Safety evaluation on concomitant immunization with inactivated poliomyelitis vaccine produced from Sabin strains and other vaccines (from 2015 to 2020)
Objective To evaluate the safety of concomitantly administering inactivated poliomyelitis vaccine produced from Sabin strains (sIPVs) with other vaccines. Methods A descriptive analysis was carried out on adverse events following immunization (AEFI) based on the administration of sIPV alone or conco...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2022-01-01
|
| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2022.2041944 |
| _version_ | 1797673198137901056 |
|---|---|
| author | Yan Deng Li Yi Ying Li Zhimei Zhao Zhilei Zhong Haoyu Shi Jiarong Li Yan Liang Jingsi Yang |
| author_facet | Yan Deng Li Yi Ying Li Zhimei Zhao Zhilei Zhong Haoyu Shi Jiarong Li Yan Liang Jingsi Yang |
| author_sort | Yan Deng |
| collection | DOAJ |
| description | Objective To evaluate the safety of concomitantly administering inactivated poliomyelitis vaccine produced from Sabin strains (sIPVs) with other vaccines. Methods A descriptive analysis was carried out on adverse events following immunization (AEFI) based on the administration of sIPV alone or concomitant with other vaccines (from 2015 to 2020) using data from the national AEFI surveillance system of China (CNAEFIS). All adverse reactions (ADRs) of the concomitant immunization were coded using a medical dictionary for regulatory activities (MedDRA) before comparison. Results The CNAEFIS reported a total of 9130 sIPV-related AEFI cases, including 6842 AEFI cases collected after immunization with sIPV alone and 2288 AEFI cases collected after immunization of sIPV concomitant with other vaccines. The combination of sIPV with diphtheria, tetanus and pertussis vaccine (DTaP) was correlated with the highest frequency of AEFI, which accounted for 53.50% of all 2288 AEFI cases. After MedDRA-based coding, the most frequent ADR was fever (70.18%), followed by erythema and swelling at the injection site (6.95%), induration at the injection site (3.85%), dermatitis allergy (3.56%) and urticaria (1.55%). A statistically significant difference (P < .001) was found between sIPV immunization and sIPV immunization concomitant with other vaccines for general reactions (95.36% and 93.22%, respectively) and abnormal reactions (4.64% and 6.78%, respectively). Conclusion No new safety signal is found for sIPV administered concomitantly, although its administration with other vaccines may increase the occurrence of abnormal reactions. Vaccine manufacturers should focus on the safety of administering sIPV with DTaP and carry out relevant clinical studies when necessary. |
| first_indexed | 2024-03-11T21:41:42Z |
| format | Article |
| id | doaj.art-699efae8520e44df83a3835d38a9e1e7 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T21:41:42Z |
| publishDate | 2022-01-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-699efae8520e44df83a3835d38a9e1e72023-09-26T13:19:05ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2022-01-0118110.1080/21645515.2022.20419442041944Safety evaluation on concomitant immunization with inactivated poliomyelitis vaccine produced from Sabin strains and other vaccines (from 2015 to 2020)Yan Deng0Li Yi1Ying Li2Zhimei Zhao3Zhilei Zhong4Haoyu Shi5Jiarong Li6Yan Liang7Jingsi Yang8Chinese Academy of Medical ScienceChinese Academy of Medical ScienceChinese Academy of Medical ScienceChinese Academy of Medical ScienceChinese Academy of Medical ScienceChinese Academy of Medical ScienceChinese Academy of Medical ScienceChinese Academy of Medical ScienceChinese Academy of Medical ScienceObjective To evaluate the safety of concomitantly administering inactivated poliomyelitis vaccine produced from Sabin strains (sIPVs) with other vaccines. Methods A descriptive analysis was carried out on adverse events following immunization (AEFI) based on the administration of sIPV alone or concomitant with other vaccines (from 2015 to 2020) using data from the national AEFI surveillance system of China (CNAEFIS). All adverse reactions (ADRs) of the concomitant immunization were coded using a medical dictionary for regulatory activities (MedDRA) before comparison. Results The CNAEFIS reported a total of 9130 sIPV-related AEFI cases, including 6842 AEFI cases collected after immunization with sIPV alone and 2288 AEFI cases collected after immunization of sIPV concomitant with other vaccines. The combination of sIPV with diphtheria, tetanus and pertussis vaccine (DTaP) was correlated with the highest frequency of AEFI, which accounted for 53.50% of all 2288 AEFI cases. After MedDRA-based coding, the most frequent ADR was fever (70.18%), followed by erythema and swelling at the injection site (6.95%), induration at the injection site (3.85%), dermatitis allergy (3.56%) and urticaria (1.55%). A statistically significant difference (P < .001) was found between sIPV immunization and sIPV immunization concomitant with other vaccines for general reactions (95.36% and 93.22%, respectively) and abnormal reactions (4.64% and 6.78%, respectively). Conclusion No new safety signal is found for sIPV administered concomitantly, although its administration with other vaccines may increase the occurrence of abnormal reactions. Vaccine manufacturers should focus on the safety of administering sIPV with DTaP and carry out relevant clinical studies when necessary.http://dx.doi.org/10.1080/21645515.2022.2041944inactivated poliomyelitis vaccine made from the sabin strainadverse events following immunizationconcomitant immunizationsafetymedical dictionary for regulatory activities |
| spellingShingle | Yan Deng Li Yi Ying Li Zhimei Zhao Zhilei Zhong Haoyu Shi Jiarong Li Yan Liang Jingsi Yang Safety evaluation on concomitant immunization with inactivated poliomyelitis vaccine produced from Sabin strains and other vaccines (from 2015 to 2020) Human Vaccines & Immunotherapeutics inactivated poliomyelitis vaccine made from the sabin strain adverse events following immunization concomitant immunization safety medical dictionary for regulatory activities |
| title | Safety evaluation on concomitant immunization with inactivated poliomyelitis vaccine produced from Sabin strains and other vaccines (from 2015 to 2020) |
| title_full | Safety evaluation on concomitant immunization with inactivated poliomyelitis vaccine produced from Sabin strains and other vaccines (from 2015 to 2020) |
| title_fullStr | Safety evaluation on concomitant immunization with inactivated poliomyelitis vaccine produced from Sabin strains and other vaccines (from 2015 to 2020) |
| title_full_unstemmed | Safety evaluation on concomitant immunization with inactivated poliomyelitis vaccine produced from Sabin strains and other vaccines (from 2015 to 2020) |
| title_short | Safety evaluation on concomitant immunization with inactivated poliomyelitis vaccine produced from Sabin strains and other vaccines (from 2015 to 2020) |
| title_sort | safety evaluation on concomitant immunization with inactivated poliomyelitis vaccine produced from sabin strains and other vaccines from 2015 to 2020 |
| topic | inactivated poliomyelitis vaccine made from the sabin strain adverse events following immunization concomitant immunization safety medical dictionary for regulatory activities |
| url | http://dx.doi.org/10.1080/21645515.2022.2041944 |
| work_keys_str_mv | AT yandeng safetyevaluationonconcomitantimmunizationwithinactivatedpoliomyelitisvaccineproducedfromsabinstrainsandothervaccinesfrom2015to2020 AT liyi safetyevaluationonconcomitantimmunizationwithinactivatedpoliomyelitisvaccineproducedfromsabinstrainsandothervaccinesfrom2015to2020 AT yingli safetyevaluationonconcomitantimmunizationwithinactivatedpoliomyelitisvaccineproducedfromsabinstrainsandothervaccinesfrom2015to2020 AT zhimeizhao safetyevaluationonconcomitantimmunizationwithinactivatedpoliomyelitisvaccineproducedfromsabinstrainsandothervaccinesfrom2015to2020 AT zhileizhong safetyevaluationonconcomitantimmunizationwithinactivatedpoliomyelitisvaccineproducedfromsabinstrainsandothervaccinesfrom2015to2020 AT haoyushi safetyevaluationonconcomitantimmunizationwithinactivatedpoliomyelitisvaccineproducedfromsabinstrainsandothervaccinesfrom2015to2020 AT jiarongli safetyevaluationonconcomitantimmunizationwithinactivatedpoliomyelitisvaccineproducedfromsabinstrainsandothervaccinesfrom2015to2020 AT yanliang safetyevaluationonconcomitantimmunizationwithinactivatedpoliomyelitisvaccineproducedfromsabinstrainsandothervaccinesfrom2015to2020 AT jingsiyang safetyevaluationonconcomitantimmunizationwithinactivatedpoliomyelitisvaccineproducedfromsabinstrainsandothervaccinesfrom2015to2020 |