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  Last Updated on 07/13/2018

European Drug Watchdog Probes Aventis, Glaxo Vaccines

 

Reuters, 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 vaccinated children.

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 expected number.

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 vaccination.

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 schedules.

 

 

 

 

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