tagged w/ GLOBAL VACCINATION
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Pandemic influenza vaccine manufacturing process and timeline
6 August 2009
24 SEPTEMBER 2009 | GENEVA -- Regulatory authorities have licensed pandemic vaccines in Australia, China, Hungary and the United States of America, soon to be followed by Japan and several countries in Europe. The length of the approval process depends on factors such as each country's regulatory pathway, the type of vaccine being licensed, and the stage of manufacturers' readiness to submit appropriate information to regulatory authorities.
Production capacity
In May 2009, WHO estimated that, in a best case scenario, worldwide production capacity for pandemic vaccines would be approximately 5 billion doses per year. Since then, better information on production yield and appropriate vaccine formulation has become available...
Availability in developing countries
Last week, donations of pandemic vaccines for use in developing countries were announced by the United States of America, in concert with Australia, Brazil, France, Italy, New Zealand, Norway, Switzerland and the United Kingdom. Similar support from additional countries is anticipated and warmly welcomed......
Vaccine safety
National regulatory authorities for medicines carefully examine the known and suspected risks and benefits of any vaccine prior to its licensing. Because the pandemic virus is new, both non-clinical and clinical trials are being conducted to gain essential information on immune response and safety. Outcomes of trials completed to date suggest that pandemic vaccines are as safe as seasonal influenza vaccines......
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6 August 2009
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