Dataset Information

Vaccine-Induced Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Response and the Path to Accelerating Development (Determining a Correlate of Protection).

ABSTRACT: As new public health challenges relating to COVID-19 emerge, such as variant strains, waning vaccine efficacy over time, and decreased vaccine efficacy for special populations (immunocompromised hosts), it is important to determine a correlate of protection (CoP) to allow accurate bridging studies for special populations and against variants of concern. Large-scale phase 3 clinical trials are inefficient to rapidly assess novel vaccine candidates for variant strains or special populations, because these trials are slow and costly. Defining a practical CoP will aid in efficiently conducting future assessments to further describe protection for individuals and on a population level for surveillance.

SUBMITTER: Sherman AC

PROVIDER: S-EPMC8563351 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Vaccine-Induced Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Response and the Path to Accelerating Development (Determining a Correlate of Protection).

Sherman Amy C AC Desjardins Michaël M Baden Lindsey R LR

Clinics in laboratory medicine 20211103 1

As new public health challenges relating to COVID-19 emerge, such as variant strains, waning vaccine efficacy over time, and decreased vaccine efficacy for special populations (immunocompromised hosts), it is important to determine a correlate of protection (CoP) to allow accurate bridging studies for special populations and against variants of concern. Large-scale phase 3 clinical trials are inefficient to rapidly assess novel vaccine candidates for variant strains or special populations, becau ...[more]

PMID: 35153045

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Project description:BackgroundSince coronavirus disease 2019 vaccines have been distributed, a debate has raised on whether pregnant women should get the vaccine. No available data exist so far regarding the safety, efficacy, and toxicology of these vaccines when administered during pregnancy. Most of the Obstetrics and Gynecology societies suggested that pregnant could agree to be vaccinated, after a thorough counseling of risks and benefits with their gynecologists, thus leading to an autonomous decision.ObjectiveThis study aimed to evaluate the attitude to coronavirus disease 2019 vaccination in pregnant and breastfeeding women in Italy.Study designA survey was made at the University of Naples Federico II and the Ospedale Cristo Re, Tor Vergata University of Rome, on pregnant and breastfeeding women asking their perspectives on the available vaccines after reading the recommendations issued by our national Obstetrics, Gynecology, and Neonatology societies. The questionnaire included 12 items finalized to evaluate general features of the women and 6 items specifically correlated to their attitudes toward the severe acute respiratory syndrome coronavirus 2 vaccination. Chi-square or Fisher's exact tests were used to compare group differences of categorical variables and Wilcoxon signed rank or Mann-Whitney U test for continuous variables. The study was approved by the institutional review boards of the University of Naples Federico II (ref. no. 409/2020) and the Ospedale Cristo Re, Tor Vergata University of Rome (ref. #Ost4-2020).ResultsMost of the included women did not agree to eventually receive severe acute respiratory syndrome coronavirus 2 vaccine during pregnancy (40 [28.2%] vs 102 [71.8%]). Being pregnant was considered a determinant factor to refuse the vaccine prophylaxis (99 [69.7%] vs 43 [30.3%]; chi-square test=24.187; P<.001), even if a very large percentage declared to be generally in favor of vaccines (128 [90.1%] vs 14 [9.9%]; chi-square test=6.091; P=.014) and most of them confirmed they received or would receive other recommended vaccines during pregnancy (75 [52.8%] vs 67 [47.2%]; chi-square test=10.996; P=.001).ConclusionUrgent data are needed on the safety, efficacy, and toxicology of severe acute respiratory syndrome coronavirus 2 vaccines during pregnancy to modify this trend and to help obstetricians during the counseling. Furthermore, pregnant women should be included in future vaccine development trials to not incur again in such uncertainty.

Dataset Information

Vaccine-Induced Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Response and the Path to Accelerating Development (Determining a Correlate of Protection).

Publications

Vaccine-Induced Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Response and the Path to Accelerating Development (Determining a Correlate of Protection).

Similar Datasets

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