FDA Approves New Flu Vaccine, Diversifying the US Supply - - BioPharm International

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FDA Approves New Flu Vaccine, Diversifying the US Supply

BioPharm Bulletin

The approval of a new seasonal influenza vaccine has further diversified the supply to the US market. With the September 28, 2007, approval of Afluria, a vaccine against seasonal influenza types A and B for people ages 18 and older, there are now six seasonal influenza vaccine manufacturers licensed for the US market, up from three in 2002.

Following the 2004 vaccine shortage that resulted from a manufacturing problem at one company (Chiron), the US Food and Drug Administration has sought to diversify the US supply of seasonal flu vaccines. One solution has been to look to manufacturers, such as CSL Limited (Parkville, Australia), the manufacturer of Afluria, who are approved for foreign markets to become licensed in the US. With diversity in vaccine types and manufacturers, the FDA hopes to be better prepared in case of a pandemic.

Afluria was approved using FDA’s accelerated approval pathway for serious or life-threatening diseases, which reduces the time for needed medical products to become available to the public. In this case, the manufacturer demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza. As part of the accelerated approval process, the manufacturer will conduct further studies to verify that the vaccine decreases seasonal influenza disease after vaccination. CSL Limited is aiming to manufacture 2 million doses of Afluria this year for US distribution. Afluria is already marketed in 22 other countries.

Based on current manufacturing trends, the Centers for Disease Control and Prevention estimates that the six manufacturers will supply 132 million doses of influenza vaccines for the 2007–2008 season, up from 120 million in 2006. In 2002, the three manufacturers of flu vaccines licensed for the US market manufactured only 83 million doses.

Commenting on the new approval, Jesse L. Goodman, MD, MPH, director of the Center of Biologics Evaluation and Research, said that diversifying the US vaccine supply is one of many steps the agency is taking to improve the country’s preparedness for seasonal and pandemic flu outbreaks. Another step is to inspect manufacturers annually, instead of once every two years. The agency is also looking towards the next generation of vaccines, he said, which include recombinant DNA vaccines and cell culture vaccines.

FDA announcement
CSL release

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