Reuters Health Information (2005-02-18): European Medicines Agency begins safety review of Hexavac
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
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
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
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.