December 2, 2003
LONDON – The European Medicines Evaluation Agency will start an active
surveillance program of so-called hexavalent vaccines early next year
following reports of a small number of sudden unexpected deaths in
In a statement on its Web site, the agency said four two-year-olds had
died soon after being vaccinated, following the authorization of Hexavac
from Aventis-Pasteur MSD, a joint venture of Aventis SA and Merck & Co
Inc, and Infanrix Hexa, made by GlaxoSmithKline Plc, in 2000.
These vaccines offer millions of children protection against six
life-threatening infectious diseases – diphtheria, tetanus, poliomyelitis,
whooping cough, hepatitis B and Haemophilus influenzae b.
The agency said statistical analysis on data from Germany, where three
children died among more than 700,000 given a booster jab, showed that the
number of deaths within 48 hours of Hexavac administration exceeded the
Experts on the agency's Committee for Proprietary Medicinal Products
considered that this raised possible suspicions, though they stressed
there was no plausible biological reason to link the deaths with
However, to find out more, prospective and retrospective studies would be
carried out by independent institutions and assessed by regulatory bodies.
"The results will be closely monitored so that timely regulatory action
can be taken, if necessary," the agency said.
In the meantime, it reaffirmed its view that the benefits of vaccination
far outweighed the possible risks of existing vaccines and that
vaccination should be continued according to national vaccination