Rotavirus vaccine administration patterns in Italy: potential impact on vaccine coverage, compliance and adherence

Abstract

Acceptance of rotavirus (RV) vaccination may be impacted by several factors including the feasibility of the full schedule administration within the fixed immunization timelines. The human RV vaccine Rotarix (GSK) and the human bovine reassortant vaccine RotaTeq (Merck & Co.) were developed with different posologies (2 doses vs 3 doses respectively), which have both scientific and technical implications. A nonsystematic literature review revealed that, in the Italian context, topics such as time to achieve RV protection in children, number of preventable cases and administration time window, compatibility/ ease of inclusion in the national vaccination calendar, potential overlaps with the peak of natural history of intussusception and adherence to posology could be impacted by the RV vaccine posology. Results suggest that a shorter schedule would allow for greater flexibility of use as well as a greater documented ease of inclusion in the vaccination calendar, thereby reducing potential direct healthcare costs.

Reply letter in response to “Letter to the editor in response to: Rotavirus vaccine administration patterns in Italy: potential impact on vaccine coverage, compliance and adherence, Martinelli D et al., Human Vaccines & Immunotherapeutics 2020” by Carias and colleagues

“…7 Concerning differences in schedule compliance and series completion between the two vaccines, our intent was not to fully draw the picture of current compliance rates in the United States, as done by Carias et al 1 but rather to show consistencies of the figures reported by Aquilani et al in their Italian experience with reports coming from other countries with wellestablished rotavirus universal vaccination, such as USA but also Mexico and Belgium. 2 Finally, we are not sure about the relevance of the durability of protection reported by Carias et al 1 as it was not considered in the context of our paper and both vaccines exert a 3-years lasting protection in infants according to their SmPCs. 3,4 In conclusion, we appreciated the comments on our review which presented an opportunity to further elaborate on its contents.…”

“…We read with interest the Letter from Carias et al 1 dealing with our paper on the potential impact on vaccine coverage, compliance and adherence exerted by the two different rotavirus vaccines (RotaTeq human bovine reassortant vaccine (HBRV) -Rotarix human rotavirus vaccine (HRV)) available in Italy. 2 The authors provided some comments on our review that in principle we certainly appreciated, as they add valuable information for the readers. Nevertheless, we respectfully comment on the arguments of the Letter which may provide a better perspective.…”

Letter to the editor in response to: Rotavirus vaccine administration patterns in Italy: potential impact on vaccine coverage, compliance and adherence

“…8 The authors also discuss the impact of the maximum age for series completion on averted cases: "If we consider the maximum vaccination periods, i.e., 24 weeks (HRV) [RV1] or 32 weeks (HBRV) [RV5], a delay of 8 weeks may lead to an estimate of approximately 120 unprevented hospitalizations due to RVGE per year". 1 Such calculations do not reflect the established epidemiology of the disease, and vaccine efficacy and effectiveness estimates from clinical trials and observational studies that show high vaccination effectiveness after the first dose. RV5 has been demonstrated to confer protection between the first and second doses, and between the second and third doses in post-hoc clinical trial analyses.…”

“…9 Martinelli et al emphasize differences in schedule compliance and series completion between the two vaccines, stating that "During the first 6 months after RV vaccination implementation, 770 (19.7%) of the 3,912 children vaccinated with HBRV [RV5] received their first dose outside the prescribed time limits." 1 The authors refer to a study involving the administration of 5,566 RV5 doses during the first 6 months of the RV5 vaccine availability (August 1, 2006, to January 31, 2007; the number of doses refer to those registered in the immunization system) in Philadelphia, PA, USA. 10 In this study, Daskalaki et al provided estimates from a single city in the immediate months following program implementation.…”

“…We read with interest the publication by Martinelli et al on rotavirus vaccines. 1 Rotavirus gastroenteritis is a diarrheal disease that, prior to universal vaccination, would infect virtually all children before the age of 5, causing high morbidity and infant mortality in low-resource settings. 2 Currently, there are two rotavirus vaccines licensed for use in Europe: Rotarix (RV1, that contains one human rotavirus strain), produced by GlaxoSmithKline and RotaTeq (also known as RV5, a live, oral vaccine that contains five reassortant rotavirus strains developed from human and bovine parent rotavirus strains, produced by Merck & Co., Inc., Kenilworth, NJ, USA).…”