Vaccines

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5 pages, 213 KiB

Open AccessEditorial

Vaccination of Elderly People Affected by Chronic Diseases: A Challenge for Public Health

by Francesco Paolo Bianchi and Silvio Tafuri

Vaccines 2022, 10(5), 641; https://doi.org/10.3390/vaccines10050641 - 19 Apr 2022

Cited by 6 | Viewed by 2014

Abstract

Elderly people have a limited regenerative capacity and are more susceptible to disease, syndromes, injuries, and illnesses than younger adults [...] Full article

(This article belongs to the Special Issue Phase IV Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

Research

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14 pages, 724 KiB

Open AccessArticle

Comparison of Social Inequality in Human Papillomavirus (HPV) Vaccination among Teenagers with Parental Reports and Healthcare Providers’ Records in the 2019 National Immunization Survey-Teen

by Sol Seo Choi and BongKyoo Choi

Vaccines 2022, 10(2), 178; https://doi.org/10.3390/vaccines10020178 - 24 Jan 2022

Cited by 1 | Viewed by 3260

Abstract

Background: Relatively little is known about social inequality in human papillomavirus (HPV) vaccination among teenagers in the United States. This study aims to investigate whether there is a social disparity in HPV vaccination among teenagers and if so, whether it can differ according [...] Read more.

Background: Relatively little is known about social inequality in human papillomavirus (HPV) vaccination among teenagers in the United States. This study aims to investigate whether there is a social disparity in HPV vaccination among teenagers and if so, whether it can differ according to the source of teen vaccination information (parental reports and provider records). Methods: We used the data from the 2019 National Immunization Survey-Teen (NIS-Teen; 42,668 teenagers, aged 13–17) including parent-reported vaccination status. Among them, 18,877 teenagers had adequate provider-reported vaccination records. Two socioeconomic status (SES) measures were used: mother’s education and annual family income. Multivariate logistic analyses were conducted. Results: False negatives of parental reports against provider records were more than two times higher (p < 0.001) in low-SES teens than in high-SES teens. In both SES measures, the proportion of HPV-unvaccinated teenagers was lowest at the highest SES level in analyses with parental reports. However, it was the opposite in analyses with provider records. Interestingly, regardless of the vaccination information source, the HPV unvaccinated rate was highest in the middle-SES teens (>12 years, non-college graduates; above poverty level, but not >USD 75 K). Conclusions: Significant social inequality in HPV vaccination among teenagers exists in the United States. The pattern of social inequality in HPV vaccination can be distorted when only parent-reported vaccination information is used. Full article

(This article belongs to the Special Issue Phase IV Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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10 pages, 2058 KiB

Open AccessArticle

Safety Profile of Recommended Vaccinations in Adolescents: Data from Surveillance of Adverse Events Following Immunization in Puglia (Italy), 2016–2020

by Antonio Di Lorenzo, Francesco Paolo Bianchi, Andrea Martinelli, Sabrina Lattanzio, Antonella Carbonara, Giusy Diella, Silvio Tafuri and Pasquale Stefanizzi

Vaccines 2021, 9(11), 1302; https://doi.org/10.3390/vaccines9111302 - 9 Nov 2021

Cited by 2 | Viewed by 1980

Abstract

Adolescence is a critical period for immunization, in which the adhesion rate to recommended vaccinations is often lower than desired. Since the safety of new vaccines is one of the most important factors determining vaccination hesitancy, post-marketing surveillance of adverse events following immunization [...] Read more.

Adolescence is a critical period for immunization, in which the adhesion rate to recommended vaccinations is often lower than desired. Since the safety of new vaccines is one of the most important factors determining vaccination hesitancy, post-marketing surveillance of adverse events following immunization (AEFIs) is recommended by the World Health Organization (WHO) to better understand the safety of these drugs. This report describes AEFIs notified in Puglia (Italy) after recommended vaccinations in adolescents aged 12 to 18 years in 2016–2020 to determine the safety profile of these products in a real-life scenario. This is a retrospective observational study. Data were gathered from the list of AEFIs notified in subjects between 12 and 18 years of age following administration of recommended vaccines in Puglia in 2016–2020. AEFIs were classified according to the WHO’s decisional algorithm, and causality assessment was carried out for serious AEFIs. From 2016 to 2020, 323,627 doses of vaccine were administered to adolescents in Puglia and 50 AEFIs were reported (reporting rate: 15.4 × 100,000 doses). Of these, 17 (34.0%) were classified as serious, and causality assessment identified 13 of them (76.5%) as vaccine related. The most common symptoms were local reactions, fever and neurological symptoms. No deaths were notified. The benefits of immunization in adolescents appear to be greater than the risk of AEFIs for all studied vaccines; in fact, AEFIs occur in less than 0.1‰ of patients and are generally mild and self-limiting. Full article

(This article belongs to the Special Issue Phase IV Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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8 pages, 688 KiB

Open AccessArticle

BNT162b2 mRNA COVID-19 Vaccine Effectiveness in the Prevention of SARS-CoV-2 Infection and Symptomatic Disease in Five-Month Follow-Up: A Retrospective Cohort Study

by Francesco Paolo Bianchi, Silvio Tafuri, Giovanni Migliore, Luigi Vimercati, Andrea Martinelli, Annamaria Lobifaro, Giusy Diella, Pasquale Stefanizzi and on behalf of the Control Room Working Group

Vaccines 2021, 9(10), 1143; https://doi.org/10.3390/vaccines9101143 - 7 Oct 2021

Cited by 27 | Viewed by 5181

Abstract

To combat the COVID-19 pandemic, a mass vaccination campaign was initiated in Italy on 27 December 2020. The vaccine available to immunize Italian healthcare workers (HCWs) was the BNT162b2 mRNA COVID-19 vaccine (Comirnaty). This study evaluated the effectiveness of the vaccine against documented [...] Read more.

To combat the COVID-19 pandemic, a mass vaccination campaign was initiated in Italy on 27 December 2020. The vaccine available to immunize Italian healthcare workers (HCWs) was the BNT162b2 mRNA COVID-19 vaccine (Comirnaty). This study evaluated the effectiveness of the vaccine against documented SARS-CoV-2 infection and symptomatic diseases in the medium- to long-term. HCWs at Bari Policlinico University-Hospital (Italy) who completed the vaccination schedule were matched with HCWs who had refused vaccination; the two groups were followed-up for 5 months (January–May 2021). Vaccine effectiveness (VE) against infection was 97.7% (95.4–99.0%) at 14–34 days after the first dose, and 94.8% (87.0–97.8%), 83.0% (65.0–92.0%), and 81.0% (42.0–94.0%) at 14–41, 42–69, and >69 days, respectively, after the second dose. The estimated VE for documented symptomatic disease was 99.2% (96.4–99.8%) at 14–34 days after the first dose and 97.2% (90.3–99.2%), 85.0% (63.0–94.2%), and 88.0% (42.0–97.6%) at 14–41, 42–69, and >69 days, respectively, after the second dose. Efforts to increase vaccination rates should be strengthened, including mandatory vaccination for HCWs and greater incentives to increase vaccine acceptance by the general population. Full article

(This article belongs to the Special Issue Phase IV Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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7 pages, 241 KiB

Open AccessArticle

First Dose of the BNT162b2 mRNA COVID-19 Vaccine Reduces Symptom Duration and Viral Clearance in Healthcare Workers

by Luca Coppeta, Ottavia Balbi, Zaira Grattagliano, Grazia Genga Mina, Antonio Pietroiusti, Andrea Magrini, Matteo Bolcato and Marco Trabucco Aurilio

Vaccines 2021, 9(6), 659; https://doi.org/10.3390/vaccines9060659 - 17 Jun 2021

Cited by 18 | Viewed by 5776

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than one hundred million people since the beginning of the worldwide pandemic. In this study, data from a large hospital in central Italy was used to evaluate the impact of the first dose [...] Read more.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than one hundred million people since the beginning of the worldwide pandemic. In this study, data from a large hospital in central Italy was used to evaluate the impact of the first dose of the BNT162b2 mRNA vaccine on SARS-CoV-2 infections in terms of the prevalence of symptomatic cases, symptom duration, and viral clearance timing. All vaccinated Healthcare Workers (HCWs) with positive RT-PCR by nasopharyngeal (NP) swabs were divided into two cohorts (positive RT-PCR within day 12 and positive RT-PCR between day 13 and day 21 after first dose administration) and compared for the presence and duration of symptoms and the timing of viral clearance. The same variables were evaluated across HCWs with positive RT-PCR within 6 days after first dose administration and non-vaccinated HCWs with positive RT-PCR between 1 October 2020 and 28 February 2021. Eighteen HCWs tested positive on RT-PCR by NP swab from day 1 to day 12 after the 1st dose administration (incidence rate 6.2 × 10⁻⁴) and 5 HCWs from day 13 to day 21 (incidence rate 2.3 × 10⁻⁴). Symptom duration and viral clearance timing are significantly shorter in the cohort of HCWs with positive RT-PCR 12 days after the first dose of the BNT162b2 mRNA vaccine. The administration of the first dose proved effective in reducing presence, symptom duration, and viral clearance even in HCWs vaccinated for less than 6 days. These results could have implications on public health and post-exposure prophylaxis. Full article

(This article belongs to the Special Issue Phase IV Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

8 pages, 2487 KiB

Open AccessArticle

Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study

by Pasquale Stefanizzi, Sara De Nitto, Giuseppe Spinelli, Sabrina Lattanzio, Paolo Stella, Domenica Ancona, Maria Dell'Aera, Margherita Padovano, Savino Soldano, Silvio Tafuri and Francesco Paolo Bianchi

Vaccines 2021, 9(5), 456; https://doi.org/10.3390/vaccines9050456 - 4 May 2021

Cited by 24 | Viewed by 2992

Abstract

Since the influenza season 2018/19, the Italian Ministry of Health recommended a dose of cell-based quadrivalent vaccine (Flucelvax Tetra) for HCWs (healthcare workers), because this vaccine seemed more efficacious in the prevention of AH3N2 virus. Due to the lack of pre-registration data, the [...] Read more.

Since the influenza season 2018/19, the Italian Ministry of Health recommended a dose of cell-based quadrivalent vaccine (Flucelvax Tetra) for HCWs (healthcare workers), because this vaccine seemed more efficacious in the prevention of AH3N2 virus. Due to the lack of pre-registration data, the safety profile of this new vaccine must be investigated in post-marketing surveillance. The aim of our study is to evaluate, through a post-marketing active surveillance program developed during the 2019/20 influenza season, any Adverse Events Following Immunization (AEFIs) that happened in the 7 days after immunization with Flucelvax Tetra. The study was carried out in a sample of HCWs of Policlinico General University-Hospital (Apulia, South Italy). AEFIs were classified as ‘serious’ or ‘not serious’ according to the WHO (World Health Organization) guidelines; the WHO causality assessment algorithm was applied to classify serious AEFIs. A total of 741 HCWs were enrolled, and 430 AEFIs (reporting rate: 58.0 (95%CI: 54.4–61.6) × 100 enrolled) were recorded. Of these, 429 of 430 (99.8%; reporting rate: 57.8 (95%CI: 54.2–61.5) × 100 enrolled) were classified as not serious and one (0.2%; reporting rate: 0.13 (0.03–0.75) × 100 enrolled) was classified as serious. Local reactions were the adverse reaction reported most frequently (88%); regarding the serious AEFI, causality assessment excluded the causal link with the administration of the vaccine. All the AEFIs resolved without sequelae. Flucelvax Tetra showed a profile of high safety. Due to their characteristics of greater sensitivity than passive surveillance, active surveillance programs can be useful in defining the safety profiles of a given vaccine/drug in certain population subgroups. Full article

(This article belongs to the Special Issue Phase IV Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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10 pages, 241 KiB

Open AccessArticle

Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian Perspective

by Davide Ferorelli, Lorenzo Spagnolo, Maricla Marrone, Serena Corradi, Maria Silvestre, Federica Misceo, Francesco Paolo Bianchi, Pasquale Stefanizzi, Biagio Solarino, Alessandro Dell’Erba and Silvio Tafuri

Vaccines 2021, 9(5), 423; https://doi.org/10.3390/vaccines9050423 - 23 Apr 2021

Cited by 3 | Viewed by 3561

Abstract

During the COVID-19 outbreak, the lack of official recommendations on the treatment has led healthcare workers to use multiple drugs not specifically tested and approved for the new insidious disease. After the availability of the first COVID-19 vaccines (Comirnaty Pfizer-BioNTech and Moderna COVID19 [...] Read more.

During the COVID-19 outbreak, the lack of official recommendations on the treatment has led healthcare workers to use multiple drugs not specifically tested and approved for the new insidious disease. After the availability of the first COVID-19 vaccines (Comirnaty Pfizer-BioNTech and Moderna COVID19 vaccine), an authorization was issued by national and international Drug Regulatory Agencies in order to speed up their introduction on the market and their administration on a large scale. Despite the authorization, the off-label use of these vaccines may still be possible especially to answer specific concerns as the lack of vaccine doses, the delay in the delivery of planned doses or the pressure from public opinion and political influence also in relation to the evolution of the pandemic. This paper aims to assess the possible off-label use of COVID-19 vaccines and the ethical and medico-legal implications of this eventuality. The scope of this paper is to point out the possible consequences of off-label use of COVID-19 vaccines and possible mitigation and preventive measures to be taken by healthcare workers involved in vaccination procedures. Full article

(This article belongs to the Special Issue Phase IV Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

8 pages, 906 KiB

Open AccessArticle

Influenza Vaccination and Health Outcomes in COVID-19 Patients: A Retrospective Cohort Study

by Pasquale Domenico Pedote, Stefano Termite, Andrea Gigliobianco, Pier Luigi Lopalco and Francesco Paolo Bianchi

Vaccines 2021, 9(4), 358; https://doi.org/10.3390/vaccines9040358 - 8 Apr 2021

Cited by 26 | Viewed by 3740

Abstract

COVID-19 is an infectious disease caused by the novel coronavirus SARS-CoV-2. Several measures aimed at containing the spread of this virus have been recommended by international and nation public health institutions, but whether the influenza vaccine, while not protective against COVID-19, nonetheless reduces [...] Read more.

COVID-19 is an infectious disease caused by the novel coronavirus SARS-CoV-2. Several measures aimed at containing the spread of this virus have been recommended by international and nation public health institutions, but whether the influenza vaccine, while not protective against COVID-19, nonetheless reduces disease severity is unclear. This study evaluated the potential role of influenza vaccine in reducing the rate of hospitalization and death in COVID-19 patients. COVID-19 cases recorded in the province of Brindisi (Apulia, Southern Italy) during the first pandemic wave (February–May 2020) and occurring in patients vaccinated with the influenza vaccine during the 2019–2020 influenza season were considered. From February 2020 to May 2020, 3872 inhabitants of the province of Brindisi underwent SARS-CoV-2 PCR testing and 664 (8.7%) tested positive. A multivariate analysis showed that among COVID-19 patients neither hospitalization nor death was significantly associated with influenza vaccination (p > 0.05), whereas within this group male sex, older age, and chronic diseases were identified as risk factors for morbidity and mortality. Our study did not show an association between the influenza vaccine and complications of COVID-19. Nonetheless, influenza vaccination must be promoted as a central public health measure, because by reducing the burden on hospitals it can greatly benefit the management of COVID-19 patients. Full article

(This article belongs to the Special Issue Phase IV Research in Vaccine Epidemiology: Immunogenicity, Effectiveness, and Safety)

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