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      Knowledge, attitudes, and practices of pregnant women regarding COVID‐19 vaccination in pregnancy in 7 low‐ and middle‐income countries: An observational trial from the Global Network for Women and Children’s Health Research

      research-article
      1 , 1 , 1 , 2 , 3 , 4 , 4 , 4 , 5 , 5 , 5 , 6 , 6 , 7 , 7 , 8 , 9 , 10 , 10 , 2 , 2 , 1 , 11 , 12 , 13 , 14 , 15 , 3 , 16 , 17 , 4 , 4 , , 18
      Bjog
      John Wiley and Sons Inc.
      COVID‐19, low‐ and middle‐income countries, pregnancy, vaccination

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          Abstract

          Objectives

          We sought to determine the knowledge, attitudes and practices of pregnant women regarding COVID‐19 vaccination in pregnancy in seven low‐ and middle‐income countries (LMIC).

          Design

          Prospective, observational, population‐based study.

          Settings

          Study areas in seven LMICs: Bangladesh, India, Pakistan, Guatemala, Democratic Republic of the Congo (DRC), Kenya and Zambia.

          Population

          Pregnant women in an ongoing registry.

          Methods

          COVID‐19 vaccine questionnaires were administered to pregnant women in the Global Network's Maternal Newborn Health Registry from February 2021 through November 2021 in face‐to‐face interviews.

          Main outcome measures

          Knowledge, attitude and practice regarding vaccination during pregnancy; vaccination status.

          Results

          No women were vaccinated except for small proportions in India (12.9%) and Guatemala (5.5%). Overall, nearly half the women believed the COVID‐19 vaccine is very/somewhat effective and a similar proportion believed that the COVID‐19 vaccine is safe for pregnant women. With availability of vaccines, about 56.7% said they would get the vaccine and a 34.8% would refuse. Of those who would not get vaccinated, safety, fear of adverse effects, and lack of trust predicted vaccine refusal. Those with lower educational status were less willing to be vaccinated. Family members and health professionals were the most trusted source of information for vaccination.

          Conclusions

          This COVID‐19 vaccine survey in seven LMICs found that knowledge about the effectiveness and safety of the vaccine was generally low but varied. Concerns about vaccine safety and effectiveness among pregnant women is an important target for educational efforts to increase vaccination rates.

          Tweetable abstract

          The COVID‐19 vaccine survey in seven LMIC indicates that the knowledge of pregnant women about the effectiveness and safety of the vaccine was generally low and a third of the women did not plan to be vaccinated.

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          Most cited references17

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          Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults

          In March 2020, the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1, a pandemic. With rapidly accumulating numbers of cases and deaths reported globally2, a vaccine is urgently needed. Here we report the available safety, tolerability and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose-escalation study (ClinicalTrials.gov identifier NCT04368728) among 45 healthy adults (18-55 years of age), who were randomized to receive 2 doses-separated by 21 days-of 10 μg, 30 μg or 100 μg of BNT162b1. BNT162b1 is a lipid-nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes the trimerized receptor-binding domain (RBD) of the spike glycoprotein of SARS-CoV-2. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 μg was not administered because of the increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared with the 30-μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titres in sera increased with dose level and after a second dose. Geometric mean neutralizing titres reached 1.9-4.6-fold that of a panel of COVID-19 convalescent human sera, which were obtained at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate.
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            Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study

            Background Vaccine effectiveness studies have not differentiated the effect of the delta (B.1.617.2) variant and potential waning immunity in observed reductions in effectiveness against SARS-CoV-2 infections. We aimed to evaluate overall and variant-specific effectiveness of BNT162b2 (tozinameran, Pfizer–BioNTech) against SARS-CoV-2 infections and COVID-19-related hospital admissions by time since vaccination among members of a large US health-care system. Methods In this retrospective cohort study, we analysed electronic health records of individuals (≥12 years) who were members of the health-care organisation Kaiser Permanente Southern California (CA, USA), to assess BNT162b2 vaccine effectiveness against SARS-CoV-2 infections and COVID-19-related hospital admissions for up to 6 months. Participants were required to have 1 year or more previous membership of the organisation. Outcomes comprised SARS-CoV-2 PCR-positive tests and COVID-19-related hospital admissions. Effectiveness calculations were based on hazard ratios from adjusted Cox models. This study was registered with ClinicalTrials.gov , NCT04848584. Findings Between Dec 14, 2020, and Aug 8, 2021, of 4 920 549 individuals assessed for eligibility, we included 3 436 957 (median age 45 years [IQR 29–61]; 1 799 395 [52·4%] female and 1 637 394 [47·6%] male). For fully vaccinated individuals, effectiveness against SARS-CoV-2 infections was 73% (95% CI 72–74) and against COVID-19-related hospital admissions was 90% (89–92). Effectiveness against infections declined from 88% (95% CI 86–89) during the first month after full vaccination to 47% (43–51) after 5 months. Among sequenced infections, vaccine effectiveness against infections of the delta variant was high during the first month after full vaccination (93% [95% CI 85–97]) but declined to 53% [39–65] after 4 months. Effectiveness against other (non-delta) variants the first month after full vaccination was also high at 97% (95% CI 95–99), but waned to 67% (45–80) at 4–5 months. Vaccine effectiveness against hospital admissions for infections with the delta variant for all ages was high overall (93% [95% CI 84–96]) up to 6 months. Interpretation Our results provide support for high effectiveness of BNT162b2 against hospital admissions up until around 6 months after being fully vaccinated, even in the face of widespread dissemination of the delta variant. Reduction in vaccine effectiveness against SARS-CoV-2 infections over time is probably primarily due to waning immunity with time rather than the delta variant escaping vaccine protection. Funding Pfizer.
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              Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons

              Background Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Methods From December 14, 2020, to February 28, 2021, we used data from the “v-safe after vaccination health checker” surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Results A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.
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                Author and article information

                Contributors
                mcclure@rti.org
                Journal
                BJOG
                BJOG
                10.1111/(ISSN)1471-0528
                BJO
                Bjog
                John Wiley and Sons Inc. (Hoboken )
                1470-0328
                1471-0528
                05 June 2022
                05 June 2022
                : 10.1111/1471-0528.17226
                Affiliations
                [ 1 ] Aga Khan University Karachi Pakistan
                [ 2 ] Maternal and Child Health Division International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) Dhaka Bangladesh
                [ 3 ] University of Virginia Charlottesville Virginia USA
                [ 4 ] RTI International Durham North Carolina USA
                [ 5 ] Instituto de Nutrición de Centroamérica y Panamá Guatemala City Guatemala
                [ 6 ] Lata Medical Research Foundation Nagpur India
                [ 7 ] KLE Academy Higher Education and Research J N Medical College Belagavi India
                [ 8 ] Moi University School of Medicine Eldoret Kenya
                [ 9 ] University Teaching Hospital Lusaka Zambia
                [ 10 ] Department of Pediatrics Kinshasa School of Public Health Kinshasa Democratic Republic of the Congo
                [ 11 ] University of North Carolina at Chapel Hill Chapel Hill North Carolina USA
                [ 12 ] Department of Pediatrics Indiana School of Medicine, University of Indiana Indianapolis Indiana USA
                [ 13 ] Section of Nutrition, Department of Pediatrics University of Colorado School of Medicine Denver Colorado USA
                [ 14 ] Thomas Jefferson University Philadelphia Pennsylvania USA
                [ 15 ] University of Alabama at Birmingham Birmingham Alabama USA
                [ 16 ] Boston University School of Public Health Boston Massachusetts USA
                [ 17 ] Eunice Kennedy Shriver National Institute of Child Health and Human Development Bethesda Maryland USA
                [ 18 ] Department of Obstetrics and Gynecology Columbia University School of Medicine New York New York USA
                Author notes
                [*] [* ] Correspondence

                Elizabeth M. McClure, 3040 E Cornwallis Rd, Research Triangle, NC 27709, USA.

                Email: mcclure@ 123456rti.org

                Author information
                https://orcid.org/0000-0002-8690-6932
                https://orcid.org/0000-0002-2558-7421
                https://orcid.org/0000-0002-8680-7053
                https://orcid.org/0000-0001-8659-5444
                Article
                BJO17226 BJOG-21-1940.R1
                10.1111/1471-0528.17226
                9347929
                35596701
                e8dc8dbd-5978-4b05-a854-e3881b402e78
                © 2022 John Wiley & Sons Ltd.

                This article is being made freely available through PubMed Central as part of the COVID-19 public health emergency response. It can be used for unrestricted research re-use and analysis in any form or by any means with acknowledgement of the original source, for the duration of the public health emergency.

                History
                : 11 April 2022
                : 30 December 2021
                : 15 May 2022
                Page count
                Figures: 0, Tables: 5, Pages: 8, Words: 4632
                Funding
                Funded by: Eunice Kennedy Shriver National Institute of Child Health and Human Development , doi 10.13039/100009633;
                Categories
                Research Article
                Research Articles
                Custom metadata
                2.0
                corrected-proof
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.7 mode:remove_FC converted:03.08.2022

                Obstetrics & Gynecology
                covid‐19,low‐ and middle‐income countries,pregnancy,vaccination
                Obstetrics & Gynecology
                covid‐19, low‐ and middle‐income countries, pregnancy, vaccination

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