RSVpreF vaccination in pregnancy: a meta-analysis of maternal-fetal safety and infant efficacy
In May 2023, the United States Food and Drug Administration approved a Pfizer©-sponsored (Pfizer, New York, NY, USA) bivalent respiratory syncytial virus prefusion F protein-based vaccine (RSVpreF) RSV vaccine (AbrysvoTM [Pfizer]) for use during pregnancy to prevent neonatal/infant RSV infection. In...
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Korean Society of Obstetrics and Gynecology
2024-11-01
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| Series: | Obstetrics & Gynecology Science |
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| Online Access: | http://ogscience.org/upload/pdf/ogs-24213.pdf |
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| author | Greg J. Marchand Ahmed Taher Massoud Ahmed Taha Abdelsattar Peter A. McCullough |
| author_facet | Greg J. Marchand Ahmed Taher Massoud Ahmed Taha Abdelsattar Peter A. McCullough |
| author_sort | Greg J. Marchand |
| collection | DOAJ |
| description | In May 2023, the United States Food and Drug Administration approved a Pfizer©-sponsored (Pfizer, New York, NY, USA) bivalent respiratory syncytial virus prefusion F protein-based vaccine (RSVpreF) RSV vaccine (AbrysvoTM [Pfizer]) for use during pregnancy to prevent neonatal/infant RSV infection. In February of 2022, trials sponsored by GSK© (Brentford, England, UK) on a similar RSVpreF vaccine were halted because of the identification of a safety signal related to preterm births. As these vaccines use identical pre-fusion F-protein technology, we sought to synthesize the existing data on their effectiveness and safety. We identified all randomized controlled trials and used RevMan 5.4.1 (The Cochrane Collaboration, England, UK) to perform the analysis with 95% confidence intervals and risk ratios (RRs). We found many maternal side effects were more prevalent in the RSVpreF group, with more local reactions, blood disorders, fatigue, joint pain, cardiac disorders, headache, fever, gastrointestinal disorders and pregnancy complications. The vaccinated group demonstrated significant reductions in RSV-lower respiratory tract cases (RR, 0.44 [0.33, 0.57]; P<0.00001), severe respiratory illness (RR, 0.29 [0.19, 0.44]; P<0.00001), and hospitalizations (RR, 0.40 [0.24, 0.67]; P=0.0005). RSVpreF vaccination was associated with a higher incidence of preterm delivery (RR, 1.24 [1.08, 1.44]; P=0.003). No significant difference in neonatal deaths was observed (RR, 1.42 [0.70, 2.89]; P=0.34). In conclusion, RSVpreF vaccination results in systemic adverse events and an increase in preterm delivery. Vaccination appears to have acceptable short-term newborn safety, but is not related to a significant decrease in neonatal death. |
| format | Article |
| id | doaj-art-84c095fe5cff4e1783c683e3a7b83e98 |
| institution | Kabale University |
| issn | 2287-8580 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Korean Society of Obstetrics and Gynecology |
| record_format | Article |
| series | Obstetrics & Gynecology Science |
| spelling | doaj-art-84c095fe5cff4e1783c683e3a7b83e982024-11-20T01:54:55ZengKorean Society of Obstetrics and GynecologyObstetrics & Gynecology Science2287-85802024-11-0167651152410.5468/ogs.242138841RSVpreF vaccination in pregnancy: a meta-analysis of maternal-fetal safety and infant efficacyGreg J. Marchand0Ahmed Taher Massoud1Ahmed Taha Abdelsattar2Peter A. McCullough3 Department of Research, Marchand Institute for Minimally Invasive Surgery, Mesa, AZ, USA Department of Research, Marchand Institute for Minimally Invasive Surgery, Mesa, AZ, USA Department of Research, Marchand Institute for Minimally Invasive Surgery, Mesa, AZ, USA Department of Internal Medicine, Cardiology, McCullough Foundation, Dallas Texas, TX, USAIn May 2023, the United States Food and Drug Administration approved a Pfizer©-sponsored (Pfizer, New York, NY, USA) bivalent respiratory syncytial virus prefusion F protein-based vaccine (RSVpreF) RSV vaccine (AbrysvoTM [Pfizer]) for use during pregnancy to prevent neonatal/infant RSV infection. In February of 2022, trials sponsored by GSK© (Brentford, England, UK) on a similar RSVpreF vaccine were halted because of the identification of a safety signal related to preterm births. As these vaccines use identical pre-fusion F-protein technology, we sought to synthesize the existing data on their effectiveness and safety. We identified all randomized controlled trials and used RevMan 5.4.1 (The Cochrane Collaboration, England, UK) to perform the analysis with 95% confidence intervals and risk ratios (RRs). We found many maternal side effects were more prevalent in the RSVpreF group, with more local reactions, blood disorders, fatigue, joint pain, cardiac disorders, headache, fever, gastrointestinal disorders and pregnancy complications. The vaccinated group demonstrated significant reductions in RSV-lower respiratory tract cases (RR, 0.44 [0.33, 0.57]; P<0.00001), severe respiratory illness (RR, 0.29 [0.19, 0.44]; P<0.00001), and hospitalizations (RR, 0.40 [0.24, 0.67]; P=0.0005). RSVpreF vaccination was associated with a higher incidence of preterm delivery (RR, 1.24 [1.08, 1.44]; P=0.003). No significant difference in neonatal deaths was observed (RR, 1.42 [0.70, 2.89]; P=0.34). In conclusion, RSVpreF vaccination results in systemic adverse events and an increase in preterm delivery. Vaccination appears to have acceptable short-term newborn safety, but is not related to a significant decrease in neonatal death.http://ogscience.org/upload/pdf/ogs-24213.pdfvaccinationrespiratory syncytial virus vaccinesneonatologymeta-analysis |
| spellingShingle | Greg J. Marchand Ahmed Taher Massoud Ahmed Taha Abdelsattar Peter A. McCullough RSVpreF vaccination in pregnancy: a meta-analysis of maternal-fetal safety and infant efficacy Obstetrics & Gynecology Science vaccination respiratory syncytial virus vaccines neonatology meta-analysis |
| title | RSVpreF vaccination in pregnancy: a meta-analysis of maternal-fetal safety and infant efficacy |
| title_full | RSVpreF vaccination in pregnancy: a meta-analysis of maternal-fetal safety and infant efficacy |
| title_fullStr | RSVpreF vaccination in pregnancy: a meta-analysis of maternal-fetal safety and infant efficacy |
| title_full_unstemmed | RSVpreF vaccination in pregnancy: a meta-analysis of maternal-fetal safety and infant efficacy |
| title_short | RSVpreF vaccination in pregnancy: a meta-analysis of maternal-fetal safety and infant efficacy |
| title_sort | rsvpref vaccination in pregnancy a meta analysis of maternal fetal safety and infant efficacy |
| topic | vaccination respiratory syncytial virus vaccines neonatology meta-analysis |
| url | http://ogscience.org/upload/pdf/ogs-24213.pdf |
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