After its emergence in around April 09, swH1N1 was considered a new influenza virus with the potential to cause the first pandemic of the 21st century. Despite the uncertainty on the timing and severity of a possible pandemic, vaccine industry had to begin immediately investing into vaccine development and preparing for large scale production. Different approaches for pandemic vaccine licensing between US and the ROW required different regulatory and clinical trial strategies. After declaration of the pandemic in June, governments reached out to secure access to pandemic vaccines as global production capacity had been limited and a "wait-and-see" strategy could not be afforded. The subsequent mild swH1N1 pandemic of 2009 has highlighted the existing shortcomings with equitable and timely global supply with influenza vaccines during a pandemic. The internal and external challenges faced