said its CHMP had started a formal review procedure following a request from Germany to the European Commission.

Further details were not immediately available.

Hexavalent vaccines offer millions of children protection against six serious life-threatening infectious diseases -- diphtheria, tetanus, poliomyelitis, whooping cough, hepatitis B and Haemophilus influenzae b.

Hexavac, along with GSK's Infanrix Hexa, was reviewed by the EMEA a couple of years after gaining marketing authorisation following reports of a number of sudden unexplained deaths. However that review found no evidence that the vaccines were to blame.

"The causes of death remain unexplained and on the basis of available data, it is not possible to establish a cause and effect association with the hexavalent vaccines," the agency's scientific committee said at the time.

"In several cases, sudden infant death syndrome, viral infection, metabolic disorders, allergic reactions or airway obstruction were plausible, however these could not be definitely proven to be the cause of death."

Although a family history of epilepsy or convulsions at an early age was reported in three cases, the committee decided that the clinical description of these cases did not provide sufficient evidence to identify this as a possible risk factor.

The committee concluded that the benefits of vaccination far outweighed the possible risks of existing vaccines and that vaccination should be continued according to national vaccination schedules.