WSR 10-14-075

DEPARTMENT OF HEALTH


[ Filed July 1, 2010, 10:36 a.m. ]


DECLARATION OF VACCINE SHORTAGE AND SUSPENSION OF RCW 70.95M.115(1) FOR JAPANESE ENCEPHALITIS VIRUS VACCINE INACTIVATED (JE-VAX¦)


     WHEREAS RCW 70.95M.115 prohibits vaccinating a person who is known to be pregnant or under three years of age with a vaccine that contains more than 0.5 micrograms thimerosal per 0.5 milliliter dose in Washington State, except for influenza vaccine which is limited to 1.0 microgram per 0.5 milliliter dose. RCW 70.95M.115(3) authorizes the secretary of the Department of Health to temporarily suspend those limits if there is an outbreak of vaccine-preventable disease or a shortage of vaccine that complies with these limits.

     On June 16, 2009, I declared a shortage of vaccine for Japanese encephalitis virus that complies with the limits in RCW 70.95M.115(1) and temporarily suspended the thimerosal limits imposed by RCW 70.95M.115(1) on use of JE-VAX¦ vaccine for a period of one year, beginning July 1, 2009. This was done to allow children one to three years of age access to protection against the Japanese encephalitis virus that they would not otherwise have. The declaration also stated that I would reassess the availability and supply of Japanese encephalitis vaccine at the end of the one-year suspension to determine if an extension of this declaration and suspension is appropriate.

     JE-VAX¦ remains the only Japanese encephalitis vaccine available in the United States for children under three years of age. The only alternative Japanese encephalitis vaccine, IXIARO¦, is licensed for those 17 years of age or older. Because JE-VAX¦ is no longer in production and in limited supply, its manufacturer is reserving the vaccine's use for children only.

     NOW, THEREFORE, I, Mary C. Selecky, Secretary of the Department of Health, under RCW 70.95M.115(3), and under the circumstances set forth above and in my original declaration signed June 16, 2009, declare that there remains a shortage of vaccine for Japanese encephalitis that complies with the limits in RCW 70.95M.115(1).

     I also, under RCW 70.95M.115(3), temporarily extend the suspension of the thimerosal limits imposed by RCW 70.95M.115(1) on use of the JE-VAX¦ vaccine to allow children one to three years of age access to protection against the Japanese encephalitis virus they would not otherwise have. This extended suspension will last for a period of one year, beginning July 1, 2010. At the end of this one-year period, I will again reassess the availability and supply of vaccine for the Japanese encephalitis virus to determine if it is necessary to continue this declaration and suspension.

     Signed this 1st day of July, 2010, at Olympia, Washington.

___________________

Mary C. Selecky

Secretary

Washington State Department of Health

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