How the Flu Vaccine Gets from the Lab to You
By Martie Moore, RN, MAOM, CPHQ | January 24, 2019
Aching, coughing, fever is associated with having “the flu.” Yet, the flu or influenza is not just a few days of being uncomfortable. It is deadly; it doesn’t care if you are busy and it doesn’t care if you are healthy. Flu season typically peaks December through February but influenza viruses are present in the community all year round.
To lessen the impact of the illness, the Centers for Disease Control and Prevention (CDC) recommends routine annual flu vaccination for all persons 6 months and older who do not have contraindications. About two weeks after vaccination, the vaccine creates antibodies in the body which help protect against infection with the viruses in the vaccine. It is a myth that you can contract the flu from the vaccination.
Many times how the vaccine is produced and made available to healthcare professionals is not well understood.
Before it arrives to inoculate patients, it has been through a series of steps:
- Formulation: Each spring, scientists formulate an influenza vaccine by placing the predicted strain into an egg or cell. This is done to create cell growth of the viruses to be used to develop the vaccine. In the U.S., flu vaccine strains are determined each year by the Food and Drug Administration (FDA) with input from the World Health Organization (WHO) and Centers for Disease Control (CDC) based on which strains are prevalent in the world. It takes several weeks to harvest this potential vaccine for production. In some years, the strains identified changed or mutated after the vaccine went into production. That is why there is a percentage of effectiveness ascribed to vaccines. Still, having the vaccination lessens the symptoms of influenza. Hospitals and health settings work closely with local and state public health departments to monitor the number and types of influenza cases being seen.
- FDA approval: The FDA evaluates the production cycle, with different vaccines requiring different review processes. This is the time to address regulatory concerns. Some lots (for example vials vs. syringes) may be approved more quickly; others may be released into the market later. Because of these variables, the approval process is not predictable year after year. A previous year’s data may not have relevance for the current cycle.
- Allocation: After FDA review and approval, manufacturers release vaccines to the market by lot, referred to as allocation. Manufacturers look at all healthcare providers and allocate percentages to them based on volume needs. Providers should have an idea of how much serum they will need. Supply chain experts advise ordering a bit more because providers are allowed to return 20% of their pre-book quantity at season-end for full credit. Extra vaccine is not always available during the season, so it is best to overestimate quantities.
Just as the influenza virus is alive and spreading around the world so does the analysis and production of the project vaccination. Providers pre-book vaccines nearly a year in advance. The 2019/2020 flu vaccine is currently in pre-booking. The cycle is not really seasonal, it is annual. By the time nurses are prepping inoculations, the next flu production season is already underway.
Learn more about how Medline is advancing infection prevention.
Martie Moore, RN, MAOM, CPHQ
Chief Nursing Officer
Martie L. Moore, RN, MAOM, CPHQ, is the chief nursing officer at Medline. As CNO, Moore develops forward-thinking, solution-driven clinical programs, as well as new products and educational services. Prior to joining Medline, Martie was the chief nursing officer at Providence St. Vincent Medical Center in Portland, Ore. Under her leadership, Providence St. Vincent earned a third and fourth designation for Magnet.