Once the strains are selected, the FDA produces materials in our laboratories that are critical for making the vaccine. These include providing some manufactures with the seed viruses used for further vaccine manufacture and the critical potency reagents needed to ensure that influenza vaccines made by one manufacturer are similar to those made by another. The FDA is also responsible for ensuring that released lots of influenza vaccines meet appropriate standards. In working to ensure vaccine quality agency scientists have already confirmed that the genetic sequence of the influenza strains used by manufacturers to produce vaccines for this season were the same as those provided to them at the beginning of the production process. Thus, for egg-based vaccines, the lower than desirable efficacy being observed is not likely related to the process of adapting the virus to grow well in eggs.
Ultimately, developing a universal influenza vaccine that provides protection against many different strains of flu from year-to-year would be ideal. However, the reality of such a vaccine is likely to still be several years away. In the meantime, the FDA is collaborating with federal partners and with industry to improve the manufacturing of the current generation of influenza vaccines. In particular, our scientists are interested in looking at continuous manufacturing technologies for cell based and recombinant vaccines, which could facilitate much more agility in responding to changes in influenza strains. It could have the potential to allow manufacturers to increase production quickly, if necessary.
During the current flu season, remember to wash your hands frequently and get vaccinated if you have not yet done so. There are still weeks of flu activity to come. People who are very sick or who are at high risk of serious flu complications who get flu symptoms should see a health care provider as soon as possible to see if they should be treated with antiviral drugs. The FDA remains committed to collaborating with other public health agencies and manufacturers to use the lessons that we are learning-and will continue to learn--from this year's flu outbreak to prepare for the next one.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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