Published online October 31, 2008
PEDIATRICS Vol. 122 No. 5 November 2008, pp. 1021-1026 (doi:10.1542/peds.2007-3025)
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ARTICLE

Potential Impact of Acceleration of the Pertussis Vaccine Primary Series for Infants

Myrick C. Shinall, Jr, BAa,b, Timothy R. Peters, MDc, Yuwei Zhu, MD, MSd, Qingxia Chen, PhDd and Katherine A. Poehling, MD, MPHc,e

a School of Medicine
b Divinity School, Vanderbilt University, Nashville, Tennessee
c Departments of Pediatrics
e Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, North Carolina
d Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee


   ABSTRACT
TOP
 ABSTRACT
METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
OBJECTIVE. This study estimates the potential impact, on rates of pertussis infections, hospitalizations, and deaths among infants in the United States, of administering the first dose of diphtheria and tetanus toxoids and acellular pertussis vaccine at 6 weeks rather than 2 months of age.

METHODS. We used existing data to estimate current US rates of pertussis infections, hospitalizations, and deaths according to age and infant population in 2004. We then estimated the potential impact of accelerating the administration of the first dose of diphtheria and tetanus toxoids and acellular pertussis vaccine from 2 months to 6 weeks of age, an alternative schedule consistent with current vaccination guidelines. We used Poisson distribution analysis to determine 95% confidence intervals for projected rates of pertussis disease.

RESULTS. Acceleration of administration of the first dose of diphtheria and tetanus toxoids and acellular pertussis vaccine from 2 months to 6 weeks of age is expected to prevent 1236 cases of pertussis, 898 hospitalizations, and 7 deaths attributable to pertussis per year in the United States. These decreases represent 9% reduction in cases, 9% reduction in hospitalizations, and 6% reduction in deaths attributable to pertussis among infants <3 months of age. Acceleration of the second and third doses by 2 weeks is expected to prevent an additional 923 cases, 520 hospitalizations, and 2 deaths attributable to pertussis each year.

CONCLUSION. Acceleration of administration of diphtheria and tetanus toxoids and acellular pertussis vaccine from 2 months to 6 weeks should reduce the burden of pertussis among young infants.

Key Words: pertussis • infants • vaccine • epidemiology • preventive health care visits

Abbreviations: DTaP—diphtheria and tetanus toxoids and acellular pertussis vaccine • DTP—diphtheria and tetanus toxoids and pertussis vaccine • Tdap—tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine • CI—confidence interval

Pertussis causes significant morbidity and death, with >50 million cases and >300000 deaths worldwide.1 Although rates of pertussis illness in the United States are 50-fold less than those from the prevaccine era,2 pertussis remains an important but under-recognized disease.3–6 Despite an effective diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine with high vaccination rates, estimates from 2001–2003 indicate an annual average of 98 pertussis-related hospitalizations per 100000 US infants 0 to 5 months of age.7

The primary recommendation to protect infants from pertussis is to administer DTaP vaccine to US infants at 2, 4, and 6 months of age. A recent study in 2 urban communities showed that the median times of administration of the first 3 DTaP vaccine doses were 62, 126, and 189 days of age.8 The 2004 National Immunization Survey estimated that 88% of infants had received 1 dose of DTaP vaccine by 3 months of age, 76% of infants had received 2 doses of DTaP vaccine by 5 months of age, and 66% of infants had received 3 doses of DTaP vaccine by 7 months of age.9

Among US infants, the incidence of pertussis peaks at 1 month of age and progressively decreases over the next 7 months.3 An important premise of this study is that the progressive decrease in pertussis seen in US infants is attributable to DTaP vaccination at 2, 4, and 6 months of age and not some other factor. This premise is supported by 2 clinical trials that estimated pertussis vaccine efficacy for the first 3 doses of DTaP vaccine to be 84% (95% confidence interval [CI]: 76%–89% for one vaccine manufacturer and 76%–90% for another vaccine manufacturer) or 85% (95% CI: 81%–89%).10,11 In a case-control study, the vaccine effectiveness of pertussis vaccine among children 6 to 23 months of age was 46% (95% CI: –147%–88%) for 1 dose, 80% (95% CI: 25%–95%) for 2 doses, and 92% (95% CI: 75%–97%) for 3 doses. The vaccine effectiveness levels were similar for children who received 3 doses of diphtheria and tetanus toxoids and pertussis vaccine (DTP) only, DTaP vaccine only, or a mixture of DTP and DTaP vaccines.12

Current guidelines for the use of DTaP vaccine (as well as rotavirus vaccine, Haemophilus influenzae type b vaccine, pneumococcal conjugate vaccine, and inactivated poliovirus vaccine) allow for vaccine administration as early as 6 weeks of age.13,14 Indeed, routine administration of DTaP vaccine at 6 weeks, 3.5 months, and 5.5 months of age is an acceptable vaccine schedule according to current US advisory panel recommendations. We sought to estimate the potential benefit of accelerating the administration of DTaP vaccine from 2 months to 6 weeks (the earliest currently recommended age), with respect to the incidence of pertussis.


   METHODS
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 ABSTRACT
 METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
We used published national rates of pertussis from 1990 through 1999 to estimate the average annual incidence of pertussis according to age (in months) for infants <7 months of age.3,15 We confirmed the internal consistency of these rates by using additional data from overlapping time periods, although they lacked sufficient detail for ascertainment of monthly rates.16–19 We multiplied these monthly rates by the 2004 US Census value of 4112052 live births to ascertain the average expected number of pertussis cases according to month of age.20 Because hospitalizations and deaths were reported for 2-month age groups, we assumed that they were equally distributed for the age groups. The proportions of all patients who were hospitalized were 82% for infants 0 to 1 month of age, 67% for infants 2 to 3 months of age, and 53% for infants 4 to 5 months of age; the respective proportions for deaths were 1%, 0.3%, and 0.2%.3,15

We then estimated the potential benefit of reducing the time infants were unvaccinated by assuming that all vaccinated infants would receive DTaP vaccine 2 weeks earlier, at 6 weeks rather than 8 weeks of age. Inherent assumptions included that infants vaccinated at 6 and 8 weeks of age would respond similarly to the first and subsequent doses of DTaP vaccine and that the time between vaccine administration and immune response would be the same, although we never had to specify that exact time. The model also assumed that the vaccine coverage remained similar to that in the 1990s, when the rates of pertussis disease were computed. To perform these calculations, we multiplied the estimated rate of pertussis for each age group by the 2004 US Census live-birth population of 4112052 infants. The current rates are represented by Fig 1A, whereas projected age-associated rates with an accelerated schedule are represented by Fig 1B for Table 1 and by Fig 1C for Table 2. The difference in rates equaled the current rate minus the projected rate. The number needed to treat equaled the infant live-birth population divided by the difference in rates. The 95% CIs were computed by assuming a Poisson distribution.21 Because not all cases of pertussis are diagnosed and because the burden of pertussis varies from year to year, we conducted sensitivity analyses on rates of pertussis disease and made projections assuming that the actual rates of pertussis disease were 25% higher or 25% lower than the current rates shown in Fig 1A.


Figure 1
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  		FIGURE 1 Published rates of pertussis infections per 100000 infants (numbers within bars), according to age (in months),3 with the current schedule of DTaP vaccine administration at 2, 4, and 6 months of age (A), projected rates among infants 0 to 3 months of age with an accelerated schedule of DTaP vaccine administration at 6 weeks of age (B), and projected rates with an accelerated schedule of DTaP vaccine administration at 6 weeks, 3.5 months, and 5.5 months of age (C). Arrowheads indicate timing of vaccine administration.

 

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  		TABLE 1 Projected Effects of Acceleration of the First Dose of DTaP Vaccine From 2 Months to 6 Weeks of Age on Overall Cases, Hospitalizations, and Deaths Attributable to Pertussis Among Infants <3 Months of Age

 

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  		TABLE 2 Projected Effects of Acceleration by 2 Weeks of the Vaccine Schedule for the Primary Series of DTaP Vaccine Doses (2-, 4-, and 6-Month Doses) on Rates of Pertussis Among Infants <6 Months of Age

 

   RESULTS
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 ABSTRACT
 METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
We estimated age-associated disease rates that would occur with administration of the first dose of DTaP vaccine at 2 months (Fig 1A) and with acceleration from 2 months to 6 weeks of age (Fig 1B) among infants 0 to 3 months of age. With this limited acceleration in dosing, we predicted 1236 fewer cases of pertussis, 898 fewer pertussis-related hospitalizations, and 7 fewer pertussis-related deaths per year among infants <3 months of age in the United States (Table 1). These changes represented a 9% reduction in pertussis infections, a 9% reduction in pertussis-related hospitalizations, and a 6% reduction in pertussis-related deaths. The number of infants needed to be vaccinated with the accelerated DTaP vaccination schedule to prevent 1 infant case of pertussis was 3326 infants, that to prevent 1 pertussis-related hospitalization was 4577, and that to prevent 1 pertussis-related death was 623099. If the actual rate of pertussis was 25% higher or 25% lower than the reported rates, then the numbers needed to be vaccinated to prevent 1 case of pertussis would be 2661 and 4444, respectively. With accelerated administration of the first 3 doses of DTaP vaccine at 6 weeks, 3.5 months, and 5.5 months (Fig 1C), we would anticipate 923 fewer cases, 520 fewer hospitalizations, and 2 fewer deaths attributable to pertussis, compared with acceleration of the first dose alone (Table 2).


   DISCUSSION
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
Vaccination is an important public health achievement and accounts for a significant reduction in the burden of childhood diseases, including pertussis.22,23 Efforts to reduce the burden of vaccine-preventable diseases often focus on improving vaccine technology or increasing vaccination rates. This study suggests that acceleration of the administration of the first dose of DTaP vaccine from 2 months to 6 weeks of age could decrease the number of infant cases of pertussis by 9%, the number of hospitalizations by 9%, and the number of deaths by 6%.

We estimate that 1 pertussis infection could be prevented with 3326 infants vaccinated at 6 weeks of age, whereas >623000 infants would need to be vaccinated at 6 weeks to prevent 1 pertussis-related death. The reason for this discrepancy between pertussis infections and deaths is that most deaths attributable to pertussis occur among the youngest infants, many of whom would be too young to be vaccinated even under the accelerated schedule.

This finding assumed similar vaccine responses of infants at 6 weeks and 8 weeks of age, but no study to date has compared infant responses to DTaP vaccine at 6 and 8 weeks of age. However, 2 similar trials compared the same combination vaccines, including DTaP vaccine, with 2 different schedules, that is, 1.5, 3, and 5 months of age and 2, 4, and 6 months of age. After the primary series, the vaccine response rates were similar (90%–100%) and the 95% CIs for the geometric mean titers for all 3 pertussis-specific antibodies overlapped.24,25 In addition, the response rates 1 month after the 1.5-month dose (no comparable data were reported in the other study) were reported to be 86% for anti-pertussis toxoid, 92% for anti-filamentous hemagglutinin, and 91% for antipertactin, with geometric mean titers of 9 to 17.25 Those studies, like all other studies in the past few decades, measured antibody responses while acknowledging that the exact correlates of protection are not well understood.

During a 1993 pertussis outbreak among young infants, consideration of accelerated DTP vaccination at 6, 10, and 14 weeks of age was recommended.26 In Cincinnati, Ohio, accelerated DTP vaccination as early as 1, 2, and 3 months of age was recommended.26,27 To our knowledge, no data have been published to document the degree of implementation or the impact of this accelerated DTP vaccination recommendation.

Another identified factor in the immune response to pertussis is transplacental passage of maternal antibodies. Maternal antibodies provide important protection to newborns and decrease after birth. However, maternal antibodies have been shown to block antibody responses to whole-cell pertussis.28–30 Interestingly, studies showed that maternal antibodies were associated with lower antipertactin antibody development in infants whose mothers had been vaccinated with DTP vaccine but not DTaP vaccine.31,32 Maternal antibody interference at least partially explains the observation that vaccination of newborns is associated with poor responses to pertussis vaccine.30,33 The interference of maternal antibodies with infant responses to vaccine deserves additional study.

Reducing the burden of pertussis among infants <6 weeks of age may be achieved through efforts to increase adult immunity through pertussis vaccination of adolescents and adults.34–38 A tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine for adolescents and adults was recently approved.14,39,40 It is hoped that successfully vaccinating adolescents and adults will decrease rates of pertussis in early infancy. Consideration is being given to vaccination of pregnant women with Tdap vaccine, as a way to enhance pertussis immunity in early infancy. US advisory panel recommendations focused differently on this topic. The Advisory Committee on Immunization Practices does not recommend Tdap vaccination during pregnancy, although it does not specifically recommend against this practice.14 In contrast, the" American Academy of Pediatrics recommends that pregnant adolescents be given the same consideration for immunization as nonpregnant adolescents," with preferred timing of administration in the second or third trimester (before 36 weeks of gestation).40

Although administration of the first dose of pertussis vaccine at 6 weeks of age is a change from the current routine practice of administration at 2 months, this modest dose acceleration falls within the current recommendations of the Advisory Committee on Immunization Practices and the American Academy of Pediatrics for the childhood vaccination schedule.14,40 Importantly, all currently recommended 2-month vaccines can be given at 6 weeks of age; therefore, an increase in the number of scheduled outpatient visits to accommodate accelerated pertussis vaccine administration would not be necessary. Instead, routine, 2-month, well-child visits with vaccinations could be performed at 6 weeks of age.

The improvements in pertussis protection did not assume any increase in overall rates of DTaP vaccination. To convey these gains in pertussis protection to their patients, outpatient practices caring for young children would need to undergo a transition to routine, 6-week, well-child visits, instead of visits at 2 months of age. There might be some cost to pediatric providers associated with accommodating more well-child visits for a limited period of time. Another potential concern about performing vaccinations at 6 weeks rather than 8 weeks of age is whether such a change would lead to increased numbers of tests or hospitalizations, or a missed significant infection, among infants who developed fever or fussiness in the days after vaccinations.

This study has important limitations. The results are based on nationally reported data from the literature. Therefore, we present probable effects of changing the timing of initial pertussis vaccination; additional studies would be necessary to evaluate the actual effects of this intervention. In particular, we lack comparative data on infant responses to DTaP vaccine at 6 and 8 weeks of age for infants born to mothers who have or have not received Tdap vaccine. We used conservative criteria to reduce the chance of overestimation but might have underestimated the true benefit. Importantly, data on pertussis rates according to month were reported in the 1990s, but the rates of pertussis have continued to increase, with the most recent report of 161 pertussis infections per 100000 infants <6 months of age in 2005.41 Therefore, the estimation should reasonably reflect the minimal magnitude of the effect of changing the timing of initial pertussis vaccination. Because the burden of pertussis can be unpredictable, we present the expected average benefit while acknowledging that the exact results would vary depending on the burden of each year. Additional benefits would be expected if second and third pertussis vaccinations were also accelerated within current vaccine guidelines.

Vaccines have tremendous potential to reduce disease rates and, as new data become available, practices should continue to modify their vaccination practices to optimize the impact. Changes in vaccination schedules involve virtually no cost and have the potential for great benefit. This relatively minor change in pediatric practice could reduce the burdens on families and society of pertussis and perhaps of other vaccine-preventable diseases. It would also complement programs to vaccinate adolescents and adults with acellular pertussis vaccine.

While this manuscript was in press, Dr Margaret Cortese et al reported rates of pertussis hospitalizations among US infants by age in months. They find rates of pertussis disease in youngest infants that are 2 times higher than previously reported.42 These findings further suggest that the benefit of early pertussis vaccination may be greater than our conservative estimates.


   ACKNOWLEDGMENTS
 
Dr Poehling received support from the Robert Wood Johnson Foundation Generalist Physician Faculty Scholar Program. The Project described was supported in part by Award Numbers K23 AI065805 (Dr Poehling) and K08 AI058006 (Dr Peters) from the National Institute of Allergy and Infectious Diseases. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health.

We thank Dr Jon Abramson for his thoughtful review and suggestions, Kim Crews for assistance in manuscript preparation, and Bobby and Jenny Peters who inspired this work. We also thank the anonymous reviewers whose insights significantly enhanced this work.


   FOOTNOTES
 
Accepted Mar 20, 2008.

Address correspondence to Katherine A. Poehling, MD, MPH, Department of Pediatrics, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157

Mr Shinall and Dr Peters contributed equally to this work.

The authors have indicated they have no financial relationships relevant to this article to disclose.


What's Known on This Subject

Pertussis is a common pediatric infection despite high DTaP vaccination coverage.

 

What This Study Adds

This study estimates the potential impact of accelerating the primary dose and primary series of DTaP vaccine doses for young infants within the currently recommended vaccine schedule guidelines.

 


   REFERENCES
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 

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Right arrow Infectious Disease & Immunity
Right arrowRelated AAP Red Book topics:
Tetanus (Lockjaw)
Pertussis (Whooping Cough)
Diphtheria
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