WSR 09-19-152

DEPARTMENT OF HEALTH


[ Filed September 23, 2009, 11:45 a.m. ]


DECLARATION OF OUTBREAK AND VACCINE SHORTAGE AND SUSPENSION OF

RCW 70.95M.115 LIMITS FOR CERTAIN INFLUENZA A (H1N1) 2009 MONOVALENT

VACCINES IN MULTI-DOSE VIAL PRESENTATIONS


WHEREAS RCW 70.95M.115 prohibits vaccinating a person who is known to be pregnant or under three years of age with influenza vaccine that contains more than 1.0 microgram of thimerosal per 0.5 milliliter dose. RCW 70.90M.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 the limits.

The H1N1 influenza virus is a new influenza virus first detected in humans in the United States in April 2009. The United States continues to report the largest number of H1N1 cases of any country worldwide. There have been confirmed cases in all states in the United States. Significant illness from H1N1 influenza has continued into the summer across the country. As of September 4, 2009, the Centers for Disease Control and Prevention (CDC) reported nine thousand seventy-nine hospitalized cases and five hundred ninety-three deaths in the United States and its territories. As of September 16, 2009, there have been one hundred seventy-one hospitalized cases and sixteen deaths in Washington state. Of the sixteen deaths in Washington state, two have been pregnant women. According to the CDC, rates of infection (the number of reported cases per 100,000 population) are highest among people zero to twenty-four years old. Rates of hospitalization among children have been highest in children younger than two years of age.

Nationally and within Washington, the spread of the H1N1 influenza virus has continued through the summer. The CDC and the department of health anticipate that the incidence of disease and influenza-related hospitalizations and deaths will increase rapidly starting in September 2009. Vaccination is considered the most effective method to stop community outbreaks as well as reduce overall sickness and death.

The H1N1 influenza virus is spread mainly by person-to-person contact though [through] coughing or sneezing. It appears that the new virus is spread as easily as seasonal influenza. In most cases, symptoms of H1N1 influenza are similar to seasonal influenza including fever, sore through [throat], cough, runny nose, headache, body aches, chills and fatigue. The degree of illness from the H1N1 influenza virus ranges from mild to severe, including hospitalization and death.

The United States Food and Drug Administration (FDA) recently licensed new vaccines for the H1N1 influenza virus for use in the United States. At the time of the signing of this declaration four manufacturers produce approved H1N1 influenza vaccines (Novartis, CSL Limited, Sanofi Pasteur and MedImmune) and vary in allowable age-ranges and thimerosal content. The H1N1 vaccine product from GlaxoSmithKline is still awaiting FDA approval. The new vaccines are expected to be available by early October.

Sanofi Pasteur is producing an injectable, single-dose vial (.25mL) that is a thimerosal-free version of H1N1 vaccine licensed for children younger than three years of age, but not for pregnant women. An intranasal, single-dose spray being produced by MedImmune is also a thimerosal-free vaccine licensed only for ages two through forty-nine years of age, and not for pregnant women. While it is possible for MedImmune's intranasal spray to be applied to the pediatric population affected by RCW 70.95M.115(1), it would only be for children over two years of age.

GlaxoSmithKline, Novartis, CSL Limited and Sanofi Pasteur are each producing an injectable, single-dose vial (0.5mL) H1N1 influenza vaccine that is thimerosal-free and may be administered to pregnant women. The minimum age-range allowed for each of these vaccines vary, but the only single-dose vial (0.5mL) licensed for children under three years of age is produced by Sanofi Pasteur.

GlaxoSmithKline, Novartis, CSL Limited and Sanofi Pasteur are each producing an injectable, multi-dose vial (5mL) H1N1 vaccine that contains thimerosal and may be administered to pregnant women. The only H1N1 vaccine in multi-dose vials (5mL) licensed for children under three years of age is produced by Sanofi Pasteur. While each of these multi-dose vaccines will contain thimerosal in varying amounts, all will exceed the limits of 1.0 micrograms per 0.5 milliliter dose as described in RCW 70.95M.115(1) for children under three years of age or pregnant women.

CDC's Advisory Committee on Immunization Practices (ACIP) has recommended that certain groups of the population receive the 2009 H1N1 vaccine when it first becomes available: Pregnant women; people who live with or care for children younger than six months of age; healthcare and emergency medical services personnel, persons between the ages of six months and twenty-four years old; and people ages twenty-five through sixty-four years of age who are at higher risk for H1N1 because of chronic health disorders or compromised immune systems. Pregnant women are a priority because of a higher risk of complications due to illness, and young children because they are more susceptible to the H1N1 influenza virus. The ACIP recommends the H1N1 vaccine be given in addition to seasonal influenza vaccine.

Because the availability and demand of thimerosal-free vaccine is expected to be unpredictable, particularly in the initial stages of vaccine distribution, there will not be enough thimerosal-free vaccine for all the state's pregnant women and children under three years of age at all times and at every location. That shortage will create a barrier to the use of effective, FDA licensed vaccine to protect the health of two groups the ACIP has determined to be among those most in need of immediate protection against H1N1 influenza.

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, declare that there is an outbreak of H1N1 influenza, a vaccine-preventable disease, in Washington state. I also, under RCW 70.95M.115(3), and under the circumstances set forth above, declare that there is a shortage of vaccine for the H1N1 influenza virus that complies with the limits in RCW 70.95M.115(2) for influenza vaccine.

I also, under RCW 70.95M.115(3), effective immediately, temporarily suspend the thimerosal limits imposed by RCW 70.95M.115 on use of the Influenza A (H1N1) 2009 Monovalent Vaccines in multi-dose vial (5mL) presentations licensed for use in the United States and produced by the manufacturers GlaxoSmithKline, Novartis, CSL Limited and Sanofi Pasteur. This suspension is to ensure pregnant women and children under three years of age to [will] have access to the new H1N1 influenza vaccine. This suspension will last for a period of six months. The department has prepared a notice document that can be provided to persons known to be pregnant or lactating or the legal guardians of children under eighteen years old regarding the thimerosal content of H1N1 influenza vaccine in multi-dose vials, as required by RCW 70.95M.115(3). At the end of that six month period of suspension, I will reassess the available supply of vaccine to determine if it is necessary to continue this declaration of vaccine shortage.


Signed this 23rd day of September, 2009 at Olympia, Washington.

Mary C. Selecky

Secretary

Washington State Code Reviser's Office