Pub Date : 2024-07-01DOI: 10.1016/j.vacune.2024.07.006
Jordi Reina, Julia Viana-Ramírez
{"title":"Returning to trivalent vaccines against human influenza","authors":"Jordi Reina, Julia Viana-Ramírez","doi":"10.1016/j.vacune.2024.07.006","DOIUrl":"10.1016/j.vacune.2024.07.006","url":null,"abstract":"","PeriodicalId":101272,"journal":{"name":"Vacunas (English Edition)","volume":"25 3","pages":"Pages 289-291"},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142097715","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
COVID-19 pandemic has challenged the National Regulatory Agencies (NRAs). One of these challenges is the transfer and validation of new vaccine methodologies so that they are safe, quality, and effective in protecting the population. In this article, we review the process that the Mexican NRA followed for the Vaxzevria and Convidecia vaccines; where communication between manufacturers and NRA allowed the methodological transfer and validation to be carried out before the first batch for application was ready in compliance with WHO guidelines. In this way, the importance of the relationship that must exist between manufacturers and NRAs is manifested to provide an immediate response and provide the population with a means of protection in the event of a public health emergency.
{"title":"Importance of national regulatory agencies and national control laboratories in the face of the COVID-19 pandemic: Experience of Federal Commission for the Protection against Sanitary Risks (COFEPRIS)","authors":"Imelda Rocío Guzmán-Cervantes , Elías Parra-Hernández , Alejandro Ernesto Svarch-Pérez , Armida Zúñiga-Estrada , Jorge C. Alcocer-Varela","doi":"10.1016/j.vacune.2024.07.004","DOIUrl":"10.1016/j.vacune.2024.07.004","url":null,"abstract":"<div><p>COVID-19 pandemic has challenged the National Regulatory Agencies (NRAs). One of these challenges is the transfer and validation of new vaccine methodologies so that they are safe, quality, and effective in protecting the population. In this article, we review the process that the Mexican NRA followed for the Vaxzevria and Convidecia vaccines; where communication between manufacturers and NRA allowed the methodological transfer and validation to be carried out before the first batch for application was ready in compliance with WHO guidelines. In this way, the importance of the relationship that must exist between manufacturers and NRAs is manifested to provide an immediate response and provide the population with a means of protection in the event of a public health emergency.</p></div>","PeriodicalId":101272,"journal":{"name":"Vacunas (English Edition)","volume":"25 3","pages":"Pages 424-427"},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142098363","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.1016/j.vacune.2024.07.003
María Fernández-Prada , Rosario Cáceres Fernández-Bolaños , José Javier Castrodeza-Sanz
Communication between health professionals and patients remains a challenge from the point of view of health education and health care. Training in patient–professional communication techniques and improving the communication skills of healthcare professionals is of particular interest. This document aims to share with the healthcare professional community the “Decalogue of good practices in vaccine communication between immunocompromised patients and healthcare professionals”. A QR code is included at the end of the document where the Decalogue can be downloaded for its use and distribution.
{"title":"Decalogue of best practices in vaccine communication between immunocompromised patients and healthcare professionals","authors":"María Fernández-Prada , Rosario Cáceres Fernández-Bolaños , José Javier Castrodeza-Sanz","doi":"10.1016/j.vacune.2024.07.003","DOIUrl":"10.1016/j.vacune.2024.07.003","url":null,"abstract":"<div><p>Communication between health professionals and patients remains a challenge from the point of view of health education and health care. Training in patient–professional communication techniques and improving the communication skills of healthcare professionals is of particular interest. This document aims to share with the healthcare professional community the “Decalogue of good practices in vaccine communication between immunocompromised patients and healthcare professionals”. A QR code is included at the end of the document where the Decalogue can be downloaded for its use and distribution.</p></div>","PeriodicalId":101272,"journal":{"name":"Vacunas (English Edition)","volume":"25 3","pages":"Pages 420-423"},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142098362","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.1016/j.vacune.2024.08.008
Marjan Talebi , Negar Bozorgchami , Rouzbeh Almasi Ghale , Hadi Esmaeeli , Azamsadat Moosavizadeh , Ali Aghajani , Bahareh Farasati Far , Saeed Aminzadeh
Nanocarrier-based formulations such as niosomes are experiencing a rise in popularity owing to their substantial benefits over conventional formulations. Niosomes, which are novel vesicular systems, are composed mainly of hydrated amphiphilic molecules encompassing a variety of non-ionic surfactant classes. They have since emerged as a significant novel drug delivery system employed by numerous research groups for sustained and targeted deliveries. As well as conventional oral and parenteral administrations, biotechnological products can also be administered via transdermal, intranasal, ocular, and vaginal routes. The use of niosomes for vaccine delivery offers an interesting and promising area of research in the field of drug delivery. Furthermore, niosomes have demonstrated their efficacy as immunoadjuvants. This overview provides an extensive viewpoint on the emerging applications of niosomes in vaccine delivery which is a milestone in the immune-providing industry. A wide range of surfactants with diverse polar head groups, in addition to 1, 2, or 3 lipophilic alkyls, perfluoroalkyl, and steroidal moieties, can be used to generate the appropriate vesicular structures for encapsulating both hydrophilic and hydrophobic substances. The techniques utilized for niosome preparation, aspects related to the stability of vesicles and the administration routes for these amphiphilic assemblies are also deliberated upon.
{"title":"The emerging applications of niosome as a nanotechnology-based approach in vaccine delivery","authors":"Marjan Talebi , Negar Bozorgchami , Rouzbeh Almasi Ghale , Hadi Esmaeeli , Azamsadat Moosavizadeh , Ali Aghajani , Bahareh Farasati Far , Saeed Aminzadeh","doi":"10.1016/j.vacune.2024.08.008","DOIUrl":"10.1016/j.vacune.2024.08.008","url":null,"abstract":"<div><p>Nanocarrier-based formulations such as niosomes are experiencing a rise in popularity owing to their substantial benefits over conventional formulations. Niosomes, which are novel vesicular systems, are composed mainly of hydrated amphiphilic molecules encompassing a variety of non-ionic surfactant classes. They have since emerged as a significant novel drug delivery system employed by numerous research groups for sustained and targeted deliveries. As well as conventional oral and parenteral administrations, biotechnological products can also be administered <em>via</em> transdermal, intranasal, ocular, and vaginal routes. The use of niosomes for vaccine delivery offers an interesting and promising area of research in the field of drug delivery. Furthermore, niosomes have demonstrated their efficacy as immunoadjuvants. This overview provides an extensive viewpoint on the emerging applications of niosomes in vaccine delivery which is a milestone in the immune-providing industry. A wide range of surfactants with diverse polar head groups, in addition to 1, 2, or 3 lipophilic alkyls, perfluoroalkyl, and steroidal moieties, can be used to generate the appropriate vesicular structures for encapsulating both hydrophilic and hydrophobic substances. The techniques utilized for niosome preparation, aspects related to the stability of vesicles and the administration routes for these amphiphilic assemblies are also deliberated upon.</p></div>","PeriodicalId":101272,"journal":{"name":"Vacunas (English Edition)","volume":"25 3","pages":"Pages 374-384"},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142098359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The emergence of the novel coronavirus-based illness, COVID-19, in late 2019 marked a watershed moment in modern history. Initially identified in Wuhan, China, this viral epidemic swiftly transformed into a global pandemic, affecting worldwide. The World Health Organization (WHO) officially labeled the virus as “Severe Acute Respiratory Syndrome Coronavirus 2” (SARS-CoV-2) and the ensuing disease as Coronavirus Disease 2019 (COVID-19) on February 11, 2020. The spectrum of effects induced by COVID-19 encompasses a diverse array of conditions, ranging from sensory disturbances like anosmia and ageusia to more intricate manifestations, including headaches and, alarmingly, multiorgan failure and neuromuscular dysfunction, and even deaths were reported. COVID-19 triggers a vigorous inflammatory response characterized by the overproduction of pro-inflammatory cytokines. “Cytokine storm” significantly underwrites the worsening of the condition of patients, resulting in abnormalities such as ARDS. The major reason behind mortality from COVID-19 is respiratory failure instigated by ARDS. Throughout the early respiratory contamination, SARS-CoV-2 was hypothesized to target type-II pneumocytes lining the respiratory passage that specifically expressed TMPRSS2 and ACE2 receptors. The extra-pulmonary consequences of COVID-19 have been linked to the occurrence of these receptors in the skeletomuscular and brain tissues. As a result, it is condemning to comprehend the unique pathophysiological mechanisms behind the virus's manner of invasion in the tissues and also the disease's consequences. In this article, we focus on the complications caused by COVID-19 on musculoskeletal and neural tissues, the route of invasion, and the future perspective of dealing with the receptors whose expression leads to COVID-19 infection.
{"title":"Musculoskeletal and neuromuscular dysfunction due to covid-19 infection: A review","authors":"Vivek Chauhan , Akash Pandey , Adrija Rakshit , Gaytri Mahajan , Shamsher S. Kanwar , Vivek Kumar Dhiman , Devendra Singh","doi":"10.1016/j.vacune.2024.08.006","DOIUrl":"10.1016/j.vacune.2024.08.006","url":null,"abstract":"<div><p>The emergence of the novel coronavirus-based illness, COVID-19, in late 2019 marked a watershed moment in modern history. Initially identified in Wuhan, China, this viral epidemic swiftly transformed into a global pandemic, affecting worldwide. The World Health Organization (WHO) officially labeled the virus as “Severe Acute Respiratory Syndrome Coronavirus 2” (SARS-CoV-2) and the ensuing disease as Coronavirus Disease 2019 (COVID-19) on February 11, 2020. The spectrum of effects induced by COVID-19 encompasses a diverse array of conditions, ranging from sensory disturbances like anosmia and ageusia to more intricate manifestations, including headaches and, alarmingly, multiorgan failure and neuromuscular dysfunction, and even deaths were reported. COVID-19 triggers a vigorous inflammatory response characterized by the overproduction of pro-inflammatory cytokines. “Cytokine storm” significantly underwrites the worsening of the condition of patients, resulting in abnormalities such as ARDS. The major reason behind mortality from COVID-19 is respiratory failure instigated by ARDS. Throughout the early respiratory contamination, SARS-CoV-2 was hypothesized to target type-II pneumocytes lining the respiratory passage that specifically expressed TMPRSS2 and ACE2 receptors. The extra-pulmonary consequences of COVID-19 have been linked to the occurrence of these receptors in the skeletomuscular and brain tissues. As a result, it is condemning to comprehend the unique pathophysiological mechanisms behind the virus's manner of invasion in the tissues and also the disease's consequences. In this article, we focus on the complications caused by COVID-19 on musculoskeletal and neural tissues, the route of invasion, and the future perspective of dealing with the receptors whose expression leads to COVID-19 infection.</p></div>","PeriodicalId":101272,"journal":{"name":"Vacunas (English Edition)","volume":"25 3","pages":"Pages 355-366"},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142097674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The equitable distribution of vaccines for infectious diseases in low- and middle-income countries (LMICs) has become a hotly debated topic among public professionals and Government The decisions made in this regard can have far-reaching consequences for the health and well-being of millions of people including general population and healthcare professionals. There is need toconsider a fair and just distribution system to ensure that vaccines are provided to those who need them the most. For instance, Hepatitis B virus (HBV), influenza, and COVID-19 are crucial for healthcare professionals as they play in the fight against infectious disease outbreaks. However, in LMICs, poor vaccine confidence and uptake rates represent substantial hurdles for healthcare practitioners in obtaining and administering vaccines. Further, equitable vaccine uptake is a debatable policy matter in LMICs. These challenges stem from doubts regarding vaccine efficacy and safety, inaccurate information, and a lack of trust in government and medical institutions. Addressing misconceptions and building confidence, robust monitoring and evaluation mechanisms requires to ensure the safety of vaccines. . This review highlighted the importance of enhancing vaccine uptake motivation among health workers. Moreover, enhance the the need to respect individual choice when refuse. Ultimately, building confidence in the healthcare system is critical for addressing healthcare providers' reluctance about vaccines. The transtheoretical model is extremely useful for for understanding the behaviours and factors increasing vaccine uptake notably for infection prevention against hepatitis B, COVID-19, and influenza. The immplication of framework provided a holistic approach by customizing solutions to each stage of behavior change, from awareness to continuing support. Emphasizing education, incentives, and a supportive environment promotes a resilient healthcare system, allowing health workers community to actively contribute to public health through effective infection control.
{"title":"Controversy on fair and exclusive vaccine decisions for controlling infectious diseases among medical professionals in LMICs. Embracing the Trans-Theoretical Model for Moving Forward","authors":"Rawshan Jabeen (Research Consultant) , Hassan Nawaz Tahir , Mubarak Jabeen Salman , Zeeshan Ahsan","doi":"10.1016/j.vacune.2024.08.007","DOIUrl":"10.1016/j.vacune.2024.08.007","url":null,"abstract":"<div><p>The equitable distribution of vaccines for infectious diseases in low- and middle-income countries (LMICs) has become a hotly debated topic among public professionals and Government The decisions made in this regard can have far-reaching consequences for the health and well-being of millions of people including general population and healthcare professionals. There is need toconsider a fair and just distribution system to ensure that vaccines are provided to those who need them the most. For instance, Hepatitis B virus (HBV), influenza, and COVID-19 are crucial for healthcare professionals as they play in the fight against infectious disease outbreaks. However, in LMICs, poor vaccine confidence and uptake rates represent substantial hurdles for healthcare practitioners in obtaining and administering vaccines. Further, equitable vaccine uptake is a debatable policy matter in LMICs. These challenges stem from doubts regarding vaccine efficacy and safety, inaccurate information, and a lack of trust in government and medical institutions. Addressing misconceptions and building confidence, robust monitoring and evaluation mechanisms requires to ensure the safety of vaccines. . This review highlighted the importance of enhancing vaccine uptake motivation among health workers. Moreover, enhance the the need to respect individual choice when refuse. Ultimately, building confidence in the healthcare system is critical for addressing healthcare providers' reluctance about vaccines. The transtheoretical model is extremely useful for for understanding the behaviours and factors increasing vaccine uptake notably for infection prevention against hepatitis B, COVID-19, and influenza. The immplication of framework provided a holistic approach by customizing solutions to each stage of behavior change, from awareness to continuing support. Emphasizing education, incentives, and a supportive environment promotes a resilient healthcare system, allowing health workers community to actively contribute to public health through effective infection control.</p></div>","PeriodicalId":101272,"journal":{"name":"Vacunas (English Edition)","volume":"25 3","pages":"Pages 367-373"},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142097717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.1016/j.vacune.2024.08.001
Abeer Saad Alsubaie , Alhanouf Khalid Alsharif , Fai Abdullah Almalki , Reham Sameer Abu Al Hamayel , Hanin Hussain Abusabah , Maqbul Muazzam Sheriff , Atheer Ghazi Alharbi , Haneen Mohammed Aljedani , Sadeem Sameer Badhaish , Ayah Ali Alzaher , Waad Waleed Khalifa , Ghaliah Karami , Samaher Gumaan Basalib
Objective
This research aimed to assess the incidence of neurological complication symptoms among residents of the Makkah province in Saudi Arabia following the rapid approval and administration of mRNA vaccines. Given the differences in demographic factors such as age, race, medical history, and lifestyle among individuals, close monitoring of vaccine-related side effects becomes crucial, especially in mass vaccination campaigns.
Method
A cross-sectional online survey study was conducted in both English and Arabic languages, with a sample size determined using the Raosoft sample size calculator statistical analyzer. The study aimed for a 95% confidence level, a 5% margin of error, and a response distribution of 50%. Descriptive statistics were employed using Statistical Package for Social Sciences version 22.0. The Shapiro–Wilk test was utilized to assess data normality, and the statistical significance of the data was determined using Pearson's Chi-Squared test and the Kruskal–Wallis test.
Result
The study included 846 volunteers aged 18 and above, all of whom had received mRNA vaccine in the Makkah region. Data were systematically tabulated and categorized for descriptive analysis. The study found P-values less than .05, and the summarized P-values were presented. The majority of participants (73%) were from the Taif area (32%) within the Makkah region.
Conclusion
This study sheds light on the challenges faced by the population of the Makkah region in Saudi Arabia following mRNA vaccinations. Although some complications were reported post-vaccination, it is noteworthy that these challenges were effectively managed by the medical authorities.
{"title":"Incidence of neurological complication symptoms post-mRNA vaccination among the urban population of Makkah Province of Kingdom of Saudi Arabia","authors":"Abeer Saad Alsubaie , Alhanouf Khalid Alsharif , Fai Abdullah Almalki , Reham Sameer Abu Al Hamayel , Hanin Hussain Abusabah , Maqbul Muazzam Sheriff , Atheer Ghazi Alharbi , Haneen Mohammed Aljedani , Sadeem Sameer Badhaish , Ayah Ali Alzaher , Waad Waleed Khalifa , Ghaliah Karami , Samaher Gumaan Basalib","doi":"10.1016/j.vacune.2024.08.001","DOIUrl":"10.1016/j.vacune.2024.08.001","url":null,"abstract":"<div><h3>Objective</h3><p>This research aimed to assess the incidence of neurological complication symptoms among residents of the Makkah province in Saudi Arabia following the rapid approval and administration of mRNA vaccines. Given the differences in demographic factors such as age, race, medical history, and lifestyle among individuals, close monitoring of vaccine-related side effects becomes crucial, especially in mass vaccination campaigns.</p></div><div><h3>Method</h3><p>A cross-sectional online survey study was conducted in both English and Arabic languages, with a sample size determined using the Raosoft sample size calculator statistical analyzer. The study aimed for a 95% confidence level, a 5% margin of error, and a response distribution of 50%. Descriptive statistics were employed using Statistical Package for Social Sciences version 22.0. The Shapiro–Wilk test was utilized to assess data normality, and the statistical significance of the data was determined using Pearson's Chi-Squared test and the Kruskal–Wallis test.</p></div><div><h3>Result</h3><p>The study included 846 volunteers aged 18 and above, all of whom had received mRNA vaccine in the Makkah region. Data were systematically tabulated and categorized for descriptive analysis. The study found <em>P</em>-values less than .05, and the summarized <em>P</em>-values were presented. The majority of participants (73%) were from the Taif area (32%) within the Makkah region.</p></div><div><h3>Conclusion</h3><p>This study sheds light on the challenges faced by the population of the Makkah region in Saudi Arabia following mRNA vaccinations. Although some complications were reported post-vaccination, it is noteworthy that these challenges were effectively managed by the medical authorities.</p></div>","PeriodicalId":101272,"journal":{"name":"Vacunas (English Edition)","volume":"25 3","pages":"Pages 292-303"},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142097716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.1016/j.vacune.2024.07.001
Isabel Almodóvar-Fernández , Antonio Real-Fernández , Manuel Jesús Romero Atanes , Carlos Andreu-Vilarroig , Miguel Ángel Beltrán-Viciano , María Francisca Monreal-Pérez
Background and objective
After the SARS-CoV-2 vaccination campaign, we observed alterations in post-vaccination international normalised ratio (INR) in patients treated with acenocoumarol. The aim of the study was to investigate whether there is an association between the observed blood coagulation alterations and SARS-CoV2 vaccination.
Materials and methods
A retrospective, longitudinal, observational study of patients over 60 years of age vaccinated against SARS-CoV-2 and treated with acenocoumarol was conducted. The main variable measured was the INR before and after vaccination, and secondary variables were date of vaccination, age, sex, type of vaccine, and dose of acenocoumarol. Paired means were compared using non-parametric Friedman and Wilcoxon tests with Benjamini–Hochberg correction, and a linear regression analysis between age and differences between pre- and post-vaccination INR measurements. The analysis was performed on the total sample and by subgroups. Statistical significance was set at p-value < .05.
Results
Overall, statistically significant differences (Friedman, p-value < .05) were found between INR measurements in the total sample, women, Comirnaty® vaccine, and Sintrom® 1 g dose, although the differences found are weak (W-Kendall < 0.01). No statistically significant differences were found between specific pairs in INR measurements (Wilcoxon, p-value > .05). The goodness-of-fit of all linear regressions was R2 < 0.1.
Conclusions
The alteration of coagulation due to vaccination against SARS-CoV-2 is not a population or generalised effect, but a possible side effect, and reinforces the safety of SARS-CoV-2 vaccination in this type of patients.
{"title":"SARS-CoV-2 vaccination effect over coagulation in 60s patients treated with acenocumarol","authors":"Isabel Almodóvar-Fernández , Antonio Real-Fernández , Manuel Jesús Romero Atanes , Carlos Andreu-Vilarroig , Miguel Ángel Beltrán-Viciano , María Francisca Monreal-Pérez","doi":"10.1016/j.vacune.2024.07.001","DOIUrl":"10.1016/j.vacune.2024.07.001","url":null,"abstract":"<div><h3>Background and objective</h3><p>After the SARS-CoV-2 vaccination campaign, we observed alterations in post-vaccination international normalised ratio (INR) in patients treated with acenocoumarol. The aim of the study was to investigate whether there is an association between the observed blood coagulation alterations and SARS-CoV2 vaccination.</p></div><div><h3>Materials and methods</h3><p>A retrospective, longitudinal, observational study of patients over 60 years of age vaccinated against SARS-CoV-2 and treated with acenocoumarol was conducted. The main variable measured was the INR before and after vaccination, and secondary variables were date of vaccination, age, sex, type of vaccine, and dose of acenocoumarol. Paired means were compared using non-parametric Friedman and Wilcoxon tests with Benjamini–Hochberg correction, and a linear regression analysis between age and differences between pre- and post-vaccination INR measurements. The analysis was performed on the total sample and by subgroups. Statistical significance was set at <em>p</em>-value <<!--> <!-->.05.</p></div><div><h3>Results</h3><p>Overall, statistically significant differences (Friedman, <em>p</em>-value <<!--> <!-->.05) were found between INR measurements in the total sample, women, Comirnaty® vaccine, and Sintrom® 1 g dose, although the differences found are weak (W-Kendall <<!--> <!-->0.01). No statistically significant differences were found between specific pairs in INR measurements (Wilcoxon, <em>p</em>-value ><!--> <!-->.05). The goodness-of-fit of all linear regressions was <em>R</em>2<!--> <!--><<!--> <!-->0.1.</p></div><div><h3>Conclusions</h3><p>The alteration of coagulation due to vaccination against SARS-CoV-2 is not a population or generalised effect, but a possible side effect, and reinforces the safety of SARS-CoV-2 vaccination in this type of patients.</p></div>","PeriodicalId":101272,"journal":{"name":"Vacunas (English Edition)","volume":"25 3","pages":"Pages 323-330"},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142098354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.1016/j.vacune.2024.08.004
Maylin Pérez-Bernal , Carlos Hernández , Rafael Ibargollín , Midalis Martínez , Migdiala Soria , Magali Delgado , Dayamí Dorta , Enrique Pérez , José M. Sánchez-Ríos
Objective
In this work, we investigate the presence of antibodies against OmicronBA.5 RBD in breast milk from puerperal women, vaccinated during pregnancy with the protein subunit vaccine Abdala, based on the Wuhan-Hu-1 RBD.
Materials and methods
Breast milk samples were collected between September 30 and November 25, 2021, from 2 groups of participants: 5- and 9-weeks after the third dose of the vaccine. Antibody titers against OmicronBA.5 RBD and Wuhan-Hu-1 RBD were evaluated simultaneously by a homemade ELISA. The relationship of antibody titers with the parity at the beginning of vaccination and with the participants health status was assessed.
Results
Binding of OmicronBA.5 RBD, such as Wuhan-Hu-1, to IgA and IgG antibodies was detected in all breast milk samples, although the anti-RBD-Wuhan-Hu-1 titers were higher. The immune response to OmicronBA.5 could be related to the glycosylation of the Abdala RBD, expressed in Pichia pastoris, which contributes to the immunogenicity and to the exposure of epitopes that are conserved in pandemic variants, such as Omicron. Antibody titers against both RBDs were lower in participants with chronic diseases and in multiparous.
Conclusions
This is the first report of simultaneous detection of antibody titers, against the Wuhan-Hu-1 RBD and OmicronBA.5 RBD, in breast milk from puerperal women vaccinated with 3 doses a COVID-19 protein subunit vaccine. There is a tendency to decrease the antibody response after vaccination, due to chronic diseases and multiparity.
{"title":"Anti-SARS-CoV-2 Omicron BA.5 RBD antibody titers generated by the protein subunit vaccine Abdala in breast milk","authors":"Maylin Pérez-Bernal , Carlos Hernández , Rafael Ibargollín , Midalis Martínez , Migdiala Soria , Magali Delgado , Dayamí Dorta , Enrique Pérez , José M. Sánchez-Ríos","doi":"10.1016/j.vacune.2024.08.004","DOIUrl":"10.1016/j.vacune.2024.08.004","url":null,"abstract":"<div><h3>Objective</h3><p>In this work, we investigate the presence of antibodies against OmicronBA.5 RBD in breast milk from puerperal women, vaccinated during pregnancy with the protein subunit vaccine Abdala, based on the Wuhan-Hu-1 RBD.</p></div><div><h3>Materials and methods</h3><p>Breast milk samples were collected between September 30 and November 25, 2021, from 2 groups of participants: 5- and 9-weeks after the third dose of the vaccine. Antibody titers against OmicronBA.5 RBD and Wuhan-Hu-1 RBD were evaluated simultaneously by a homemade ELISA<em>.</em> The relationship of antibody titers with the parity at the beginning of vaccination and with the participants health status was assessed.</p></div><div><h3>Results</h3><p>Binding of OmicronBA.5 RBD, such as Wuhan-Hu-1, to IgA and IgG antibodies was detected in all breast milk samples, although the anti-RBD-Wuhan-Hu-1 titers were higher. The immune response to OmicronBA.5 could be related to the glycosylation of the Abdala RBD, expressed in <em>Pichia pastoris</em>, which contributes to the immunogenicity and to the exposure of epitopes that are conserved in pandemic variants, such as Omicron. Antibody titers against both RBDs were lower in participants with chronic diseases and in multiparous.</p></div><div><h3>Conclusions</h3><p>This is the first report of simultaneous detection of antibody titers, against the Wuhan-Hu-1 RBD and OmicronBA.5 RBD, in breast milk from puerperal women vaccinated with 3 doses a COVID-19 protein subunit vaccine. There is a tendency to decrease the antibody response after vaccination, due to chronic diseases and multiparity.</p></div>","PeriodicalId":101272,"journal":{"name":"Vacunas (English Edition)","volume":"25 3","pages":"Pages 331-339"},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142098355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}