The Vac-Scene Newsletter (Volume 6, No. 2

New Pneumococcal Conjugate Vaccine Licensed

The first multivalent conjugate pneumococcal vaccine to prevent invasive disease caused by Streptococcus pneumoniae (pneumococcus) in infants and toddlers was approved by the FDA in February 2000. It is known as Prevnar^© (dubbed "PCV7") and is manufactured by Wyeth-Lederle Vaccines. The vaccine contains the seven most common strains of pneumococcus that account for approximately 80% of invasive disease (e.g. bacteremia and meningitis) in infants.

With the decline of invasive Hib disease (since the advent of Hib conjugate vaccine), S. pneumoniae has become the leading cause of bacterial meningitis among children <5 years of age in the U.S. Children <1 year have the highest rates of pneumococcal meningitis, approximately 10 cases per 100,000 population.

Clinical trials included a large multicenter safety and efficacy study conducted at Northern California Kaiser Permanente. The controlled, double-blind trial enrolled approximately 38,000 children, about half of whom received Prevnar. In this trial, the vaccine was 100% effective in preventing invasive pneumococcal disease caused by the seven strains of pneumococcus in the vaccine. The vaccine was shown to be 90 percent effective in preventing invasive disease from illnesses caused by all pneumococcal subtypes. Children who received PCV7 had 8% fewer visits for acute otitis media and experienced 20% fewer visits for tympanostomy tube placements. The duration of protection following PCV7 is currently unknown. Also, the effect of PCV7 on nasopharyngeal carriage of pneumococci is not clear at this time.

Side effects in the trials were generally mild and included local injection site reactions, irritability, drowsiness and decreased appetite. Approximately 21 percent of the children had fevers over 100.3 compared to about 14 percent in the control group not receiving Prevnar.

"This new vaccine is great news for parents and their children because now, for the first time, we have a highly effective way to prevent a major cause of meningitis and serious blood infections in the most susceptible children - those under two years of age," said Dr. Jane Henney, Commissioner of Food and Drugs. "When we prevent these infections, we are also preventing brain damage and mortality from pneumococcal diseases."

ACIP has not yet published recommendations for the use of pneumococcal conjugate vaccine, but will likely do so by late summer. ACIP is expected to recommend that all children <60 months of age be vaccinated with PCV7. The primary series consists of three IM injections routinely given at 2, 4, and 6 months of age with a fourth (booster) dose at 12-15 months of age. A Vaccine Information Statement (VIS) will be released when the ACIP statement is published. Until the vaccine is included on the federal contract, providers who purchase Prevnar may give the vaccine without a VIS. The cost per five-dose box is approximately $290.

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News From The PHSKC Vaccine Distribution Program

Hepatitis A Vaccine for all children in Washington? Not Yet!
Discussions are underway for Washington State's response to the new ACIP recommendation to make Hepatitis A vaccine available to all children 2 -- 18 years of age in selected states. Selected states have consistently elevated rates of hepatitis A (i.e. >20 cases per 100,000 population which represents twice the 1987-1997 national average).
Washington State was identified as one of the 11 states having a high incidence of hepatitis A (30/100,000). Arizona had the highest rate of all states (48/100,000). The other nine high-incidence states included: AK, OR, NM, UT, OK, SD, ID, NV, and CA. Nationally reported incidence of hepatitis A is highest among children 5-14 years of age, however in King County the incidence is highest in adults.

The Washington State Vaccine Advisory Committee (VAC) provides guidance on which vaccines to make available through Washington State's universal distribution program. Preliminary recommendations of the VAC include a strategy that focuses on routine vaccination of children in counties and communities with a high incidence of hepatitis A in Washington State, of which King County is one. However, state funding for hepatitis A vaccine in high-incidence communities in Washington State is not likely to be confirmed until late this year. In the meantime, eligibility for the publicly funded hepatitis A vaccine remains unchanged. If you need a copy of the Guidelines for Administration of State-Supplied Vaccines please call 206-296-4774. The updated recommendations for hepatitis A may be accessed at: http://www.cdc.gov/nip/. Click on ACIP Statements.
Optional Two-Dose Hepatitis B Schedule for Adolescents (11-15 years)
You may soon have the option to vaccinate adolescents 11-15 years of age according to either a 2- or a 3-dose hepatitis B immunization schedule. In September 1999, Merck Vaccine Division received approval for an optional 2-dose schedule of Recombivax HB (10 mcg) for adolescents aged 11-15 years. The 2-dose schedule is only available using Recombivax 10 mcg, given at 0 and 4-6 months, and only for adolescents 11 through 15 years of age. Adolescents who have already begun the 3-dose series with Recombivax (5 mcg) may NOT be switched to the new 2-dose series. Adolescents immunized according to the alternative schedule appear to develop immunity levels similar to those immunized with the 3-dose schedule, however, data on long-term mmunity is not yet available.

This newly approved 2-dose schedule will be available through the public funded vaccine distribution program following the CDC's negotiation of a vaccine contract for this alternative dosing schedule. Healthcare providers will receive information in the Vac Scene when the new schedule becomes available.

If you have any questions about hepatitis B or hepatitis B immunization, please contact Shelly McKeirnan at 206-296-4717.
New Storage Recommendation for Oral Polio Vaccine
On February 7, 2000, Wyeth-Lederle Vaccines informed health care providers that OPV should be stored in the freezer for maximum shelf life, at a temperature of 0° C (32° F) or below. The previous policy to allow for up to ten freeze-thaw cycles, as long as the total cumulative duration of thaw does not exceed 24 hours, is no longer in effect. Do not use the vaccine if a color change occurs after a vial is opened and thawed.

Note: For procedures on how to return OPV expiring at the end of June 2000, call 206-296-4782.
Another New Preservative-Free Hepatitis B Vaccine
The FDA has approved a reformulated hepatitis B vaccine (Engerix-B) manufactured by SmithKline Beecham which will be available within the next few weeks. The new Engerix-B contains only trace amounts of thimerosal (<1mcg) which "have no clinically relevant effects making it equivalent to a thimerosal-free product", according to Dr. Neal Halsey, Director of the Institute for Vaccine Safety at Johns Hopkins University.

The availability of this vaccine means that there will soon be sufficient quantities of preservative-free hepatitis B vaccine for children of all ages.

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Community Immunization Survey

The Immunization Program at Public Health - Seattle & King County is currently conducting a household immunization survey of children ages 19-35 months in Central and South Seattle. This survey supplements the National Immunization Survey, conducted by the Centers for Disease Control and Prevention, and will allow us to examine immunization rates for these lower income areas within King County.

The survey asks several questions about immunizations, including the types of vaccine information desired by parents, current sources of information about immunizations, insurance coverage, and parent's acceptance of multiple simultaneous injections.

To accurately assess the immunization status of children in this survey, we are also asking parents to give us immunization administration dates from their child's immunization record, and requesting permission to contact the child's provider. If you are identified as the immunization provider for one of these children, you will receive a request from us for the child's vaccine history. In order for us to get an accurate estimate of immunization coverage in South and Central Seattle, it is crucial that we obtain complete immunization histories for all the children in our sample. Please assist us by sending or faxing these records to us in a timely manner once requested.

While King County as a whole has a very good over-all immunization rate of 87% for this age group (19-35 months), it is unknown if some areas within the county have lower immunization rates. The results of the survey will be used to identify any undervaccinated populations in lower income areas of King County so that we can target appropriate public health interventions designed to increase immunization rates among susceptible children. Data from our survey will be presented in future issues of the Vac Scene.

If you have any questions about this survey, please contact Laurie Stewart at 206-296-4774.

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Hep Squad Gets Providers Involved

The Hep Squad, a Public Health - Seattle & King County program, is dedicated to promoting awareness about the increased risks of hepatitis A and B among men who have sex with men (MSM). All sexually active MSM who have not previously had hepatitis A and B are strongly encouraged to receive routine immunizations for both of these types of vaccine-preventable hepatitis.

In King County, it is estimated that MSM are at least 20 times more likely to acquire hepatitis A than the general population and 7 times more likely to contract hepatitis B. Coinfection with either hepatitis C or HIV is especially dangerous in these populations.

The Hep Squad launched their education program in January 2000 with a highly visible media campaign featured on Metro buses with the tag line "Hepatitis hurts. Get the shots." Now the campaign is reaching out to area providers to educate them on the importance of discussing hepatitis A and B immunizations with their high risk clients. In a consumer survey of over 500 MSM last summer, the Hep Squad found that MSM were three to four times more likely to have received hepatitis A and/or B immunization when their regular health care provider recommended immunization.

In addition, the Hep Squad is working to increase access to hepatitis A and B vaccines by offering free or reduced cost vaccines for those who are uninsured or whose insurance does not cover routine services like hepatitis A and B immunizations.

Free Vaccine Available
Providers who do not offer hepatitis A and B immunizations for adults are encouraged to refer their clients to the Public Health-Seattle & King County HIV/STD Hotline at 206-205-7837. The Hotline is staffed M-F, 8:00 AM - 5:00 PM to refer clients to clinics that offer immunization services, STD screenings and HIV counseling and testing. Providers who see uninsured clients can refer them directly to one of the following clinics for free hepatitis A and B vaccine: Country Doctor (206-461-4503); Downtown Public Health (206-296-4960); 45th Street Clinic (206-633-3350); HIV/AIDS Program (206-205-7837); North Public Health (206-296-4765); Seattle Gay Clinic (206-461-4540); or STD Clinic at Harborview (206-744-3590).

If you would like a guide on how to assure insurance reimbursement to cover immunization costs for high risk adults, including information on risk groups for both hepatitis A and B, contact Drew Emery at 206-296-4774.

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Polio Vaccine Information Statement 2000

The most current polio Vaccine Information Statement (VIS) and an OPV Supplement dated 1-1-00 are now available in up to 22 languages. To obtain camera-ready copies of the polio VISs, go to the VIS index page (organized by language) on the Immunization Action Coalition website at http://www.immunize.org/vis/index.htm or call Amy Patton at 206-205-5803.

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New Immunization Card 2000

The revised 2000 Immunization Card for healthcare providers is a pocket-sized card containing the current Recommended Childhood Immunization Schedule and footnotes, and a minimum interval table. The panel entitled, "General Rules of Childhood Vaccination," offers some fundamental immunization guidelines for the vaccine provider.

The Immunization Card is a collaborative project of the Immunization Action Coalition of Washington; Healthy Mothers, Healthy Babies Coalition of Washington; Public Health – Seattle & King County, Snohomish Health District and the Washington State Department of Health. Funding for printing has been graciously provided by: Aventis Pasteur; Merck, Inc.; SmithKline Beecham Pharmaceuticals and Wyeth-Lederle Vaccines.

To order additional cards, healthcare providers in King County may call us at 206-296-4774. Providers outside of King County, call the Healthy Mothers, Healthy Babies Coalition of WA at 800-322-2588.

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