Commentary on the implications of safety and efficacy studies in pediatric patients with administration of human rabies immune globulin (HRIG)?
The FDA strongly encourages rigorous safety and efficacy studies in all age groups for which vaccines and treatments for pervasive and severe diseases are intended. Until recently, there had been no safety and efficacy studies conducted in children for human rabies immune globulins. The publication,...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2022-11-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2022.2054262 |
| _version_ | 1797673195234394112 |
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| author | Jerry Siegel Karl Kappeler |
| author_facet | Jerry Siegel Karl Kappeler |
| author_sort | Jerry Siegel |
| collection | DOAJ |
| description | The FDA strongly encourages rigorous safety and efficacy studies in all age groups for which vaccines and treatments for pervasive and severe diseases are intended. Until recently, there had been no safety and efficacy studies conducted in children for human rabies immune globulins. The publication,” Safety, and efficacy of rabies immunoglobulin in pediatric patients with suspected exposure”, Human Vaccines & Immunotherapeutics, 17:7, 2090–2096, was the first study that prospectively reviewed the use of KEDRAB® 150 IU/ml in 30 pediatric patients ages 0.5–14.9 years old. The results showed that 93.3% achieved RVNA titer >/ = 5 IU/ml, on day 14. Also, no participants reported a serious adverse event (SAE), or an adverse event (AE) leading to study discontinuation, and there were no deaths. The most common treatment emergent adverse events (TEAE) were injection-site pain. Currently there are 3 HRIG products on the US market, KEDRAB®, HyperRab® and Imogam® Rabies HT, but only KEDRAB® has published safety and efficacy data in a pediatric population. While it is common practice to prescribe medications for pediatric patients “off-label” there now exists one product with safety data in children. It is worth considering if this creates a higher medical liability for the prescriber and institution |
| first_indexed | 2024-03-11T21:41:36Z |
| format | Article |
| id | doaj.art-5027053b119b471c85baa2d2340f4c25 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T21:41:36Z |
| publishDate | 2022-11-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-5027053b119b471c85baa2d2340f4c252023-09-26T13:19:06ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2022-11-0118510.1080/21645515.2022.20542622054262Commentary on the implications of safety and efficacy studies in pediatric patients with administration of human rabies immune globulin (HRIG)?Jerry Siegel0Karl Kappeler1The Ohio State UniversityThe Ohio State UniversityThe FDA strongly encourages rigorous safety and efficacy studies in all age groups for which vaccines and treatments for pervasive and severe diseases are intended. Until recently, there had been no safety and efficacy studies conducted in children for human rabies immune globulins. The publication,” Safety, and efficacy of rabies immunoglobulin in pediatric patients with suspected exposure”, Human Vaccines & Immunotherapeutics, 17:7, 2090–2096, was the first study that prospectively reviewed the use of KEDRAB® 150 IU/ml in 30 pediatric patients ages 0.5–14.9 years old. The results showed that 93.3% achieved RVNA titer >/ = 5 IU/ml, on day 14. Also, no participants reported a serious adverse event (SAE), or an adverse event (AE) leading to study discontinuation, and there were no deaths. The most common treatment emergent adverse events (TEAE) were injection-site pain. Currently there are 3 HRIG products on the US market, KEDRAB®, HyperRab® and Imogam® Rabies HT, but only KEDRAB® has published safety and efficacy data in a pediatric population. While it is common practice to prescribe medications for pediatric patients “off-label” there now exists one product with safety data in children. It is worth considering if this creates a higher medical liability for the prescriber and institutionhttp://dx.doi.org/10.1080/21645515.2022.2054262rabiesimmune globulinpediatricssafetyefficacyprophylaxis |
| spellingShingle | Jerry Siegel Karl Kappeler Commentary on the implications of safety and efficacy studies in pediatric patients with administration of human rabies immune globulin (HRIG)? Human Vaccines & Immunotherapeutics rabies immune globulin pediatrics safety efficacy prophylaxis |
| title | Commentary on the implications of safety and efficacy studies in pediatric patients with administration of human rabies immune globulin (HRIG)? |
| title_full | Commentary on the implications of safety and efficacy studies in pediatric patients with administration of human rabies immune globulin (HRIG)? |
| title_fullStr | Commentary on the implications of safety and efficacy studies in pediatric patients with administration of human rabies immune globulin (HRIG)? |
| title_full_unstemmed | Commentary on the implications of safety and efficacy studies in pediatric patients with administration of human rabies immune globulin (HRIG)? |
| title_short | Commentary on the implications of safety and efficacy studies in pediatric patients with administration of human rabies immune globulin (HRIG)? |
| title_sort | commentary on the implications of safety and efficacy studies in pediatric patients with administration of human rabies immune globulin hrig |
| topic | rabies immune globulin pediatrics safety efficacy prophylaxis |
| url | http://dx.doi.org/10.1080/21645515.2022.2054262 |
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