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1.
Vaccine ; 40(26): 3605-3613, 2022 06 09.
Article in English | MEDLINE | ID: covidwho-1873313

ABSTRACT

INTRODUCTION: Since the establishment of the Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) case definitions in 2015, there has been an urgent need for field validation of pharmacovigilance feasibility in low- and middle-income countries. In this study, we assess the availability and quality of archival medical records at ten randomly selected high-traffic maternity wards in Kinshasa province, Democratic Republic of Congo (DRC). METHODS: A retrospective cohort of mother-child pairs was established from all recorded births taking place at study sites between July 1, 2019 to February 28, 2020 through digitization of medical records. Adverse birth outcomes and maternal vaccination status, where available and linkable, were defined according to GAIA. Basic demographic information on mothers and newborns was also tabulated; birth outcomes were assessed for both intra-site prevalence and a pooled prevalence. RESULTS: A total of 7,697 mother-newborn pair records were extracted, with 37% of infants screening positive as cases of adverse outcomes. Maternal vaccination information was linkable to 67% of those cases. In total, 51% of stillbirths, 98% of preterm births, 100% of low birthweight infants, 90% of small for gestational age infants, 100% of microcephalic infants, and 0% of neonatal bloodstream infections were classifiable according to GAIA standards following initial screening. Forty percent of case mothers had some indication of tetanus vaccination prior to delivery in their medical records, but only 26% of case mothers met some level of GAIA definition for maternal vaccination during the pregnancy of interest. CONCLUSIONS: Archival birth records from delivery centers can be feasibly utilized to screen for stillbirth and maternal tetanus vaccination, and to accurately classify preterm birth, low birthweight, small for gestational age, and congenital microcephaly. Assessment of other neonatal outcomes were limited by inconsistent postpartum infant follow-up and records keeping.


Subject(s)
Premature Birth , Tetanus , Birth Weight , Democratic Republic of the Congo/epidemiology , Feasibility Studies , Female , Humans , Immunization/adverse effects , Infant , Infant, Newborn , Medical Records , Pregnancy , Premature Birth/epidemiology , Premature Birth/etiology , Retrospective Studies , Stillbirth , Vaccination/adverse effects
2.
Gates Open Research ; 2021.
Article in English | ProQuest Central | ID: covidwho-1835891

ABSTRACT

Background: Given that pregnant women are now included among those for receipt coronavirus disease 2019 (COVID-19) vaccines, it is important to ensure that information systems can be used (or available) for active safety surveillance, especially in low- and middle-income countries (LMICs). The aim of this study was to build consensus about the use of existing maternal and neonatal data collection systems in LMICs for COVID-19 vaccines active safety surveillance, a basic set of variables, and the suitability and feasibility of including pregnant women and LMIC research networks in COVID-19 vaccines pre-licensure activities. Methods: A three-stage modified Delphi study was conducted over three months in 2020. An international multidisciplinary panel of 16 experts participated. Ratings distributions and consensus were assessed, and ratings’ rationale was analyzed. Results: The panel recommended using maternal and neonatal data collection systems for active safety surveillance in LMICs (median 9;disagreement index [DI] -0.92), but there was no consensus (median 6;DI 1.79) on the feasibility of adapting these systems. A basic set of 14 maternal, neonatal, and vaccination-related variables. Out of 16 experts, 11 supported a basic set of 14 maternal, neonatal, and vaccination-related variables for active safety surveillance. Seven experts agreed on a broader set of 26 variables.The inclusion of pregnant women for COVID-19 vaccines research (median 8;DI -0.61) was found appropriate, although there was uncertainty on its feasibility in terms of decision-makers’ acceptability (median 7;DI 10.00) and regulatory requirements (median 6;DI 0.51). There was no consensus (median 6;DI 2.35) on the feasibility of including research networks in LMICs for conducting clinical trials amongst pregnant women. Conclusions: Although there was some uncertainty regarding feasibility, experts recommended using maternal and neonatal data collection systems and agreed on a common set of variables for COVID-19 vaccines active safety surveillance in LMICs.

3.
SSRN; 2022.
Preprint in English | SSRN | ID: ppcovidwho-332152

ABSTRACT

Background: Assessment of COVID-19 vaccine safety during pregnancy is urgently needed to inform the public, advisory committees, and policymakers. Methods: We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 vaccines, including their components and technological platforms used in other vaccines during pregnancy. We searched literature databases from inception to September 2021 without language restriction, COVID-19 vaccine pregnancy websites, and reference lists of systematic reviews and the included studies. Pairs of reviewers independently selected studies through COVIDENCE and performed the data extraction and risk of bias assessment. Discrepancies were resolved by consensus. The study is registered in PROSPERO (CRD42021234185). Findings: We retrieved 8,837 records from the search strategy;71 studies (61 clinical and 10 non-clinical studies, involving 17,719,495 pregnant persons and 389 pregnant animals, respectively) were included. Most studies (94%) were conducted in high-income countries and were cohort studies (51%). Less than 15% of studies were classified as high risk of bias. We identified nine COVID-19 vaccine studies, two preclinical studies, and seven involving 309,164 pregnant persons, mostly exposed to mRNA vaccines. Among non-COVID-19 vaccines, the most frequent exposures were to the AS03 adjuvant (23 studies) and aluminum-based adjuvants (31 clinical and five preclinical studies).A meta-analysis of the studies that adjusted for potential confounders and compared exposure to maternal COVID-19 vaccines or adjuvanted non-COVID-19 vaccines with no exposure showed no association with adverse outcomes, regardless of the vaccine or the trimester of vaccination. Proportional meta-analyses of uncontrolled studies or arms assessing pregnancy and safety outcomes of COVID-19 vaccines or adjuvanted non-COVID-19 vaccines (with AS03 or aluminum) estimated the ranges for each of the following outcomes: hypertensive disorders 2·37-3·98%;antenatal bleeding 0·37-0·44%;gestational diabetes mellitus 2·63-7·74%;spontaneous abortion/miscarriage 4·97-11·98%;stillbirth 0·06-0·20%;fetal death 0·82-1·36%;fetal growth restriction 0·49-0·89%;preterm birth 5·52-5·61%;low birth weight 3·73-6·84%;small for gestational age 6·84-11·98%;congenital malformations 2·32-4·97%;neonatal infections 3·24-7·23%;neonatal encephalopathy 0·23%;newborn respiratory distress syndrome 1·23-1·82%;and neonatal death 0·07-0·43%. Medically attended adverse events (33·9%) and serious adverse events (12·31%) were only available for aluminum-based adjuvant exposure. Neither pregnancy outcomes nor reactogenicity exceeded the expected rates. The only exception was postpartum hemorrhage after COVID-19 vaccination (10·40%;95% CI: 6·49-15·10%), reported by two studies;however, the comparison with non-exposed pregnant persons in one study found non-statistically significant differences (adjusted OR 1·09;CI 95% 0·56 to 2·12). Interpretation: We found no safety concerns for currently administered COVID-19 vaccines during pregnancy. Further experimental and real-world evidence should expand these findings that reinforce current recommendations about vaccinating pregnant persons with approved COVID-19 vaccines. Robust safety data for non-mRNA-based COVID-19 vaccines are urgently needed.

4.
Am J Hematol ; 97(6): 770-779, 2022 06 01.
Article in English | MEDLINE | ID: covidwho-1750295

ABSTRACT

The efficacy of COVID-19 convalescent plasma (CCP) as a treatment for hospitalized patients with COVID-19 remains somewhat controversial; however, many studies have not evaluated CCP documented to have high neutralizing antibody titer by a highly accurate assay. To evaluate the correlation of the administration of CCP with titer determined by a live viral neutralization assay with 7- and 28-day death rates during hospitalization, a total of 23 118 patients receiving a single unit of CCP were stratified into two groups: those receiving high titer CCP (>250 50% inhibitory dilution, ID50; n = 13 636) or low titer CCP (≤250 ID50; n = 9482). Multivariable Cox regression was performed to assess risk factors. Non-intubated patients who were transfused with high titer CCP showed 1.1% and 1.7% absolute reductions in overall 7- and 28-day death rates, respectively, compared to those non-intubated patients receiving low titer CCP. No benefit of CCP was observed in intubated patients. The relative benefit of high titer CCP was confirmed in multivariable Cox regression. Administration of CCP with high titer antibody content determined by live viral neutralization assay to non-intubated patients is associated with modest clinical efficacy. Although shown to be only of modest clinical benefit, CCP may play a role in the future should viral variants develop that are not neutralized by other available therapeutics.


Subject(s)
COVID-19 , SARS-CoV-2 , Antibodies, Neutralizing , Antibodies, Viral , COVID-19/therapy , Humans , Immunization, Passive , Treatment Outcome
5.
Frontiers in digital health ; 3, 2021.
Article in English | EuropePMC | ID: covidwho-1601903

ABSTRACT

Introduction: The Food and Drug Administration Center for Biologics Evaluation and Research conducts post-market surveillance of biologic products to ensure their safety and effectiveness. Studies have found that common vaccine exposures may be missing from structured data elements of electronic health records (EHRs), instead being captured in clinical notes. This impacts monitoring of adverse events following immunizations (AEFIs). For example, COVID-19 vaccines have been regularly administered outside of traditional medical settings. We developed a natural language processing (NLP) algorithm to mine unstructured clinical notes for vaccinations not captured in structured EHR data. Methods: A random sample of 1,000 influenza vaccine administrations, representing 995 unique patients, was extracted from a large U.S. EHR database. NLP techniques were used to detect administrations from the clinical notes in the training dataset [80% (N = 797) of patients]. The algorithm was applied to the validation dataset [20% (N = 198) of patients] to assess performance. Full medical charts for 28 randomly selected administration events in the validation dataset were reviewed by clinicians. The NLP algorithm was then applied across the entire dataset (N = 995) to quantify the number of additional events identified. Results: A total of 3,199 administrations were identified in the structured data and clinical notes combined. Of these, 2,740 (85.7%) were identified in the structured data, while the NLP algorithm identified 1,183 (37.0%) administrations in clinical notes;459 were not also captured in the structured data. This represents a 16.8% increase in the identification of vaccine administrations compared to using structured data alone. The validation of 28 vaccine administrations confirmed 27 (96.4%) as “definite” vaccine administrations;18 (64.3%) had evidence of a vaccination event in the structured data, while 10 (35.7%) were found solely in the unstructured notes. Discussion: We demonstrated the utility of an NLP algorithm to identify vaccine administrations not captured in structured EHR data. NLP techniques have the potential to improve detection of vaccine administrations not otherwise reported without increasing the analysis burden on physicians or practitioners. Future applications could include refining estimates of vaccine coverage and detecting other exposures, population characteristics, and outcomes not reliably captured in structured EHR data.

6.
Vaccine ; 39(40): 5891-5908, 2021 09 24.
Article in English | MEDLINE | ID: covidwho-1356479

ABSTRACT

BACKGROUND: Rapid assessment of COVID-19 vaccine safety during pregnancy is urgently needed. METHODS: We conducted a rapid systematic review, to evaluate the safety of COVID-19 vaccines selected by the COVID-19 Vaccines Global Access-Maternal Immunization Working Group in August 2020, including their components and their technological platforms used in other vaccines for pregnant persons. We searched literature databases, COVID-19 vaccine pregnancy registries, and explored reference lists from the inception date to February 2021 without language restriction. Pairs of reviewers independently selected studies through COVIDENCE, and performed the data extraction and the risk of bias assessment. Discrepancies were resolved by consensus. Registered on PROSPERO (CRD42021234185). RESULTS: We retrieved 6757 records and 12 COVID-19 pregnancy registries from the search strategy; 38 clinical and non-clinical studies (involving 2,398,855 pregnant persons and 56 pregnant animals) were included. Most studies (89%) were conducted in high-income countries and were cohort studies (57%). Most studies (76%) compared vaccine exposures with no exposure during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant, in the context of A/H1N1 pandemic influenza vaccines, (n = 24) and aluminum-based adjuvants (n = 11). Only one study reported exposure to messenger RNA in lipid nanoparticles COVID-19 vaccines. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03), corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns. CONCLUSION: This rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted, given their novelty. Our findings support current WHO guidelines recommending that pregnant persons may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.


Subject(s)
COVID-19 , Influenza A Virus, H1N1 Subtype , Influenza Vaccines , Influenza, Human , Animals , COVID-19 Vaccines , Female , Humans , Influenza Vaccines/adverse effects , Influenza, Human/prevention & control , Pregnancy , SARS-CoV-2 , Vaccination
7.
Transfusion ; 60(9): 1987-1997, 2020 09.
Article in English | MEDLINE | ID: covidwho-796294

ABSTRACT

Risk assessments of transfusion-transmitted emerging infectious diseases (EIDs) are complicated by the fact that blood donors' demographics and behaviors can be different from the general population. Therefore, when assessing potential blood donor exposure to EIDs, the use of general population characteristics, such as U.S. travel statistics, may invoke uncertainties that result in inaccurate estimates of blood donor exposure. This may, in turn, lead to the creation of donor deferral policies that do not match actual risk. STUDY DESIGN AND METHODS: This article reports on the development of a system to rapidly assess EID risks for a nationally representative portion of the U.S. blood donor population. To assess the effectiveness of this system, a test survey was developed and deployed to a statistically representative sample frame of blood donors from five blood collecting organizations. Donors were directed to an online survey to ascertain their recent travel and potential exposure to Middle East respiratory syndrome coronavirus (MERS-CoV). RESULTS: A total of 7128 responses were received from 54 256 invitations. The age-adjusted estimated total number of blood donors potentially exposed to MERS-CoV was approximately 15 640 blood donors compared to a lower U.S. general population-based estimate of 9610 blood donors. CONCLUSION: The structured donor demographic sample-based data provided an assessment of blood donors' potential exposure to an emerging pathogen that was 63% larger than the U.S. population-based estimate. This illustrates the need for tailored blood donor-based EID risk assessments that provide more specific demographic risk intelligence and can inform appropriate regulatory decision making.


Subject(s)
Blood Donors , Blood Transfusion , Blood-Borne Infections/epidemiology , Communicable Diseases, Emerging/epidemiology , Communicable Diseases, Imported/epidemiology , Coronavirus Infections/epidemiology , Environmental Exposure , Risk Assessment/methods , Surveys and Questionnaires , Travel-Related Illness , Adolescent , Adult , Aged , Aged, 80 and over , Blood Banks , Blood Donors/statistics & numerical data , Blood-Borne Infections/blood , Blood-Borne Infections/prevention & control , Blood-Borne Infections/transmission , Communicable Diseases, Emerging/blood , Communicable Diseases, Emerging/prevention & control , Communicable Diseases, Emerging/transmission , Communicable Diseases, Imported/blood , Communicable Diseases, Imported/prevention & control , Communicable Diseases, Imported/transmission , Coronavirus Infections/blood , Coronavirus Infections/prevention & control , Coronavirus Infections/transmission , Decision Making , Female , Humans , Male , Middle Aged , Middle East , Middle East Respiratory Syndrome Coronavirus , Sample Size , Sampling Studies , Transfusion Reaction/prevention & control , United States/epidemiology , Young Adult
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