Issue Number 46             January 15, 1999

CONTENTS OF THIS ISSUE

1. Download the just-published "1999 Childhood Immunization Schedule"
2. MMWR publishes erratum on ACIP recommendations on human rabies prevention
3. Needle safety is topic of articles published in the San Francisco Chronicle
4. California mandates safer needle devices

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(1)
January 15, 1999
DOWNLOAD THE JUST-PUBLISHED "1999 CHILDHOOD IMMUNIZATION SCHEDULE"

The "1999 Childhood Immunization Schedule" was published in the Friday, January 15, 1999, issue of the MMWR as a "Notice to Readers." The new schedule has significant changes and new vaccine recommendations that were not on the 1998 schedule.

To download the issue of the MMWR that contains the "1999 Childhood Immunization Schedule, United States, January-December 1999," click here: http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/00056261.htm

To download a copy of the "1999 Childhood Immunization Schedule" that is suitable for posting in exam rooms, click here: http://www.cdc.gov/nip/pdf/child-schedule.pdf

If you don't have the capability to get this document from the Internet, call your state immunization program to request a hard copy. Click here if you need the phone number: http://www.immunize.org/nslt.d/n18/coord18.htm

The "Notice to Readers" contains detailed explanations of the new recommendations that are incorporated into the "1999 Childhood Immunization Schedule." This information is reprinted below for those who are unable to download the MMWR:

NOTICE TO READERS: RECOMMENDED CHILDHOOD IMMUNIZATION SCHEDULE -- UNITED STATES, 1999
Each year, CDC's Advisory Committee on Immunization Practices (ACIP) reviews the recommended childhood immunization schedule to ensure it remains current with changes in manufacturers' vaccine formulations, revised recommendations for the use of licensed vaccines, and recommendations for newly licensed vaccines. This report presents the recommended childhood immunization schedule for 1999 and explains the changes that have occurred since January 1998.

Since the publication of the recommended childhood immunization schedule in January 1998 (1), the ACIP, the American Academy of Family Physicians (AAFP), and the American Academy of Pediatrics (AAP) have narrowed the recommended options for the use of poliovirus vaccine and have endorsed the use of the newly licensed oral, tetravalent rotavirus vaccine. In addition, recommendations were revised or clarified for the use of hepatitis B vaccine in infants born to hepatitis B surface antigen (HBsAg)-negative mothers, the use of diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP), and the use of Haemophilus influenzae type b (Hib) conjugate and DTaP combination vaccines for infants aged 2, 4, and 6 months. Detailed recommendations for the use of vaccines are available from the manufacturers' package inserts, ACIP statements on specific vaccines, and the 1997 Red Book (2), ACIP statements for each recommended childhood vaccine may be viewed, downloaded, and printed at CDC's National Immunization Program World-Wide Web site, www.cdc.gov/nip.

INACTIVATED POLIOVIRUS VACCINE FOR FIRST TWO DOSES
As a result of progress in the global eradication of poliomyelitis, the need for further reductions in the risk for acquiring vaccine-associated paralytic polio, and the acceptance of inactivated poliovirus vaccine (IPV) by parents and physicians, the ACIP, AAFP, and AAP recommend IPV for the first two doses of poliovirus vaccine for routine childhood vaccination.

The ACIP continues to recommend a sequential schedule of two doses of IPV administered at ages 2 and 4 months, followed by two doses of oral poliovirus vaccine (OPV) at ages 12-18 months and 4-6 years. The administration of IPV for all four poliovirus vaccine doses also is acceptable and is recommended for immunocompromised persons and their household contacts. OPV is no longer recommended for the first two doses of the schedule and is acceptable only for special circumstances (e.g., vaccination of children whose parents do not accept the recommended sequential schedule, late initiation of vaccination that would require an unacceptable number of injections, and imminent travel to countries where polio is endemic). OPV remains the vaccine of choice for mass vaccination campaigns to control outbreaks of wild poliovirus.

INTRODUCTION OF ROTAVIRUS VACCINE
On August 31, an oral, tetravalent vaccine for rotavirus (RotaShield, Wyeth-Lederle Pediatrics and Vaccines, Inc., Philadelphia, Pennsylvania)* was licensed by the Food and Drug Administration (FDA) to prevent rotavirus gastroenteritis among infants and children. Rotavirus vaccine is administered as an oral formulation to infants at ages 2, 4, and 6 months, and the three-dose series should be completed by the first birthday.

The vaccine also is approved by the ACIP for inclusion in the Vaccines for Children Program (VFC), and it will be available for distribution through VFC after a supply contract is arranged. Rotavirus vaccine has been shaded and italicized on the schedule chart to indicate that the ACIP, AAFP, and AAP recognize that the incorporation of this vaccine into clinical practice may require additional time and resources from health-care providers.

RECOMBIVAX HB HEPATITIS B VACCINE FOR PERSONS AGED 0-19 YEARS
On August 27, the Merck Vaccine Division (Merck and Co., Inc., West Point, Pennsylvania) discontinued production and distribution of the 2.5 ug/0.5 mL pediatric dose of Recombivax HB hepatitis B vaccine, which was licensed by FDA for infants of HBsAg-negative mothers and children aged less than 11 years. The 5 ug/0.5 mL dose of Recombivax HB is now indicated for all vaccinees aged 0-19 years regardless of the mother's HBsAg status. The change was made to simplify the dosing of Recombivax HB and eliminate potential confusion when determining the correct dose of hepatitis B vaccine. In addition to receiving the hepatitis B vaccine series, infants born to HBsAg-positive mothers also should receive 0.5 mL of hepatitis B immune globulin within 12 hours of birth at separate injection sites. Infants born to HBsAg-negative mothers or children who received one or two doses of the 2.5 ug/0.5 mL dose of Recombivax HB may complete the hepatitis B vaccination series with either the 2.5 ug/0.5 mL or the 5.0 ug/0.5 mL dose. Children who have completed the hepatitis B vaccination series with the 2.5 ug/0.5 mL dose do not require revaccination. The standard adult dose for Recombivax HB remains 10 ug/1.0 mL.

The standard doses for the other licensed hepatitis B vaccine (Engerix B, SmithKline Beecham, Pittsburgh, Pennsylvania) remain unchanged. For the purposes of completing the hepatitis B vaccine series and achieving complete vaccination for hepatitis B, the two licensed hepatitis B vaccines are interchangeable when administered in doses recommended by the manufacturers.

DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS VACCINES PREFERRED
DTaP is the recommended vaccine for primary vaccination against diphtheria, tetanus, and pertussis. This change makes DTaP the preferred vaccine formulation for all doses in the vaccination series. Whole-cell diphtheria and tetanus toxoids and pertussis vaccine remains an acceptable alternative when DTaP is not available.

HIB CONJUGATE AND DTAP COMBINATION VACCINES NOT FOR INFANTS
Combination vaccines containing Hib conjugate vaccine and DTaP are licensed only for use in children aged 15-18 months. Because studies in infants have demonstrated that using one of these combination products may induce a lower immune response to the Hib component (3), DTaP/Hib combination products should not be used for primary vaccination in infants aged 2, 4, or 6 months (4).

References
1. CDC. Recommended childhood immunization schedule -- United
    States, 1998. MMWR 1998;47:8-12.
2. American Academy of Pediatrics. Active and passive immunization.
    In: Peter G, ed. 1997 Red book: report of the Committee on Infectious
    Diseases. 24th ed. Elk Grove Village, Illinois: American Academy of
    Pediatrics 1997:1-71.
3. Edwards K, Decker MD. Combination vaccines consisting of acellular
    pertussis vaccines. Pediatr Infect Dis J 1997; 16:S97-S102.
4. CDC. Unlicensed use of combination of Haemophilus influenzae type
    b conjugate vaccine and diphtheria and tetanus toxoid and acellular
    pertussis vaccine for infants. MMWR 1998;47:787.

*Use of trade names and commercial sources is for identification only and does not imply endorsement by CDC or the U.S. Department of Health and Human Services." --------------------------------------------------------------

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(2)
January 15, 1999
MMWR PUBLISHES ERRATUM ON ACIP RECOMMENDATIONS ON HUMAN RABIES PREVENTION

The following erratum concerning the ACIP statement on "Human Rabies Prevention -- United States, 1999," was published in the January 15, 1999, issue of MMWR:

ERRATUM: Vol. 48, No. RR-1 In the MMWR Recommendations and Reports, "Human Rabies Prevention -- United States, 1999," on page 1, the fifth sentence of the first paragraph stated erroneously that the number of human cases reported was the average number reported each year rather than the number reported for the entire 1980-1997 period. The sentence should read: "Between 1980 and 1997, 95-247 cases were reported each year among dogs, and only two human cases were reported in which rabies was attributable to variants of the virus associated with indigenous dogs (2)." --------------------------------------------------------------

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(3)
October 27, 1998
NEEDLE SAFETY IS TOPIC OF ARTICLES PUBLISHED IN THE SAN FRANCISCO CHRONICLE

Two 3-part series of articles on needle safety were published in 1998 by the San Francisco Chronicle. The first series, "Deadly Needles," caught the attention of readers by claiming that "one million health care workers each year are injured by needle sticks - more than 100,000 of them in California." The second series, "The Invisible Epidemic, 1920-87," began with an article on health risks associated with the use of contaminated needles and resulted in the publication of a "Dear Colleague" letter from the Centers for Disease Control and Prevention (CDC).

The letter, dated October 27, 1998, was written by Ben Schwartz, MD, Acting Deputy Director, Epidemiology and Surveillance Division, National Immunization Program, CDC, and read as follows:

Dear Colleague:

Earlier today, the San Francisco Chronicle and San Francisco Examiner released the first of a three-part story on the health risks associated with use of contaminated needles...

The article focuses on problems in the developing world, quoting an unpublished WHO study suggesting that 10 million infections and 1.8 million deaths occur annually from infections such as HIV and hepatitis B and C that are spread by contaminated needles. The article also focuses on warnings that were ignored, information that was not disseminated, and new technologies that were slow to be introduced.

Because this article may raise concern about injections associated with immunization in the United States, we wanted to alert you to this issue and to offer some messages that can be communicated to concerned persons or the media.

The Advisory Committee on Immunization Practices (ACIP) states in their general recommendations that, "Syringes and needles used for injections must be sterile and preferably disposable to minimize the risk of contamination. A separate needle and syringe should be used for each vaccination." (MMWR 1994;43,RR-1)

The conditions described in the San Francisco Chronicle article which result in spread of infection -- poverty and ignorance -- are not relevant to immunization delivery in the United States today. The only U.S. examples of infection linked with injection were a 1960 outbreak of hepatitis associated with non-vaccine injections in a physician's office and "a hepatitis outbreak...among U.S. soldiers after [receiving] multiple-dose tetanus shots from reused syringes."

Most injections worldwide are not associated with immunization but with injection of other medications.

Severe infections such as hepatitis and HIV do continue to occur in the U.S. among injecting drug users where needle reuse still occurs.

Rarely, local infections at the site of vaccination have occurred in the U.S. linked with poor skin disinfection and rare outbreaks of bacterial infections associated with contamination of a multi-dose vial have been reported (e.g., Simon, et al, Pediatr Infect Dis J 1993;12:368-71).

Despite the uncommon occurrence of adverse effects, vaccination remains an important disease prevention measure. Millions of cases of infection and thousands of deaths are prevented in the U.S. each year because of immunization.

The issue of injection safety is a serious problem for immunization programs in developing countries due to scarce funds available for sterile needles and syringes. This series of articles does a service by drawing attention to this issue. But the solutions are not easy for public health ministries facing severe resource shortages. (END OF LETTER)

All of the articles in both of the San Francisco Chronicle series on needle safety are on the web. To read and/or download any or all of the articles, click here: http://www.sfgate.com/news/special/pages/1998/04/needles/ --------------------------------------------------------------

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(4)
September 30, 1998
CALIFORNIA MANDATES SAFER NEEDLE DEVICES

Governor Pete Wilson of California signed a bill on September 30, 1998, making California the first state in the nation to mandate that the health-care industry provide workers with safer needle devices.

A story on the legislation that will require the use of safety needles appeared in the December 7, 1998, issue of the California Department of Health Service's publication, "IMMUNIZATION UPDATE," and reads as follows:

AB 1208 on Safety Needles Passed The Governor signed this bill aimed at preventing accidental needlesticks of health care workers. Though this legislation likely will affect immunization providers, the bill language itself is rather general. More specifics won't be available until the Occupational Safety and Health Standards Board publishes regulations, and Cal-OSHA provides information on needles engineered with sharps injury protection and needle-less systems. Both of these events are expected to occur some time in 1999. (END OF ARTICLE)

Staff of the California Department of Health Services informed IAC EXPRESS that on February 18 public hearings will be held to discuss these proposed changes in the California OSHA bloodborne regulations. To review the California OSHA working regulations in which the new needle safety regulations are included, click here: http://www.dir.ca.gov/DIR/OS&H/OSHSB/bloodborne.html