ACIP 2010 Vaccine Updates: Meningococcal Conjugate Vaccines and Tdap
ACIP 2010 Vaccine Updates: Meningococcal Conjugate Vaccines and Tdap
Abstract & Commentary
By Mary-Louise Scully, MD,
Dr. Scully is Director, Travel and Tropical Medicine Center, Sansum Clinic, Santa Barbara, California
Dr. Scully reports no financial relationship to this field of study.
Synopsis: New guidelines for the use of quadrivalent meningococcal conjugate vaccine (MCV4) and Tdap are now in place to eliminate breakthrough cases of meningococcal disease and to curb a rising tide of pertussis cases.
Sources: Updated recommendations for use of meningococcal conjugate vaccines Advisory Committee on Immunization Practices (ACIP), 2010. Morb Mortal Wkly Rep 2011;60:72-76; Updated Recommendations for the use of tetanus toxoid reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) from the ACIP. Morb Mortal Wkly Rep 2011;60:13-15.
On Oct. 27, 2010, the Advisory Committee on Immunization Practices (ACIP) approved updated recommendations for the use of quadrivalent (serogroup A, C, Y, and W-135) meningococcal conjugated vaccines (Menveo®, Novartis; and Menactra®, Sanofi Pasteur) for adolescents and persons with high risk for meningococcal disease. The two main recommendations are: 1) routine vaccination of adolescents, preferably at age 11 or 12 years, with the a booster dose at age 16 years and 2) a two-dose primary series administered 2 months apart for persons age 2-54 years with persistent complement component deficiency, functional or anatomic asplenia, and adolescents with human immunodeficiency virus (HIV) infection. The rationales for these changes were based on a review of additional data on bactericidal antibody persistence, vaccine effectiveness, current trends in meningococcal disease epidemiology, and immunogenicity in high-risk groups by the Meningococcal Vaccines Work Group of ACIP.
The goal of meningococcal immunization of adolescents is to protect persons age 16-21 years, since this is the time when rates of meningococcal disease peak. The original recommendation to vaccinate at the 11- or 12-year-old preventive care visit was, in part, because data show that as adolescents grow older, they are less likely to visit a health care provider. Also, it was initially expected that the vaccine would protect adolescents through age 21. However, in 2010, the Centers for Disease Control and Protection (CDC) received 12 reports of serogroup C or Y meningococcal disease among persons who had received a meningococcal conjugate vaccine. The mean age of these persons was 18.2 years and the mean time since vaccination was 3.25 years. Five of these 12 persons had an underlying condition that may have increased their risk of meningococcal disease (CDC, unpublished data).
In addition, a case control study evaluating the vaccine effectiveness (VE) of meningococcal vaccine showed that VE for persons vaccinated less than 1 year earlier was 95%, at 1 year was 91%, and for persons vaccinated 2-5 years earlier VE fell to 58%. Similarly, the Work Group looked at five studies of circulating bactericidal antibody levels and concluded that approximately 50% of persons vaccinated 5 years earlier had protective levels against meningococcal disease. This implies that 50% of persons given vaccine at age 11 or 12 might not be protected at the time they are at highest risk, that is, at age 16-21.
Therefore, for persons 11-18 years old, the primary series should be one dose, preferably at age 11 or 12 years. The booster dose should be at age 16 if the primary dose was at 11 or 12 years, and at ages 16 to 18 if the primary dose was at age 13-15. If the primary dose was given on or after age 16 years, no booster dose is needed.
The Work Group also reviewed the data supporting the need for a two-dose primary meningococcal vaccine series in persons with certain special medical conditions (see table, below). They concluded that persons with persistent complement component deficiencies (e.g., components C5-C9, properidin, factor H, or factor D) and anatomic or functional asplenia should receive a two-dose primary series administered 2 months apart and then receive a booster dose every 5 years. For HIV-infected persons 11-18 years old, the primary series should also be two doses given 2 months apart, with the same booster schedule followed as in non-HIV infected adolescents. Other persons with HIV who are vaccinated should receive a two-dose primary series as well.
Additional ACIP recommendations were made with regard to tetanus toxoid reduced diphtheria toxoid and acellular pertussis vaccine (Tdap). These include: 1) use of Tdap regardless of the interval since the last tetanus- or diphtheria-containing vaccine, 2) use of Tdap in adults age 65 and older, and 3) the use of Tdap in under-vaccinated children age 7-10 years. Specifically, for all adults, including those age 65 years and older, a single dose of Tdap is recommended and can be given regardless of the interval since the last Td. This is especially important for those adults who have, or anticipate having, close contact with an infant younger than 12 months.
Persons age 7-10 years who are not fully vaccinated against pertussis should receive a single dose of Tdap. If additional doses of tetanus- and diphtheria-containing vaccine are needed (those never vaccinated or with unknown status), these patients should receive a series of three vaccinations preferably the first being Tdap, with subsequent doses of Td. For now, Tdap is recommended only for single-dose administration across all age groups.
Commentary
The new quadrivalent meningococcal conjugate vaccine (MCV4) recommendations will likely cause some initial confusion with health care providers as well as parents. Yet the important goal of reducing breakthrough infections with this deadly disease more than justifies the changes. The idea, at its simplest, was to not let go of immunizing adolescents at 11-12 years, yet boost protection before the time of peak risk at age 16-21.
The addition of a two-dose MCV4 primary series for persons with a reduced response to a single-dose vaccine (asplenia, HIV, etc.) will ensure better protection as well. The ACIP recommends that these patients who have had only a one-dose primary series (which is everyone, as of now) receive a booster dose at the earliest opportunity and then every 5 years. Of note, the ACIP is not advocating at this time vaccinating all HIV-infected patients with MCV4; rather, if an HIV patient is going to receive the vaccine (i.e., traveling to the meningitis belt of Africa), then a two-dose primary series should be given.
All other persons at risk for meningococcal disease age 7-55 should receive a single dose of vaccine with subsequent dose after 5 years only if the person remains at increased risk (microbiologists or travelers to an endemic or highly endemic country). This interval should be shortened to 3 years for persons age 2-6 years. Refer to table 1 in the MMWR report as useful guide to the new MCV4 schedule.
Pertussis cases in the United States continue to rise with 20,127 provisional cases reported as of Dec. 18, 2010, up from 16,858 in 2009.1 Despite the 2005 ACIP recommendations for use of Tdap in adolescents and adults, Tdap coverage is only 56% among adolescents and < 6% among adults.2,3 These new recommendations to broaden the use of Tdap in children older than age 7 and older adults may help turn the tide on these rising numbers.
At the February 2011 ACIP meeting, there was discussion about recommending Tdap in pregnant woman, but this decision was deferred for the moment due to lack of available data (there are two studies ongoing in this area). For now, women of child bearing potential should be given Tdap prior to pregnancy or in the immediate postpartum period to reduce the risk of pertussis in the unimmunized newborn. Further guidelines on the use of Tdap in pregnancy may be forthcoming when the data from the studies in progress become available.
References
- Centers for Disease Control and Prevention. Notifiable Diseases and Mortality Tables. Morb Mortal Wkly Rep 2010;59:1658-1671.
- Centers for Disease Control and Prevention. National, state, and local area vaccination coverage among adolescents aged 13-17 years United States, 2009. Morb Mortal Wkly Rep 2010;59:1018-1023.
- Centers for Disease Control and Prevention. Tetanus and pertussis vaccination coverage among adults aged ≥18 years United States, 1999 and 2008. Morb Mortal Wkly Rep 2010;59:1302-1306.
Table. Summary of meningococcal conjugate vaccine recommendations, by risk group Advisory Committee on Immunization Practices (ACIP), 2010
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Risk Group | Primary Series | Booster Dose |
Persons age 11-18 years | 1 dose, preferably at age 11 or 12 years | At age 16 years if primary dose at age 11 or 12 years At age 16-18 years if primary dose at age 13-15 years No booster needed if primary dose on or after age 16 years |
HIV-infected persons in this age group | 2 doses, 2 months apart | At age 16 if primary dose at age 11 or 12 years At age 16-18 years if primary dose at age 13-15 years No booster needed if primary dose on or after age 16 years |
Persons age 2-55 with persistent complement component deficiency* or functional or anatomical asplenia |
2 doses, 2 months apart | Every 5 years At the earliest opportunity if a 1-dose primary series administered, then every 5 years |
Persons age 2-55 years with prolonged increased risk for exposure | 1 dose | Persons age 2-6 years: after 3 years Persons age 7 years or older: after 5 years§ |
Abbreviations: HIV = human immunodeficiency virus. * Such as C5-C9, properidin, or factor D. Microbiologists routinely working with Neisseria meningitidis and travelers to or residents of countries where meningococcal disease is hyperendemic or epidemic. § If the person remains at increased risk.Source: Updated recommendations for use of meningococcal conjugate vaccines Advisory Committee on Immunization Practices (ACIP), 2010. Morb Mortal Wkly Rep 2011;60:72-76. |
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