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

Maternal Vaccination and Neonatal Feeding Strategies Among Polish Women DOI Creative Commons
Jolanta Lis-Kuberka, Magdalena Orczyk‐Pawiłowicz

Vaccines, Год журнала: 2025, Номер 13(4), С. 376 - 376

Опубликована: Март 31, 2025

Background/Objectives: Maternal vaccination and breastfeeding are important aspects of public health that should be recommended by medical staff caring for pregnant postpartum women. We aimed to analyze factors affecting women’s likelihood dual during pregnancy their infant feeding strategies. Methods: A cross-sectional study was conducted with 953 Polish mothers. An online questionnaire used included questions on sociodemographic obstetric variables, attitudes towards COVID-19 influenza vaccination, practices. Results: reported 66.0%, 18.2%, 15.6% Increasing willingness receive vaccines significantly associated older maternal age, lower BMI, living in urban areas >100,000 residents, high levels knowledge regarding vaccination. No significant association between neonatal strategy detected. The group exclusively mothers, comparison formula- mixed-feeding women, characterized having pre-pregnancy BMI previous experience. Conclusions: Rates against seasonal (influenza COVID-19) remain low among promotion antenatal reliable information about short- long-term advantages related crucial perinatal care the mother–infant dyad. Young, primiparous women who overweight or obese targets preventive programs focused

Язык: Английский

Процитировано

0

COVID-19 vaccination rates among pregnant women in France: A nationwide cohort study DOI Creative Commons

Cécilia Bernard,

Jérôme Drouin, Stéphane Le Vu

и другие.

Vaccine, Год журнала: 2025, Номер 53, С. 127070 - 127070

Опубликована: Апрель 1, 2025

Pregnant women are at an elevated risk for severe COVID-19, but nationwide rates of vaccination and its timing during pregnancy not well documented in France. To assess COVID-19 among pregnant France, compare them to those the general population, analyse factors associated with status timing. A study using EPI-MERES register, which includes all 1,203,454 who delivered between April 2021 December 2022 Standardization by age social index was used female population. Associations sociodemographic factors, monitoring indicators, pre-existing comorbidities were measured multivariable logistic regression. Overall, 52 % received least one vaccine dose, 62.1 vaccinated before conception 8.2 %, 20.9 8.8 1st, 2nd, 3rd trimester, respectively. Vaccination initially lagged behind population converged June 2022, a six-month lag. Younger more socially deprived less highly vaccinated. Unvaccinated likely be their third (aOR, 1.21 [1.19-1.22]), had fewer ultrasound scans 0.71 [0; 70-0.73]), often took folic acid 0.73 [0.72-0.74]). Women comorbidities, such as obesity, diabetes, hypertension, antidepressant use, or chronic respiratory disease, unvaccinated (aORs ranged from 0.69 0.89). France than crucial pandemic periods eventually reached similar rates. Socioeconomic level prenatal care strongly low uptake. This should focus future interventions policy adjustments across segments this

Язык: Английский

Процитировано

0

Safety, immunogenicity, efficacy, and effectiveness of Lassa fever vaccines in pregnant persons, children, and adolescents: a protocol for a living systematic review and meta-analysis DOI Creative Commons
Jamile Ballivian, Mabel Berrueta, Agustín Ciapponi

и другие.

Reproductive Health, Год журнала: 2025, Номер 22(1)

Опубликована: Апрель 15, 2025

Lassa fever (LF), caused by the virus (LASV), is a zoonotic viral hemorrhagic disease endemic to West Africa, primarily transmitted through rodent excreta and infected bodily fluids. It poses significant public health challenges due its high morbidity mortality rates, particularly among at-risk populations like pregnant persons children. Despite decades of research, vaccine development has been hindered virus's genetic diversity complex epidemiology. While several candidates have developed, none received regulatory approval. Given rapidly evolving landscape, living systematic review (LSR) was selected enable real-time evidence synthesis. This protocol outlines evaluate safety, efficacy, effectiveness, immunogenicity LASV vaccines, providing guide interventions recommendations. We will conduct biweekly updated LSR meta-analysis, systematically searching databases (e.g., MEDLINE, EMBASE, CENTRAL) clinical trial registries from January 2014 onward identify studies vaccines in persons, children, adolescents. All study designs, including randomized trials, cohort studies, case-control case reports, be eligible. Pairs reviewers independently assess eligibility, extract data, risk bias. Primary outcomes include effectiveness (including neonatal outcomes), adolescents, while secondary reactogenicity. Data on adult also included, results this group reported as available. paired meta-analyses, prespecified subgroup sensitivity analyses. use grading recommendations assessment, development, evaluation approach certainty evidence. offers dynamic framework generate timely for vulnerable populations. By integrating findings into an interactive Microsoft Power BI dashboard, stakeholders can access utilize updates inform strategies. heterogeneity platform variability, analyses mitigate these issues. aims support policy, improve fever-endemic regions. Two protocols were registered International Prospective Register Systematic Reviews (PROSPERO) database: CRD42024514513 CRD42024516754.

Язык: Английский

Процитировано

0

Assessing the Impact of COVID-19 Vaccination on Preterm Birth: A Systematic Review with Meta-Analysis DOI Creative Commons
Mihaela Uta,

Marius Craina,

Felicia Marc

и другие.

Vaccines, Год журнала: 2024, Номер 12(1), С. 102 - 102

Опубликована: Янв. 19, 2024

During the coronavirus diseases 2019 (COVID-19) pandemic, safety and efficacy of vaccination during pregnancy, particularly regarding risk preterm birth, have been a subject concern. This systematic review aims to evaluate impact COVID-19 on birth inform clinical practice public health policies. Following PRISMA (Preferred Reporting Items for Systematic Reviews Meta-Analyses) guidelines, database search included PubMed, Embase, Scopus, conducted up until October 2023. Inclusion criteria focused studies that examined pregnancy its correlation with defined as before 37 weeks gestation. Six met these criteria, encompassing 35,612 patients. A quality assessment was performed using Newcastle–Ottawa Scale Cochrane Collaboration’s tool, bias evaluated via funnel plot analysis an Egger’s regression test. The demonstrated geographical diversity, mainly from Israel, Romania, United States, blend prospective retrospective designs. patient cohort’s mean age 31.2 years, common comorbidities such gestational diabetes obesity affecting 9.85% total population. types varied across studies, BNT162b2 being most used. results indicated low heterogeneity among evidenced by Cochran’s Q statistic 2.10 I2 13%. meta-analysis yielded pooled odds ratio (OR) post-vaccination approximately 1.03 (95% CI: 0.82–1.30), suggesting no significant increase in associated vaccination. Notable findings rate (as 0.6% 6.1%) minimal differences neonatal outcomes, weight APGAR (appearance, pulse, grimace, activity, respiration) scores between vaccinated unvaccinated groups. study concludes does not significantly birth. These are crucial reassuring healthcare providers pregnant women about vaccines supporting their use strategies pandemic.

Язык: Английский

Процитировано

3

Safe in pregnancy: A global living systematic review and meta-analysis of COVID-19 vaccines in pregnancy DOI
Pierre Buekens, Mabel Berrueta, Agustín Ciapponi

и другие.

Vaccine, Год журнала: 2024, Номер 42(7), С. 1414 - 1416

Опубликована: Фев. 9, 2024

Язык: Английский

Процитировано

3

Pregnancy Outcomes among Pregnant Persons after COVID-19 Vaccination: Assessing Vaccine Safety in Retrospective Cohort Analysis of U.S. National COVID Cohort Collaborative (N3C) DOI Creative Commons
Emily A. Groene, Kenneth J. Wilkins, Sara Jones

и другие.

Vaccines, Год журнала: 2024, Номер 12(3), С. 289 - 289

Опубликована: Март 11, 2024

COVID-19 vaccines have been shown to be effective in preventing severe illness, including among pregnant persons. The appear safe pregnancy, supporting a continuously favorable overall risk/benefit profile, though supportive data for the U.S. over different periods of variant predominance are lacking. We sought analyze association adverse pregnancy outcomes with vaccinations pre-Delta, Delta, and Omicron SARS-CoV-2 variants’ dominant (constituting 50% or more each pregnancy) persons large, nationally sampled electronic health record repository Our analysis included 311,057 from December 2020 October 2023 at time when there were approximately 3.6 million births per year. compared rates preterm stillbirths who vaccinated before during after those not vaccinated. performed multivariable Poisson regression generalized estimated equations address site heterogeneity unadjusted exact models stillbirths, stratified by period. found lower birth majority modeled (adjusted incidence rate ratio [aIRR] range: 0.42 0.85; p-value <0.001 0.06) stillbirth (IRR 0.53 1.82; 0.976) most largely no associations between vaccination stillbirth; these findings reinforce safety bolster confidence persons, providers, policymakers importance this group despite end public emergency.

Язык: Английский

Процитировано

3

Vacunación en el embarazo. Documento de consenso del CAV-AEP y la SEGO DOI Creative Commons

Javier Álvarez Aldeán,

Francisco José Álvarez García, María de la Calle Fernández-Miranda

и другие.

Anales de Pediatría, Год журнала: 2024, Номер 100(4), С. 268 - 274

Опубликована: Март 14, 2024

Durante el embarazo, los cambios fisiológicos en la respuesta inmunitaria favorecen que las gestantes sean más susceptibles a infecciones graves, tanto para ellas como feto, recién nacido y lactante. Todas mujeres deberían entrar período reproductivo con su calendario vacunal correctamente cumplimentado, sobre todo lo respecta enfermedades tétanos, hepatitis B, sarampión, rubeola varicela. Además de vacunas recomendadas, situaciones riesgo inactivadas podrían ser administradas aquellas no estuvieran inmunizadas anterioridad, mientras atenuadas están contraindicadas. A pesar vacunación durante embarazo es una medida preventiva muy importante, recomendaciones autoridades sanitarias, sociedades científicas profesionales sanitarios, coberturas vacunales son claramente mejorables, especialmente gripe COVID-19, por profesional sanitario atienda embarazada debe proactivo aconsejarlas. La Asociación Española Pediatría (AEP), través Comité Asesor Vacunas (CAV), Sociedad Ginecología Obstetricia (SEGO) recomiendan siguientes vacunaciones gestación: frente cualquier trimestre del puerperio (hasta 6 meses) hubieran sido vacunadas gestación; tosferina Tdpa, entre 27 36 semanas gestación (el CAV-AEP da preferencia 28 semanas); al VRS RSVPreF, 24 gestación, 32 semanas. During pregnancy, physiological changes in the immune response make pregnant women more susceptible to serious infection, increasing risk for mother as well foetus, newborn and infant. All should be correctly fully vaccinated they enter their reproductive years, especially against diseases such tetanus, measles, rubella varicella. In addition recommended vaccines, situations, inactivated vaccines could administered who were not before, while attenuated are contraindicated. Despite fact that vaccination during pregnancy is very important preventive measure existing recommendations from public health authorities, scientific societies professionals, coverage clearly improved, influenza SARS-CoV-2, so any professional involved care of proactively recommend these vaccines. The Spanish Association Pediatrics through its Advisory Committee on Vaccines Society Gynaecology Obstetrics following pregnancy: trimester postpartum period (up months post birth) pregnancy; pertussis, with Tdap vaccine, between weeks gestation (in recommendations, preferably 28); RSV, gestation, 36.

Процитировано

3

The Ambivalence of Post COVID-19 Vaccination Responses in Humans DOI Creative Commons
Radha Gopalaswamy, Vivekanandhan Aravindhan, Selvakumar Subbian

и другие.

Biomolecules, Год журнала: 2024, Номер 14(10), С. 1320 - 1320

Опубликована: Окт. 17, 2024

The Coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has prompted a massive global vaccination campaign, leading to the rapid development and deployment of several vaccines. Various COVID-19 vaccines are under different phases clinical trials include whole virus or its parts like DNA, mRNA, protein subunits administered directly through vectors. Beginning in 2020, few mRNA (Pfizer-BioNTech BNT162b2 Moderna mRNA-1273) adenovirus-based (AstraZeneca ChAdOx1-S Janssen Ad26.COV2.S) were recommended WHO for emergency use before completion phase 3 4 trials. These mostly two three doses at defined frequency between doses. While these vaccines, mainly based on viral nucleic acids conferred protection against progression SARS-CoV-2 infection into COVID-19, prevented death due disease, their also been accompanied plethora side effects. Common effects localized reactions such as pain injection site, well systemic fever, fatigue, headache. symptoms generally mild moderate resolve within days. However, rare but more serious have reported, including allergic anaphylaxis and, some cases, myocarditis pericarditis, particularly younger males. Ongoing surveillance research efforts continue refine understanding adverse effects, providing critical insights risk-benefit profile Nonetheless, overall safety supports continued combating with regulatory agencies health organizations emphasizing importance preventing COVID-19's outcomes. In this review, we describe types summarize various autoimmune inflammatory response(s) manifesting predominantly cardiac, hematological, neurological, psychological dysfunctions. incidence, presentation, risk factors, diagnosis, management possible mechanisms contributing discussed. review highlights potential ambivalence human response post-COVID-19 necessitates need mitigate

Язык: Английский

Процитировано

3

Hybrid Immunity to Severe Acute Respiratory Syndrome Coronavirus 2 During Pregnancy Provides More Durable Infant Antibody Responses Compared to Natural Infection or Vaccination Alone DOI Open Access
Sylvia M. LaCourse, Erica Wetzler, Morgan C Aurelio

и другие.

The Journal of Infectious Diseases, Год журнала: 2024, Номер 229(4), С. 1241 - 1243

Опубликована: Янв. 29, 2024

In pregnant people with prior SARS-CoV-2 infection, hybrid immunity (infection plus vaccination) before delivery provided more durable maternally-derived antibody responses than infection or vaccination alone in infants through 6 months of age.

Язык: Английский

Процитировано

2

Planning for the future of maternal immunization: Building on lessons learned from the COVID-19 pandemic DOI Creative Commons
Dana Meaney‐Delman,

Sarah Carroll,

Kara N.D. Polen

и другие.

Vaccine, Год журнала: 2024, Номер 42, С. 125644 - 125644

Опубликована: Фев. 29, 2024

Язык: Английский

Процитировано

2