How Are Flu Vaccines Manufactured?
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Virus Identification
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Public health officials begin making flu vaccines by identifying the flu strains most likely to be virulent each year. This is done through careful coordination among health monitoring agencies in many countries. Once the most common strains have been identified, the information is sent to the U.S. Food and Drug Administration. The FDA then meets to decide which three strains are most likely to cause problems in the United States. Monitoring takes place all year long, but selection of viruses begins in January. Seed viruses are given out early in the year to vaccine makers who can then start the process of growing the important strains. Scientists employed by the manufacturing companies work with officials at the FDA to help determine the composition of the final vaccine product. This generally happens by March. All three strains are grown separately in specific labs.
Vaccine Creation
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Production of specially prepared chicken eggs that will be used to culture the vaccine begins once the flu strains have been identified. The chicken eggs are carefully washed and then disinfected. Each egg will grow a single strand of virus. The eggs are placed in a special incubator kept at a constant temperature that will enable the flu strands to grow properly. Once this is done, the virus is ready to be harvested from the eggs. The collected fluid is purified and all virus material is inactivated to render it harmless. The virus then is split into multiple pieces. The resulting fragments are gathered together in a single laboratory. The material is tested extensively to make sure that all virus particles remain inactive. The particles from all three viruses are then combined. Further testing takes place as manufacturers attempt to determine how much vaccine is needed to ensure optimum vaccine success. The process of harvesting fluid and testing it generally takes place from June to October. Once the vaccine has been adequately tested, it is submitted for approval by the FDA. Syringes then are prepared for immunization efforts. Each vial is given a label showing the lot numbers, expiration date and vaccine batch used.
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Vaccine Distribution
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Flu vaccine shipments begin in August and continue into December if necessary after further confirmation by FDA officials of the vaccine's efficacy and safety. Those at particularly high risk for the coming flu season may be able to gain access to the vaccine as early as August. The rest of the population generally begin receiving the flu vaccine by October.
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