Vaccine
Volume 33, Issue 8, Pages 943-1098 (18 February 2015)
http://www.sciencedirect.com/science/journal/0264410X/33/8

Commentary
Open vial policy in India—A commentary
Pages 943-945
S.K. Panigrahi, S. Mahapatro

Reviews
An assessment of enterotoxigenic Escherichia coli and Shigella vaccine candidates for infants and children
Review Article
Pages 954-965
Richard I. Walker
Abstract
Highlights
:: ETEC and Shigella are the most important bacterial pathogens for which there is no licensed vaccine.
:: Cellular and subunit vaccine approaches are currently under development for both pathogens.
:: There are several possible strategies for maximizing the potential benefit of these vaccines.
:: Impact studies show that ETEC and Shigella vaccines could strongly benefit global public health.

Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy
Review Article
Pages 966-972
Jeffrey N. Roberts, Marion F. Gruber
Abstract
Despite supportive public health policies (e.g., ACIP recommendations), the potential for providing clinical benefit through maternal immunization has yet to be fully realized. For vaccines already licensed and approved for use in adults, specific FDA approval for use during pregnancy to prevent disease in the mother and/or infant may have a significant impact on uptake and usage in pregnant women. In addition, for either a licensed vaccine or a novel vaccine, FDA approval for use during pregnancy would result in labeling that would serve as a resource for practitioners and would facilitate the safe and effective use of the vaccine during pregnancy.
In the U.S., while many vaccines are approved for use in adults and most are not contraindicated for use in pregnant women, no vaccine is licensed for use specifically during pregnancy. Among the perceived obstacles hindering the clinical development of vaccines for use in pregnancy, regulatory issues are frequently cited. One aim of this article is to address the perceived regulatory obstacles. General concepts and regulatory considerations for clinical safety and effectiveness evaluations for vaccines indicated for use during pregnancy will be discussed. This discussion is not intended to establish data requirements or to articulate agency policy or guidance regarding specific vaccine products.

Human papillomavirus vaccination: Assessing knowledge, attitudes, and intentions of college female students in Lebanon, a developing country
Original Research Article
Pages 1001-1007
Mohammed Dany, Alissar Chidiac, Anwar H. Nassar
Abstract
Human papillomavirus (HPV) infection is a common cause for genital warts and cervical cancer. Developing countries in the Middle East such as Lebanon are traditionally considered to be conservative societies with low incidence of sexually transmitted infections. However, nowadays, there is an unexpected increase in the incidence of HPV infections among Middle Eastern females. Thus, the objective of this study is to assess the behavioral perceptions of HPV vaccination among female students attending an academic institution in Lebanon. This cross-sectional study invited 512 students to complete a self-administered questionnaire that assessed the knowledge, attitudes, and intentions towards HPV vaccination. Data analysis included the calculation of knowledge scores ranging from 0 to 100, attitude scores ranging from most positive (1) to most negative (5), and intention scores ranging from lowest intention (0) to highest intention (10). With a response rate of n = 215 (42%), 36.5% never heard of the vaccine before, and only 16.5% were already HPV vaccinated. The median knowledge score of 52.7% ± 1.71 reflects poor to moderate knowledge. Still, the median attitude score of 2.47 ± 0.05 shows a general positive attitude towards HPV vaccination where most of the participants agreed that female college students in Lebanon have a good chance of contracting HPV (62.1%) and that all gynecologists should recommend the vaccine (76.0%). Students in graduate programs, health related majors, and those who are vaccinated had significantly higher knowledge scores compared with students in undergraduate programs, non-health related majors, and HPV non-vaccinated students, respectively. Finally, the survey helped in increasing the intention to obtain HPV vaccine as the intention score increased significantly from 5.24 ± 0.27 before the students went through the survey to 6.98 ± 0.22 after the students completed the survey. Our study highlights the importance of offering guidance to female college students about HPV and its vaccination in developing countries where the incidence of sexually transmitted infections is on the rise.

Intussusception risk after RotaTeq vaccination: Evaluation from worldwide spontaneous reporting data using a self-controlled case series approach
Original Research Article
Pages 1017-1020
Sylvie Escolano, Catherine Hill, Pascale Tubert-Bitter
Abstract
The increased risk of intussusception after vaccination with the rhesus-human reassortant rotavirus vaccine Rotashield led to its withdrawal in 2005. We assess the risk of intussusception following the pentavalent rotavirus vaccine (RV5) on the basis of worldwide reports to the manufacturer up to May 2014, using a self-controlled case series. The method had to be modified to account for the under-reporting, a specific feature of pharmacovigilance spontaneous reports. The risk of intussusception occurring in either of the 0- to 2-day, 3- to 7-day or 8- to 14-day risk periods, was compared to the risk in the 15- to 30-day period. A total of 502 cases occurring 0–30 days after a vaccine dose were studied, including 188 cases after the first dose, 190 cases after the second dose, and 124 cases after the third dose. The incidence risk ratio relative to the control period was highest for the 3- to 7-day period and equal to 3.45 (95% CI 1.84–6.55), 1.63 (0.86–3.13) and 1.73 (0.86–3.51) after the first, second and third dose, respectively. Rotavirus vaccination with RV5 increases the risk of intussusception 3–7 days following vaccination, mainly after the first dose and marginally after the second and third doses. The risk is small and restricted to a short time window. It does not outweigh the benefit of the vaccination, but parents of vaccinated infants should be informed in order to react appropriately to the first symptoms. With appropriate assumptions about the reporting rate, spontaneous reports of adverse events after vaccination can be studied to evaluate vaccine safety.

Vaccine-criticism on the internet: New insights based on French-speaking websites
Original Research Article
Pages 1063-1070
Jeremy K. Ward, Patrick Peretti-Watel, Heidi J Larson, Jocelyn Raude, Pierre Verger
Abstract
The internet is playing an increasingly important part in fueling vaccine related controversies and in generating vaccine hesitant behaviors. English language Antivaccination websites have been thoroughly analyzed, however, little is known of the arguments presented in other languages on the internet. This study presents three types of results: (1) Authors apply a time tested content analysis methodology to describe the information diffused by French language vaccine critical websites in comparison with English speaking websites. The contents of French language vaccine critical websites are very similar to those of English language websites except for the relative absence of moral and religious arguments. (2) Authors evaluate the likelihood that internet users will find those websites through vaccine-related queries on a variety of French-language versions of google. Queries on controversial vaccines generated many more vaccine critical websites than queries on vaccination in general. (3) Authors propose a typology of vaccine critical websites. Authors distinguish between (a) websites that criticize all vaccines (“antivaccine” websites) and websites that criticize only some vaccines (“vaccine-selective” websites), and between (b) websites that focus on vaccines (“vaccine-focused” websites) and those for which vaccines were only a secondary topic of interest (“generalist” websites). The differences in stances by groups and websites affect the likelihood that they will be believed and by whom. This study therefore helps understand the different information landscapes that may contribute to the variety of forms of vaccine hesitancy. Public authorities should have better awareness and understanding of these stances to bring appropriate answers to the different controversies about vaccination.