|
1
|
Domnich A, Amicizia D, Lai PL, Ogliastro M, Piedrahita-Tovar M, Orsi A, Icardi G, Panatto D. Three seasons of enhanced safety surveillance of a cell culture-based quadrivalent influenza vaccine. Hum Vaccin Immunother 2023; 19:2261689. [PMID: 37787067 PMCID: PMC10549188 DOI: 10.1080/21645515.2023.2261689] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/20/2023] [Accepted: 09/19/2023] [Indexed: 10/04/2023] Open
Abstract
The objective of this paper is to summarize annual enhanced safety surveillance activity across three seasons (2019/20-2021/22) for cell culture-based quadrivalent influenza vaccine (QIVc; Flucelvax® Tetra) in all age groups. This activity was conducted in primary care setting in Genoa (Italy) during the seasons 2019/20, 2020/21 and 2021/22. All adverse events registered within the first seven days following immunization were analyzed by season, type, age group and seriousness. Over three seasons, 3,603 QIVc exposures were recorded within the enhanced passive safety surveillance activity. No safety signals were identified. The overall reporting rates of individual case safety reports for the seasons 2019/20, 2020/21 and 2021/22 were 1.75%, 0.48% and 0.40%, respectively. The average number of adverse events per individual case safety report was similar (range 3.3-3.8 adverse events per case report) across the three seasons. Most adverse events were reactogenic in nature. The rate of adverse events was similarly low in all age groups. Enhanced passive safety surveillance activity is a feasible approach for the post-marketing monitoring of seasonal influenza vaccines. Within its limitations, results of this study support the favorable safety profile of QIVc. These safety data could further bolster public trust in influenza vaccines with the goal to increase vaccination uptake in all target groups.
Collapse
Affiliation(s)
- Alexander Domnich
- Hygiene Unit, San Martino Polyclinic Hospital-IRCCS for Oncology and Neurosciences, Genoa, Italy
| | - Daniela Amicizia
- Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy
- Interuniversity Research Center on Influenza and Other Transmissible Infections (CIRI-IT), Genoa, Italy
| | - Piero Luigi Lai
- Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy
- Interuniversity Research Center on Influenza and Other Transmissible Infections (CIRI-IT), Genoa, Italy
| | - Matilde Ogliastro
- Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy
| | | | - Andrea Orsi
- Hygiene Unit, San Martino Polyclinic Hospital-IRCCS for Oncology and Neurosciences, Genoa, Italy
- Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy
- Interuniversity Research Center on Influenza and Other Transmissible Infections (CIRI-IT), Genoa, Italy
| | - Giancarlo Icardi
- Hygiene Unit, San Martino Polyclinic Hospital-IRCCS for Oncology and Neurosciences, Genoa, Italy
- Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy
- Interuniversity Research Center on Influenza and Other Transmissible Infections (CIRI-IT), Genoa, Italy
| | - Donatella Panatto
- Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy
- Interuniversity Research Center on Influenza and Other Transmissible Infections (CIRI-IT), Genoa, Italy
| |
Collapse
|
|
2
|
Nyombayire J, Ingabire R, Magod B, Mazzei A, Mazarati JB, Noben J, Katwere M, Parker R, Nsanzimana S, Wall KM, Sayinzoga F, Tichacek A, Robinson C, Hammoud N, Priddy F, Allen S, Karita E. Monitoring of Adverse Events in Recipients of the 2-Dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in the UMURINZI Ebola Vaccination Campaign. J Infect Dis 2023; 227:268-277. [PMID: 35776140 PMCID: PMC9833427 DOI: 10.1093/infdis/jiac283] [Citation(s) in RCA: 11] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/12/2022] [Revised: 06/23/2022] [Accepted: 06/29/2022] [Indexed: 01/19/2023] Open
Abstract
BACKGROUND From 2019 to 2021, Rwandan residents of the border with the Democratic Republic of the Congo were offered the Ad26.ZEBOV (adenovirus type 26 vector vaccine encoding Ebola virus glycoprotein) and MVA-BN-Filo (modified vaccinia virus Ankara vector vaccine, encoding glycoproteins from Ebola, Sudan, Marburg, and nucleoprotein from Tai Forest viruses) Ebola vaccine regimen. METHODS Nonpregnant persons aged ≥2 years were eligible. Unsolicited adverse events (UAEs) were reported through phone calls or visits, and serious adverse events (SAEs) were recorded per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines. RESULTS Following Ad26.ZEBOV, UAEs were reported by 0.68% of 216 113 vaccinees and were more common in younger children (aged 2-8 years, 1.2%) compared with older children (aged 9-17 years, 0.4%) and adults (aged ≥18 years, 0.7%). Fever and headache were the most reported symptoms. All 17 SAEs related to vaccine were in children aged 2-8 years (10 postvaccination febrile convulsions ± gastroenteritis and 7 fever and/or gastroenteritis). The incidence of febrile seizures was 8 of 26 062 (0.031%) prior to initiation of routine acetaminophen in December 2020 and 2 of 15 897 (0.013%) thereafter. Nonobstetric SAEs were similar in males and females. All 20 deaths were unrelated to vaccination. Young girls and adult women with UAEs were less likely to receive the second dose than those without UAEs. Seven unrelated SAEs occurred in 203 267 MVA-BN-Filo recipients. CONCLUSIONS Postvaccination febrile convulsions in young children were rare but not previously described after Ad26.ZEBOV and were reduced with routine acetaminophen. The regimen was otherwise safe and well-tolerated.
Collapse
Affiliation(s)
| | | | - Ben Magod
- Rwanda Zambia Health Research Group, Department of Pathology and Laboratory Medicine, School of Medicine, Emory University, Atlanta, Georgia, USA
| | - Amelia Mazzei
- Center for Family Health Research, Kigali, Rwanda
- Department of Pathology, School of Medicine, Emory University,Atlanta, Georgia, USA
| | | | - Jozef Noben
- Janssen Global Public Health R&D, Beerse, Belgium
| | | | - Rachel Parker
- Rwanda Zambia Health Research Group, Department of Pathology and Laboratory Medicine, School of Medicine, Emory University, Atlanta, Georgia, USA
| | | | - Kristin M Wall
- Rwanda Zambia Health Research Group, Department of Pathology and Laboratory Medicine, School of Medicine, Emory University, Atlanta, Georgia, USA
- Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA
| | | | - Amanda Tichacek
- Rwanda Zambia Health Research Group, Department of Pathology and Laboratory Medicine, School of Medicine, Emory University, Atlanta, Georgia, USA
| | | | - Niina Hammoud
- Janssen Vaccines and Prevention, Leiden, The Netherlands
| | | | - Susan Allen
- Rwanda Zambia Health Research Group, Department of Pathology and Laboratory Medicine, School of Medicine, Emory University, Atlanta, Georgia, USA
| | - Etienne Karita
- Department of Pathology, School of Medicine, Emory University,Atlanta, Georgia, USA
| |
Collapse
|
|
3
|
Lee H, Hong B, Kim S, Kim JH, Choi NK, Jung SY, Shin JY. Post-marketing surveillance study on influenza vaccine in South Korea using a nationwide spontaneous reporting database with multiple data mining methods. Sci Rep 2022; 12:20256. [PMID: 36424402 PMCID: PMC9691710 DOI: 10.1038/s41598-022-21986-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/28/2022] [Accepted: 10/07/2022] [Indexed: 11/26/2022] Open
Abstract
Safety profiles of the influenza vaccine and its subtypes are still limited. We aimed to address this knowledge gap using multiple data mining methods and calculated performance measurements to evaluate the precision of different detection methods. We conducted a post-marketing surveillance study between 2005 and 2019 using the Korea Adverse Event Reporting System database. Three data mining methods were applied: (a) proportional reporting ratio, (b) information component, and (c) tree-based scan statistics. We evaluated the performance of each method in comparison with the known adverse events (AEs) described in the labeling information. Compared to other vaccines, we identified 36 safety signals for the influenza vaccine, and 7 safety signals were unlabeled. In subtype-stratified analyses, application site disorders were reported more frequently with quadrivalent and cell-based vaccines, while a wide range of AEs were noted for trivalent and egg-based vaccines. Tree-based scan statistics showed well-balanced performance. Among the detected signals of influenza vaccines, narcolepsy requires special attention. A wider range of AEs were detected as signals for trivalent and egg-based vaccines. Although tree-based scan statistics showed balanced performance, complementary use of other techniques would be beneficial when large noise due to false positives is expected.
Collapse
Affiliation(s)
- Hyesung Lee
- grid.264381.a0000 0001 2181 989XSchool of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si, Gyeonggi-do 16419 South Korea ,grid.264381.a0000 0001 2181 989XDepartment of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South Korea
| | - Bin Hong
- grid.264381.a0000 0001 2181 989XSchool of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si, Gyeonggi-do 16419 South Korea
| | - SangHee Kim
- grid.264381.a0000 0001 2181 989XSchool of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si, Gyeonggi-do 16419 South Korea
| | - Ju Hwan Kim
- grid.264381.a0000 0001 2181 989XSchool of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si, Gyeonggi-do 16419 South Korea ,grid.264381.a0000 0001 2181 989XPresent Address: Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South Korea
| | - Nam-Kyong Choi
- grid.255649.90000 0001 2171 7754Department of Health Convergence, Ewha Womans University, Seoul, South Korea ,grid.255649.90000 0001 2171 7754Graduate School of Industrial Pharmaceutical Science, Ewha Womans University, Seoul, Korea
| | - Sun-Young Jung
- grid.254224.70000 0001 0789 9563College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea ,grid.254224.70000 0001 0789 9563Department of Global Innovative Drugs, Graduate School of Chung-Ang University, College of Pharmacy, Chung-Ang University, 84 Heukseok-ro, Dongjak-gu, Seoul, 06974 South Korea
| | - Ju-Young Shin
- grid.264381.a0000 0001 2181 989XSchool of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si, Gyeonggi-do 16419 South Korea ,grid.264381.a0000 0001 2181 989XDepartment of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South Korea ,grid.264381.a0000 0001 2181 989XDepartment of Clinical Research Design & Evaluation, Samsung Advanced Institute for Health Sciences & Technology (SAIHST), Sungkyunkwan University, Seoul, South Korea
| |
Collapse
|
|
4
|
Esposito S, Abu-Raya B, Bonanni P, Cahn-Sellem F, Flanagan KL, Martinon Torres F, Mejias A, Nadel S, Safadi MAP, Simon A. Coadministration of Anti-Viral Monoclonal Antibodies With Routine Pediatric Vaccines and Implications for Nirsevimab Use: A White Paper. Front Immunol 2021; 12:708939. [PMID: 34456918 PMCID: PMC8386277 DOI: 10.3389/fimmu.2021.708939] [Citation(s) in RCA: 17] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/12/2021] [Accepted: 07/15/2021] [Indexed: 02/01/2023] Open
Abstract
Routine childhood vaccinations are key for the protection of children from a variety of serious and potentially fatal diseases. Current pediatric vaccine schedules mainly cover active vaccines. Active vaccination in infants is a highly effective approach against several infectious diseases; however, thus far, for some important viral pathogens, including respiratory syncytial virus (RSV), vaccine development and license by healthcare authorities have not been accomplished. Nirsevimab is a human-derived, highly potent monoclonal antibody (mAb) with an extended half-life for RSV prophylaxis in all infants. In this manuscript, we consider the potential implications for the introduction of an anti-viral mAb, such as nirsevimab, into the routine pediatric vaccine schedule, as well as considerations for coadministration. Specifically, we present evidence on the general mechanism of action of anti-viral mAbs and experience with palivizumab, the only approved mAb for the prevention of RSV infection in preterm infants, infants with chronic lung disease of prematurity and certain infants with hemodynamically significant heart disease. Palivizumab has been used for over two decades in infants who also receive routine vaccinations without any alerts concerning the safety and efficacy of coadministration. Immunization guidelines (Advisory Committee on Immunization Practices, Joint Committee on Vaccination and Immunization, National Advisory Committee on Immunization, Centers for Disease Control and Prevention, American Academy of Pediatrics, The Association of the Scientific Medical Societies in Germany) support coadministration of palivizumab with routine pediatric vaccines, noting that immunobiologics, such as palivizumab, do not interfere with the immune response to licensed live or inactivated active vaccines. Based on the mechanism of action of the new generation of anti-viral mAbs, such as nirsevimab, which is highly specific targeting viral antigenic sites, it is unlikely that it could interfere with the immune response to other vaccines. Taken together, we anticipate that nirsevimab could be concomitantly administered to infants with routine pediatric vaccines during the same clinic visit.
Collapse
Affiliation(s)
- Susanna Esposito
- Pediatric Clinic, University Hospital, Department of Medicine and Surgery, University of Parma, Parma, Italy
| | - Bahaa Abu-Raya
- Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada
| | - Paolo Bonanni
- Specialization Medical School of Hygiene, Department of Health Sciences, University of Florence, Florence, Italy
| | | | - Katie L. Flanagan
- Tasmanian Vaccine Trial Centre, Launceston General Hospital, Launceston, TAS, Australia
- School of Medicine, University of Tasmania, Launceston, TAS, Australia
- Department of Immunology and Pathology, Monash University, Melbourne, VIC, Australia
- School of Health and Biomedical Science, Royal Melbourne Institute of Technology (RMIT) University, Melbourne, VIC, Australia
| | - Federico Martinon Torres
- Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain
- Genetics, Vaccines and Pediatrics Research Group, Instituto de Investigación Sanitaria de Santiago de Compostela, Universidad de Santiago, Santiago de Compostela, Spain
| | - Asuncion Mejias
- Division of Infectious Diseases, Department of Pediatrics, Center for Vaccines and Immunity Nationwide Children’s Hospital-The Ohio State University College of Medicine, Columbus, OH, United States
- Department of Pharmacology and Pediatrics, Malaga Medical School, Malaga University, Malaga, Spain
| | | | - Marco A. P. Safadi
- Department of Pediatrics, Santa Casa de Sao Paulo School of Medical Sciences, Sao Paulo, Brazil
| | - Arne Simon
- Klinik für Pädiatrische Onkologie und Hämatologie Universitätsklinikum des Saarlandes, Homburg, Germany
| |
Collapse
|
|
5
|
Dey A, Wang H, Quinn H, Pillsbury A, Glover C, Hickie M, Wood N, Beard F, Macartney K. Surveillance of adverse events following immunisation in Australia annual report, 2019. ACTA ACUST UNITED AC 2021; 45. [PMID: 33934694 DOI: 10.33321/cdi.2021.45.23] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
Abstract This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2019 reported to the Therapeutic Goods Administration (TGA) and describes reporting trends over the 20-year period from 1 January 2000 to 31 December 2019. There were 3,782 AEFI records for vaccines administered in 2019, an annual AEFI reporting rate of 14.9 per 100,000 population. There was an 11.8% decrease in the overall AEFI reporting rate in 2019 compared to 2018 (16.9 per 100,000 population). This decrease in the AEFI reporting rate in 2019 was mainly attributable to a decline in reported adverse events related to the human papillomavirus (HPV), dTpa, meningococcal ACWY and seasonal influenza vaccines. AEFI reporting rates for most individual vaccines in 2019 were similar to 2018. The most commonly-reported adverse events were injection site reaction (35.8%), rash (16.6%), pyrexia (15.3%), vomiting (8.1%), urticaria (5.8%), pain (5.8%) and headache (5.7%). There were five deaths reported to the TGA. In one report, the timing and clinical findings were consistent with a causal association with vaccination. In the remaining four reports, no clear causal relationship with vaccination was found.
Collapse
Affiliation(s)
- Aditi Dey
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| | - Han Wang
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| | - Helen Quinn
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| | - Alexis Pillsbury
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| | - Catherine Glover
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| | - Megan Hickie
- Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration, Department of Health, Canberra, Australia
| | - Nicholas Wood
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| | - Frank Beard
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| | - Kristine Macartney
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| |
Collapse
|
|
6
|
Dey A, Wang H, Quinn H, Pillsbury A, Glover C, Hickie M, Wood N, Beard F, Macartney K. Surveillance of adverse events following immunisation in Australia: annual report, 2018. ACTA ACUST UNITED AC 2020; 44. [PMID: 32178607 DOI: 10.33321/cdi.2020.44.12] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2018 reported to the Therapeutic Goods Administration and describes reporting trends over the 19-year period 1 January 2000 to 31 December 2018. There were 4221 AEFI records for vaccines administered in 2018, an annual AEFI reporting rate of 16.9 per 100,000 population. There was a 2.9% increase in the overall AEFI reporting rate in 2018 compared to 2017. This slight increase in reported adverse events in 2018 was likely due to new additions to the National Immunisation Program schedule, namely meningococcal ACWY vaccination for children aged 12 months, enhanced immunogenicity trivalent influenza vaccines for adults aged ≥65 years, and state- and territory-funded seasonal influenza vaccination programs for children aged 6 months to <5 years. AEFI reporting rates for most individual vaccines in 2018 were similar to 2017. The most commonly reported adverse events were injection site reaction (34%), pyrexia (15%), rash (15%), vomiting (8%), headache (6%) and pain (6%). Two deaths were reported to the TGA but no clear causal relationship with vaccination was found.
Collapse
Affiliation(s)
- Aditi Dey
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| | - Han Wang
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| | - Helen Quinn
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| | - Alexis Pillsbury
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| | - Catherine Glover
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| | - Megan Hickie
- Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration, Department of Health, Canberra, Australia
| | - Nicholas Wood
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| | - Frank Beard
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| | - Kristine Macartney
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children's Hospital at Westmead, Sydney, Australia
| |
Collapse
|
|
7
|
Dhar R, Ghoshal AG, Guleria R, Sharma S, Kulkarni T, Swarnakar R, Samaria JK, Chaudhary S, Gaur SN, Christopher DJ, Singh V, Abraham G, Sarkar A, Mukhopadhyay A, Panda J, Swaminathan S, Nene A, Krishnan S, Shahi PK, Sarangdhar N, Mishra N, Chowdury SR, Halder I, Katiyar SK, Jain VK, Chawla R, Koul PA. Clinical practice guidelines 2019: Indian consensus-based recommendations on pneumococcal vaccination for adults. Lung India 2020; 37:S19-S29. [PMID: 32830790 PMCID: PMC7703813 DOI: 10.4103/lungindia.lungindia_272_20] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022] Open
Abstract
Similar to the global scenario, pneumococcal diseases are a significant health concern in India. Pneumococcal diseases occur frequently among adults and are largely preventable through vaccines. Globally, several guidelines and recommendations are available for pneumococcal vaccination in adults. However, owing to wide variations in the disease burden, regulatory landscape, and health-care system in India, such global guidelines cannot be unconditionally implemented throughout the country. To address these gaps, the Indian Chest Society and National College of Chest Physicians of India jointly conducted an expert meeting in January 2019. The aim of the discussion was to lay down specific evidence-based recommendations on adult pneumococcal vaccination for the country, with a view to further ameliorate the disease burden in the country. This article presents an overview of the closed-door discussion by the expert members on clinical practice guidelines to be followed for adult pneumococcal vaccination in India.
Collapse
Affiliation(s)
- Raja Dhar
- Department of Pulmonology, Fortis Hospital, Kolkata, West Bengal, India
| | - Aloke Gopal Ghoshal
- Department of Pulmonary Medicine, National Allergy Asthma Bronchitis Institute, Kolkata, West Bengal, India
| | - Randeep Guleria
- Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India
| | - Shubham Sharma
- Department of Pulmonology and Critical Care Medicine, Fortis Hospital, Kolkata, West Bengal, India
| | - Tarang Kulkarni
- Department of Pulmonology and Critical Care Medicine, Fortis Hospital, Kolkata, West Bengal, India
| | - Rajesh Swarnakar
- Department of Respiratory, Critical Care and Sleep Medicine, Getwell Hospital and Research Institute, Nagpur, Maharashtra, India
| | - J K Samaria
- Department of TB and Chest Diseases, Centre for Research and Treatment of Allergy, Asthma and Bronchitis, Varanasi, Uttar Pradesh, India
| | - Sudhir Chaudhary
- Department of Pulmonology, Kulwanti Hospitals and Research Center, Kanpur, Uttar Pradesh, India
| | - S N Gaur
- Department of Respiratory Medicine and Tuberculosis, School of Medical Sciences and Research, Greater Noida, Uttar Pradesh, India
| | - D J Christopher
- Department of Pulmonary Medicine, Christian Medical College, Vellore, Tamil Nadu, India
| | - Virendra Singh
- Department of Pulmonary Medicine, Asthma Bhawan, Shastri Nagar, Jaipur, Rajasthan, India
| | - Georgi Abraham
- Department of Nephrology, Madras Medical Mission, Chennai, Tamil Nadu, India
| | - Anirban Sarkar
- Department of Pulmonology, Zenith Superspeciality Hospital, Kolkata, West Bengal, India
| | - Ansuman Mukhopadhyay
- Department of Pulmonology, National Allergy Asthma Bronchitis Institute, Kolkata, West Bengal, India
| | - Jayant Panda
- Department of Medicine, SCB Medical College, Cuttack, Odisha, India
| | | | - Amita Nene
- Department of Chest Medicine, Bombay Hospital, Mumbai, Maharashtra, India
| | - Shyam Krishnan
- Department of Chest Medicine, Apollo Hospital, Bengaluru, Karnataka, India
| | - Praveen Kumar Shahi
- Department of Pulmonology and Critical Care Medicine, Fortis Hospital, Kolkata, West Bengal, India
| | - Nikhil Sarangdhar
- Department of Pulmonary Medicine, Lung Clinica, Andheri West Mumbai, Maharashtra, India
| | - Narayan Mishra
- Department of Pulmonary Medicine, MKCG Medical College, Berhampur, Odisha, India
| | | | - Indranil Halder
- Department of Pulmonary Medicine, College Of Medicine & JNM Hospital, Kalyani, Nadia, Uttar Pradesh, India
| | - S K Katiyar
- Chest Care Center, Kanpur, Uttar Pradesh, India
| | - V K Jain
- Department of Respiratory Medicine, Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan, India
| | - Rakesh Chawla
- Dr Rakesh Chawla's Chest, Asthma Allergy and Sleep Clinic, Delhi, India
| | - Parvaiz A Koul
- Department of Internal and Pulmonary Medicine, Sher-i-Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India
| |
Collapse
|
|
8
|
Shimabukuro TT, Su JR, Marquez PL, Mba-Jonas A, Arana JE, Cano MV. Safety of the 9-Valent Human Papillomavirus Vaccine. Pediatrics 2019; 144:e20191791. [PMID: 31740500 PMCID: PMC6935554 DOI: 10.1542/peds.2019-1791] [Citation(s) in RCA: 29] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 08/01/2019] [Indexed: 02/05/2023] Open
Abstract
BACKGROUND The 9-valent human papillomavirus vaccine (9vHPV) was approved for females and males aged 9 to 26 years in 2014. We analyzed postlicensure surveillance reports to the Vaccine Adverse Event Reporting System (VAERS). METHODS We searched VAERS data for US reports of adverse events (AEs) after 9vHPV from December 2014 through December 2017. We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reporting. Physicians reviewed reports for selected prespecified conditions. RESULTS VAERS received 7244 reports after 9vHPV: 31.2% among females, 21.6% among males, and for 47.2%, sex was not reported. Overall, 97.4% of reports were nonserious. Dizziness, syncope, headache, and injection site reactions were most commonly reported; the most commonly reported AEs were similar between females and males. Two reports of death after 9vHPV were verified; no information in autopsy reports or death certificates suggested a causal relationship with vaccination. Approximately 28 million 9vHPV doses were distributed during the study period; crude AE reporting rates were 259 reports per million 9vHPV doses distributed for all reports and 7 per million doses distributed for serious reports. Syncope (a known AE associated with human papillomavirus vaccination) and several types of vaccine administration errors (eg, administered at wrong age) exceeded the statistical threshold for empirical Bayesian data mining findings. CONCLUSIONS No new or unexpected safety concerns or reporting patterns of 9vHPV with clinically important AEs were detected. The safety profile of 9vHPV is consistent with data from prelicensure trials and from postmarketing safety data of its predecessor, the quadrivalent human papillomavirus vaccine.
Collapse
Affiliation(s)
- Tom T Shimabukuro
- Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; and
| | - John R Su
- Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; and
| | - Paige L Marquez
- Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; and
| | - Adamma Mba-Jonas
- Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
| | - Jorge E Arana
- Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; and
| | - Maria V Cano
- Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; and
| |
Collapse
|
|
9
|
Moro PL, Haber P, McNeil MM. Challenges in evaluating post-licensure vaccine safety: observations from the Centers for Disease Control and Prevention. Expert Rev Vaccines 2019; 18:1091-1101. [PMID: 31580725 DOI: 10.1080/14760584.2019.1676154] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/25/2022]
Abstract
Introduction: Vaccination is one of the most successful and cost-effective public health interventions. Although vaccines undergo extensive safety and efficacy evaluations prior to licensure, vaccine safety assessment post-licensure is essential for detecting rare and longer-term adverse events (AEs) and maintaining public confidence in vaccines and recommended immunization programs. Despite the proven effect of vaccines to save lives and prevent disease and overwhelming evidence of vaccines' safety and societal benefit, like any drug, no vaccine can be considered as completely safe and completely effective. New vaccines continue to be introduced and require rapid safety assessment post-licensure through pharmacovigilance reports as well as epidemiologic studies to investigate any potential safety signals.Areas covered: We discuss selected challenges for conducting pharmacovigilance and epidemiologic studies of AEs after vaccination in the United States using the post-licensure safety surveillance infrastructure of the Centers for Disease Control and Prevention (CDC).Expert opinion: The availability of specific post-licensure surveillance systems to monitor and study AEs after vaccination, such as the Vaccine Adverse Event Reporting System, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment Project, each with its unique set of strengths and limitations, provide a harmonized and supportive approach to meet several of these barriers.
Collapse
Affiliation(s)
- Pedro L Moro
- Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA
| | - Penina Haber
- Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA
| | - Michael M McNeil
- Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA
| |
Collapse
|
|
10
|
Dey A, Wang H, Quinn H, Hiam R, Wood N, Beard F, Macartney K. Surveillance of adverse events following immunisation in Australia annual report, 2017. Commun Dis Intell (2018) 2019. [DOI: 10.33321/cdi.2019.43.29] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2017 reported to the Therapeutic Goods Administration and describes reporting trends over the 18-year period 1 January 2000 to 31 December 2017. There were 3,878 AEFI records for vaccines administered in 2017; an annual AEFI reporting rate of 15.8 per 100,000 population. There was a 12% increase in the overall AEFI reporting rate in 2017 compared with 2016. This increase in reported adverse events in 2017 compared to the previous year was likely due to the introduction of the zoster vaccine (Zostavax®) provided free for people aged 70–79 years under the National Immunisation Program (NIP) and also the state- and territory-based meningococcal ACWY conjugate vaccination programs. AEFI reporting rates for most other individual vaccines in 2017 were similar to 2016. The most commonly reported reactions were injection site reaction (34%), pyrexia (17%), rash (15%), vomiting (8%) and pain (7%). The majority of AEFI reports (88%) described non-serious events. Two deaths were reported that were determined to have a causal relationship with vaccination; they occurred in immunocompromised people contraindicated to receive the vaccines.
Collapse
Affiliation(s)
- Aditi Dey
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
| | - Han Wang
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
| | - Helen Quinn
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
| | - Rona Hiam
- Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration, Canberra, Australia
| | - Nicholas Wood
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
| | - Frank Beard
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
| | - Kristine Macartney
- National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
| |
Collapse
|
|
11
|
Abstract
Influenza vaccination is recommended for all children 6 months of age and older who do not have contraindications. This article provides an overview of information concerning burden of influenza among children in the United States; US-licensed influenza vaccines; vaccine immunogenicity, effectiveness, and safety; and recent updates relevant to use of these vaccines in pediatric populations. Influenza antiviral medications are discussed. Details concerning vaccine-related topics may be found in the current US Centers for Disease Control and Prevention/Advisory Committee on Immunization Practices recommendations for use of influenza vaccines (https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html). Additional information on influenza antivirals is located at https://www.cdc.gov/flu/professionals/antivirals/index.htm.
Collapse
|
|
12
|
Moro PL, Perez-Vilar S, Lewis P, Bryant-Genevier M, Kamiya H, Cano M. Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines. Pediatrics 2018; 142:e20174171. [PMID: 29866795 PMCID: PMC6476554 DOI: 10.1542/peds.2017-4171] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 02/16/2018] [Indexed: 11/24/2022] Open
Abstract
OBJECTIVE To assess the safety of currently licensed diphtheria-tetanus-acellular pertussis (DTaP) vaccines in the United States by using data from the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. METHODS We searched VAERS for US reports of DTaP vaccinations occurring from January 1, 1991, through December 31, 2016, and received by March 17, 2017. We reviewed available medical records for all death reports and a random sample of reports classified as nondeath serious. We used Empirical Bayesian data mining to identify adverse events that were disproportionally reported after DTaP vaccination. RESULTS VAERS received 50 157 reports after DTaP vaccination; 43 984 (87.7%) of them reported concomitant administration of other vaccines, and 5627 (11.2%) were serious. Median age at vaccination was 19 months (interquartile range 35 months). The most frequently reported events were injection site erythema (12 695; 25.3%), pyrexia (9913; 19.8%), injection site swelling (7542; 15.0%), erythema (5599; 11.2%), and injection site warmth (4793; 9.6%). For 3 of the DTaP vaccines, we identified elevated values for vaccination errors using Empirical Bayesian data mining. CONCLUSIONS No new or unexpected adverse events were detected. The observed disproportionate reporting for some nonserious vaccination errors calls for better education of vaccine providers on the specific indications for each of the DTaP vaccines.
Collapse
Affiliation(s)
- Pedro L Moro
- Immunization Safety Office, Division of Healthcare Quality Promotion and
| | - Silvia Perez-Vilar
- Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland; and
| | - Paige Lewis
- Immunization Safety Office, Division of Healthcare Quality Promotion and
| | - Marthe Bryant-Genevier
- Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland; and
| | - Hajime Kamiya
- Epidemiology Intelligence Service, Meningitis and Vaccine Preventable Diseases Branch, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
- Infectious Disease Surveillance Center, National Institute of Infectious Diseases, Tokyo, Japan
| | - Maria Cano
- Immunization Safety Office, Division of Healthcare Quality Promotion and
| |
Collapse
|
|
13
|
Håberg SE, Aaberg KM, Surén P, Trogstad L, Ghaderi S, Stoltenberg C, Magnus P, Bakken IJ. Epilepsy in Children After Pandemic Influenza Vaccination. Pediatrics 2018; 141:peds.2017-0752. [PMID: 29449342 DOI: 10.1542/peds.2017-0752] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 12/05/2017] [Indexed: 11/24/2022] Open
Abstract
OBJECTIVES To determine if pandemic influenza vaccination was associated with an increased risk of epilepsy in children. METHODS Information from Norwegian registries from 2006 through 2014 on all children <18 years living in Norway on October 1, 2009 was used in Cox regression models to estimate hazard ratios for incident epilepsy after vaccination. A self-controlled case series analysis was used to estimate incidence rate ratios in defined risk periods after pandemic vaccination. RESULTS In Norway, the main period of the influenza A subtype H1N1 pandemic was from October 2009 to December 2009. On October 1, 2009, 1 154 113 children <18 years of age were registered as residents in Norway. Of these, 572 875 (50.7%) were vaccinated against pandemic influenza. From October 2009 through 2014 there were 3628 new cases of epilepsy (incidence rate 6.09 per 10 000 person-years). The risk of epilepsy was not increased after vaccination: hazard ratio: 1.07; 95% confidence interval: 0.94-1.23. Results from the self-controlled case series analysis supported the finding of no association between vaccination and subsequent epilepsy. CONCLUSIONS Pandemic influenza vaccination was not associated with increased risk of epilepsy. Concerns about pandemic vaccination causing epilepsy in children seem to be unwarranted.
Collapse
Affiliation(s)
| | - Kari M Aaberg
- Norwegian Institute of Public Health, Oslo, Norway.,The National Center for Epilepsy, Oslo University Hospital, Oslo, Norway
| | - Pål Surén
- Norwegian Institute of Public Health, Oslo, Norway.,The National Center for Epilepsy, Oslo University Hospital, Oslo, Norway
| | | | - Sara Ghaderi
- Norwegian Institute of Public Health, Oslo, Norway
| | - Camilla Stoltenberg
- Norwegian Institute of Public Health, Oslo, Norway.,Department of Global Public Health and Community Care, University of Bergen, Bergen, Norway; and
| | - Per Magnus
- Norwegian Institute of Public Health, Oslo, Norway.,Institute of Health and Society, University of Oslo, Oslo, Norway
| | | |
Collapse
|
|
14
|
Li X, Lin Y, Yao G, Wang Y. The Influence of Vaccine on Febrile Seizure. Curr Neuropharmacol 2018; 16:59-65. [PMID: 28745219 PMCID: PMC5771385 DOI: 10.2174/1570159x15666170726115639] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/11/2017] [Revised: 06/09/2017] [Accepted: 04/27/2017] [Indexed: 11/22/2022] Open
Abstract
BACKGROUND The protective value of vaccines to the public has made vaccines among the major public health prophylactic measures through the entire history. However, there has been some controversy about their safety; particularly concerns have been rising about febrile seizures (FS). Vaccination was found to be the second most common cause of FS. METHODS We research and collect relative online content for reviewing the effects of vaccine in FS. RESULTS there is no causal relationship between FS and vaccination. This relationship is complex by other factors, such as age, genetic inheritance, type of vaccine, combination of different types of vaccines and the timing of vaccination. CONCLUSION In order to reduce FS after vaccination, it is important to understand the mechanism of epilepsy and relationship between specific vaccines and FS. Parents should be informed that some vaccines could be associated with an increased risk of FS, particularly, in children with personal and family history of FS. Children with genetic epilepsy syndrome are prone to seizures and certain vaccinations should be avoided in these children. It is highly recommended to choose vaccines with lower risk of developing FS and to administer these vaccines during the low risk window of immunizations schedule.
Collapse
Affiliation(s)
- Xin Li
- Jilin Provincial Key Laboratory on Molecular and Chemical Genetics, The Second Hospital of Jilin University, Changchun, Jilin130041, P.R. China
- Department of Genetics, University of Alabama at Birmingham, Birmingham, AL, 35294, USA
| | - Yang Lin
- Jilin Provincial Key Laboratory on Molecular and Chemical Genetics, The Second Hospital of Jilin University, Changchun, Jilin130041, P.R. China
| | - Gang Yao
- Jilin Provincial Key Laboratory on Molecular and Chemical Genetics, The Second Hospital of Jilin University, Changchun, Jilin130041, P.R. China
| | - Yicun Wang
- Jilin Provincial Key Laboratory on Molecular and Chemical Genetics, The Second Hospital of Jilin University, Changchun, Jilin130041, P.R. China
- Department of Genetics, University of Alabama at Birmingham, Birmingham, AL, 35294, USA
| |
Collapse
|
|
15
|
Wu W, Liu D, Li K, Nuorti JP, Nohynek HM, Xu D, Ye J, Zheng J, Wang H. Post-marketing safety surveillance for inactivated and live-attenuated Japanese encephalitis vaccines in China, 2008-2013. Vaccine 2017; 35:3666-3671. [PMID: 28552510 DOI: 10.1016/j.vaccine.2017.05.021] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/03/2017] [Revised: 05/05/2017] [Accepted: 05/08/2017] [Indexed: 10/19/2022]
Abstract
INTRODUCTION Two types of Japanese encephalitis (JE) vaccines, inactivated JE vaccine (JE-I) and live-attenuated JE vaccine (JE-L), are available and used in China. In particular, one JE-L, produced by a domestic manufacturer in China, was prequalified by WHO in 2013. We assessed the safety of JE vaccines in China during 2008-2013 using the Chinese National Adverse Events Following Immunization Information System (CNAEFIS) data. METHODS We retrieved AEFI reporting data about JE vaccines from CNAEFIS, 2008-2013, examined demographic characteristics of AEFI cases, and used administrative data on vaccine doses as denominator to calculate and compare crude reporting rates. We also used disproportionality reporting analysis between JE-I and JE-L to assess potential safety signals. RESULTS A total of 34,879 AEFIs related with JE-I and JE-L were reported, with a ratio of male to female as 1.3:1; 361 (1.0%) cases were classified as serious. JE vaccines were administered concurrently with one or more other vaccines in 13,592 (39.0%) of cases. The overall AEFI reporting rates were 214.4 per million vaccination doses for JE-L and 176.9 for JE-I (rate ratio [RR]: 1.2, 95% confidence interval [CI]: 1.1-1.3) in 2010-2013. Febrile convulsions (FC) following JE-I was found as a signal of disproportionate reporting (SDR). However, there was no significant difference between the reporting rates of FC of JE-I and JE-L (0.3 per million vaccination doses for JE-L, 0.4 for JE-I, p=0.05). CONCLUSIONS While our analysis did not find apparent safety concern of JE vaccines in China, further study should consider JE-I vaccines and febrile convulsion, and taking more sensitive methods to detect signals.
Collapse
Affiliation(s)
- Wendi Wu
- National Immunization Programme, Chinese Center for Disease Control and Prevention, China; Department of Epidemiology, School of Health Sciences, FIN-33014 University of Tampere, Finland
| | - Dawei Liu
- National Immunization Programme, Chinese Center for Disease Control and Prevention, China
| | - Keli Li
- National Immunization Programme, Chinese Center for Disease Control and Prevention, China.
| | - J Pekka Nuorti
- Department of Epidemiology, School of Health Sciences, FIN-33014 University of Tampere, Finland
| | - Hanna M Nohynek
- National Institute for Health and Welfare THL, Helsinki, Finland
| | - Disha Xu
- National Immunization Programme, Chinese Center for Disease Control and Prevention, China
| | - Jiakai Ye
- National Immunization Programme, Chinese Center for Disease Control and Prevention, China
| | - Jingshan Zheng
- National Immunization Programme, Chinese Center for Disease Control and Prevention, China
| | - Huaqing Wang
- National Immunization Programme, Chinese Center for Disease Control and Prevention, China.
| |
Collapse
|
|
16
|
Moro PL, Li R, Haber P, Weintraub E, Cano M. Surveillance systems and methods for monitoring the post-marketing safety of influenza vaccines at the Centers for Disease Control and Prevention. Expert Opin Drug Saf 2016; 15:1175-83. [PMID: 27268157 PMCID: PMC6500454 DOI: 10.1080/14740338.2016.1194823] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/12/2016] [Accepted: 05/24/2016] [Indexed: 12/29/2022]
Abstract
INTRODUCTION Annual influenza vaccine safety monitoring is an important component of the influenza vaccination program in the United States to ensure that vaccines are safe, which is important for maintaining public trust in the national vaccination program. This is specially the case for influenza vaccines since the antigen composition of the viruses of which the vaccine is made often changes from one season to the next, based on the circulating strain of influenza virus. AREAS COVERED This review describes the two surveillance systems used by the Centers for Disease Control and Prevention (CDC) to monitor the safety of influenza vaccines: 1) the Vaccine Adverse Event Reporting System (VAERS); and 2) the Vaccine Safety datalink (VSD). EXPERT OPINION VAERS and VSD are used routinely to monitor the safety of influenza vaccines in the United States, and over the years they have demonstrated their value in monitoring vaccine safety since their implementation in 1990. Both systems, although different, complemented each other well to study febrile seizures in young children following influenza vaccination during the 2010-2011 influenza season. Other examples of potential safety concerns after influenza vaccines are also presented and discussed.
Collapse
Affiliation(s)
- Pedro L Moro
- a Immunization Safety Office, Division of Healthcare Quality Promotion , National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , GA , USA
| | - Rongxia Li
- a Immunization Safety Office, Division of Healthcare Quality Promotion , National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , GA , USA
| | - Penina Haber
- a Immunization Safety Office, Division of Healthcare Quality Promotion , National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , GA , USA
| | - Eric Weintraub
- a Immunization Safety Office, Division of Healthcare Quality Promotion , National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , GA , USA
| | - Maria Cano
- a Immunization Safety Office, Division of Healthcare Quality Promotion , National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , GA , USA
| |
Collapse
|
|
17
|
Grohskopf LA, Sokolow LZ, Broder KR, Olsen SJ, Karron RA, Jernigan DB, Bresee JS. Prevention and Control of Seasonal Influenza with Vaccines. MMWR Recomm Rep 2016; 65:1-54. [PMID: 27560619 DOI: 10.15585/mmwr.rr6505a1] [Citation(s) in RCA: 298] [Impact Index Per Article: 33.1] [Reference Citation Analysis] [Abstract] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/13/2023] Open
Abstract
This report updates the 2015-16 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines (Grohskopf LA, Sokolow LZ, Olsen SJ, Bresee JS, Broder KR, Karron RA. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices, United States, 2015-16 influenza season. MMWR Morb Mortal Wkly Rep 2015;64:818-25). Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For the 2016-17 influenza season, inactivated influenza vaccines (IIVs) will be available in both trivalent (IIV3) and quadrivalent (IIV4) formulations. Recombinant influenza vaccine (RIV) will be available in a trivalent formulation (RIV3). In light of concerns regarding low effectiveness against influenza A(H1N1)pdm09 in the United States during the 2013-14 and 2015-16 seasons, for the 2016-17 season, ACIP makes the interim recommendation that live attenuated influenza vaccine (LAIV4) should not be used. Vaccine virus strains included in the 2016-17 U.S. trivalent influenza vaccines will be an A/California/7/2009 (H1N1)-like virus, an A/Hong Kong/4801/2014 (H3N2)-like virus, and a B/Brisbane/60/2008-like virus (Victoria lineage). Quadrivalent vaccines will include an additional influenza B virus strain, a B/Phuket/3073/2013-like virus (Yamagata lineage).Recommendations for use of different vaccine types and specific populations are discussed. A licensed, age-appropriate vaccine should be used. No preferential recommendation is made for one influenza vaccine product over another for persons for whom more than one licensed, recommended product is otherwise appropriate. This information is intended for vaccination providers, immunization program personnel, and public health personnel. Information in this report reflects discussions during public meetings of ACIP held on October 21, 2015; February 24, 2016; and June 22, 2016. These recommendations apply to all licensed influenza vaccines used within Food and Drug Administration-licensed indications, including those licensed after the publication date of this report. Updates and other information are available at CDC's influenza website (http://www.cdc.gov/flu). Vaccination and health care providers should check CDC's influenza website periodically for additional information.
Collapse
Affiliation(s)
- Lisa A Grohskopf
- Influenza Division, National Center for Immunization and Respiratory Diseases, CDC
| | | | | | | | | | | | | |
Collapse
|
|
18
|
Motala L, Eslick GD. Prevalence of recent immunisation in children with febrile convulsions. World J Clin Pediatr 2016; 5:301-305. [PMID: 27610346 PMCID: PMC4978623 DOI: 10.5409/wjcp.v5.i3.301] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/25/2016] [Revised: 05/03/2016] [Accepted: 07/11/2016] [Indexed: 02/06/2023] Open
Abstract
AIM To determine the prevalence of recent immunisation amongst children under 7 years of age presenting for febrile convulsions. METHODS This is a retrospective study of all children under the age of seven presenting with febrile convulsions to a tertiary referral hospital in Sydney. A total of 78 cases occurred in the period January 2011 to July 2012 and were included in the study. Data was extracted from medical records to provide a retrospective review of the convulsions. RESULTS Of the 78 total cases, there were five medical records which contained information on whether or not immunisation had been administered in the preceding 48 h to presentation to the emergency department. Of these five patients only one patient (1.28% of the study population) was confirmed to have received a vaccination with Infanrix, Prevnar and Rotavirus. The majority of cases reported a current infection as a likely precipitant to the febrile convulsion. CONCLUSION This study found a very low prevalence of recent immunisation amongst children with febrile convulsions presenting to an emergency department at a tertiary referral hospital in Sydney. This finding, however, may have been distorted by underreporting of vaccination history.
Collapse
|
|
19
|
Haber P, Moro PL, Lewis P, Woo EJ, Jankosky C, Cano M. Post-licensure surveillance of quadrivalent inactivated influenza (IIV4) vaccine in the United States, Vaccine Adverse Event Reporting System (VAERS), July 1, 2013-May 31, 2015. Vaccine 2016; 34:2507-12. [PMID: 27015735 PMCID: PMC4916262 DOI: 10.1016/j.vaccine.2016.03.048] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/22/2016] [Revised: 03/14/2016] [Accepted: 03/15/2016] [Indexed: 11/18/2022]
Abstract
BACKGROUND Quadrivalent inactivated influenza vaccines (IIV4) were first available for use during 2013-14 influenza season for individuals aged ≥6 months. IIV4 is designed to protect against four different flu viruses; two influenza A viruses and two influenza B viruses. METHODS We searched the Vaccine Adverse Event Reporting System (VAERS) for US reports after IIV4 and trivalent inactivated influenza vaccine (IIV3) from 7/1/2013-5/31/2015. Medical records were requested for non-manufacturer reports classified as serious (i.e. death, hospitalization, prolonged hospitalization, life-threatening illness, permanent disability). The review included automated data analysis, clinical review of all serious reports, reports of special interest, and empirical Bayesian data mining. RESULTS VAERS received 1,838 IIV4 reports; 512 (28%) in persons aged 6 months-17 years of which 42 (8.2%) were serious reports; 1,265 (69%) in persons aged >18 years of which 84 (6.6%) were serious reports; two in children <6 months and 59 in persons of unknown age. Injection site erythema (24%), fever (14%) and injection site swelling (17%) were the most frequent adverse events among persons aged 6 months-17 years, while injection site pain (16%), pain (15%) and pain in extremity (13%) were the most frequent among persons aged 18-64 years given the vaccine alone. Among non-death serious reports, injection site reactions, constitutional symptoms, Guillain-Barré syndrome, seizures, and anaphylaxis were the most frequently reported adverse events. Data mining detected disproportional reporting for incorrect vaccine administration with no associated adverse events. Adverse events following IIV4 reported to VAERS were similar to those following IIV3. CONCLUSIONS In our review of VAERS reports, IIV4 had a similar safety profile to IIV3. Most of the reported AEs were non-serious. Our findings are consistent with data from pre-licensure studies of IIV4.
Collapse
Affiliation(s)
- Penina Haber
- Immunization Safety Office, Division of Healthcare Quality Promotion, National Center Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) , 1600 Clifton Rd NE, Atlanta GA 30329, United States.
| | - Pedro L Moro
- Immunization Safety Office, Division of Healthcare Quality Promotion, National Center Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) , 1600 Clifton Rd NE, Atlanta GA 30329, United States
| | - Paige Lewis
- Immunization Safety Office, Division of Healthcare Quality Promotion, National Center Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) , 1600 Clifton Rd NE, Atlanta GA 30329, United States
| | - Emily Jane Woo
- Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Silver Spring, MD, United States
| | - Christopher Jankosky
- Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Silver Spring, MD, United States
| | - Maria Cano
- Immunization Safety Office, Division of Healthcare Quality Promotion, National Center Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) , 1600 Clifton Rd NE, Atlanta GA 30329, United States
| |
Collapse
|
|
20
|
Halsey NA, Talaat KR, Greenbaum A, Mensah E, Dudley MZ, Proveaux T, Salmon DA. The safety of influenza vaccines in children: An Institute for Vaccine Safety white paper. Vaccine 2015; 33 Suppl 5:F1-F67. [PMID: 26822822 DOI: 10.1016/j.vaccine.2015.10.080] [Citation(s) in RCA: 34] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/26/2015] [Revised: 10/02/2015] [Accepted: 10/06/2015] [Indexed: 01/19/2023]
Abstract
Most influenza vaccines are generally safe, but influenza vaccines can cause rare serious adverse events. Some adverse events, such as fever and febrile seizures, are more common in children than adults. There can be differences in the safety of vaccines in different populations due to underlying differences in genetic predisposition to the adverse event. Live attenuated vaccines have not been studied adequately in children under 2 years of age to determine the risks of adverse events; more studies are needed to address this and several other priority safety issues with all influenza vaccines in children. All vaccines intended for use in children require safety testing in the target age group, especially in young children. Safety of one influenza vaccine in children should not be extrapolated to assumed safety of all influenza vaccines in children. The low rates of adverse events from influenza vaccines should not be a deterrent to the use of influenza vaccines because of the overwhelming evidence of the burden of disease due to influenza in children.
Collapse
Affiliation(s)
- Neal A Halsey
- Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States; Institute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.
| | - Kawsar R Talaat
- Institute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States; Center for Immunization Research, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States
| | - Adena Greenbaum
- Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, MD, United States
| | - Eric Mensah
- Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States
| | - Matthew Z Dudley
- Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States; Institute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States
| | - Tina Proveaux
- Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States; Institute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States
| | - Daniel A Salmon
- Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States; Institute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States
| |
Collapse
|
|
21
|
Yih WK, Kulldorff M, Sandhu SK, Zichittella L, Maro JC, Cole DV, Jin R, Kawai AT, Baker MA, Liu C, McMahill-Walraven CN, Selvan MS, Platt R, Nguyen MD, Lee GM. Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System. Pharmacoepidemiol Drug Saf 2015; 25:481-92. [PMID: 26572776 PMCID: PMC5019152 DOI: 10.1002/pds.3908] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/23/2015] [Revised: 09/28/2015] [Accepted: 10/06/2015] [Indexed: 11/13/2022]
Abstract
Purpose To develop the infrastructure to conduct timely active surveillance for safety of influenza vaccines and other medical countermeasures in the Sentinel System (formerly the Mini‐Sentinel Pilot), a Food and Drug Administration‐sponsored national surveillance system that typically relies on data that are mature, settled, and updated quarterly. Methods Three Data Partners provided their earliest available (“fresh”) cumulative claims data on influenza vaccination and health outcomes 3–4 times on a staggered basis during the 2013–2014 influenza season, collectively producing 10 data updates. We monitored anaphylaxis in the entire population using a cohort design and seizures in children ≤4 years of age using both a self‐controlled risk interval design (primary) and a cohort design (secondary). After each data update, we conducted sequential analysis for inactivated (IIV) and live (LAIV) influenza vaccines using the Maximized Sequential Probability Ratio Test, adjusting for data‐lag. Results Most of the 10 sequential analyses were conducted within 6 weeks of the last care‐date in the cumulative dataset. A total of 6 682 336 doses of IIV and 782 125 doses of LAIV were captured. The primary analyses did not identify any statistical signals following IIV or LAIV. In secondary analysis, the risk of seizures was higher following concomitant IIV and PCV13 than historically after IIV in 6‐ to 23‐month‐olds (relative risk = 2.7), which requires further investigation. Conclusions The Sentinel System can implement a sequential analysis system that uses fresh data for medical product safety surveillance. Active surveillance using sequential analysis of fresh data holds promise for detecting clinically significant health risks early. Limitations of employing fresh data for surveillance include cost and the need for careful scrutiny of signals. © 2015 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.
Collapse
Affiliation(s)
- Weiling Katherine Yih
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
| | - Martin Kulldorff
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
| | - Sukhminder K Sandhu
- Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
| | - Lauren Zichittella
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
| | - Judith C Maro
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
| | - David V Cole
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
| | - Robert Jin
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
| | - Alison Tse Kawai
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
| | - Meghan A Baker
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
| | - Chunfu Liu
- Government and Academic Research, HealthCore, Alexandria, VA, USA
| | | | - Mano S Selvan
- Comprehensive Health Insights, Humana Inc., Louisville, KY, USA
| | - Richard Platt
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
| | - Michael D Nguyen
- Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
| | - Grace M Lee
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
| |
Collapse
|
|
22
|
Kawai AT, Martin D, Kulldorff M, Li L, Cole DV, McMahill-Walraven CN, Selvam N, Selvan MS, Lee GM. Febrile Seizures After 2010-2011 Trivalent Inactivated Influenza Vaccine. Pediatrics 2015; 136:e848-55. [PMID: 26371192 DOI: 10.1542/peds.2015-0635] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 07/08/2015] [Indexed: 11/24/2022] Open
Abstract
OBJECTIVES In the Post-Licensure Rapid Immunization Safety Monitoring Program, we examined risk of febrile seizures (FS) after trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) during the 2010-2011 influenza season, adjusted for concomitant diphtheria tetanus acellular pertussis-containing vaccines (DTaP). Assuming children would receive both vaccines, we examined whether same-day TIV and PCV13 vaccination was associated with greater FS risk when compared with separate-day vaccination. METHODS We used a self-controlled risk interval design, comparing the FS rate in a risk interval (0-1 days) versus control interval (14-20 days). Vaccinations were identified in claims and immunization registry data. FS were confirmed with medical records. RESULTS No statistically significant TIV-FS associations were found in unadjusted or adjusted models (incidence rate ratio [IRR] adjusted for age, seasonality, and concomitant PCV13 and DTaP: 1.36, 95% confidence interval [CI] 0.78 to 2.39). Adjusted for age and seasonality, PCV13 was significantly associated with FS (IRR 1.74, 95% CI 1.06 to 2.86), but not when further adjusting for concomitant TIV and DTaP (IRR 1.61, 95% CI 0.91 to 2.82). Same-day TIV and PCV13 vaccination was not associated with excess risk of FS when compared with separate-day vaccination (1.08 fewer FS per 100 000 with same day administration, 95% CI -5.68 to 6.09). CONCLUSIONS No statistically significant increased risk of FS was found for 2010-2011 TIV or PCV13, when adjusting for concomitant vaccines. Same-day TIV and PCV13 vaccination was not associated with more FS compared with separate-day vaccination.
Collapse
Affiliation(s)
- Alison Tse Kawai
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts;
| | - David Martin
- US Food and Drug Administration Center for Biologics Evaluation and Research, Silver Spring, Maryland
| | - Martin Kulldorff
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts
| | - Lingling Li
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts
| | - David V Cole
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts
| | | | | | - Mano S Selvan
- Comprehensive Health Insights, Humana Inc, Louisville, Kentucky; and
| | - Grace M Lee
- Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts; Division of Infectious Diseases, Boston Children's Hospital, Boston, Massachusetts
| |
Collapse
|
|
23
|
Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine 2015; 33:4398-405. [PMID: 26209838 PMCID: PMC4632204 DOI: 10.1016/j.vaccine.2015.07.035] [Citation(s) in RCA: 398] [Impact Index Per Article: 39.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/26/2014] [Revised: 07/09/2015] [Accepted: 07/11/2015] [Indexed: 10/23/2022]
Abstract
The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) conduct post-licensure vaccine safety monitoring using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous (or passive) reporting system. This means that after a vaccine is approved, CDC and FDA continue to monitor safety while it is distributed in the marketplace for use by collecting and analyzing spontaneous reports of adverse events that occur in persons following vaccination. Various methods and statistical techniques are used to analyze VAERS data, which CDC and FDA use to guide further safety evaluations and inform decisions around vaccine recommendations and regulatory action. VAERS data must be interpreted with caution due to the inherent limitations of passive surveillance. VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination. CDC makes VAERS data available to the public and readily accessible online. We describe fundamental vaccine safety concepts, provide an overview of VAERS for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and explain how CDC and FDA analyze VAERS data. We also describe strengths and limitations, and address common misconceptions about VAERS. Information in this review will be helpful for healthcare professionals counseling patients, parents, and others on vaccine safety and benefit-risk balance of vaccination.
Collapse
Affiliation(s)
- Tom T Shimabukuro
- Immunization Safety Office, Division of Health care Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States.
| | - Michael Nguyen
- Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States
| | - David Martin
- Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States
| | - Frank DeStefano
- Immunization Safety Office, Division of Health care Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States
| |
Collapse
|
|
24
|
Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000-2013. Vaccine 2015; 33:3171-8. [PMID: 25980429 DOI: 10.1016/j.vaccine.2015.05.006] [Citation(s) in RCA: 48] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/25/2015] [Revised: 04/30/2015] [Accepted: 05/04/2015] [Indexed: 11/21/2022]
Abstract
IMPORTANCE Vaccination errors are preventable events. Errors can have impacts including inadequate immunological protection, possible injury, cost, inconvenience, and reduced confidence in the healthcare delivery system. OBJECTIVES To describe vaccination error reports submitted to the Vaccine Adverse Event Reporting System (VAERS) and identify opportunities for prevention. METHODS We conducted descriptive analyses using data from VAERS, the U.S. spontaneous surveillance system for adverse events following immunization. The VAERS database was searched from 2000 through 2013 for U.S. reports describing vaccination errors and reports were categorized into 11 error groups. We analyzed numbers and types of vaccination error reports, vaccines involved, reporting trends over time, and descriptions of errors for selected reports. RESULTS We identified 20,585 vaccination error reports documenting 21,843 errors. Annual reports increased from 10 in 2000 to 4324 in 2013. The most common error group was "Inappropriate Schedule" (5947; 27%); human papillomavirus (quadrivalent) (1516) and rotavirus (880) vaccines were most frequently involved. "Storage and Dispensing" errors (4983; 23%) included mostly expired vaccine administered (2746) and incorrect storage of vaccine (2202). "Wrong Vaccine Administered" errors (3372; 15%) included mix-ups between vaccines with similar antigens such as varicella/herpes zoster (shingles), DTaP/Tdap, and pneumococcal conjugate/polysaccharide. For error reports with an adverse health event (5204; 25% of total), 92% were classified as non-serious. We also identified 936 vaccination error clusters (i.e., same error, multiple patients, in a common setting) involving over 6141 patients. The most common error in clusters was incorrect storage of vaccine (582 clusters and more than 1715 patients). CONCLUSIONS Vaccination error reports to VAERS have increased substantially. Contributing factors might include changes in reporting practices, increasing complexity of the immunization schedule, availability of products with similar sounding names or acronyms, and increased attention to storage and temperature lapses. Prevention strategies should be considered.
Collapse
|
|
25
|
Datwani H, Moro PL, Harrington T, Broder KR. Chorioamnionitis following vaccination in the Vaccine Adverse Event Reporting System. Vaccine 2015; 33:3110-3. [PMID: 25976546 DOI: 10.1016/j.vaccine.2015.04.097] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/18/2015] [Revised: 04/28/2015] [Accepted: 04/29/2015] [Indexed: 01/23/2023]
Abstract
BACKGROUND In October 2012, the Advisory Committee on Immunization Practices (ACIP) recommended a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) during each pregnancy, irrespective of the woman's prior history of receiving Tdap. A retrospective cohort study to assess the safety of Tdap vaccination in pregnant women in two Vaccine Safety Datalink (VSD) sites during 2010-2012 found a small but statistically significant increased risk of chorioamnionitis. OBJECTIVE We conducted a review of the VAERS database to describe reports of chorioamnionitis following receipt of any vaccines. METHODS We searched the VAERS database for reports of chorioamnionitis after any vaccine in the United States during the period from July 1, 1990 through February 2, 2014. RESULTS VAERS received 31 reports of chorioamnionitis out of 3389 pregnancy reports in 24 years. The three most common vaccines in these reports were 2009 H1N1 inactivated influenza, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32%, 29% and 26% of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported. CONCLUSION Chorioamnionitis was found to be uncommonly reported, representing 1% of pregnancy reports to VAERS. A majority of reports had at least one risk factor for chorioamnionitis.
Collapse
Affiliation(s)
- Hema Datwani
- Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333, United States
| | - Pedro L Moro
- Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333, United States.
| | - Theresa Harrington
- Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333, United States
| | - Karen R Broder
- Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333, United States
| |
Collapse
|
|
26
|
Moro PL, Jankosky C, Menschik D, Lewis P, Duffy J, Stewart B, Shimabukuro TT. Adverse events following Haemophilus influenzae type b vaccines in the Vaccine Adverse Event Reporting System, 1990-2013. J Pediatr 2015; 166:992-7. [PMID: 25598306 PMCID: PMC6500451 DOI: 10.1016/j.jpeds.2014.12.014] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/20/2014] [Revised: 10/20/2014] [Accepted: 12/05/2014] [Indexed: 10/24/2022]
Abstract
OBJECTIVE To characterize adverse events (AEs) after Haemophilus influenzae type b (Hib) vaccines reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. STUDY DESIGN We searched VAERS for US reports after Hib vaccines among reports received from January 1, 1990, to December 1, 2013. We reviewed a random sample of reports and accompanying medical records for reports classified as serious. All reports of death were reviewed. Physicians assigned a primary clinical category to each reviewed report. We used empirical Bayesian data mining to identify AEs that were disproportionally reported after Hib vaccines. RESULTS VAERS received 29,747 reports after Hib vaccines; 5179 (17%) were serious, including 896 reports of deaths. Median age was 6 months (range 0-1022 months). Sudden infant death syndrome was the stated cause of death in 384 (51%) of 749 death reports with autopsy/death certificate records. The most common nondeath serious AE categories were neurologic (80; 37%), other noninfectious (46; 22%) (comprising mainly constitutional signs and symptoms); and gastrointestinal (39; 18%) conditions. No new safety concerns were identified after clinical review of reports of AEs that exceeded the data mining statistical threshold. CONCLUSION Review of VAERS reports did not identify any new or unexpected safety concerns for Hib vaccines.
Collapse
Affiliation(s)
- Pedro L Moro
- Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA.
| | - Christopher Jankosky
- Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
| | - David Menschik
- Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
| | - Paige Lewis
- Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA
| | - Jonathan Duffy
- Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA
| | - Brock Stewart
- Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA
| | - Tom T Shimabukuro
- Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA
| |
Collapse
|
|
27
|
Abstract
Vaccine administration is the second leading cause of febrile seizures (FS). FS occurrence in children is a serious concern because it leads to public apprehension of vaccinations. This review discusses the clinical implications of FS, its potential link to vaccinations and its impact on official recommendations for vaccinations in children. Vaccines such as the pertussis antigen-containing vaccine, the measles-containing vaccine and the influenza vaccine have been linked to FS. However, FS events are very rare and are not usually associated with downstream complications or severe neurologic diseases. Considering their significant health benefits, vaccinations have not been restricted in the pediatric population. Nevertheless, vaccine-induced FS could be a problem, particularly in genetically predisposed children. Therefore, post-marketing surveillance studies are required to accurately assess the incidence of FS and identify individuals who are particularly susceptible to FS after vaccination.
Collapse
Affiliation(s)
- Nicola Principi
- Department of Pathophysiology and Transplantation, Pediatric Clinic 1, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Commenda 9, 20122 Milano, Italy
| | | |
Collapse
|
|
28
|
Lafond KE, Englund JA, Tam JS, Bresee JS. Overview of Influenza Vaccines in Children. J Pediatric Infect Dis Soc 2013; 2:368-78. [PMID: 26619499 DOI: 10.1093/jpids/pit053] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/08/2013] [Accepted: 06/06/2013] [Indexed: 11/15/2022]
Abstract
Prevention of influenza infection through vaccination is the best strategy to reduce its disease burden; however, annual revaccination is required to provide protection from circulating virus strains. Currently available influenza vaccines are trivalent inactivated influenza vaccines (IIV) or live-attenuated influenza vaccines (LAIV); however, quadrivalent formulations of IIV and LAIV are expected to be available for the 2013-2014 influenza season. Among children 6 months through 8 years of age receiving their first influenza vaccination, 2 doses of vaccines are required to provide adequate protection. Because of the wide range of circulating influenza viruses and host immune responses, estimates of vaccine effectiveness vary widely by year, age group, and vaccine studied. We summarize the evidence base for pediatric influenza vaccination, and we describe the challenges and limitations of protecting this population with currently available vaccines.
Collapse
Affiliation(s)
- Kathryn E Lafond
- Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Janet A Englund
- Pediatric Infectious Diseases, Seattle Children's Hospital, University of Washington, Seattle
| | - John S Tam
- Initiative for Vaccine Research, World Health Organization, Geneva, Switzerland
| | - Joseph S Bresee
- Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
| |
Collapse
|
|
29
|
Thyagarajan V, Su S, Gee J, Duffy J, McCarthy NL, Chan KA, Weintraub ES, Lin ND. Identification of seizures among adults and children following influenza vaccination using health insurance claims data. Vaccine 2013; 31:5997-6002. [PMID: 24148576 DOI: 10.1016/j.vaccine.2013.10.026] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/15/2013] [Revised: 08/23/2013] [Accepted: 10/08/2013] [Indexed: 11/29/2022]
Abstract
INTRODUCTION Post-licensure surveillance of adverse events following vaccination or prescription drug use often relies on electronic healthcare data to efficiently detect and evaluate safety signals. The accuracy of seizure-related diagnosis codes in identifying true incident seizure events in vaccine safety studies is influenced by factors such as clinical setting of diagnosis and age. To date, most studies of post-vaccination seizure have focused on pediatric populations. More information is needed on how well seizure can be identified in adults and children using algorithms that rely on electronic healthcare data. METHODS This validation study was part of a larger safety study of influenza vaccination during the 2009-2010 and 2010-2011 influenza seasons. Children and adults receiving influenza vaccination were drawn from an administrative claims database of a large United States healthcare insurer. Potential seizure events were identified using an algorithm of ICD-9 diagnosis codes associated with an emergency department (ED) visit or hospitalization within pre-specified risk windows following influenza vaccination. Seizure events were confirmed through medical record review. The positive predictive value (PPV) of the algorithm was calculated within each diagnostic setting and stratified by age group, ICD-9 code group, and sex. RESULTS Review confirmed 113 out of 176 potential seizure events. The PPVs were higher in the ED setting (93.9%) than in the inpatient setting (38.3%). The PPVs by age varied within the ED setting (98.2% in <7 years, 76.9% in 7-24 years, 92.3% in ≥25 years) and within the inpatient setting (64.7% in <7 years, 33.3% in 7-24 years, 32.3% in ≥25 years). CONCLUSIONS Our algorithm for identification of seizure events using claims data had a high level of accuracy in the emergency department setting in young children and older adults and a lower, but acceptable, level of accuracy in older children and young adults.
Collapse
Affiliation(s)
- Veena Thyagarajan
- Optum Epidemiology, 315 E. Eisenhower Parkway Suite 305, Ann Arbor, MI 48108, USA.
| | | | | | | | | | | | | | | |
Collapse
|
|
30
|
Abstract
Seizures are a commonly encountered condition within the emergency department and, because of this, can engender complacency on the part of the physicians and staff. Unfortunately, there is significant associated morbidity and mortality with seizures, and they should never be regarded as routine. This point is particularly important with respect to seizures in pediatric patients. The aim of this review is to provide a current view of the various issues that make pediatric seizures unique and to help elucidate emergent evaluation and management strategies.
Collapse
MESH Headings
- Anticonvulsants/therapeutic use
- Child
- Child, Preschool
- Diagnosis, Differential
- Humans
- Infant
- Infant, Newborn
- Infant, Newborn, Diseases/diagnosis
- Infant, Newborn, Diseases/etiology
- Infant, Newborn, Diseases/therapy
- Seizures/diagnosis
- Seizures/etiology
- Seizures/therapy
- Seizures, Febrile/diagnosis
- Seizures, Febrile/therapy
Collapse
Affiliation(s)
- Maneesha Agarwal
- Department of Emergency Medicine, Carolinas Medical Center, 3rd Floor Medical Education Building, 1000 Blythe Boulevard, Charlotte, NC 28203, USA
| | | |
Collapse
|
|
31
|
Arnheim-Dahlström L, Hällgren J, Weibull CE, Sparén P. Risk of presentation to hospital with epileptic seizures after vaccination with monovalent AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine (Pandemrix): self controlled case series study. BMJ 2012; 345:e7594. [PMID: 23274350 PMCID: PMC3532724 DOI: 10.1136/bmj.e7594] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/05/2022]
Abstract
OBJECTIVE To assess the risk of epileptic seizures in people with and without epilepsy after vaccination with a monovalent AS03 adjuvanted pandemic A/H1N1 influenza vaccine (Pandemrix; Glaxo SmithKline, Sweden). DESIGN Register based self controlled case series. SETTING Three Swedish counties (source population 750,000). PARTICIPANTS 373,398 people (age 0-106, median 41.2) who were vaccinated. Vaccinated people with epileptic seizures, diagnosed as inpatients or outpatients, at any time from 90 days before until 90 days after any dose of vaccine. MAIN OUTCOME MEASURES Endpoints were admission to hospital or outpatient hospital care with epileptic seizures as the main diagnosis. The effect estimate of relative incidence was calculated as the incidence of epileptic seizures in period after exposure relative to the incidence of epileptic seizures in two control periods, one before and one after vaccination. RESULTS 859 people experienced epileptic seizures during the study period. There was no increased risk of seizures in people with previously diagnosed epilepsy (relative incidence 1.01, 95% confidence interval 0.74 to 1.39) and a non-significant decrease in risk for people without epilepsy (0.67, 0.27 to 1.65) during the day 1-7 risk period (where day 1 is the day of vaccination). In a second risk period (day 8-30), there was a non-significant increased risk of seizures in people without epilepsy (1.11, 0.73 to 1.70) but no increase in risk for those with epilepsy (1.00, 0.83 to 1.21). CONCLUSIONS This study found no evidence of an increase in risk of presentation to hospital with epileptic seizures after vaccination with a monovalent AS03 adjuvanted pandemic H1N1 influenza vaccine.
Collapse
Affiliation(s)
- Lisen Arnheim-Dahlström
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Nobels väg 12A, 171 77 Stockholm, Sweden
| | | | | | | |
Collapse
|
|
32
|
Beeler JA, Eichelberger MC. Influenza and respiratory syncytial virus (RSV) vaccines for infants: safety, immunogenicity, and efficacy. Microb Pathog 2012; 55:9-15. [PMID: 23247146 PMCID: PMC7127028 DOI: 10.1016/j.micpath.2012.11.013] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/19/2012] [Revised: 11/28/2012] [Accepted: 11/29/2012] [Indexed: 02/04/2023]
Abstract
Respiratory viral infections in infants and young children frequently cause illness that can easily progress to hospitalization and death. There are currently no licensed vaccines to prevent respiratory viral disease in children younger than 6 months, reflecting safety concerns and the difficulty in inducing effective immune responses in infants. This review discusses vaccines that have been developed, or are currently being developed, against influenza and respiratory syncytial virus, with a focus on studies performed to demonstrate their safety and efficacy, and the impact of immunologic immaturity and maternal antibodies on the infant response to vaccines.
Collapse
Affiliation(s)
- Judy A Beeler
- Division of Viral Products, CBER, OVRR, FDA, United States.
| | | |
Collapse
|
|
33
|
Esposito S, Marchisio P, Montinaro V, Bianchini S, Weverling GJ, Pariani E, Amendola A, Fabiano V, Pivetti V, Zanetti A, Zuccotti GV. The immunogenicity and safety of a single 0.5 mL dose of virosomal subunit influenza vaccine administered to unprimed children aged ≥6 to <36 months: data from a randomized, Phase III study. Vaccine 2012; 30:7005-12. [PMID: 23059357 DOI: 10.1016/j.vaccine.2012.09.069] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/21/2012] [Revised: 09/17/2012] [Accepted: 09/26/2012] [Indexed: 11/25/2022]
Abstract
This study evaluated the immunogenicity, safety and tolerability of a single 0.5 mL dose of the seasonal virosomal subunit influenza vaccine (Inflexal V, Crucell, Switzerland) in 205 healthy, unprimed children aged at least 6 to <36 months, evaluated at four weeks post-vaccination and seven months from baseline. Of the enrolled children, 102 received one single 0.5 mL dose and 103 received the standard two 0.25 mL doses given four weeks apart. Both treatments evoked an immune response that satisfied the EMA/CHMP criteria for yearly vaccine licensing for all three vaccine strains. Exploratory analyses revealed no differences between the groups at four weeks post-vaccination. Furthermore, immunogenicity was maintained seven months after the first vaccination after both the 0.5 mL and standard two 0.25 mL doses. Adverse events were comparable between groups and were as expected according to the safety profile of the vaccine; overall, the vaccine was well tolerated. Our results show that a single 0.5 mL dose effectively and safely provided long-term immunogenicity to all three influenza strains in unprimed children aged at least 6 to <36 months.
Collapse
Affiliation(s)
- Susanna Esposito
- Pediatric Clinic 1, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Commenda 9, 20122 Milan, Italy.
| | | | | | | | | | | | | | | | | | | | | |
Collapse
|
|
34
|
Zheteyeva YA, Moro PL, Tepper NK, Rasmussen SA, Barash FE, Revzina NV, Kissin D, Lewis PW, Yue X, Haber P, Tokars JI, Vellozzi C, Broder KR. Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women. Am J Obstet Gynecol 2012; 207:59.e1-7. [PMID: 22727350 DOI: 10.1016/j.ajog.2012.05.006] [Citation(s) in RCA: 88] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/17/2012] [Revised: 03/29/2012] [Accepted: 05/09/2012] [Indexed: 11/25/2022]
Abstract
OBJECTIVE We sought to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) of pregnant women who received tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap). STUDY DESIGN We searched VAERS for reports of pregnant women who received Tdap from Jan. 1, 2005, through June 30, 2010. We conducted a clinical review of reports and available medical records. RESULTS We identified 132 reports of Tdap administered to pregnant women; 55 (42%) described no adverse event (AE). No maternal or infant deaths were reported. The most frequent pregnancy-specific AE was spontaneous abortion in 22 (16.7%) reports. Injection site reactions were the most frequent non-pregnancy-specific AE found in 6 (4.5%) reports. One report with a major congenital anomaly (gastroschisis) was identified. CONCLUSION During a time when Tdap was not routinely recommended in pregnancy, review of reports to VAERS in pregnant women after Tdap did not identify any concerning patterns in maternal, infant, or fetal outcomes.
Collapse
|
|
35
|
Broder KR, Martin DB, Vellozzi C. In the heat of a signal: Responding to a vaccine safety signal for febrile seizures after 2010–11 influenza vaccine in young children, United States. Vaccine 2012; 30:2032-4. [DOI: 10.1016/j.vaccine.2011.12.040] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/03/2011] [Revised: 11/23/2011] [Accepted: 12/01/2011] [Indexed: 11/29/2022]
|