The FDA issued a new guidance outlining the regulatory pathways for the rapid development and approval of these products.
In March 2006, the FDA issued two draft guidance documents for public comment — one for seasonal influenza vaccines and another for pandemic influenza vaccines. The draft documents outline specific approaches for manufacturers to develop new vaccines that are safe, pure and potent. The final guidances reflect input from vaccine companies and public health officials.
The guidances describe conventional and accelerated approval pathways to vaccine licensure. Companies selecting the conventional pathway must provide clinical evidence that the vaccine prevents influenza. Adequate and well-controlled clinical trials are also required for accelerated approval but companies may use a biological indicator — such as immune response to the vaccine — to predict effectiveness, an approach that may reduce the vaccine’s development time. Further clinical studies are then required to verify the vaccine’s clinical benefit.