The Saudi Food and Drug Authority (SFDA) approved on Sunday night the swine flu (H1N1) vaccine for rollout, the Saudi Press Agency (SPA) reported. An expert committee headed by Muhammad Al-Kanhal, chairman of the SFDA, agreed that Pandemrix, made by GlaxoSmithKline (GSK), can be used in adults and children over six months old and pregnant women. 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. The first results from a trial of the vaccine in Germany suggested a good response after one dose, however. The SFDA has urged the public not to pay heed to the rumors making the rounds about the vaccine, but rather refer authentic medical sources for consultation. For effective monitoring of the vaccine, the SFDA has also called on the public and health professionals to report any comments on the vaccine through filling out a form that can be obtained at medical centers across the Kingdom or at www.sfda.gov.sa/npc. The SFDA can be reached at 01-2759222 Ext: 2356, 2371, 2353, 2340; fax: 02-2107398 or e
