Discovery and development of COVID-19 vaccines and therapeutics: nonclinical perspectives DOI Open Access
Nasir Ali Khan, Jean G. Sathish,

Cynthia M. Rohde

и другие.

The Journal of Toxicological Sciences, Год журнала: 2024, Номер 49(3), С. 79 - 94

Опубликована: Янв. 1, 2024

The development and regulatory review of BNT162b2, a COVID-19 vaccine, PaxlovidTM (nirmatrelvir tablets/ritonavir tablets), therapeutic, are benchmarks for accelerated innovation during global pandemic. Rapid choice the SARS-CoV-2 spike protein main protease (Mpro) as targets vaccine respectively, leveraged available knowledge biology related viruses. nonclinical immunogenicity safety BNT162b2 was rigorously assessed. Likewise, comprehensive assessment conducted therapeutic candidates, lufotrelvir (PF-07304814) nirmatrelvir (PF-07321332). Paxlovid enabled through close collaboration pharmaceutical industry with agencies public health organizations. This experience highlights approaches that could be adopted pandemic preparedness including risk-based investment strategies, conduct activities in parallel normally sequentially, quick kill decisions, simultaneous evaluation multiple use flexible, established platforms.

Язык: Английский

In Utero Exposure to Maternal COVID-19 Vaccination and Offspring Neurodevelopment at 12 and 18 Months DOI
Eleni A. Greenwood, Marcelle I. Cedars, Karla Lindquist

и другие.

JAMA Pediatrics, Год журнала: 2024, Номер 178(3), С. 258 - 258

Опубликована: Янв. 22, 2024

Importance Uptake of COVID-19 vaccines among pregnant individuals was hampered by safety concerns around potential risks to unborn children. Data clarifying early neurodevelopmental outcomes offspring exposed vaccination in utero are lacking. Objective To determine whether exposure maternal associated with differences scores on the Ages and Stages Questionnaire, third edition (ASQ-3), at 12 18 months age. Design, Setting, Participants This prospective cohort study, Assessing Safety Pregnancy During Coronavirus Pandemic (ASPIRE), enrolled participants from May 2020 August 2021; follow-up children these pregnancies is ongoing. Participants, which included their all 50 states, self-enrolled online. Study activities were performed remotely. Exposure In fetus during pregnancy compared those unexposed. Main Outcomes Measures Neurodevelopmental validated ASQ-3, completed birth mothers months. A score below established cutoff any 5 subdomains (communication, gross motor, fine problem solving, social skills) constituted an abnormal screen for developmental delay. Results total 2487 (mean [SD] age, 33.3 [4.2] years) less than 10 weeks’ gestation research activities, yielding a 2261 1940 infants aged months, respectively, assessments. crude analyses, 471 1541 (30.6%) screened abnormally delay vs 203 720 unexposed (28.2%; χ 2 = 1.32; P .25); corresponding prevalences 262 1301 (20.1%) 148 639 (23.2%), respectively (χ 2.35; .13). multivariable mixed-effects logistic regression models adjusting race, ethnicity, education, income, depression, anxiety, no difference risk ASQ-3 screens observed either time point (12 months: adjusted ratio [aRR], 1.14; 95% CI, 0.97-1.33; aRR, 0.88; 0.72-1.07). Further adjustment preterm infant sex did not affect results 1.16; 0.98-1.36; 0.87; 0.71-1.07). Conclusions Relevance this study suggest that safe perspective neurodevelopment Additional longer-term should be conducted corroborate findings buttress clinical guidance strong evidence base.

Язык: Английский

Процитировано

9

Association between maternal anemia during pregnancy with low birth weight their infants DOI Creative Commons
Rozhan Khezri, Fatemeh Rezaei, Shayesteh Jahanfar

и другие.

Scientific Reports, Год журнала: 2025, Номер 15(1)

Опубликована: Фев. 22, 2025

Low birth weight and anemia are significant public health challenges in developing countries. This study seeks to evaluate the relationship between hemoglobin levels during first second trimesters of pregnancy occurrence low weight, while accounting for potential confounding factors. multi-center cross-sectional was conducted among all pregnant women with COVID-19 no history receiving vaccine who delivered private hospitals three counties, Mahabad, Miandoab, Bukan Iran, using routinely collected maternity data on pregnancies. Hemoglobulin were measured (6–10th weeks) (24–28th pregnancy, outcomes recorded information system. Hb categorized into four groups as follows: ≥110 g/L, 100–109 90–99 < 90 g/L trimester ≥ 105 100–104 trimester. Multivariable logistic regression analysis determined association weight. P-values 0.05 considered statistically significant. A total 385 mothers included. The mean age 30.01 ± 6.24 years. After multivariable adjustment, 110 had a [OR, 4.13; (95% CI 2.11–8.10)]. Morevoer, [OR:3.91; CI:1.98–7.75)]. Maternal including trimesters, even after adjusting common confounders. Effective management monitoring women, particularly low- middle-income countries, crucial preventing

Язык: Английский

Процитировано

1

COVID-19 Vaccine Safety Technical (VaST) Work Group: Enhancing vaccine safety monitoring during the pandemic DOI Creative Commons
Lauri E. Markowitz,

Robert Hopkins,

Karen R. Broder

и другие.

Vaccine, Год журнала: 2024, Номер 42, С. 125549 - 125549

Опубликована: Фев. 9, 2024

During the COVID-19 pandemic, candidate vaccines were being developed for potential use in United States on an unprecedented, accelerated schedule. It was anticipated that once available, under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or FDA approval, would be broadly used potentially administered to millions of individuals a short period time. Intensive monitoring post-EUA/licensure necessary timely detection assessment safety concerns. To address this, Centers Disease Control Prevention (CDC) convened Advisory Committee Immunization Practices (ACIP) work group focused solely vaccine safety, consisting independent experts representatives from federal agencies - ACIP Vaccine Safety Technical Work Group (VaST). This report provides overview organization activities VaST, summarizes data reviewed as part comprehensive effort monitor during highlights selected actions taken by CDC, ACIP, response accumulating post-authorization data. VaST regular meetings over course 29 months, November 2020 through April 2023; March 2023 issued EUAs six four different manufacturers subsequently licensed two these vaccines. The collaborated with ensure this worked closely Vaccines Group; VaST's assessments benefit-risk guidance vaccination policy. topics included those identified systems other scientific public interest. provided CDC's efforts, forum review several government systems, assured diverse scientists clinicians, external government, promptly In event future pandemic biological health emergency, model could strengthen monitoring, enhance confidence, increase transparency incorporation independent, non-government into process, strong collaboration among partners.

Язык: Английский

Процитировано

7

Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis DOI Creative Commons
Agustín Ciapponi, Mabel Berrueta, Fernando Argento

и другие.

Drug Safety, Год журнала: 2024, Номер 47(10), С. 991 - 1010

Опубликована: Июль 15, 2024

Pregnant persons are susceptible to significant complications following COVID-19, even death. However, worldwide COVID-19 vaccination coverage during pregnancy remains suboptimal.

Язык: Английский

Процитировано

6

Maternal Exposures to COVID-19 Vaccine and Adverse Birth Outcomes: National Population Study in Korea DOI Creative Commons

Ki‐Jeong Kim,

Erdenetuya Bolormaa, Eunseon Gwak

и другие.

Journal of Korean Medical Science, Год журнала: 2025, Номер 40

Опубликована: Янв. 1, 2025

Язык: Английский

Процитировано

0

Pneumonie et grossesse DOI

A Shalaby,

Marie Lachâtre, Caroline Charlier

и другие.

Revue des Maladies Respiratoires, Год журнала: 2025, Номер 42(2), С. 104 - 116

Опубликована: Янв. 31, 2025

Язык: Английский

Процитировано

0

COVID-19 and influenza vaccine uptake among pregnant women in national cohorts of England and Wales DOI Creative Commons
Xinchun Gu, Utkarsh Agrawal, William Midgley

и другие.

npj Vaccines, Год журнала: 2024, Номер 9(1)

Опубликована: Авг. 14, 2024

Abstract Vaccines against COVID-19 and influenza can reduce the adverse outcomes caused by infections during pregnancy, but vaccine uptake among pregnant women has been suboptimal. We examined disparities in pandemic to inform vaccination interventions. used data from Oxford-Royal College of General Practitioners Research Surveillance Centre database England Secure Anonymised Information Linkage Databank Wales. The at least one dose was 40.2% for 41.8% eligible women. observed uptake, with socioeconomically deprived ethnic minority groups showing lower rates. suboptimal vaccines, especially those backgrounds Black, mixed or other groups, underscores necessity interventions hesitancy enhance acceptance

Язык: Английский

Процитировано

4

Multi-System Dysregulation in Placental Malaria Contributes to Adverse Perinatal Outcomes in Mice DOI Creative Commons

Phebe Ekregbesi,

Brittany Seibert, Maclaine Parish

и другие.

bioRxiv (Cold Spring Harbor Laboratory), Год журнала: 2025, Номер unknown

Опубликована: Янв. 16, 2025

ABSTRACT Sequestration of Plasmodium parasites in the placental vasculature causes increased morbidity and mortality pregnant compared to non-pregnant patients malaria- endemic regions. In this study, outbred CD1 mice with semi allogeneic fetuses were infected transgenic berghei or mock-inoculated by mosquito bite at either embryonic day (E) 6 (first trimester-equivalent) 10 (second trimester- equivalent) females. P. -infected mosquitoes had greater biting avidity for E10 dams than uninfected mosquitoes, which was not apparent E6 nor Infected numbers uterus spleen, but blood liver. While found placentas, no present fetuses. Maternal infection caused maternal morbidity, rates fetal reabsorption stillbirths E10. Infection adverse offspring outcomes, including growth restriction. To identify possible mechanisms euthanized during peak parasitemia (8 days post infection), outcomes mock-infected dams. significant systemic immune activation elevated circulating lymphocytes, eosinophils, neutrophils splenic cytokine concentrations. corticosterone decreased progesterone concentrations, could contribute perinatal through immunomodulation. There limited changes fecal microbiome after infection. Mosquito malaria provides a novel, tractable model investigate therapeutic treatments.

Язык: Английский

Процитировано

0

COVID‐19 in pregnancy DOI Creative Commons
Orene Greer,

Zainab Saeed,

Ee Von Woon

и другие.

The Obstetrician & Gynaecologist, Год журнала: 2025, Номер 27(1), С. 43 - 56

Опубликована: Янв. 1, 2025

Key content COVID‐19 is known to be associated with significant morbidity for pregnant women and their babies. This susceptibility adverse clinical outcomes may the unique physiological characteristics of host. Public health measures recommended management prevention critical in pregnancy lactation evolved during 2020 pandemic; some decisions were controversial. We highlight lessons learnt considerations future pandemic preparedness. Learning objectives To outline pathology pregnancy, including placental involvement. summarise current evidence‐based signpost resources updates. discuss role vaccines reduce mortality existing novel SARS‐CoV‐2 viral strains. Ethical issues Sustained international collaborative strategies are crucial ensure global equity access treatment communicable diseases.

Язык: Английский

Процитировано

0

Research Priorities for Maternal Immunization DOI
Janet A. Englund, Alisa Kachikis

The Pediatric Infectious Disease Journal, Год журнала: 2025, Номер 44(2S), С. S13 - S15

Опубликована: Фев. 1, 2025

Background: The maternal immunization platform has multiple vaccines already being utilized with more considered. Methods: We describe areas knowledge gaps regarding including (1) pathogen, (2) vaccine product, (3) strategy, (4) implementation research and (5) Regulatory Public Health Policy. Results: Despite advances in clinical during pregnancy, many questions remain administration, products, coadministration of acceptance. Issues antibody transfer high-risk pregnancies need further study. Conclusions: Moving new forward will take support from a broad array experts.

Язык: Английский

Процитировано

0