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Willingness of pregnant women to vaccinate themselves and their newborns with the HPV vaccine
Vaccine 29 (2011) 4618–4622
Contents lists available at ScienceDirect
Vaccine journal homepage: www.elsevier.com/locate/vaccine
Willingness of pregnant women to vaccinate themselves and their newborns with the HPV vaccine Katherine P. Heyman a , Michael J. Worley Jr b , Melissa K. Frey b , Robin T. Kessler b , Diane C. Bodurka c , Brian M. Slomovitz d,∗ a
Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY 10021, United States Department of Obstetrics and Gynecology, New York Presbyterian Hospital-Cornell University Medical Center, New York, NY, United States c Department of Gynecologic Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX, United States d Department of Gynecologic Oncology, Morristown Memorial Hospital, Morristown, NJ, United States b
a r t i c l e
i n f o
Article history: Received 25 October 2010 Accepted 17 April 2011 Available online 8 May 2011 Keywords: Human papillomavirus Vaccine Gardasil Pregnancy
a b s t r a c t Objective: To evaluate the willingness of pregnant women to accept the HPV vaccine for their newborns as well as themselves. Methods: An 18-item questionnaire was distributed to antepartum women. Demographic data about the respondent’s current pregnancy and her knowledge of HPV and the HPV vaccine was collected. Information about the respondent’s HPV and HPV vaccine status as well as her acceptance of the vaccine for herself during pregnancy and her newborn son and/or daughter after delivery was also collected. Results: Three hundred surveys were completed and available for review. Only 6 respondents (2%) had received the HPV vaccine. Despite the small group of patients who had previously been vaccinated, 112 respondents (37.3%) stated that they would receive the HPV vaccine during pregnancy if recommended by an obstetrician. 99 respondents (33%) stated that they would vaccinate their newborn female infant and 83 (27.7%) stated would vaccinate their male infants. Conclusion: Providing the HPV vaccine to pregnant women as well as newborns could be an important way to increase the patient population who is protected against HPV. A percentage of pregnant women are willing to accept the vaccine for themselves and their newborns. © 2011 Elsevier Ltd. All rights reserved.
1. Introduction Human papillomavirus (HPV) is the most commonly diagnosed sexually transmitted infection in the United States and represents the causative agent in over 99% of cervical cancer cases. A quadrivalent HPV vaccine has been available in the United States since June 2006 and the U.S. Food and Drug Administration licensed a bivalent HPV vaccine in 2009. Although long-term follow-up is necessary to demonstrate reductions in cervical cancer incidence and mortality, these prophylactic HPV vaccines have proven to be highly effective in preventing both HPV infection as well as precancerous cervical dysplasia [1]. The Advisory Committee on Immunization Practices currently recommends vaccinating female adolescents, 11–12 years of age. However, the vaccine has been approved for women between 9 and 26 years of age [2]. As the vaccine does not eliminate HPV
∗ Corresponding author at: Department of Gynecologic Oncology, Women’s Cancer Center, Morristown Memorial Hospital, 100 Madison Avenue, Morristown, NJ 07962, United States. E-mail address: [email protected] (B.M. Slomovitz). 0264-410X/$ – see front matter © 2011 Elsevier Ltd. All rights reserved. doi:10.1016/j.vaccine.2011.04.062
after a patient is infected, it is preferable to vaccinate patients prior to exposure to the virus. Clinical trials have demonstrated protection against HPV infection for at least five and a half years but, it is believed that the vaccine is effective for much longer [3]. Studies are currently in progress to determine the exact duration of protection. The success of future HPV programs depends on the availability of the vaccine to as many at-risk patients as possible, especially before they are exposed to the vaccine. Although newborns are not exposed to sexually transmitted infections for many years, there is precedence for early vaccination. In 2006, the Centers for Disease Control and Prevention (CDC) began recommending the implementation of a universal infant vaccination beginning at birth to eliminate the hepatitis B virus [4]. In addition, there is also precedence for administering vaccines to women during pregnancy as the CDC recommends the influenza vaccine in all pregnant women, regardless of gestational age during influenza season [5]. Although the HPV vaccine is not yet approved in women during pregnancy, the acceptance of the vaccine by this population of patients would also improve the success of future HPV programs. The purpose of this study was to evaluate the willingness of pregnant women to accept the HPV vaccine for their newborns as
K.P. Heyman et al. / Vaccine 29 (2011) 4618–4622 Table 1 Summary of patient demographics.
Information Collected 1.
Age
2.
Race
3.
Religion
4.
Education level
5.
Marital status
4619
6.
Expected delivery date
7.
Sex of newborn
8.
Is this your first pregnancy? If no, how many previous pregnancies have you had?
9.
Is this your first delivery? If no, how many previous deliveries have you had?
10. Have you ever heard of HPV? If yes, where have you heard of it? 11. Are you aware that HPV can cause cervical cancer? 12. Have you ever heard of the HPV vaccine? If yes, where have you heard of it? 13. Are you currently vaccinated against any STD? If yes, do you know which one(s)? 14. Have you ever been HPV positive? If yes, are you still HPV positive? 15. Have you received the HPV vaccine? 16. If your ob/gyn recommended that you get the HPV vaccine during your pregnancy, would you be willing to get it? If no, why not? 17. Have you received any vaccine during this pregnancy or any previous pregnancy? 18. Currently the HPV vaccine is effective for up to 7 years. The duration of protection may be much longer (these studies are currently ongoing). If it is shown that the vaccine would be effective with a prolonged duration of protection if administered as part of newborn vaccinations, would you let your pediatrician administer the vaccine to your daughter? Son? (before
Variable
Number
Mean age (years) Race Black/African American Hispanic Asian White/Caucasian Other Blank Religion Catholic Jewish Buddhist Protestant Hindu Muslim None Other Blank Marital status Single Married Divorced Education level Less than high school Completed high school Completed college Professional degree Other Blank First pregnancy Yes No First delivery Yes No Blank Trimester 1st 2nd 3rd Blank Sex of fetus(es) Male Female Unknown Both Blank
33 (range 16–47) 29 (9.7%) 58 (19.3%) 33 (11.0%) 159 (53.0%) 17 (5.7%) 4 (1.3%) 107 (35.7%) 40 (13.3%) 2 (0.7%) 28 (9.3%) 10 (3.3%) 11 (3.7%) 60 (20%) 37 (12.3%) 5 (1.7%) 49 (16.3%) 248 (82.7%) 3 (1%) 13 (4.3%) 58 (19.3%) 109 (36.3%) 118 (39.3%) 1 (0.3%) 1 (0.3%) 133 (44.3%) 167 (55.7%) 182 (60.7%) 116 (38.7%) 2 (0.7%) 18 (6%) 104 (34.7%) 169 (56.3%) 9 (3%) 108 (36%) 91 (30.3%) 90 (30%) 8 (2.7%) 3 (1%)
leaving the hospital? within the first six months?) Fig. 1. Sample of patient survey.
well as themselves. If potential barriers to acceptance are identified early, they can be addressed when the vaccine becomes available to these populations of patients. 2. Materials and methods After approval was received from the institutional review board, surveys were distributed to antepartum women between June 2008 and August 2008. The respondents were outpatients at two obstetrics and gynecology clinics at NewYork-Presbyterian Hospital/Weill Medical College of Cornell University. Four hundred and four potential participants were approached by a medical student, who determined their willingness to participate in the survey. Surveys were available in both English and Spanish. Those who were unable to read either English or Spanish were excluded. An 18-item questionnaire was used (Fig. 1). After completing the first 13 questions, each participant received an educational component before completing the last 5 questions. The first part of the questionnaire collected demographic data as well as information about the respondent’s current pregnancy and her knowledge of
HPV and the HPV vaccine. The educational component provided current facts about HPV, the vaccine and cervical cancer. The second part of the questionnaire collected information about the respondent’s HPV and HPV vaccine status as well as her acceptance of the vaccine for herself during pregnancy and her newborn son and/or daughter after delivery (before leaving the hospital and within the first six months). Descriptive statistics were used to evaluate patient responses. Subgroup analyses were conducted according to age, race, religion, educational level, marital status, sex of newborn, and pregnancy history. Chi-square analysis was performed to compare the results from these groups. 3. Results Three hundred surveys were completed and available for review. Patient demographics are shown in Table 1. Patient knowledge of HPV and the HPV vaccine are summarized in Table 2. A large majority of patients stated that they had prior knowledge of HPV (237, 79%) and the HPV vaccine (217, 72.3%). The most common source of information stated for both areas was television. While 18 respondents (6%) stated that they had previously been
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K.P. Heyman et al. / Vaccine 29 (2011) 4618–4622
Table 2 Description of patient awareness of HPV and HPV vaccine. Variable
Number
Prior knowledge of HPV virus Source of HPV knowledge Television OBGYN News Media Another MD Internet Friend Other Prior knowledge of HPV vaccine Source of HPV vaccine knowledge Television OBGYN News Media Another MD Internet Friend Other Previously received the HPV vaccine Would receive HPV vaccine during pregnancy
237 (79%) 148 (62.5%) 116 (48.9%) 72 (30.4%) 34 (14.4%) 31 (13.1%) 40 (16.9%) 25 (10.6%) 217 (72.3%) 167 (77.0%) 55 (25.3%) 64 (29.5%) 25 (11.5%) 24 (11.1%) 19 (8.8%) 13 (6.0%) 6 (2%) 112 (37.3%)
vaccinated against a sexually transmitted disease (e.g. HPV and hepatitis B), only 6 respondents (2%) had received the HPV vaccine. Despite the small group of patients who had previously been vaccinated, 112 respondents (37.3%) stated that they would receive the HPV vaccine during pregnancy if recommended by an obstetrician. Common concerns with receiving the HPV vaccine during pregnancy included: perceived side effects to the fetus, the belief that they were not at high risk of becoming infected and the need for more information. Many women also responded that they were opposed to vaccines in general or that they were opposed to taking any medication or receiving any vaccine during pregnancy. Many respondents cited being over the age limit recommended by the CDC and some women cited the high cost, the recent development of the vaccine, and the lack of long-term studies. Several women commented that they would wait until after their delivery to receive the vaccine and one woman responded that men should receive the vaccine instead of women. There were no significant differences among patients that would be willing to receive HPV vaccination during pregnancy, with respect to: fetal sex, education level, marital status, religion, prior knowledge of the HPV vaccine or whether this was their first pregnancy. However, 46 (41.1%,) of the 112 respondents who would receive vaccination during pregnancy were categorized as white/Caucasian. Hispanic (28, 25.0%) and black/African American (18, 16.1%) respondents were the next most likely to receive vaccination. Asian (10, 8.9%) respondents were the least likely to receive antepartum vaccination (Table 3). If the duration of protection allowed for vaccination without requiring a booster and if recommended as part of a newborn vaccination program, 99 respondents (33%) stated that they would vaccinate their newborn female infant. Within this group, 38 (12.7%) desired vaccination prior to hospital discharge and 61 (20.3%) would have the vaccination within the first 6 months of life. For male infants, 83 (27.7%) respondents desired vaccination. Thirty (10.0%) respondents desired vaccination prior to hospital discharge and 53 (17.7%) respondents would have the vaccination administered within the first 6 months of life (Table 4). Some women did not respond to this question regarding a daughter if they were having a son and other women did not respond to this question regarding a son if they were having a daughter so the results may reflect a lower than expected acceptance. In addition, some women misunderstood the survey and cited their reluctance to vaccinate their newborn as a result of the vaccine only lasting 7 years.
Table 3 Comparison of characteristics among patients willing to receive HPV vaccine during pregnancy (n = 112). Variable
Number
Fetal sex Female Male Unknown Both Blank Education level Less than high school Completed high school Completed college Professional degree Other Blank First pregnancy Yes No Prior knowledge of HPV vaccine Yes No Marital status Single Married Divorced Religion Catholic Jewish Buddhist Protestant Hindu Muslim None Other Blank Race Black/African American Hispanic Asian White/Caucasian Other Blank
P value 0.514
34 (30.4%) 44 (39.3%) 29 (25.9%) 4 (3.6%) 1 (0.9%) 0.187 9 (8.0%) 28 (25.0%) 39 (34.8%) 35 (31.2%) 0 (0%) 1 (0.9%) 0.614 45 (40.2%) 67 (59.8%) 0.724 86 (76.8%) 26 (23.2%) 0.779 21 (18.8%) 90 (80.4%) 1 (0.9%) 0.676 44 (39.3%) 11 (9.8%) 1 (0.9%) 9 (8.0%) 3 (2.7%) 7 (6.2%) 22 (19.6%) 13 (11.6%) 2 (1.8%) 0.011 18 (16.1%) 28 (25.0%) 10 (8.9%) 46 (41.1%) 6 (5.4%) 4 (3.6%)
Among 83 women willing to vaccinate their male infant, 35 (42.2%) held a professional degree, 60 (72.3%) had prior knowledge of the HPV vaccine and 45 (54.2%) were white/Caucasian. There was no significant difference in if this was their first pregnancy, marital status or religion (Table 5). Patient characteristics of women willing to vaccinate their female infant are shown in Table 6. Among 99 women, 37 (37.4%) held a professional degree. However, there was no significant difference with respect to if the current pregnancy was their first, if they had prior knowledge of the HPV vaccine, marital status, religion or race. Most of the women who would not accept the vaccine for their newborn daughter responded that they were trying to minimize the number of vaccines given to their newborn and some
Table 4 Willingness to vaccinate infant. Sex of Infant
Response
Number
Male
Yes, before discharge home Yes, <6 months of age No Unsure Blank Yes, before discharge home Yes, <6 months of age No Unsure Blank
30 (10.0%) 53 (17.7%) 120 (40.0%) 26 (8.7%) 69 (23.0%) 38 (12.7%) 61 (20.3%) 135 (45.0%) 33 (11.0%) 31 (10.3%)
Female
K.P. Heyman et al. / Vaccine 29 (2011) 4618–4622 Table 5 Comparison of characteristics among patients willing to vaccinate their male infant (n = 83). Variable Education level Less than high school Completed high school Completed college Professional degree Other Blank First pregnancy Yes No Prior knowledge of HPV vaccine Yes No Marital status Single Married Divorced Religion Catholic Jewish Buddhist Protestant Hindu Muslim None Other Blank Race Black/African American Hispanic Asian White/Caucasian Other Blank
Number
P value 0.01
4 (4.8%) 22 (26.5%) 21 (25.3%) 35 (42.2%) 0 (0%) 1 (1.2%) 0.692 34 (41.0%) 49 (59.0%) 0.011 60 (72.3%) 22 (26.5%)
Education level Less than high school Completed high school Completed college Professional degree Other Blank First pregnancy Yes No Prior knowledge of HPV vaccine Yes No Marital status Single Married Divorced Religion Catholic Jewish Buddhist Protestant Hindu Muslim None Other Blank Race Black/African American Hispanic Asian White/Caucasian Other Blank
responded that they were opposed to all newborn vaccines. Several women cited their fear of newborn vaccines causing autism and one woman was worried that it would interact with other vaccines. Many respondents cited the need for more information, the newness of the vaccine, and the unknown long-term effects. One woman indicated her mistrust of new drugs and the FDA approval process, another woman wanted her daughter to be able to choose for herself, and one woman responded that she would teach her daughter to use a condom instead. In July 2008, there were many news stories about potential adverse events of the HPV vaccine and several women cited the bad press in the subsequent questionnaires [6]. The respondents cited many of the same concerns about vaccinating their newborn sons. In addition, some women responded that they were unsure how HPV affects males and that males are not at risk of cervical cancer.
0.453 15 (18.1%) 68 (81.9%) 0 (0%)
4. Discussion 0.275
22 (26.5%) 9 (10.8%) 0 (0%) 5 (6.0%) 3 (3.6%) 5 (6.0%) 25 (30.1%) 12 (14.5%) 2 (2.4%) 0.031 13 (15.7%) 15 (18.1%) 6 (7.2%) 45 (54.2%) 2 (2.4%) 2 (2.4%)
Table 6 Comparison of characteristics among patients willing to vaccinate their female infant (n = 99). Variable
4621
Number
P value 0.011
3 (3.0%) 29 (29.3%) 29 (29.3%) 37 (37.4%) 0 (0%) 1 (1.0%) 0.094 37 (37.4%) 62 (62.6%) 0.181 64 (64.6%) 34 (34.3%) 0.505 15 (15.2%) 84 (84.8%) 0 (0%) 0.132 31 (31.3%) 10 (10.1%) 0 (0%) 7 (7.1%) 4 (4.0%) 6 (6.1%) 24 (24.2%) 14 (14.1%) 3 (3.0%) 0.088 14 (14.1%) 21 (21.2%) 9 (9.1%) 50 (50.5%) 4 (4.0%) 1 (1.0%)
The effectiveness of an HPV vaccination program would be greatly enhanced by the availability of the vaccine to as many patient populations as possible, including pregnant women and newborns. In our survey of 300 antepartum women between the ages of 16 and 47, we found a limited willingness to accept the HPV vaccine for themselves and their newborns. While 37.3% of respondents would be willing to receive the vaccine during pregnancy, 33.0% of women were willing to vaccinate their newborn daughter and 27.7% were willing to vaccinate their newborn son. Many women cited the recent development of the vaccine and the lack of long-term studies as reasons for not accepting the vaccine. In addition, many women were opposed to receiving any vaccine during pregnancy and many women wanted to limit the number of vaccines administered to their newborn. Despite the variety of concerns about vaccinating a newborn, a large percentage of respondents commented that they would be willing to vaccinate their child at a later age. The ages cited for daughters included: after 6 months, at 12 months, 6–8 years, 12–13 years, as a teenager, at puberty and when sexually active. For sons, respondents cited ages including: after 6 months and at school age. In our study, only 8.3% of women were willing to receive any form of antepartum vaccination. These findings are consistent with other studies displaying an apprehension about taking any medication or receiving any vaccine during pregnancy, even if recommended by a physician. Although the CDC currently recommends the influenza vaccine for all pregnant women, Silverman et al. found that 44% of women interviewed during the postpartum period said they believed that all vaccines should be avoided during pregnancy [7]. Despite women’s apprehension, Ogburn et al. found that influenza vaccination rates in pregnant women increased from <1% to 37% in a prenatal clinic over two years as a result of interventions to increase immunization rates. These included provider and staff education, stocking of the vaccine in the clinic and implementation of standing orders [8]. These interventions may provide equal success in improving acceptance of the HPV vaccine if recommended during pregnancy. Currently, many parents of newborns are reluctant to accept any vaccine for their newborn for many reasons including the potential risk of developing autism. Despite compelling scientific evidence against a causal association, many parents and parent advocacy groups continue to suspect that vaccines can cause autism [9]. As a result, acceptance of the HPV vaccine for newborns may have been higher several years ago before the association with autism was suspected. Many studies have determined the need for educational programs as well as an understanding of patients’ concerns in order to increase vaccination rates. Návar et al. reported that only 23% of
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K.P. Heyman et al. / Vaccine 29 (2011) 4618–4622
surveyed obstetric practices reported providing pregnant women with information on routine childhood immunizations and that 20% of surveyed hospitals did not provide information about routine childhood immunizations to prenatal class participants [10]. The conclusion was that prenatal visits are a missed opportunity for providing education about infant immunizations and that incorporating immunization education into routine obstetric prenatal care may increase maternal knowledge of infant vaccines and reduce delayed immunization. In a review examining barriers, benefits, and risks of immunizations, Kimmel et al. determined that physicians must be knowledgeable about vaccines and incorporate systems to record, remind, and recall patients for vaccinations [11]. In addition, they must clearly communicate vaccine benefits and risks while understanding those factors that affect an individual’s acceptance and perception of those benefits and risks. Reluctance to accept the HPV vaccine may also be due in part to a lack of knowledge about the virus, as many studies indicate that patients have a limited understanding of HPV [12,13]. In our study, the majority of respondents had heard of HPV and knew that it caused cervical cancer, but many women seemed surprised by the idea of vaccinating their son as males. In a study of 227 women, Watts et al. found that 70% of respondents agreed to vaccinate their daughters and 86% of participants agreed to vaccinate their sons [14]. Cervical cancer prevention and anal/penile cancer prevention were the primary motivation reported for accepting the vaccine in their daughters and sons, respectively. If the educational component of our study had indicated the association between HPV and other cancers including anal/penile cancer, perhaps more respondents would have showed a willingness to vaccinate their sons. There were several limitations to this study. The HPV vaccine is not currently recommended for pregnant women or newborns so it is difficult to determine the acceptance. In addition, there are no long-term studies about the vaccine’s effectiveness and safety and there was negative publicity at the time of the study about the vaccine’s potential side effects. Finally, our sample size was small and our results only represent the views of patients visiting two obstetrics and gynecology clinics at one hospital. In conclusion, providing the HPV vaccine to pregnant women as well as newborns could be an important way to increase the patient
population who is protected against HPV. This study illustrates that a percentage of pregnant women are willing to accept the vaccine for themselves and their newborns. The study also identified potential barriers to acceptance that must be addressed before the vaccine becomes available to these populations. References [1] Rambout L, Hopkins L, Hutton B, Fergusson D. Prophylactic vaccination against human papillomavirus infection and disease in women: a systematic review of randomized controlled trials. CMAJ 2007;177(August (5)):469–79. [2] Centers for Disease Control and Prevention. Quadrivalent human papillomavirus vaccine: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep 2007;56:1–24. [3] Villa LL, Costa RL, Petta CA, Andrade RP, Paavonen J, Iversen OE, et al. High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up. Br J Cancer 2006;95(December (11)):1459–66. [4] Advisory Committee on Immunization Practices (ACIP). A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). Part 1: Immunization of infants, children, and adolescents. MMWR Recomm Rep 2005;54(December (RR-16)):1–31. [5] Advisory Committee on Immunization Practices, Smith NM, Bresee JS, Shay DK, Uyeki TM, Cox NJ, Strikas RA. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2006;55:1–42. [6] “Should parents worry about HPV vaccine?”. http://www.cnn.com/ 2008/HEALTH/conditions/07/07/cervical.cancer.vaccine/. [7] Silverman NS, Greif A. Influenza vaccination during pregnancy. Patients’ and physicians’ attitudes. J Reprod Med 2001;46:989–94. [8] Ogburn T, Espey EL, Contreras V, Arroyo P. Impact of clinic interventions on the rate of influenza vaccination in pregnant women. J Reprod Med 2007;52(September (9)):753–6. [9] DeStefano F. Vaccines and autism: evidence does not support a causal association. Clin Pharmacol Ther 2007;82(December (6)):756–9. [10] Návar AM, Halsey NA, Carter TC, Montgomery MP, Salmon DA. Prenatal immunization education the pediatric prenatal visit and routine obstetric care. Am J Prev Med 2007;33(September (3)):211–3. [11] Kimmel SR, Burns IT, Wolfe RM, Zimmerman RK. Addressing immunization barriers, benefits, and risks. J Fam Pract 2007;56(February):S61–9. [12] Walsh CD, Gera A, Shah M, Sharma A, Powell JE, Wilson S. Public knowledge and attitudes towards Human Papilloma Virus (HPV) vaccination. BMC Public Health 2008;8(October):368. [13] Nøhr B, Munk C, Tryggvadottir L, Sparén P, Tran TN, Nygård M, et al. Awareness of human papillomavirus in a cohort of nearly 70,000 women from four Nordic countries. Acta Obstet Gynecol Scand 2008;87(10):1048–54. Links. [14] Watts LA, Joseph N, Wallace M, Rauh-Hain JA, Muzikansky A, Growdon WB, et al. HPV vaccine: a comparison of attitudes and behavioral perspectives between Latino and non-Latino women. Gynecol Oncol 2009;(January).
Contents lists available at ScienceDirect
Vaccine journal homepage: www.elsevier.com/locate/vaccine
Willingness of pregnant women to vaccinate themselves and their newborns with the HPV vaccine Katherine P. Heyman a , Michael J. Worley Jr b , Melissa K. Frey b , Robin T. Kessler b , Diane C. Bodurka c , Brian M. Slomovitz d,∗ a
Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY 10021, United States Department of Obstetrics and Gynecology, New York Presbyterian Hospital-Cornell University Medical Center, New York, NY, United States c Department of Gynecologic Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX, United States d Department of Gynecologic Oncology, Morristown Memorial Hospital, Morristown, NJ, United States b
a r t i c l e
i n f o
Article history: Received 25 October 2010 Accepted 17 April 2011 Available online 8 May 2011 Keywords: Human papillomavirus Vaccine Gardasil Pregnancy
a b s t r a c t Objective: To evaluate the willingness of pregnant women to accept the HPV vaccine for their newborns as well as themselves. Methods: An 18-item questionnaire was distributed to antepartum women. Demographic data about the respondent’s current pregnancy and her knowledge of HPV and the HPV vaccine was collected. Information about the respondent’s HPV and HPV vaccine status as well as her acceptance of the vaccine for herself during pregnancy and her newborn son and/or daughter after delivery was also collected. Results: Three hundred surveys were completed and available for review. Only 6 respondents (2%) had received the HPV vaccine. Despite the small group of patients who had previously been vaccinated, 112 respondents (37.3%) stated that they would receive the HPV vaccine during pregnancy if recommended by an obstetrician. 99 respondents (33%) stated that they would vaccinate their newborn female infant and 83 (27.7%) stated would vaccinate their male infants. Conclusion: Providing the HPV vaccine to pregnant women as well as newborns could be an important way to increase the patient population who is protected against HPV. A percentage of pregnant women are willing to accept the vaccine for themselves and their newborns. © 2011 Elsevier Ltd. All rights reserved.
1. Introduction Human papillomavirus (HPV) is the most commonly diagnosed sexually transmitted infection in the United States and represents the causative agent in over 99% of cervical cancer cases. A quadrivalent HPV vaccine has been available in the United States since June 2006 and the U.S. Food and Drug Administration licensed a bivalent HPV vaccine in 2009. Although long-term follow-up is necessary to demonstrate reductions in cervical cancer incidence and mortality, these prophylactic HPV vaccines have proven to be highly effective in preventing both HPV infection as well as precancerous cervical dysplasia [1]. The Advisory Committee on Immunization Practices currently recommends vaccinating female adolescents, 11–12 years of age. However, the vaccine has been approved for women between 9 and 26 years of age [2]. As the vaccine does not eliminate HPV
∗ Corresponding author at: Department of Gynecologic Oncology, Women’s Cancer Center, Morristown Memorial Hospital, 100 Madison Avenue, Morristown, NJ 07962, United States. E-mail address: [email protected] (B.M. Slomovitz). 0264-410X/$ – see front matter © 2011 Elsevier Ltd. All rights reserved. doi:10.1016/j.vaccine.2011.04.062
after a patient is infected, it is preferable to vaccinate patients prior to exposure to the virus. Clinical trials have demonstrated protection against HPV infection for at least five and a half years but, it is believed that the vaccine is effective for much longer [3]. Studies are currently in progress to determine the exact duration of protection. The success of future HPV programs depends on the availability of the vaccine to as many at-risk patients as possible, especially before they are exposed to the vaccine. Although newborns are not exposed to sexually transmitted infections for many years, there is precedence for early vaccination. In 2006, the Centers for Disease Control and Prevention (CDC) began recommending the implementation of a universal infant vaccination beginning at birth to eliminate the hepatitis B virus [4]. In addition, there is also precedence for administering vaccines to women during pregnancy as the CDC recommends the influenza vaccine in all pregnant women, regardless of gestational age during influenza season [5]. Although the HPV vaccine is not yet approved in women during pregnancy, the acceptance of the vaccine by this population of patients would also improve the success of future HPV programs. The purpose of this study was to evaluate the willingness of pregnant women to accept the HPV vaccine for their newborns as
K.P. Heyman et al. / Vaccine 29 (2011) 4618–4622 Table 1 Summary of patient demographics.
Information Collected 1.
Age
2.
Race
3.
Religion
4.
Education level
5.
Marital status
4619
6.
Expected delivery date
7.
Sex of newborn
8.
Is this your first pregnancy? If no, how many previous pregnancies have you had?
9.
Is this your first delivery? If no, how many previous deliveries have you had?
10. Have you ever heard of HPV? If yes, where have you heard of it? 11. Are you aware that HPV can cause cervical cancer? 12. Have you ever heard of the HPV vaccine? If yes, where have you heard of it? 13. Are you currently vaccinated against any STD? If yes, do you know which one(s)? 14. Have you ever been HPV positive? If yes, are you still HPV positive? 15. Have you received the HPV vaccine? 16. If your ob/gyn recommended that you get the HPV vaccine during your pregnancy, would you be willing to get it? If no, why not? 17. Have you received any vaccine during this pregnancy or any previous pregnancy? 18. Currently the HPV vaccine is effective for up to 7 years. The duration of protection may be much longer (these studies are currently ongoing). If it is shown that the vaccine would be effective with a prolonged duration of protection if administered as part of newborn vaccinations, would you let your pediatrician administer the vaccine to your daughter? Son? (before
Variable
Number
Mean age (years) Race Black/African American Hispanic Asian White/Caucasian Other Blank Religion Catholic Jewish Buddhist Protestant Hindu Muslim None Other Blank Marital status Single Married Divorced Education level Less than high school Completed high school Completed college Professional degree Other Blank First pregnancy Yes No First delivery Yes No Blank Trimester 1st 2nd 3rd Blank Sex of fetus(es) Male Female Unknown Both Blank
33 (range 16–47) 29 (9.7%) 58 (19.3%) 33 (11.0%) 159 (53.0%) 17 (5.7%) 4 (1.3%) 107 (35.7%) 40 (13.3%) 2 (0.7%) 28 (9.3%) 10 (3.3%) 11 (3.7%) 60 (20%) 37 (12.3%) 5 (1.7%) 49 (16.3%) 248 (82.7%) 3 (1%) 13 (4.3%) 58 (19.3%) 109 (36.3%) 118 (39.3%) 1 (0.3%) 1 (0.3%) 133 (44.3%) 167 (55.7%) 182 (60.7%) 116 (38.7%) 2 (0.7%) 18 (6%) 104 (34.7%) 169 (56.3%) 9 (3%) 108 (36%) 91 (30.3%) 90 (30%) 8 (2.7%) 3 (1%)
leaving the hospital? within the first six months?) Fig. 1. Sample of patient survey.
well as themselves. If potential barriers to acceptance are identified early, they can be addressed when the vaccine becomes available to these populations of patients. 2. Materials and methods After approval was received from the institutional review board, surveys were distributed to antepartum women between June 2008 and August 2008. The respondents were outpatients at two obstetrics and gynecology clinics at NewYork-Presbyterian Hospital/Weill Medical College of Cornell University. Four hundred and four potential participants were approached by a medical student, who determined their willingness to participate in the survey. Surveys were available in both English and Spanish. Those who were unable to read either English or Spanish were excluded. An 18-item questionnaire was used (Fig. 1). After completing the first 13 questions, each participant received an educational component before completing the last 5 questions. The first part of the questionnaire collected demographic data as well as information about the respondent’s current pregnancy and her knowledge of
HPV and the HPV vaccine. The educational component provided current facts about HPV, the vaccine and cervical cancer. The second part of the questionnaire collected information about the respondent’s HPV and HPV vaccine status as well as her acceptance of the vaccine for herself during pregnancy and her newborn son and/or daughter after delivery (before leaving the hospital and within the first six months). Descriptive statistics were used to evaluate patient responses. Subgroup analyses were conducted according to age, race, religion, educational level, marital status, sex of newborn, and pregnancy history. Chi-square analysis was performed to compare the results from these groups. 3. Results Three hundred surveys were completed and available for review. Patient demographics are shown in Table 1. Patient knowledge of HPV and the HPV vaccine are summarized in Table 2. A large majority of patients stated that they had prior knowledge of HPV (237, 79%) and the HPV vaccine (217, 72.3%). The most common source of information stated for both areas was television. While 18 respondents (6%) stated that they had previously been
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Table 2 Description of patient awareness of HPV and HPV vaccine. Variable
Number
Prior knowledge of HPV virus Source of HPV knowledge Television OBGYN News Media Another MD Internet Friend Other Prior knowledge of HPV vaccine Source of HPV vaccine knowledge Television OBGYN News Media Another MD Internet Friend Other Previously received the HPV vaccine Would receive HPV vaccine during pregnancy
237 (79%) 148 (62.5%) 116 (48.9%) 72 (30.4%) 34 (14.4%) 31 (13.1%) 40 (16.9%) 25 (10.6%) 217 (72.3%) 167 (77.0%) 55 (25.3%) 64 (29.5%) 25 (11.5%) 24 (11.1%) 19 (8.8%) 13 (6.0%) 6 (2%) 112 (37.3%)
vaccinated against a sexually transmitted disease (e.g. HPV and hepatitis B), only 6 respondents (2%) had received the HPV vaccine. Despite the small group of patients who had previously been vaccinated, 112 respondents (37.3%) stated that they would receive the HPV vaccine during pregnancy if recommended by an obstetrician. Common concerns with receiving the HPV vaccine during pregnancy included: perceived side effects to the fetus, the belief that they were not at high risk of becoming infected and the need for more information. Many women also responded that they were opposed to vaccines in general or that they were opposed to taking any medication or receiving any vaccine during pregnancy. Many respondents cited being over the age limit recommended by the CDC and some women cited the high cost, the recent development of the vaccine, and the lack of long-term studies. Several women commented that they would wait until after their delivery to receive the vaccine and one woman responded that men should receive the vaccine instead of women. There were no significant differences among patients that would be willing to receive HPV vaccination during pregnancy, with respect to: fetal sex, education level, marital status, religion, prior knowledge of the HPV vaccine or whether this was their first pregnancy. However, 46 (41.1%,) of the 112 respondents who would receive vaccination during pregnancy were categorized as white/Caucasian. Hispanic (28, 25.0%) and black/African American (18, 16.1%) respondents were the next most likely to receive vaccination. Asian (10, 8.9%) respondents were the least likely to receive antepartum vaccination (Table 3). If the duration of protection allowed for vaccination without requiring a booster and if recommended as part of a newborn vaccination program, 99 respondents (33%) stated that they would vaccinate their newborn female infant. Within this group, 38 (12.7%) desired vaccination prior to hospital discharge and 61 (20.3%) would have the vaccination within the first 6 months of life. For male infants, 83 (27.7%) respondents desired vaccination. Thirty (10.0%) respondents desired vaccination prior to hospital discharge and 53 (17.7%) respondents would have the vaccination administered within the first 6 months of life (Table 4). Some women did not respond to this question regarding a daughter if they were having a son and other women did not respond to this question regarding a son if they were having a daughter so the results may reflect a lower than expected acceptance. In addition, some women misunderstood the survey and cited their reluctance to vaccinate their newborn as a result of the vaccine only lasting 7 years.
Table 3 Comparison of characteristics among patients willing to receive HPV vaccine during pregnancy (n = 112). Variable
Number
Fetal sex Female Male Unknown Both Blank Education level Less than high school Completed high school Completed college Professional degree Other Blank First pregnancy Yes No Prior knowledge of HPV vaccine Yes No Marital status Single Married Divorced Religion Catholic Jewish Buddhist Protestant Hindu Muslim None Other Blank Race Black/African American Hispanic Asian White/Caucasian Other Blank
P value 0.514
34 (30.4%) 44 (39.3%) 29 (25.9%) 4 (3.6%) 1 (0.9%) 0.187 9 (8.0%) 28 (25.0%) 39 (34.8%) 35 (31.2%) 0 (0%) 1 (0.9%) 0.614 45 (40.2%) 67 (59.8%) 0.724 86 (76.8%) 26 (23.2%) 0.779 21 (18.8%) 90 (80.4%) 1 (0.9%) 0.676 44 (39.3%) 11 (9.8%) 1 (0.9%) 9 (8.0%) 3 (2.7%) 7 (6.2%) 22 (19.6%) 13 (11.6%) 2 (1.8%) 0.011 18 (16.1%) 28 (25.0%) 10 (8.9%) 46 (41.1%) 6 (5.4%) 4 (3.6%)
Among 83 women willing to vaccinate their male infant, 35 (42.2%) held a professional degree, 60 (72.3%) had prior knowledge of the HPV vaccine and 45 (54.2%) were white/Caucasian. There was no significant difference in if this was their first pregnancy, marital status or religion (Table 5). Patient characteristics of women willing to vaccinate their female infant are shown in Table 6. Among 99 women, 37 (37.4%) held a professional degree. However, there was no significant difference with respect to if the current pregnancy was their first, if they had prior knowledge of the HPV vaccine, marital status, religion or race. Most of the women who would not accept the vaccine for their newborn daughter responded that they were trying to minimize the number of vaccines given to their newborn and some
Table 4 Willingness to vaccinate infant. Sex of Infant
Response
Number
Male
Yes, before discharge home Yes, <6 months of age No Unsure Blank Yes, before discharge home Yes, <6 months of age No Unsure Blank
30 (10.0%) 53 (17.7%) 120 (40.0%) 26 (8.7%) 69 (23.0%) 38 (12.7%) 61 (20.3%) 135 (45.0%) 33 (11.0%) 31 (10.3%)
Female
K.P. Heyman et al. / Vaccine 29 (2011) 4618–4622 Table 5 Comparison of characteristics among patients willing to vaccinate their male infant (n = 83). Variable Education level Less than high school Completed high school Completed college Professional degree Other Blank First pregnancy Yes No Prior knowledge of HPV vaccine Yes No Marital status Single Married Divorced Religion Catholic Jewish Buddhist Protestant Hindu Muslim None Other Blank Race Black/African American Hispanic Asian White/Caucasian Other Blank
Number
P value 0.01
4 (4.8%) 22 (26.5%) 21 (25.3%) 35 (42.2%) 0 (0%) 1 (1.2%) 0.692 34 (41.0%) 49 (59.0%) 0.011 60 (72.3%) 22 (26.5%)
Education level Less than high school Completed high school Completed college Professional degree Other Blank First pregnancy Yes No Prior knowledge of HPV vaccine Yes No Marital status Single Married Divorced Religion Catholic Jewish Buddhist Protestant Hindu Muslim None Other Blank Race Black/African American Hispanic Asian White/Caucasian Other Blank
responded that they were opposed to all newborn vaccines. Several women cited their fear of newborn vaccines causing autism and one woman was worried that it would interact with other vaccines. Many respondents cited the need for more information, the newness of the vaccine, and the unknown long-term effects. One woman indicated her mistrust of new drugs and the FDA approval process, another woman wanted her daughter to be able to choose for herself, and one woman responded that she would teach her daughter to use a condom instead. In July 2008, there were many news stories about potential adverse events of the HPV vaccine and several women cited the bad press in the subsequent questionnaires [6]. The respondents cited many of the same concerns about vaccinating their newborn sons. In addition, some women responded that they were unsure how HPV affects males and that males are not at risk of cervical cancer.
0.453 15 (18.1%) 68 (81.9%) 0 (0%)
4. Discussion 0.275
22 (26.5%) 9 (10.8%) 0 (0%) 5 (6.0%) 3 (3.6%) 5 (6.0%) 25 (30.1%) 12 (14.5%) 2 (2.4%) 0.031 13 (15.7%) 15 (18.1%) 6 (7.2%) 45 (54.2%) 2 (2.4%) 2 (2.4%)
Table 6 Comparison of characteristics among patients willing to vaccinate their female infant (n = 99). Variable
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Number
P value 0.011
3 (3.0%) 29 (29.3%) 29 (29.3%) 37 (37.4%) 0 (0%) 1 (1.0%) 0.094 37 (37.4%) 62 (62.6%) 0.181 64 (64.6%) 34 (34.3%) 0.505 15 (15.2%) 84 (84.8%) 0 (0%) 0.132 31 (31.3%) 10 (10.1%) 0 (0%) 7 (7.1%) 4 (4.0%) 6 (6.1%) 24 (24.2%) 14 (14.1%) 3 (3.0%) 0.088 14 (14.1%) 21 (21.2%) 9 (9.1%) 50 (50.5%) 4 (4.0%) 1 (1.0%)
The effectiveness of an HPV vaccination program would be greatly enhanced by the availability of the vaccine to as many patient populations as possible, including pregnant women and newborns. In our survey of 300 antepartum women between the ages of 16 and 47, we found a limited willingness to accept the HPV vaccine for themselves and their newborns. While 37.3% of respondents would be willing to receive the vaccine during pregnancy, 33.0% of women were willing to vaccinate their newborn daughter and 27.7% were willing to vaccinate their newborn son. Many women cited the recent development of the vaccine and the lack of long-term studies as reasons for not accepting the vaccine. In addition, many women were opposed to receiving any vaccine during pregnancy and many women wanted to limit the number of vaccines administered to their newborn. Despite the variety of concerns about vaccinating a newborn, a large percentage of respondents commented that they would be willing to vaccinate their child at a later age. The ages cited for daughters included: after 6 months, at 12 months, 6–8 years, 12–13 years, as a teenager, at puberty and when sexually active. For sons, respondents cited ages including: after 6 months and at school age. In our study, only 8.3% of women were willing to receive any form of antepartum vaccination. These findings are consistent with other studies displaying an apprehension about taking any medication or receiving any vaccine during pregnancy, even if recommended by a physician. Although the CDC currently recommends the influenza vaccine for all pregnant women, Silverman et al. found that 44% of women interviewed during the postpartum period said they believed that all vaccines should be avoided during pregnancy [7]. Despite women’s apprehension, Ogburn et al. found that influenza vaccination rates in pregnant women increased from <1% to 37% in a prenatal clinic over two years as a result of interventions to increase immunization rates. These included provider and staff education, stocking of the vaccine in the clinic and implementation of standing orders [8]. These interventions may provide equal success in improving acceptance of the HPV vaccine if recommended during pregnancy. Currently, many parents of newborns are reluctant to accept any vaccine for their newborn for many reasons including the potential risk of developing autism. Despite compelling scientific evidence against a causal association, many parents and parent advocacy groups continue to suspect that vaccines can cause autism [9]. As a result, acceptance of the HPV vaccine for newborns may have been higher several years ago before the association with autism was suspected. Many studies have determined the need for educational programs as well as an understanding of patients’ concerns in order to increase vaccination rates. Návar et al. reported that only 23% of
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surveyed obstetric practices reported providing pregnant women with information on routine childhood immunizations and that 20% of surveyed hospitals did not provide information about routine childhood immunizations to prenatal class participants [10]. The conclusion was that prenatal visits are a missed opportunity for providing education about infant immunizations and that incorporating immunization education into routine obstetric prenatal care may increase maternal knowledge of infant vaccines and reduce delayed immunization. In a review examining barriers, benefits, and risks of immunizations, Kimmel et al. determined that physicians must be knowledgeable about vaccines and incorporate systems to record, remind, and recall patients for vaccinations [11]. In addition, they must clearly communicate vaccine benefits and risks while understanding those factors that affect an individual’s acceptance and perception of those benefits and risks. Reluctance to accept the HPV vaccine may also be due in part to a lack of knowledge about the virus, as many studies indicate that patients have a limited understanding of HPV [12,13]. In our study, the majority of respondents had heard of HPV and knew that it caused cervical cancer, but many women seemed surprised by the idea of vaccinating their son as males. In a study of 227 women, Watts et al. found that 70% of respondents agreed to vaccinate their daughters and 86% of participants agreed to vaccinate their sons [14]. Cervical cancer prevention and anal/penile cancer prevention were the primary motivation reported for accepting the vaccine in their daughters and sons, respectively. If the educational component of our study had indicated the association between HPV and other cancers including anal/penile cancer, perhaps more respondents would have showed a willingness to vaccinate their sons. There were several limitations to this study. The HPV vaccine is not currently recommended for pregnant women or newborns so it is difficult to determine the acceptance. In addition, there are no long-term studies about the vaccine’s effectiveness and safety and there was negative publicity at the time of the study about the vaccine’s potential side effects. Finally, our sample size was small and our results only represent the views of patients visiting two obstetrics and gynecology clinics at one hospital. In conclusion, providing the HPV vaccine to pregnant women as well as newborns could be an important way to increase the patient
population who is protected against HPV. This study illustrates that a percentage of pregnant women are willing to accept the vaccine for themselves and their newborns. The study also identified potential barriers to acceptance that must be addressed before the vaccine becomes available to these populations. References [1] Rambout L, Hopkins L, Hutton B, Fergusson D. Prophylactic vaccination against human papillomavirus infection and disease in women: a systematic review of randomized controlled trials. CMAJ 2007;177(August (5)):469–79. [2] Centers for Disease Control and Prevention. Quadrivalent human papillomavirus vaccine: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep 2007;56:1–24. [3] Villa LL, Costa RL, Petta CA, Andrade RP, Paavonen J, Iversen OE, et al. High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up. Br J Cancer 2006;95(December (11)):1459–66. [4] Advisory Committee on Immunization Practices (ACIP). A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). Part 1: Immunization of infants, children, and adolescents. MMWR Recomm Rep 2005;54(December (RR-16)):1–31. [5] Advisory Committee on Immunization Practices, Smith NM, Bresee JS, Shay DK, Uyeki TM, Cox NJ, Strikas RA. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2006;55:1–42. [6] “Should parents worry about HPV vaccine?”. http://www.cnn.com/ 2008/HEALTH/conditions/07/07/cervical.cancer.vaccine/. [7] Silverman NS, Greif A. Influenza vaccination during pregnancy. Patients’ and physicians’ attitudes. J Reprod Med 2001;46:989–94. [8] Ogburn T, Espey EL, Contreras V, Arroyo P. Impact of clinic interventions on the rate of influenza vaccination in pregnant women. J Reprod Med 2007;52(September (9)):753–6. [9] DeStefano F. Vaccines and autism: evidence does not support a causal association. Clin Pharmacol Ther 2007;82(December (6)):756–9. [10] Návar AM, Halsey NA, Carter TC, Montgomery MP, Salmon DA. Prenatal immunization education the pediatric prenatal visit and routine obstetric care. Am J Prev Med 2007;33(September (3)):211–3. [11] Kimmel SR, Burns IT, Wolfe RM, Zimmerman RK. Addressing immunization barriers, benefits, and risks. J Fam Pract 2007;56(February):S61–9. [12] Walsh CD, Gera A, Shah M, Sharma A, Powell JE, Wilson S. Public knowledge and attitudes towards Human Papilloma Virus (HPV) vaccination. BMC Public Health 2008;8(October):368. [13] Nøhr B, Munk C, Tryggvadottir L, Sparén P, Tran TN, Nygård M, et al. Awareness of human papillomavirus in a cohort of nearly 70,000 women from four Nordic countries. Acta Obstet Gynecol Scand 2008;87(10):1048–54. Links. [14] Watts LA, Joseph N, Wallace M, Rauh-Hain JA, Muzikansky A, Growdon WB, et al. HPV vaccine: a comparison of attitudes and behavioral perspectives between Latino and non-Latino women. Gynecol Oncol 2009;(January).