This document discusses including pregnant women in COVID-19 vaccine trials. It notes that pregnant women may be at higher risk for complications from COVID-19. Previous vaccine studies using adenovirus vectors showed immune responses in mothers without risks to fetuses. The document advocates for including pregnant women in phase 3 trials of adenovirus-vectored and protein-based COVID-19 vaccines to evaluate safety and efficacy in pregnancy. International organizations should endorse the recruitment of pregnant women in vaccine trial protocols with provisions for monitoring safety.
This document discusses including pregnant women in COVID-19 vaccine trials. It notes that pregnant women may be at higher risk for complications from COVID-19. Previous vaccine studies using adenovirus vectors showed immune responses in mothers without risks to fetuses. The document advocates for including pregnant women in phase 3 trials of adenovirus-vectored and protein-based COVID-19 vaccines to evaluate safety and efficacy in pregnancy. International organizations should endorse the recruitment of pregnant women in vaccine trial protocols with provisions for monitoring safety.
This document discusses including pregnant women in COVID-19 vaccine trials. It notes that pregnant women may be at higher risk for complications from COVID-19. Previous vaccine studies using adenovirus vectors showed immune responses in mothers without risks to fetuses. The document advocates for including pregnant women in phase 3 trials of adenovirus-vectored and protein-based COVID-19 vaccines to evaluate safety and efficacy in pregnancy. International organizations should endorse the recruitment of pregnant women in vaccine trial protocols with provisions for monitoring safety.
Nielsen-Saines, COVID-19 vaccines and Shabir A Madhi, *David Baud neglected pregnancy integration into the host cell chemoprophylaxis from COPY_01&utm_medium=email&utm_ term=0_10959edeb5-18fd118248-18978 On June 18, 2020, WHO genome. vaccine trials. WHO’s global 7901 (accessed Aug 26, 2020). presented a strategic ChAdOx1, the chimpanzee commitment to fair access to 2 Ellington S, Strid P, Tong VT, et al. framework to ensure the adeno virus-vectored vaccine COVID-19 vaccines should, Characteristics of women of reproductive age with laboratory equitable allocation of scarce platform that was used in the therefore, include pregnant confirmed SARS-CoV-2 infection by COVID-19 resources, Oxford trials, has pre viously women. Accordingly, we 5 pregnancy status—United States, been shown to safely induce advocate that pregnant January 22–June 7, 2020. MMWR Morb including vac Mortal Wkly Rep 2020; 69: 769–75. cines. Health-care workers, 1 potent humoral and women should be included in 3 Collin J, Bystrom E, Carnahan A, people older than 65 years, cell-mediated immune the phase 3 trial protocols of Ahrne M. Public Health Agency of and people with responses that confer robust adenovirus-vectored vaccines Sweden’s brief report: pregnant and postpartum women with severe acute cardiovascular disease, protection from Rift Valley and also protein-based respiratory syndrome coronavirus 2 chronic respiratory disease, fever disease in pregnant vaccines (eg, NVX CoV2373, infection in intensive care in Sweden. cancer, diabetes, or obesity sheep that were vaccinated ina recombinant nanopar ticle Acta Obstet Gynecol Scand 2020; 99: 819–22. 4 Khalil A, von Dadelszen P, will be prioritised for initial the first trimester, without vaccine [NCT04368988]) for Draycott T, Ugwumadu A, O’Brien P, vaccination. Pregnant women risks of maternal viraemia or COVID-19, for which there are Magee L. Change in the incidence of stillbirth and preterm delivery during the do not appear to constitute a miscarriage.7 Murine studies of even less safety concerns, COVID-19 pandemic. JAMA 2020; 324: high-priority group, despite gorilla adenovirus-vectored and implore international 705–06. representing a cohort who vaccines for Zika obstetric societies to endorse 5 Folegatti PM, Ewer KJ, Aley PK, et al. virus.8 The immunity paradox their recruitment. The Safety and immunogenicity of the are at increased risk for ChAdOx1 nCoV-19 vaccine against severe complications of during pregnancy that favours protocols should include SARS-CoV-2: a preliminary COVID-19. A growing body of tolerance to the fetus (ie, provisions for monitoring of report of a phase 1/2, single-blind, evidence exists to suggest stops the maternal immune maternal and fetal safety and randomised controlled trial. Lancet 2020; 396: 467–78. 6 Zhu F-C, Guan that pregnant women are at a system from rejecting the for documentation of X-H, Li Y-H, et al. higher risk of morbidity and fetus), but leaves the mother iatrogenic complications, Immunogenicity and safety of a mortality from COVID-19, susceptible to viral infections, including follow-up of recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults including increased risk of can be opportunistically offspring after delivery. aged 18 years or older: a randomised, respiratory failure with the leveraged by simian SAM reports grants and personal fees double-blind, placebo need for admission to adenoviral vectors. The from the Bill & Melinda Gates controlled, phase 2 trial. Lancet 2020; Foundation, Pfizer, Minervax, and 396: 479–88. intensive care and ChAdOx1 vaccine platform is 7 Stedman A, Wright D, Wichgers GlaxoSmithKline, unrelated to this mechanical ventilation, non-replicating and could be Correspondence. All other authors Schreur PJ, et al. Safety and efficacy of compared with age-matched used to deliver proteins to the declare no competing interests. ChAdOx1 RVF vaccine against Rift Valley fever in pregnant sheep and women who are not mother for the induction of an david.baud@chuv.ch goats. NPJ Vaccines 2019; 4: 44. pregnant. COVID-19 has 2,3 immune response without Division of Maternal-Fetal Medicine, 8 Hassan AO, Dmitriev IP, Kashentseva also been associated with an adversely affecting the fetus. Department of Obstetrics and EA, et al. A gorilla adenovirus-based Gynecology, National University vaccine against Zika virus induces increased rate of stillbirth. 4 Transplacental transfer of durable immunity and confers protection Hospital, Singapore (PD); Division of Two trials of maternal induced anti bodies Infectious Diseases, Department of in pregnancy. Cell Rep 2019; adenovirus-vectored vaccinescan ensue, but without trans Pediatrics, David Geffen UCLA School 28: 2634–46. (phase 1/2 and phase 2)5,6 for fer of the virus vector to the of Medicine, Los Angeles, CA, USA Published Online August 27, 2020 fetus. Unfortunately, pregnant (KN-S); Vaccine Preventable Diseases, COVID-19 have shown Department of Science and https://doi.org/10.1016/ sustained T-cell and women have historically been Technology/National Research S0140-6736(20)31822-5 neutralising antibody excluded from Foundation and South African Medical responses against the pharmaceutical research, Research Council Vaccines and trimeric spike glycoprotein of owing to well intentioned, but Infectious Diseases Analytical Research Unit, University of the Witwatersrand, severe acute respiratory sometimes mis guided, Johannesburg, South Africa (SAM); and syndrome coronavirus 2 in concerns about fetal safety. Materno fetal and Obstetrics Research healthy adult partici pants who The development of an Unit, Department Woman-Mother-Child, effective COVID-19 vaccine Lausanne University Hospital, 1011 were not pregnant. Lausanne, Switzerland (DB) Replication-defective is a global health priority. adenoviruses, when Pregnant women, who are at 1equitable WHO. A global framework to ensure and fair allocation of chemically attenuated, are increased risk of adverse COVID-19 products. WHO Member ideal vectors because of their outcomes from COVID-19, States briefing. June 18, 2020. https://apps.who.int/gb/COVID-19/pdf_ ability to accommodate large would be additionally harmed files/18_06/Global%20Allocation%20 transgenes and encode if they were unable to access Framework.pdf?utm_source=POLITICO. evidence-based EU&utm_campaign=18fd118248-EMAIL_ proteins without viral CAMPAIGN_2020_06_22_04_52_ electronic submission system at http://ees.elsevier.com/ thelancet/
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