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H1N1 (Swine Flu) Vaccine Mercury Suspension

Declaration of Outbreak and Vaccine Shortage
On September 23, 2009, the Secretary of Health declared an outbreak of the H1N1 (swine flu) influenza virus and a shortage of mercury-free H1N1 vaccines. The declaration also temporarily suspends the state's mercury limits for certain mercury-containing H1N1 vaccines. The six-month suspension is effective September 23, 2009 through March 23, 2010 and applies only to H1N1 vaccines.

Washington State law allows the Secretary of Health to suspend the state’s legal mercury limit for a vaccine if the secretary determines there is an outbreak of disease or shortage of vaccine available to protect the public health against vaccine-preventable disease.

Suspension of Mercury Limits
Mercury-free H1N1 vaccine may not be available at all times. The state's mercury limit could prevent pregnant women and children under three years who want the vaccine from getting it. Lifting mercury limits for H1N1 vaccine will give pregnant women and parents or guardians of children under three the option of getting the vaccine if they want it. The suspension applies only to H1N1 vaccines.

Patient Notification
When the mercury limits are suspended, Washington State law requires patients to be notified that they're getting vaccine containing more mercury than is usually allowed if they are:

  • Pregnant or lactating.

  • The parent or guardian of a child under 18 years getting the vaccine.

Materials to Assist Providers

Below is a chart to help health care providers identify which patients must be notified. There is also a sample notification form that can be used. There is no requirement in the law about how the notification is done. This sample patient notification is provided as a written example of what would meet the requirements of the law. Providers may use this sample notification, give their own written notice, or give the notice orally. Because providers administering vaccine are the most familiar with the needs of their patients and practice, it is appropriate that they tailor the notification accordingly.

When notifying patients, providers may also use the law itself as a resource regarding vaccine safety. The law includes a section that states:

"...scientifically reputable organizations such as the centers for disease control and prevention, the national institute of medicine, the American academy of pediatrics, the food and drug administration, and the world health organization have all determined that there is no credible evidence that the use of thimerosal in vaccines poses a threat to the health and safety of children.

Notwithstanding these assurances of the safety of the vaccine supply, the legislature finds that where there is public concern over the safety of vaccines, vaccination rates may be reduced to the point that deadly, vaccine-preventable, childhood diseases return. This measure is being enacted to maintain public confidence in vaccine programs, so that the public will continue to seek vaccinations and their health benefits may continue to protect the people of Washington."

The full law is available on the Washington State Legislature Web site.

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Last Update: 10/16/2009 12:02 PM