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FDA Finalizes Guidances for Manufacturers of Pandemic and Seasonal Flu Vaccines

Both guidances recommend using recent technologies such as cell culture and recombinant manufacturing to enhance the development and evaluation of vaccines. They also recommend adding substances that improve the immune response from the vaccine (novel adjuvants). The guidances describe conventional and accelerated approval pathways to vaccine licensure.

Source: http://www.pandemicflu.gov
 

 

Each year, millions of people contract influenza and flu-like infections in the United States, resulting in over 100,000 hospitalizations and approximately 20,000 deaths.

 

 

 

 

 

 

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