Rotavirus gastroenteritis can lead to serious illness or death, a significant burden on children and families and considerable health care costs, even in developed nations.1 Consequently, many countries have adopted universal publicly funded rotavirus vaccination programs. Although recommended by Canada’s National Advisory Committee on Immunization and the European Society for Pediatric Infectious Diseases, not all jurisdictions in Canada or Europe have implemented such programs.1,2 The purpose of this study was to determine the uptake and determinants of rotavirus vaccination in a privately funded program, to inform future vaccine policy decision-making in jurisdictions considering adopting a universal program.
This retrospective population-based cohort study of children born between January 1, 2008, and December 31, 2013, took place in the Canadian province of Alberta, population 4.1 million. During the study period, there was no universal rotavirus vaccine program, but 2 rotavirus vaccines were available for private purchase: RotaTeq, a pentavalent vaccine requiring 3 doses, and Rotarix, a monovalent vaccine requiring 2 doses.1 In Canada, both brands are recommended for oral administration starting at 6 weeks of age, with series completion by 32 weeks of age (differing from the recommended age of 24 weeks for Rotarix listed in the drug monograph). The cost of the vaccine (≈$250–300 for the full vaccine series) was paid by the parent or through private health insurance programs.
All privately funded vaccines are dispensed by pharmacies in Alberta, and dispensing data are submitted daily to the Pharmaceutical Information Network database by 97% of community pharmacies.3 We calculated vaccine coverage, that is, the number of children who were dispensed ≥1 doses of either rotavirus vaccine during the recommended administration period (≥6 to ≤32 weeks) divided by the number of age-eligible children. The eligible population and determinants of uptake were ascertained from 2 databases, with data available through December 31, 2014: Alberta Vital Statistics, which includes every live birth in Alberta, and the Alberta Health Care Insurance Plan, which includes information on all Alberta residents in the publicly funded health care plan (99% of the population) and identifies deaths and departures from the province. We calculated the proportion of vaccinated children who completed the vaccine series (those who received 3 doses of RotaTeq or 2 doses of Rotarix between 6 and 32 weeks) and schedule noncompliance (those who received a dose(s) at <6 weeks or >32 weeks to 12 months). We compared the characteristics of children who received ≥1 doses of either vaccine during the recommended period to those with no doses in a multivariable logistic regression model. Postal code at birth was used to determine neighborhood income quintile and rural/urban status based on Canada Census data. Data were linked using unique lifetime identifiers, and analyses were conducted using SAS version 9.3. Ethical consent was obtained from the University of Alberta Health Research Ethics Board.
After exclusions for death or departure from the province before age 12 months, the final study population was 299,486. Only 8067 (2.7%) children received ≥1 rotavirus vaccine doses during the recommended time frame of 6–32 weeks of age. Half (52.1%, n = 4205) of vaccinated children completed the series; an additional 25.3% (n = 2044) received 2 doses of RotaTeq, which may confer immunity.4 Of those vaccinated, 7.9% (n = 635) received a dose(s) before 6 weeks and 3.8% (n = 308) after 32 weeks of age. Of all doses administered, 98.6% (n = 7951) were RotaTeq. Only 6 children received both RotaTeq and Rotarix doses.
Table 1 presents rotavirus vaccine coverage and the characteristics of children who received ≥1 doses between 6 and 32 weeks as compared with those who received no doses. Vaccine coverage increased from 1.2% in 2008 to 4.0% in 2013 and did not differ by child’s sex. Children living in urban and higher income areas were more likely to be vaccinated; there was an interaction effect, with higher income positively influencing coverage in urban areas, but having no effect in rural areas. Vaccine coverage was higher in non-First Nations children (adjusted odds ratio 2.29, 95% confidence interval: 1.780–2.94) and among married mothers (adjusted odds ratio 1.76, 95% confidence interval: 1.64–1.88). The likelihood of vaccinating increased in a stepwise manner as number of children in the household decreased and with increasing maternal age. Children born preterm (<36 weeks) were more likely to be vaccinated than full-term infants (adjusted odds ratio 1.32, 95% confidence interval: 1.23–1.42).
Coverage for privately funded rotavirus vaccine in Alberta was low, ranging from 1.2% the year of vaccine introduction to 4.0%, where it plateaued in 2012. Coverage in our study is lower than that reported in other Canadian provinces (12.7%–42%) and European countries (5%–35%) with privately funded models.2,5,6 This may be due to regional disease awareness, vaccination practices, or type of care provider, but differences in data sources (eg, parent-report) and method of calculating coverage may also play a role. Uptake of other recommended vaccines (eg, varicella) before implementation of publicly funded programs is known to be low and is largely dependent on parents’ perception of vulnerability and severity of the disease, the safety and effectiveness of the vaccine and their willingness or ability to pay.7,8 These are all influenced by health care providers’ recommendations.5,7 In the case of rotavirus, Canadian pediatricians, family doctors and nurses all ranked rotavirus vaccine as the lowest priority of all the new vaccines entering the market.8 Uptake is expected to increase significantly in Alberta since the vaccine became publicly funded in June 2015.
Only 52.1% of children vaccinated had completed the full vaccine series. If the 2044 children who received 2 doses of RotaTeq are considered immune, as has been proposed in recent literature,4 protection increases to 77.5% of those vaccinated. This suggests that series completion would improve with increased use of the 2-dose Rotarix vaccine.
Compliance with the recommended schedule was a problem, with 11.7% of children being dispensed vaccine doses outside the recommended period of 6–32 weeks. Interchanging vaccine brands was not a significant problem (n = 6). Schedule compliance is known to be higher in settings where the vaccine is part of the routine vaccination schedule.9 Thus, it is expected that compliance will improve in our setting now that the vaccine is part of the publicly funded vaccine program.
Our study was able to assess determinants of privately funded rotavirus vaccine uptake through deterministic linkage with individual-level data. The positive association between income and rotavirus vaccination in our study is not surprising, given that parents without supplementary private health insurance paid up to $300 for the complete vaccine series. A previous Canadian study found the same association.5 This highlights an important equity issue in accessing a vaccine that has been recommended by Canadian and European vaccine advisory committees. In addition to the cost of the vaccine being a direct deterrent to uptake, lack of public funding also sends a message to parents about the apparent importance of the vaccine.5 We found that even after controlling for income, younger mothers were the least likely to vaccinate. While no other rotavirus studies have assessed this association, uptake of other childhood vaccines have a similar pattern.10 The lower vaccine coverage in Canadian First Nations’ children, as with US and Australian aboriginal children, is cause for concern given that these populations have historically exhibited much higher incidence of rotavirus disease.11 The increased likelihood of vaccinating with decreasing number of children in the household is consistent with another Canadian study of rotavirus vaccine.7 This association may be because of logistical problems in accessing services and the fact that rotavirus vaccine was not available when the older siblings were infants, thereby decreasing awareness or perceived importance among parents.7 It is reassuring that children born prematurely were more likely to receive the vaccine, given their higher risk for morbidity and mortality from rotavirus disease.12
We made the assumption that every dispensed dose was administered, given that parents were paying ≈$85–$150 per dose and travelling to the pharmacy to obtain the vaccine. If this is an incorrect assumption, vaccine coverage may be even lower. Our study was not able to assess the influence of maternal education, a variable that typically has a positive association with vaccine uptake.10 The Pharmaceutical Information Network database has only been in use since 2007 and has not been validated for research purposes. However, compliance with submission guidelines is closely monitored by the health ministry for clinical, policy and funding purposes.
Some Canadian jurisdictions and many European countries are still grappling with the issue of whether to introduce a universal publicly funded rotavirus vaccination program. Our study found that vaccine coverage in a privately funded model was very low, and high risk populations who would particularly benefit from the vaccine were largely unvaccinated. Failure to fund nationally recommended vaccines may lead to significant inequity in provision of preventive health care to vulnerable populations.
The authors thank Larry Svenson, Celine O’Brien and Stephen Freedman for their critical revision of the manuscript and support for this work.
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