Cell Culture Flu Vaccine Approved in Europe…Is the United States Next?

Baxter’s cell culture-based seasonal influenza vaccine, Preflucel, has recently received European Repeat Mutual Recognition Approval. This approval means that 13 European Union countries will make the vaccine available for the 2011-2012 flu season. Preflucel is already available in Austria and the Czech Republic.

Preflucel is recommended for adults over 18 and the elderly to protect against anticipated influenza strains for the upcoming flu season. A recent study of Preflucel, printed in The Lancet, demonstrated safety and efficacy in protecting against influenza with a 78.5% success rate (the average for conventional vaccine is about 73%). Preflucel is unique because it is produced using cell culture, specifically vero cells, instead of standard egg-based production. Unlike cell culture, egg-based production requires that a genetically modified strain of the virus be produced before vaccine production can begin. This extra step adds significant time to the vaccine production process.

Saving time is particularly critical when facing a potential pandemic. In the 2009 H1N1 influenza outbreak, vaccine production was delayed and the vaccine was not available until the virus had already infected many people. If the strain had been as deadly as initially feared, this delay would have meant significant loss of life. According to a recent Los Angeles Times article, using cell culture can shorten vaccine production time by up to ten weeks allowing vaccines to be made available sooner and authorities more time to decide which influenza strains should be included in that year’s seasonal vaccine.

Preflucel will also allow more people to get vaccinated. Cell culture vaccines are free of antibiotics typically used to prevent contamination in egg-based production. They are also free of any egg proteins, which means that individuals with antibiotic or egg allergies can be safely vaccinated.

Now that Baxter has received approval in Europe, the question is when will the United States get access to this vaccine? Experts agree that cell-based vaccine production is faster, more reliable, and safer than egg-based production, so why the delay? After all, Preflucel was developed using a $1.3 billion dollar grant from the United States Department of Health and Human Services. Baxter representatives have said that they are working with the Food and Drug Administration to win approval. Hopefully the United States will adopt this important, time-saving technology before another potential pandemic.

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