SFDA approves Swine Flu Vaccine for rollout

Published 2 Nov 2009
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SFDA approves Swine Flu Vaccine for rollout
Riyadh - The Saudi Food and Drug Authority (SFDA) approved on Sunday the swine flu (H1N1) vaccine for rollout.
An expert committee agreed that Pandemrix, made by GlaxoSmithKline (GSK), can be used in adults and children over six months old and pregnant women, "Al-Jazirah" newspaper quoted.
The SFDA said that it has monitored the manufacturing phases of the vaccine and has followed up on its production with the US Food and Drug Administration (FDA), the World Health Organization (WHO) and the European Medicines Agency (EMA).
The SFDA said that it tested the vaccine and examined all studies previously done on it to ensure its safety and compliance with the EMA standards as the vaccine is now in use in 17 European countries.
Data submitted by the manufacturer GSK suggests the vaccine is generally well tolerated, with the most commonly reported side-effects, like regular seasonal flu, being headache, joint pain, muscle pain, reactions at the site of the injection (such as pain and redness), fever and fatigue.

Last Modified Date: 10/02/2013 - 4:12 PM Saudi Arabia Time


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