{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T18:27:45Z","timestamp":1781893665006,"version":"3.54.5"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T00:00:00Z","timestamp":1694304000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Brazilian National Research Council"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,12,25]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>COVID-19 vaccines have been shown to protect pregnant individuals against mild and severe COVID-19 outcomes. However, limited safety data are available for inactivated (CoronaVac) and mRNA (BNT162b2) vaccines during pregnancy regarding their effect on birth outcomes and neonatal mortality, especially in low- and middle-income countries.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted a retrospective population-based cohort study in Rio de Janeiro, Brazil, with 17\u200a513 singleton live births conceived between 15 May 2021 and 23 October 2021. The primary exposure was maternal vaccination with CoronaVac or mRNA BNT162b2 vaccines and sub-analyses were performed by the gestational trimester of the first dose and the number of doses given during pregnancy. The outcomes were pre-term birth (PTB), small for gestational age (SGA), low birthweight (LBW), low Apgar 5 and neonatal death. We used the Cox model to estimate the hazard ratio (HR) with a 95% CI and applied the inverse probability of treatment weights to generate adjusted HRs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We found no significant increase in the risk of PTB (HR: 0.98; 95% CI 0.88, 1.10), SGA (HR: 1.09; 95% CI 0.96, 1.27), LBW (HR: 1.00; 95% CI 0.88, 1.14), low Apgar 5 (HR: 0.81; 95% CI 0.55, 1.22) or neonatal death (HR: 0.88; 95% CI 0.56, 1.48) in women vaccinated with CoronaVac or BNT162b2 vaccines. These findings were consistent across sub-analyses stratified by the gestational trimester of the first dose and the number of doses given during pregnancy. We found mild yet consistent protection against PTB in women who received different vaccine platforms during the third trimester of pregnancy (any vaccines, HR: 0.78; 95% CI 0.63, 0.98; BNT162b2, HR: 0.75; 95% CI 0.59, 0.99).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This study provides evidence that COVID-19 vaccination in all trimesters of pregnancy, irrespective of the vaccine type, is safe and does not increase the risk of adverse birth outcomes or neonatal deaths.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ije\/dyad120","type":"journal-article","created":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T16:59:17Z","timestamp":1694365157000},"page":"1708-1715","source":"Crossref","is-referenced-by-count":11,"title":["Safety of BNT162b2 and CoronaVac during pregnancy on birth outcomes and neonatal mortality: a cohort study from Brazil"],"prefix":"10.1093","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8077-8100","authenticated-orcid":false,"given":"Pilar","family":"Tavares Veras Florentino","sequence":"first","affiliation":[{"name":"Centro de Integra\u00e7\u00e3o de Dados e Conhecimentos para Sa\u00fade, Instituto Gon\u00e7alo Moniz , Funda\u00e7\u00e3o Oswaldo Cruz, Salvador, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thiago","family":"Cerqueira-Silva","sequence":"additional","affiliation":[{"name":"Centro de Integra\u00e7\u00e3o de Dados e Conhecimentos para Sa\u00fade, Instituto Gon\u00e7alo Moniz , Funda\u00e7\u00e3o Oswaldo Cruz, Salvador, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luciana","family":"Freire De Carvalho","sequence":"additional","affiliation":[{"name":"Centro de Intelig\u00eancia Epidemiol\u00f3gica, Secretaria Municipal de Sa\u00fade do Rio de Janeiro , Rio de Janeiro, Brazil"},{"name":"Instituto de Estudos em Sa\u00fade Coletiva, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fl\u00e1via","family":"J\u00f4se Oliveira Alves","sequence":"additional","affiliation":[{"name":"Centro de Integra\u00e7\u00e3o de Dados e Conhecimentos para Sa\u00fade, Instituto Gon\u00e7alo Moniz , Funda\u00e7\u00e3o Oswaldo Cruz, Salvador, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinicius","family":"De Ara\u00fajo Oliveira","sequence":"additional","affiliation":[{"name":"Centro de Integra\u00e7\u00e3o de Dados e Conhecimentos para Sa\u00fade, Instituto Gon\u00e7alo Moniz , Funda\u00e7\u00e3o Oswaldo Cruz, Salvador, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gislani","family":"Mateus Oliveira Aguilar","sequence":"additional","affiliation":[{"name":"Centro de Intelig\u00eancia Epidemiol\u00f3gica, Secretaria Municipal de Sa\u00fade do Rio de Janeiro, Rio de Janeiro , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodrigo","family":"De Sousa Prado","sequence":"additional","affiliation":[{"name":"Centro de Intelig\u00eancia Epidemiol\u00f3gica, Secretaria Municipal de Sa\u00fade do Rio de Janeiro , Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Soranz","sequence":"additional","affiliation":[{"name":"C\u00e2mara dos Deputados, C\u00e2mara Legislativa do Distrito Federal , Congresso Nacional, Bras\u00edlia, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9938-7852","authenticated-orcid":false,"given":"Neil","family":"Pearce","sequence":"additional","affiliation":[{"name":"Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine , London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viviane","family":"Boaventura","sequence":"additional","affiliation":[{"name":"Laborat\u00f3rio de Medicina e Sa\u00fade P\u00fablica de Precis\u00e3o, Instituto Gon\u00e7alo Moniz, Funda\u00e7\u00e3o Oswaldo Cruz , Salvador, Brazil"},{"name":"Faculdade de Medicina, Universidade Federal da Bahia , Salvador, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guilherme","family":"Loreiro Werneck","sequence":"additional","affiliation":[{"name":"Instituto de Estudos em Sa\u00fade Coletiva, Universidade Federal do Rio de Janeiro , Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerson","family":"Oliveira Penna","sequence":"additional","affiliation":[{"name":"Centro de Medicina Tropical, Universidade de Bras\u00edlia , Escola do Governo de Bras\u00edlia\u2014Fiocruz, Bras\u00edlia, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mauricio","family":"Lima Barreto","sequence":"additional","affiliation":[{"name":"Centro de Integra\u00e7\u00e3o de Dados e Conhecimentos para Sa\u00fade, Instituto Gon\u00e7alo Moniz , Funda\u00e7\u00e3o Oswaldo Cruz, Salvador, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M\u00e1rcio","family":"Henrique De Oliveira Garcia","sequence":"additional","affiliation":[{"name":"Departamento de Emerg\u00eancias em Sa\u00fade P\u00fablica, Secretaria de Sa\u00fade, Minist\u00e9rio da Sa\u00fade , Bras\u00edlia, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manoel","family":"Barral-Netto","sequence":"additional","affiliation":[{"name":"Laborat\u00f3rio de Medicina e Sa\u00fade P\u00fablica de Precis\u00e3o, Instituto Gon\u00e7alo Moniz, Funda\u00e7\u00e3o Oswaldo Cruz , Salvador, Brazil"},{"name":"Faculdade de Medicina, Universidade Federal da Bahia , Salvador, 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