The safety of H1N1 vaccine in children in Saudi Arabia

A cohort study using modern technology in a developing country

Hisham Aljadhey, Mesnad Alyabsi, Adel Alrwisan, Nasser Alqahtani, Reem Almutairi, Esraa Al Tawil, Mansour Adam, Saad Shakir, Majed Aljeraisy, Ali Al-Blowi, Hesham Alkhashan, Yasser Albogami, Michael D. Murray

Research output: Contribution to journalArticleResearchpeer-review

5 Citations (Scopus)

Abstract

Background: With its rapid introduction in 2009, concerns about the safety of the H1N1 vaccines have been raised. Data were especially limited on the pediatric safety of H1N1 vaccine in Saudi Arabia. Objectives: The objectives of this study were to investigate the safety of the H1N1 vaccine (Pandemrix®) in children and examine the feasibility of obtaining information on possibly associated adverse reactions using mobile telephone contact with child caregivers. Methods: A cohort study was conducted in Riyadh, Saudi Arabia. Patients were included if they were aged between 6 and 18 years and had received one dose of the H1N1 vaccine. A control group involved children from the same school system who had not received the vaccine. Six months following vaccination, a clinical pharmacist called the caregiver of the child to ask about hospitalization, emergency room visits and events related to H1N1 vaccine administration using a standardized questionnaire. Results: Caregivers of 372 school-age children were contacted. The response rate was 97% (n = 359). A total of 169 children who received at least one dose of the H1N1 vaccine were compared with 190 children in the control group who had not received the vaccine. Controlling for age, sex, education and use of medications, the odds ratio (OR) of hospitalization or emergency room visits for children within the 6 months after vaccination relative to the unvaccinated children was 1.25 (95% CI 0.47, 3.35). The risk of influenza-like symptoms was significantly reduced in vaccinated children compared with unvaccinated children (OR 0.63; 95% CI 0.41, 0.99). Conclusion: School-age children in Saudi Arabia who received the H1N1 vaccine did not have an increased risk of hospitalization or emergency room visits. Larger studies are needed to confirm these results. Proactive pharmacovigilance is important in assessing the safety of vaccines and other medications. It is feasible to collect information on adverse drug reactions using mobile telephones, a method that can be of benefit in both developed and developing countries.

Original languageEnglish
Pages (from-to)555-561
Number of pages7
JournalDrug Safety
Volume35
Issue number7
DOIs
Publication statusPublished - 25 Jun 2012

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Saudi Arabia
Developing countries
Developing Countries
Cohort Studies
Vaccines
Technology
Safety
Emergency rooms
Caregivers
Hospital Emergency Service
Cell Phones
Hospitalization
Vaccination
Telephone sets
Odds Ratio
Pediatrics
Pharmacovigilance
Control Groups
Telephone
Sex Education

Keywords

  • Emergency-department
  • Hospitalisation
  • Immunisation
  • Influenza-A-virus- vaccine-H1N1 Pharmacovigilance

Cite this

Aljadhey, Hisham ; Alyabsi, Mesnad ; Alrwisan, Adel ; Alqahtani, Nasser ; Almutairi, Reem ; Al Tawil, Esraa ; Adam, Mansour ; Shakir, Saad ; Aljeraisy, Majed ; Al-Blowi, Ali ; Alkhashan, Hesham ; Albogami, Yasser ; Murray, Michael D. / The safety of H1N1 vaccine in children in Saudi Arabia : A cohort study using modern technology in a developing country. In: Drug Safety. 2012 ; Vol. 35, No. 7. pp. 555-561.
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abstract = "Background: With its rapid introduction in 2009, concerns about the safety of the H1N1 vaccines have been raised. Data were especially limited on the pediatric safety of H1N1 vaccine in Saudi Arabia. Objectives: The objectives of this study were to investigate the safety of the H1N1 vaccine (Pandemrix{\circledR}) in children and examine the feasibility of obtaining information on possibly associated adverse reactions using mobile telephone contact with child caregivers. Methods: A cohort study was conducted in Riyadh, Saudi Arabia. Patients were included if they were aged between 6 and 18 years and had received one dose of the H1N1 vaccine. A control group involved children from the same school system who had not received the vaccine. Six months following vaccination, a clinical pharmacist called the caregiver of the child to ask about hospitalization, emergency room visits and events related to H1N1 vaccine administration using a standardized questionnaire. Results: Caregivers of 372 school-age children were contacted. The response rate was 97{\%} (n = 359). A total of 169 children who received at least one dose of the H1N1 vaccine were compared with 190 children in the control group who had not received the vaccine. Controlling for age, sex, education and use of medications, the odds ratio (OR) of hospitalization or emergency room visits for children within the 6 months after vaccination relative to the unvaccinated children was 1.25 (95{\%} CI 0.47, 3.35). The risk of influenza-like symptoms was significantly reduced in vaccinated children compared with unvaccinated children (OR 0.63; 95{\%} CI 0.41, 0.99). Conclusion: School-age children in Saudi Arabia who received the H1N1 vaccine did not have an increased risk of hospitalization or emergency room visits. Larger studies are needed to confirm these results. Proactive pharmacovigilance is important in assessing the safety of vaccines and other medications. It is feasible to collect information on adverse drug reactions using mobile telephones, a method that can be of benefit in both developed and developing countries.",
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Aljadhey, H, Alyabsi, M, Alrwisan, A, Alqahtani, N, Almutairi, R, Al Tawil, E, Adam, M, Shakir, S, Aljeraisy, M, Al-Blowi, A, Alkhashan, H, Albogami, Y & Murray, MD 2012, 'The safety of H1N1 vaccine in children in Saudi Arabia: A cohort study using modern technology in a developing country', Drug Safety, vol. 35, no. 7, pp. 555-561. https://doi.org/10.2165/11597450-000000000-00000

The safety of H1N1 vaccine in children in Saudi Arabia : A cohort study using modern technology in a developing country. / Aljadhey, Hisham; Alyabsi, Mesnad; Alrwisan, Adel; Alqahtani, Nasser; Almutairi, Reem; Al Tawil, Esraa; Adam, Mansour; Shakir, Saad; Aljeraisy, Majed; Al-Blowi, Ali; Alkhashan, Hesham; Albogami, Yasser; Murray, Michael D.

In: Drug Safety, Vol. 35, No. 7, 25.06.2012, p. 555-561.

Research output: Contribution to journalArticleResearchpeer-review

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T2 - A cohort study using modern technology in a developing country

AU - Aljadhey, Hisham

AU - Alyabsi, Mesnad

AU - Alrwisan, Adel

AU - Alqahtani, Nasser

AU - Almutairi, Reem

AU - Al Tawil, Esraa

AU - Adam, Mansour

AU - Shakir, Saad

AU - Aljeraisy, Majed

AU - Al-Blowi, Ali

AU - Alkhashan, Hesham

AU - Albogami, Yasser

AU - Murray, Michael D.

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N2 - Background: With its rapid introduction in 2009, concerns about the safety of the H1N1 vaccines have been raised. Data were especially limited on the pediatric safety of H1N1 vaccine in Saudi Arabia. Objectives: The objectives of this study were to investigate the safety of the H1N1 vaccine (Pandemrix®) in children and examine the feasibility of obtaining information on possibly associated adverse reactions using mobile telephone contact with child caregivers. Methods: A cohort study was conducted in Riyadh, Saudi Arabia. Patients were included if they were aged between 6 and 18 years and had received one dose of the H1N1 vaccine. A control group involved children from the same school system who had not received the vaccine. Six months following vaccination, a clinical pharmacist called the caregiver of the child to ask about hospitalization, emergency room visits and events related to H1N1 vaccine administration using a standardized questionnaire. Results: Caregivers of 372 school-age children were contacted. The response rate was 97% (n = 359). A total of 169 children who received at least one dose of the H1N1 vaccine were compared with 190 children in the control group who had not received the vaccine. Controlling for age, sex, education and use of medications, the odds ratio (OR) of hospitalization or emergency room visits for children within the 6 months after vaccination relative to the unvaccinated children was 1.25 (95% CI 0.47, 3.35). The risk of influenza-like symptoms was significantly reduced in vaccinated children compared with unvaccinated children (OR 0.63; 95% CI 0.41, 0.99). Conclusion: School-age children in Saudi Arabia who received the H1N1 vaccine did not have an increased risk of hospitalization or emergency room visits. Larger studies are needed to confirm these results. Proactive pharmacovigilance is important in assessing the safety of vaccines and other medications. It is feasible to collect information on adverse drug reactions using mobile telephones, a method that can be of benefit in both developed and developing countries.

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