Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials
Background and Objectives The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and Eud...
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| Veröffentlicht in: | Drug safety 2023-06, Vol.46 (6), p.575-585 |
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| creator | Ahmadizar, Fariba Luxi, Nicoletta Raethke, Monika Schmikli, Sandor Riefolo, Fabio Saraswati, Putri Widi Bucsa, Camelia Osman, Alhadi Liddiard, Megan Maques, Francisco Batel Petrelli, Giuliana Sonderlichová, Simona Thurin, Nicolas H. Villalobos, Felipe Trifirò, Gianluca Sturkenboom, Miriam |
| description | Background and Objectives
The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials.
Methods
In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed.
Results
The CVM study enrolled 658 first-dose vaccinees (children aged 5–11 years;
n
= 250 and adolescents aged 12–17 years;
n
= 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000.
Conclusions
The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data. |
| doi_str_mv | 10.1007/s40264-023-01304-5 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_2820607267</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2820607267</sourcerecordid><originalsourceid>FETCH-LOGICAL-c419t-5500a29b9e30317c718dae6d9f7adf5b59a671e7940c74959b8848adbd4cca813</originalsourceid><addsrcrecordid>eNp9kM1u1DAURi1ERYfCC7BAllgHrn8Sx-xG0wKVKnWkKd1aN45TXGXswU4qzQvw3Hg6he66upZ9vu_Kh5APDD4zAPUlS-CNrICLCpgAWdWvyIIxpSumJX9NFsBYudSsOSVvc74HgJY37RtyKhQD0UixIH82OLhpT-NAV9e3l-clSm_RWh9cpsttDHd0-uXoGl3vcUre0nXczSNOPoavdBlw3GefD_EDdjGnuHMY6GZOD86PIwbr6GafJ7fNFENP1_4hTjjS1eiDt-VwkzyO-R05Gcpw75_mGfn57eJm9aO6uv5-uVpeVVYyPVV1DYBcd9oJEExZxdoeXdPrQWE_1F2tsVHMKS3BKqlr3bWtbLHvemkttkyckU_H3l2Kv2eXJ3Mf51R-kQ1vOTSgeKMKxY-UTTHn5AazS36LaW8YmIN6c1RvinrzqN7UJfTxqXrutq7_H_nnugDiCOTyFO5cet79Qu1fOAOO2A</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2820607267</pqid></control><display><type>article</type><title>Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials</title><source>MEDLINE</source><source>SpringerLink Journals</source><creator>Ahmadizar, Fariba ; Luxi, Nicoletta ; Raethke, Monika ; Schmikli, Sandor ; Riefolo, Fabio ; Saraswati, Putri Widi ; Bucsa, Camelia ; Osman, Alhadi ; Liddiard, Megan ; Maques, Francisco Batel ; Petrelli, Giuliana ; Sonderlichová, Simona ; Thurin, Nicolas H. ; Villalobos, Felipe ; Trifirò, Gianluca ; Sturkenboom, Miriam</creator><creatorcontrib>Ahmadizar, Fariba ; Luxi, Nicoletta ; Raethke, Monika ; Schmikli, Sandor ; Riefolo, Fabio ; Saraswati, Putri Widi ; Bucsa, Camelia ; Osman, Alhadi ; Liddiard, Megan ; Maques, Francisco Batel ; Petrelli, Giuliana ; Sonderlichová, Simona ; Thurin, Nicolas H. ; Villalobos, Felipe ; Trifirò, Gianluca ; Sturkenboom, Miriam ; ilmiovaccinoCOVID19 collaborating group</creatorcontrib><description>Background and Objectives
The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials.
Methods
In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed.
Results
The CVM study enrolled 658 first-dose vaccinees (children aged 5–11 years;
n
= 250 and adolescents aged 12–17 years;
n
= 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000.
Conclusions
The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.</description><identifier>ISSN: 0114-5916</identifier><identifier>EISSN: 1179-1942</identifier><identifier>DOI: 10.1007/s40264-023-01304-5</identifier><identifier>PMID: 37103643</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Adolescent ; Adolescents ; Age groups ; BNT162 Vaccine ; Child ; Child, Preschool ; Children ; Clinical trials ; Coronaviruses ; COVID-19 - prevention & control ; COVID-19 vaccines ; COVID-19 Vaccines - adverse effects ; Drug dosages ; Drug Safety and Pharmacovigilance ; Drug-Related Side Effects and Adverse Reactions - epidemiology ; Fatigue ; Fever ; Headache ; Headache - chemically induced ; Headache - epidemiology ; Headaches ; Humans ; Immunization ; Injection ; International organizations ; Medicine ; Medicine & Public Health ; Original Research Article ; Pain ; Pediatrics ; Pharmacology/Toxicology ; Population ; Prospective Studies ; Questionnaires ; Safety ; Severe acute respiratory syndrome coronavirus 2 ; Surveillance systems ; Teenagers ; Vaccines</subject><ispartof>Drug safety, 2023-06, Vol.46 (6), p.575-585</ispartof><rights>The Author(s) 2023</rights><rights>2023. The Author(s).</rights><rights>Copyright Springer Nature B.V. Jun 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c419t-5500a29b9e30317c718dae6d9f7adf5b59a671e7940c74959b8848adbd4cca813</citedby><cites>FETCH-LOGICAL-c419t-5500a29b9e30317c718dae6d9f7adf5b59a671e7940c74959b8848adbd4cca813</cites><orcidid>0000-0002-6261-9445</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40264-023-01304-5$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40264-023-01304-5$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37103643$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ahmadizar, Fariba</creatorcontrib><creatorcontrib>Luxi, Nicoletta</creatorcontrib><creatorcontrib>Raethke, Monika</creatorcontrib><creatorcontrib>Schmikli, Sandor</creatorcontrib><creatorcontrib>Riefolo, Fabio</creatorcontrib><creatorcontrib>Saraswati, Putri Widi</creatorcontrib><creatorcontrib>Bucsa, Camelia</creatorcontrib><creatorcontrib>Osman, Alhadi</creatorcontrib><creatorcontrib>Liddiard, Megan</creatorcontrib><creatorcontrib>Maques, Francisco Batel</creatorcontrib><creatorcontrib>Petrelli, Giuliana</creatorcontrib><creatorcontrib>Sonderlichová, Simona</creatorcontrib><creatorcontrib>Thurin, Nicolas H.</creatorcontrib><creatorcontrib>Villalobos, Felipe</creatorcontrib><creatorcontrib>Trifirò, Gianluca</creatorcontrib><creatorcontrib>Sturkenboom, Miriam</creatorcontrib><creatorcontrib>ilmiovaccinoCOVID19 collaborating group</creatorcontrib><title>Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials</title><title>Drug safety</title><addtitle>Drug Saf</addtitle><addtitle>Drug Saf</addtitle><description>Background and Objectives
The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials.
Methods
In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed.
Results
The CVM study enrolled 658 first-dose vaccinees (children aged 5–11 years;
n
= 250 and adolescents aged 12–17 years;
n
= 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000.
Conclusions
The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.</description><subject>Adolescent</subject><subject>Adolescents</subject><subject>Age groups</subject><subject>BNT162 Vaccine</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Children</subject><subject>Clinical trials</subject><subject>Coronaviruses</subject><subject>COVID-19 - prevention & control</subject><subject>COVID-19 vaccines</subject><subject>COVID-19 Vaccines - adverse effects</subject><subject>Drug dosages</subject><subject>Drug Safety and Pharmacovigilance</subject><subject>Drug-Related Side Effects and Adverse Reactions - epidemiology</subject><subject>Fatigue</subject><subject>Fever</subject><subject>Headache</subject><subject>Headache - chemically induced</subject><subject>Headache - epidemiology</subject><subject>Headaches</subject><subject>Humans</subject><subject>Immunization</subject><subject>Injection</subject><subject>International organizations</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original Research Article</subject><subject>Pain</subject><subject>Pediatrics</subject><subject>Pharmacology/Toxicology</subject><subject>Population</subject><subject>Prospective Studies</subject><subject>Questionnaires</subject><subject>Safety</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Surveillance systems</subject><subject>Teenagers</subject><subject>Vaccines</subject><issn>0114-5916</issn><issn>1179-1942</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kM1u1DAURi1ERYfCC7BAllgHrn8Sx-xG0wKVKnWkKd1aN45TXGXswU4qzQvw3Hg6he66upZ9vu_Kh5APDD4zAPUlS-CNrICLCpgAWdWvyIIxpSumJX9NFsBYudSsOSVvc74HgJY37RtyKhQD0UixIH82OLhpT-NAV9e3l-clSm_RWh9cpsttDHd0-uXoGl3vcUre0nXczSNOPoavdBlw3GefD_EDdjGnuHMY6GZOD86PIwbr6GafJ7fNFENP1_4hTjjS1eiDt-VwkzyO-R05Gcpw75_mGfn57eJm9aO6uv5-uVpeVVYyPVV1DYBcd9oJEExZxdoeXdPrQWE_1F2tsVHMKS3BKqlr3bWtbLHvemkttkyckU_H3l2Kv2eXJ3Mf51R-kQ1vOTSgeKMKxY-UTTHn5AazS36LaW8YmIN6c1RvinrzqN7UJfTxqXrutq7_H_nnugDiCOTyFO5cet79Qu1fOAOO2A</recordid><startdate>20230601</startdate><enddate>20230601</enddate><creator>Ahmadizar, Fariba</creator><creator>Luxi, Nicoletta</creator><creator>Raethke, Monika</creator><creator>Schmikli, Sandor</creator><creator>Riefolo, Fabio</creator><creator>Saraswati, Putri Widi</creator><creator>Bucsa, Camelia</creator><creator>Osman, Alhadi</creator><creator>Liddiard, Megan</creator><creator>Maques, Francisco Batel</creator><creator>Petrelli, Giuliana</creator><creator>Sonderlichová, Simona</creator><creator>Thurin, Nicolas H.</creator><creator>Villalobos, Felipe</creator><creator>Trifirò, Gianluca</creator><creator>Sturkenboom, Miriam</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7RV</scope><scope>7T2</scope><scope>7TK</scope><scope>7U7</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><orcidid>https://orcid.org/0000-0002-6261-9445</orcidid></search><sort><creationdate>20230601</creationdate><title>Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials</title><author>Ahmadizar, Fariba ; Luxi, Nicoletta ; Raethke, Monika ; Schmikli, Sandor ; Riefolo, Fabio ; Saraswati, Putri Widi ; Bucsa, Camelia ; Osman, Alhadi ; Liddiard, Megan ; Maques, Francisco Batel ; Petrelli, Giuliana ; Sonderlichová, Simona ; Thurin, Nicolas H. ; Villalobos, Felipe ; Trifirò, Gianluca ; Sturkenboom, Miriam</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c419t-5500a29b9e30317c718dae6d9f7adf5b59a671e7940c74959b8848adbd4cca813</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adolescent</topic><topic>Adolescents</topic><topic>Age groups</topic><topic>BNT162 Vaccine</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Children</topic><topic>Clinical trials</topic><topic>Coronaviruses</topic><topic>COVID-19 - prevention & control</topic><topic>COVID-19 vaccines</topic><topic>COVID-19 Vaccines - adverse effects</topic><topic>Drug dosages</topic><topic>Drug Safety and Pharmacovigilance</topic><topic>Drug-Related Side Effects and Adverse Reactions - epidemiology</topic><topic>Fatigue</topic><topic>Fever</topic><topic>Headache</topic><topic>Headache - chemically induced</topic><topic>Headache - epidemiology</topic><topic>Headaches</topic><topic>Humans</topic><topic>Immunization</topic><topic>Injection</topic><topic>International organizations</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original Research Article</topic><topic>Pain</topic><topic>Pediatrics</topic><topic>Pharmacology/Toxicology</topic><topic>Population</topic><topic>Prospective Studies</topic><topic>Questionnaires</topic><topic>Safety</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><topic>Surveillance systems</topic><topic>Teenagers</topic><topic>Vaccines</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ahmadizar, Fariba</creatorcontrib><creatorcontrib>Luxi, Nicoletta</creatorcontrib><creatorcontrib>Raethke, Monika</creatorcontrib><creatorcontrib>Schmikli, Sandor</creatorcontrib><creatorcontrib>Riefolo, Fabio</creatorcontrib><creatorcontrib>Saraswati, Putri Widi</creatorcontrib><creatorcontrib>Bucsa, Camelia</creatorcontrib><creatorcontrib>Osman, Alhadi</creatorcontrib><creatorcontrib>Liddiard, Megan</creatorcontrib><creatorcontrib>Maques, Francisco Batel</creatorcontrib><creatorcontrib>Petrelli, Giuliana</creatorcontrib><creatorcontrib>Sonderlichová, Simona</creatorcontrib><creatorcontrib>Thurin, Nicolas H.</creatorcontrib><creatorcontrib>Villalobos, Felipe</creatorcontrib><creatorcontrib>Trifirò, Gianluca</creatorcontrib><creatorcontrib>Sturkenboom, Miriam</creatorcontrib><creatorcontrib>ilmiovaccinoCOVID19 collaborating group</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Docstoc</collection><collection>Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><jtitle>Drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ahmadizar, Fariba</au><au>Luxi, Nicoletta</au><au>Raethke, Monika</au><au>Schmikli, Sandor</au><au>Riefolo, Fabio</au><au>Saraswati, Putri Widi</au><au>Bucsa, Camelia</au><au>Osman, Alhadi</au><au>Liddiard, Megan</au><au>Maques, Francisco Batel</au><au>Petrelli, Giuliana</au><au>Sonderlichová, Simona</au><au>Thurin, Nicolas H.</au><au>Villalobos, Felipe</au><au>Trifirò, Gianluca</au><au>Sturkenboom, Miriam</au><aucorp>ilmiovaccinoCOVID19 collaborating group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials</atitle><jtitle>Drug safety</jtitle><stitle>Drug Saf</stitle><addtitle>Drug Saf</addtitle><date>2023-06-01</date><risdate>2023</risdate><volume>46</volume><issue>6</issue><spage>575</spage><epage>585</epage><pages>575-585</pages><issn>0114-5916</issn><eissn>1179-1942</eissn><abstract>Background and Objectives
The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials.
Methods
In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed.
Results
The CVM study enrolled 658 first-dose vaccinees (children aged 5–11 years;
n
= 250 and adolescents aged 12–17 years;
n
= 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000.
Conclusions
The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>37103643</pmid><doi>10.1007/s40264-023-01304-5</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-6261-9445</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0114-5916 |
| ispartof | Drug safety, 2023-06, Vol.46 (6), p.575-585 |
| issn | 0114-5916 1179-1942 |
| language | eng |
| recordid | cdi_proquest_journals_2820607267 |
| source | MEDLINE; SpringerLink Journals |
| subjects | Adolescent Adolescents Age groups BNT162 Vaccine Child Child, Preschool Children Clinical trials Coronaviruses COVID-19 - prevention & control COVID-19 vaccines COVID-19 Vaccines - adverse effects Drug dosages Drug Safety and Pharmacovigilance Drug-Related Side Effects and Adverse Reactions - epidemiology Fatigue Fever Headache Headache - chemically induced Headache - epidemiology Headaches Humans Immunization Injection International organizations Medicine Medicine & Public Health Original Research Article Pain Pediatrics Pharmacology/Toxicology Population Prospective Studies Questionnaires Safety Severe acute respiratory syndrome coronavirus 2 Surveillance systems Teenagers Vaccines |
| title | Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials |
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