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1.
SSRN; 2022.
Preprint in English | SSRN | ID: ppcovidwho-343328

ABSTRACT

Introduction: The surveillance of adverse events following vaccination plays a key role in the success of a vaccination programme.Aim To identify the types and burden of programmatic adverse events (PAE) associated with the COVID-19 vaccination programme in Scotland, as well as their potential public health impact. Method: Data relating to PAE were collected from the fourteen geographical health boards and special boards in Scotland for a one-year period from the start of the COVID-19 vaccination programme in Scotland (08 December 2020 to 07 December 2021). A descriptive analysis of the PAE was carried out to identify themes of adverse events that have occurred. An additional quantitative analysis was used to determine the frequency of PAE reports, quantify the number of PAE within each theme and compare PAEs by vaccine location. Findings: A total of 979 PAE were reported in the context of over 10 million vaccine doses corresponding to a PAE reporting rate of 1/10,000 vaccine doses administered. Seven themes of PAE were identified. The most common theme identified was;“Issues With Pre-Vaccination Checks and Protocols Not Followed, Data Entry Errors and Errors Involving Use of Vaccine Management Tool (VMT)” (41.7%, n = 408). The second most frequently reported theme of PAE, accounting for 20.9% of all PAE (n=205) was;'Vaccine Transport, Storage, Vials and Equipment, and Vaccine Wastage'. 53.6% (525) of errors occurred within the mass vaccination centres, reflecting the large proportion of vaccinations delivered in such settings. Conclusion: This analysis provides a snapshot of adverse events during the COVID-19 vaccination programme in Scotland. This surveillance system has been extremely valuable in terms of learning and taking prompt mitigating actions during the COVID-19 vaccination programme in Scotland.

2.
SSRN; 2022.
Preprint in English | SSRN | ID: ppcovidwho-343271

ABSTRACT

Background: The U.S. Food and Drug Administration (FDA) Biologics Effectiveness and Safety (BEST) Initiative conducts active surveillance of adverse events of special interest (AESI) after COVID-19 vaccination. Historical incidence rates (IRs) of AESI are comparators to evaluate safety. Methods: We estimated IRs of 17 AESI in six administrative claims databases from January 1, 2019, to December 11, 2020: Medicare claims for adults ≥65 years and commercial claims (Blue Health Intelligence®, CVS Health, HealthCore Integrated Research Database, IBM® MarketScan® Commercial Database, Optum pre-adjudicated claims) for adults <65 years. IRs were estimated by sex, age, race/ethnicity (Medicare), and nursing home residency (Medicare) in 2019 and for specific periods in 2020. Results: The study included >100 million enrollees annually. In 2019, rates of most AESI increased with age. However, compared with commercially insured adults, Medicare enrollees had lower IRs of anaphylaxis (11 vs. 12–19 per 100,000 person-years), appendicitis (80 vs. 117–155), and narcolepsy (38 vs. 41–53). Rates were higher in males than females for most AESI across databases and varied by race/ethnicity and nursing home status (Medicare). Acute myocardial infarction (Medicare) and anaphylaxis (all databases) IRs varied by season. IRs of most AESI were lower during March–May 2020 compared with March–May 2019 but returned to pre-pandemic levels after May 2020. However, rates of Bell’s palsy, Guillain-Barré syndrome, narcolepsy, and hemorrhagic/non-hemorrhagic stroke remained lower in multiple databases after May 2020, whereas some AESI (e.g., disseminated intravascular coagulation) exhibited higher rates after May 2020 compared with 2019. Conclusion: AESI background rates varied by database and demographics and fluctuated in March–December 2020, but most returned to pre-pandemic levels after May 2020. It is critical to standardize demographics and consider seasonal and other trends when comparing historical rates with post-vaccination AESI rates in the same database to evaluate COVID-19 vaccine safety.

3.
Vaccine ; 2022 Aug 03.
Article in English | MEDLINE | ID: covidwho-2016158

ABSTRACT

BACKGROUND: Recent rises in the incidence of vaccine-preventable illnesses and suboptimal vaccine acceptance are considered a consequence of accumulating misinformation. Evidence-based approaches to patient-provider communication are key to addressing vaccine hesitancy. OBJECTIVES: The aim of this study was to assess vaccination attitudes and foundational knowledge among healthcare professions students. METHODS: A 72-item survey was developed to assess vaccine attitudes and knowledge about vaccination among health professions students. The survey incorporated 14 demographics questions, 41 attitude questions, and 17 knowledge questions. 16 of the attitude questions, derived from a set of core questions used to diagnose vaccine hesitancy from the WHO Strategic Advisory Group of Experts on Immunization (SAGE) Vaccine Hesitancy Matrix, were analyzed together to derive a vaccine acceptance score. RESULTS: 295 anonymous survey responses were collected between July 2019 and November 2020. Respondents represented students enrolled in medical, dental, pharmacy, optometry, and biomedical science health professions programs. Respondents scored 82.0% ± 0.8% (mean ± standard error of the mean) on questions that gauged vaccine acceptance. The mean vaccine acceptance score was 85.4% ± 1.0% for medical students and 88.0% ± 1.6% for biomedical science students. The mean knowledge score across all programs was 67.7% ± 1.1%. The greatest proficiency in knowledge scores was seen amongst medical students (79.0% ± 1.3%). CONCLUSIONS: Amongst the different health professions, students in the fields of medicine and biomedical sciences had the highest levels of vaccine acceptance attitudes and knowledge. The vaccine acceptance score can be utilized by health professions educators to guide vaccine education for future health professionals to better prepare them to address vaccine hesitancy and educate patients on vaccination.

4.
Vaccine ; 2022.
Article in English | ScienceDirect | ID: covidwho-1996605

ABSTRACT

Introduction Brazil has been at the core of the COVID-19 pandemic, with the second-highest death toll worldwide. A mass vaccination campaign was initiated on May 16th, 2021, in Botucatu, Brazil, where two doses of ChadOx1-nCoV19 were offered 12 weeks apart to all 18-60- year-olds. This context offers a unique opportunity to study the vaccine safety during a mass campaign. Methods The first and second doses of the vaccine were administered in May and August 2021, respectively. Emergency room (ER) and hospitalization records were obtained from the Hospital das Clínicas da Faculdade de Medicina de Botucatu for six weeks before and six weeks after the first and second doses, from 4 April to 19 September 2021. Diagnoses with COVID-19-related ICD codes were excluded to distinguish any trends resulting from the COVID-19 pandemic. ER and hospital visits during the two time periods were compared, including an ICD code comparison, to identify any changes in disease distributions. Data were scanned for a defined list of Adverse Events of Special Interest (AESIs), as presented by the Safety Platform for Emergency Vaccines. Results and Discussion A total of 77,683 and 74,051 subjects received dose 1 and dose 2 of ChadOx1-nCoV19, respectively. Vaccination was well tolerated and not associated with any major safety concerns. Increases in ER visits 1 week following both doses were primarily seen in ICD codes related to non-serious side effects of the vaccine, including vaccination site pain and other local events. The neurological AESIs identified (2 of 3 cases of multiple sclerosis) were relapses of a pre-existing condition. One potentially serious hospitalization event for Bell’s palsy had onset before vaccination with dose 1, in a patient who also had a viral infection of the central nervous system. There was no myocarditis, pericarditis cases, or vaccine-related increases in thromboembolic events.

5.
Cureus ; 14(8): e27953, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1994485

ABSTRACT

Alopecia areata (AA) is a patchy autoimmune nonscarring hair loss. Various pathophysiological explanations are described with immune dysregulation being the most well established. In this report, we describe a 63-year-old lady with AA recurrence, in the form of AA universalis, after 32 years of remission, following administration of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. We also briefly reviewed published cases with similar presentations after receiving the SARS-CoV-2 vaccine.

6.
J Clin Immunol ; 2022 Aug 17.
Article in English | MEDLINE | ID: covidwho-1990712

ABSTRACT

BACKGROUND: Information on anaphylaxis among recipients of vaccines against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remains scarce. OBJECTIVE: To identify the observed incidence of anaphylaxis in recipients of different anti-SARS-CoV-2 vaccines. METHODS: A nationwide observational study among recipients of 61,414,803 doses of seven different anti-SARS-CoV-2 vaccines, describing the incidence and characteristics of adult patients (age ≥ 18 years) who developed anaphylaxis as an adverse event following immunization (AEFI) against SARS-CoV-2 vaccines between December 24, 2020, and October 15, 2021, in Mexico. RESULTS: Sixty-six patients developed anaphylaxis as an AEFI, for an overall observed incidence of 1.07 cases per 1,000,000 (95% CI 0.84-1.37) administered doses. Eighty-six percent of the patients were female, consistent with previous reports of AEFI to COVID-19 vaccines. mRNA-based vaccine recipients had the highest frequency of anaphylaxis, followed by adenovirus-vectored vaccines and inactivated virus recipients, with an observed incidence of 2.5, 0.7, and 0.2 cases per 1,000,000 doses administered, respectively. Only 46% of the patients received correct treatment with epinephrine as the first-line treatment through the appropriate route and dose. We detected one case of anaphylactic reaction-related death occurring 5 min following immunization with ChAdOx1 nCov-19 for a mortality rate of 1.5% among those who developed this AEFI. CONCLUSIONS: In our population, anaphylactic reactions were infrequent. Our study provides further evidence supporting the security of these newly developed vaccines.

8.
Vaccine ; 40(32): 4334-4338, 2022 Jul 30.
Article in English | MEDLINE | ID: covidwho-1972348

ABSTRACT

INTRODUCTION: The aim of this study was to assess the relationship between double COVID-19 vaccine uptake and trust in effectiveness and safety of vaccination in general in 23 European Union (EU) countries. METHODS: Ecological study. Data was retrieved from the Flash Eurobarometer 494 and Our World in Data. We estimated Pearson's correlation coefficients and fitted multiple linear regression models. RESULTS: There is a negative linear correlation between the percentage of people doubly vaccinated and the percentage of low trust in vaccine effectiveness (r = -0.48, p-value = 0.021), and the percentage of low trust in vaccine safety (r = -0.43, p-value = 0.041). There is a negative adjusted relation between the percentage of low trust in vaccine safety and the percentage of people doubly vaccinated (aß% low trust in vaccinesafety:-0.25; 95% CI: -0.49,-0.01, p-value = 0.045). CONCLUSION: An increase in health literacy of people living in certain countries in the EU may be needed to boost COVID-19 vaccine uptake.


Subject(s)
COVID-19 , Vaccines , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , European Union , Humans , Trust , Vaccination/adverse effects
9.
Cell Rep ; 40(7): 111214, 2022 Aug 16.
Article in English | MEDLINE | ID: covidwho-1966424

ABSTRACT

Vaccine-associated enhanced respiratory disease (VAERD) is a severe complication for some respiratory infections. To investigate the potential for VAERD induction in coronavirus disease 2019 (COVID-19), we evaluate two vaccine leads utilizing a severe hamster infection model: a T helper type 1 (TH1)-biased measles vaccine-derived candidate and a TH2-biased alum-adjuvanted, non-stabilized spike protein. The measles virus (MeV)-derived vaccine protects the animals, but the protein lead induces VAERD, which can be alleviated by dexamethasone treatment. Bulk transcriptomic analysis reveals that our protein vaccine prepares enhanced host gene dysregulation in the lung, exclusively up-regulating mRNAs encoding the eosinophil attractant CCL-11, TH2-driving interleukin (IL)-19, or TH2 cytokines IL-4, IL-5, and IL-13. Single-cell RNA sequencing (scRNA-seq) identifies lung macrophages or lymphoid cells as sources, respectively. Our findings imply that VAERD is caused by the concerted action of hyperstimulated macrophages and TH2 cytokine-secreting lymphoid cells and potentially links VAERD to antibody-dependent enhancement (ADE). In summary, we identify the cytokine drivers and cellular contributors that mediate VAERD after TH2-biased vaccination.

10.
Vaccines (Basel) ; 10(7)2022 Jul 11.
Article in English | MEDLINE | ID: covidwho-1964129

ABSTRACT

Vaccine safety is measured by the disease protection it confers compared to the harm it may cause; both factors and their relative numbers have been the subject of disagreement. Cross-reactive attack of analogous self-antigens modified by dietary and microbiome factors is one of the poorly explored likely causes of harm. Screening for that and other risk factors might point out those most likely to develop severe vaccine reactions. Cooperation from those with opinions for and against vaccination in data gathering and vetting will lead to greater safety. Screening should include an integrative medical perspective regarding diet, microbiome, leaky gut, and other antigen sources. It might include emerging electronic technology or integrative energetic techniques vetted ultimately by cross-reactive lymphocyte testing or genetic evaluation. The knowledge gained from evaluating those with reactions could enhance the screening process and, since similar antigenic stimuli and reactions are involved, help long COVID sufferers. Centers for early identification and rescue from vaccine reactions could lower morbidity and mortality, and increase the percentage of people choosing to be vaccinated. Additional platforms for boosting; using lower dosage; other routes of administration, such as intranasal or intradermal needles; and possibly different antigens could make it easier to vaccinate globally to address the new variants of viruses rapidly arising.

11.
Front Public Health ; 10: 907652, 2022.
Article in English | MEDLINE | ID: covidwho-1963639

ABSTRACT

Reports of side effects of vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are increasing worldwide. Capillary leak syndrome and vaccine-induced immune thrombotic thrombocytopenia are very rare but life-threatening adverse events that should be identified early and treated. However, isolated thrombocytopenia can indicate pseudothrombocytopenia. In certain people, ethylenediaminetetraacetic acid (EDTA) induces an in vitro platelet aggregation, resulting in misleading underestimation of platelet counts. It is essential to recognize pseudothrombocytopenia to prevent diagnostic errors, overtreatment, anxiety, and unnecessary invasive procedures. We present a case who developed generalized edema and persistent pseudothrombocytopenia after the first dose of the ChAdOx1 nCoV-19 vaccine (AstraZeneca).


Subject(s)
COVID-19 , Thrombocytopenia , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , Edema , Humans , SARS-CoV-2 , Thrombocytopenia/chemically induced , Thrombocytopenia/diagnosis , Vaccination/adverse effects
12.
13.
Front Immunol ; 13: 915580, 2022.
Article in English | MEDLINE | ID: covidwho-1933697

ABSTRACT

Myocarditis (MYO) is a relatively uncommon inflammatory disease that involves the heart muscle. It can be a very severe disease as it can lead to the development of acute or chronic heart failure and, in a not marginal number of cases, to death. Most of the cases are diagnosed in healthy people younger than 30 years of age. Moreover, males are affected about twice as much as females. Viruses are among the most common causes of MYO, but how viral infection can lead to MYO development is not precisely defined. After COVID-19 pandemic declaration, incidence rate of MYO has significantly increased worldwide because of the SARS-CoV-2 infection. After the introduction of anti-COVID-19 vaccines, reports of post-immunization MYO have emerged, suggesting that a further cause of MYO together with the SARS-CoV-2 infection could increase the risk of heart damage during pandemic. Main aim of this study is to discuss present knowledge regarding etiopathogenesis and clinical findings of MYO associated with COVID-19 vaccine administration and whether the risk of this adverse events can modify the initially suggested recommendation for the use of COVID-19 vaccines in pediatric age. Literature analysis showed that MYO is an adverse event that can follow the COVID-19 immunization with mRNA vaccines in few persons, particularly young adults, adolescents, and older children. It is generally a mild disease that should not modify the present recommendations for immunization with the authorized COVID-19 mRNA vaccines. Despite this, further studies are needed to evaluate presently undefined aspects of MYO development after COVID-19 vaccine administration and reduce the risk of development of this kind of vaccine complication. Together with a better definition of the true incidence of MYO and the exact role of the various factors in conditioning incidence variations, it is essential to establish long-term evolution of acute COVID-19 related MYO.


Subject(s)
COVID-19 Vaccines , COVID-19 , Myocarditis , Adolescent , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Child , Female , Humans , Immunization Schedule , Male , Myocarditis/epidemiology , Myocarditis/etiology , Pandemics/prevention & control , SARS-CoV-2 , Vaccines , Young Adult
14.
Vaccine ; 2022 Jul 12.
Article in English | MEDLINE | ID: covidwho-1926970

ABSTRACT

BACKGROUND: Evidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males. It is not clear if risk differs between mRNA-1273 versus BNT162b2. We assessed if risk differs using comprehensive health records on a diverse population. METHODS: Members 18-39 years of age at eight integrated healthcare-delivery systems were monitored using data updated weekly and supplemented with medical record review of myocarditis and pericarditis cases. Incidence of myocarditis and pericarditis events that occurred among vaccine recipients 0 to 7 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by conditional Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. Head-to-head comparison directly assessed risk following mRNA-1273 versus BNT162b2 during 0-7 days post-vaccination. RESULTS: From December 14, 2020 - January 15, 2022 there were 41 cases after 2,891,498 doses of BNT162b2 and 38 cases after 1,803,267 doses of mRNA-1273. Cases had similar demographic and clinical characteristics. Most were hospitalized for ≤1 day; none required intensive care. During days 0-7 after dose 2 of BNT162b2, the incidence was 14.3 (CI: 6.5-34.9) times higher than the comparison interval, amounting to 22.4 excess cases per million doses; after mRNA-1273 the incidence was 18.8 (CI: 6.7-64.9) times higher than the comparison interval, amounting to 31.2 excess cases per million doses. In head-to-head comparisons 0-7 days after either dose, risk was moderately higher after mRNA-1273 than after BNT162b2 (RR: 1.61, CI 1.02-2.54). CONCLUSIONS: Both vaccines were associated with increased risk of myocarditis and pericarditis in 18-39-year-olds. Risk estimates were modestly higher after mRNA-1273 than after BNT162b2.

15.
2nd International Conference on Applied Mathematics, Modelling, and Intelligent Computing, CAMMIC 2022 ; 12259, 2022.
Article in English | Scopus | ID: covidwho-1923092

ABSTRACT

Large-scale injections of COVID-19 vaccine and formation of herd immunity are currently the most effective way to combat COVID-19 epidemic in the world. During the vaccination process, unexpected security incidents are likely to occur, and the government and relevant emergency departments have the responsibility to deal with these emergent security incidents. This paper proposes an AHP-TOPSIS method, establishes the evaluation index system, determines the index weight combined with AHP, and uses TOPSIS to rank the evaluation objects, so as to evaluate the emergency management ability of the government and relevant departments on the emergency safety events of COVID-19 vaccine. This is of great positive significance for continuously strengthening the emergency management capacity of the government and relevant departments and ensuring people's life, health and safety. © 2022 SPIE

16.
Vaccines (Basel) ; 10(7)2022 Jul 02.
Article in English | MEDLINE | ID: covidwho-1917875

ABSTRACT

Given the increasing anti-vaccine movements erroneously touting vaccine danger, this review has investigated the rare adverse events potentially associated with BNT162b2 (Pfizer-BioNTech), an mRNA vaccine against the severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2). Only real-world surveillance studies with at least 0.1 million BNT162b2-vaccinated participants and one unvaccinated control group were selected for review. A total of 21 studies examining the potential association of BNT162b2 with cardiovascular, herpetic, thrombotic or thrombocytopenic, neurological, mortality, and other miscellaneous rare adverse events were described in this review. Only myocarditis is consistently associated with BNT162b2. An unclear direction of association was seen with stroke (hemorrhagic and ischemic), herpes zoster, and paresthesia from BNT162b2, which may require more studies to resolve. Fortunately, most surveillance studies detected no increased risks of the remaining rare adverse events reviewed herein, further reassuring the safety of BNT162b2. In conclusion, this review has concisely summarized the current rare adverse events related and unrelated to BNT162b2, arguably for the first time in sufficient depth, to better communicate vaccine safety to the public.

17.
Romanian Journal of Legal Medicine ; 29(4):387-391, 2021.
Article in English | Web of Science | ID: covidwho-1913723

ABSTRACT

Introduction. SARS_CoV_2 pandemic triggered international measures, from genomic sequencing, PCR tests and accelerated studies for vaccines and treatments approval, to extreme restriction of civil rights, through stringent measures as social distance, work and online education etc. The lack of population??s adherence to the authorities?? measures can compromise the success in limiting the pandemic. Material and method. This cross-sectional study identified the opinions of vaccinated and unvaccinated participants regarding the severity of the pandemic, vaccination and stringency measures, the objective being to highlight the ethical and moral aspects on which these opinions are based. The responders (n = 412) declared their vaccinal status in a questionnaire, their opinions on disease, on the vaccine, their attitude towards the green certificate etc. The data analysis followed the internal consistency of the questionnaire through Cronbach???s alpha, correlations, inferential tests. Results. Respondents are not worried about getting sick at work but are concerned about their families and friends safety;are not convinced of the quality of approved vaccines (for which regulators cannot guarantee the safety);are concerned about the lack of transparency in pharmacovigilance and vaccine efficacy studies;they think that vaccines do not stop the viruses transmission, do not provide lasting protection or eradicate the virus. They consider that both the virus and human immune response are insufficiently known and the green certificate does not limit the burden of disease, being discriminatory. Conclusions. For the quality of life, already compromised in the pandemic, the absence of restrictions and voluntary vaccination are important.

18.
Vaccine ; 40(31): 4065-4080, 2022 Jul 29.
Article in English | MEDLINE | ID: covidwho-1900241

ABSTRACT

BACKGROUND: Post-licensure adverse events following immunization (AEFI) surveillance is conducted to monitor vaccine safety, such as identifying batch/brand issues and rare reactions, which consequently improves community confidence. The integration of technology has been proposed to improve AEFI surveillance, however, there is an absence of description regarding which digital solutions are successfully being used and their unique characteristics. OBJECTIVES: The objectives of this scoping review were to 1) map the research landscape on digital systems used for active, participant-centred, AEFI surveillance and 2) describe their core components. METHODS: We conducted a scoping review informed by the PRISMA Extension for Scoping Reviews (PRSIMA-ScR) guideline. OVID-Medline, Embase Classic + Embase, and Medrxiv were searched by a medical librarian from January 1, 2000 to January 28th, 2021. Two independent reviewers determined which studies met inclusion based on pre-specified eligibility criteria. Data extraction was conducted using pre-made tables with specific variables by one investigator and verified by a second. RESULTS: Twenty-seven publications met inclusion, the majority of which came from Australia (n = 15) and Canada (n = 6). The most studied active, participant-centred, digital AEFI surveillance systems were SmartVax (n = 8) (Australia), Vaxtracker (n = 7) (Australia), and Canadian National Vaccine Safety (CANVAS) Network (Canada) (n = 6). The two most common methods of communicating with vaccinees reported were short-message-service (SMS) (n = 15) and e-mail (n = 14), with online questionnaires being the primary method of data collection (n = 20). CONCLUSION: Active, participant-centred, digital AEFI surveillance is an area actively being researched as depicted by the literature landscape mapped by this scoping reviewWe hypothesize that the AEFI surveillance approach herein described could become a primary method of collecting self-reported subjective symptoms and reactogenicity from vaccinees, complementing existing systems. Future evaluation of identified digital solutions is necessary to bring about improvements to current vaccine surveillance systems to meet contemporary and future public health needs.


Subject(s)
Adverse Drug Reaction Reporting Systems , Vaccines , Canada , Humans , Immunization/adverse effects , Self Report , Surveys and Questionnaires , Vaccination/adverse effects , Vaccines/adverse effects
19.
Int J Environ Res Public Health ; 19(12)2022 06 10.
Article in English | MEDLINE | ID: covidwho-1887194

ABSTRACT

Post-marketing safety surveillance of new vaccines aimed to be administered during pregnancy is crucial to orchestrate efficient adverse events evaluation. This is of special relevance in the current landscape of new vaccines being introduced in the pregnant women population, and particularly due to the recent administration of COVID-19 vaccines in pregnant women. This multi-center prospective cohort study, nested within the WHO-Global Vaccine Safety-MCC study, involved two hospitals in the Valencia region. Hereby, the incidence rates of seven perinatal and neonatal outcomes in the Valencia region are presented. The pooled data analysis of the two Valencian hospitals allowed the estimation of incidence rates in the Valencia Region (per 1000 live births): 86.7 for low birth weight, 78.2 for preterm birth, 58.8 for small for gestational age, 13 for congenital microcephaly, 0.4 for stillbirth, 1.2 for neonatal death and 6.5 for neonatal infection. These figures are in line with what is expected from a high-income country and the previously reported rates for Spain and Europe, except for the significantly increased rate for congenital microcephaly. Regarding the data for maternal immunization, the vaccination status was collected for 94.4% of the screened pregnant women, highlighting the high quality of the Valencian Vaccine Registry. The study also assessed the Valencian hospitals' capacity for identifying and collecting data on maternal immunization status, as well as the applicability of the GAIA definitions to the identified outcomes.


Subject(s)
COVID-19 , Microcephaly , Premature Birth , Vaccines , Adolescent , COVID-19 Vaccines , Female , Hospitals , Humans , Infant, Newborn , Morbidity , Pregnancy , Pregnancy Outcome , Premature Birth/epidemiology , Prospective Studies
20.
Vaccines (Basel) ; 10(6)2022 Jun 02.
Article in English | MEDLINE | ID: covidwho-1884426

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgently. In most trials of COVID-19 vaccines patients affected by malignancies or on treatment with immunosuppressive drugs were excluded. PATIENTS AND METHODS: A retrospective monocentric study was conducted at Medical Oncological Unit of Santa Chiara Hospital (Pisa, Italy) in this subset of population to investigate safety and tolerability of COVID-19 vaccines; 377 patients with solid tumor on treatment were enrolled. Vaccine-related adverse events were recorded using a face-to-face questionnaire including a toxicity grading scale. Most of the patients (94%) received mRNA vaccine as indicated by Italian health ministry guidelines. Mean age was 66 years (range 27-87), 62% of the patients were older than 65 years and 68% had at least one additional comorbidity. The majority (86%) of patients were in a metastatic setting and 29% received immunotherapy-based treatment. For statistical analysis, multivariate binary logistic regression models were performed and linear regression models were applied. RESULTS: Adverse events were mild and transient and ended in a few days without any sequelae. No severe or uncommon adverse events were recorded. In multivariate analysis, we found that the female sex was associated with a greater risk of more severe and longer lasting adverse events, and a higher risk of adverse events was found for patients treated with immunotherapy. CONCLUSIONS: Our results demonstrate that COVID-19 vaccines were safe and well-tolerated in this population of patients being treated for solid tumors.

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