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1.
Int J Infect Dis ; 111: 310-312, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34492394

RESUMO

OBJECTIVES: Facial nerve palsy (or Bell's palsy) has occasionally been reported following the administration of coronavirus disease 2019 (COVID-19) mRNA vaccines (BNT162b2 and mRNA-1273). Our study investigated such cases using a large self-reporting database from the USA (Vaccine Adverse Event Reporting System [VAERS]). METHODS: A disproportionality analysis, adjusted for age and sex, was conducted for VAERS reports from individuals who were vaccinated at the age of 18 years or over, between January 2010 and April 2021. RESULTS: The analysis revealed that the adverse events following immunization (AEFI) of facial nerve palsy, after administration of COVID-19 mRNA vaccines, was significantly highly reported, both for BNT162b2 (reporting odds ratio [ROR] 1.84; 95% confidence interval [CI] 1.65-2.06) and mRNA-1273 (ROR 1.54; 95% CI 1.39-1.70). These levels were comparable to that following influenza vaccination reported before the COVID-19 pandemic (ROR 2.04; 95% CI 1.76-2.36). CONCLUSIONS: Our pharmacovigilance study results suggest that the incidence of facial nerve palsy as a non-serious AEFI may be lower than, or equivalent to, that for influenza vaccines. This information might be of value in the context of promoting worldwide vaccination, but needs to be validated in future observational studies.


Assuntos
Paralisia de Bell , COVID-19 , Vacinas contra Influenza , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Paralisia de Bell/epidemiologia , Vacinas contra COVID-19/efeitos adversos , Nervo Facial , Humanos , Vacinas contra Influenza/efeitos adversos , Pandemias , Paralisia , RNA Mensageiro/genética , SARS-CoV-2 , Adulto Jovem
2.
Vaccine ; 39(40): 5891-5908, 2021 09 24.
Artigo em Inglês | MEDLINE | ID: mdl-34489131

RESUMO

BACKGROUND: Rapid assessment of COVID-19 vaccine safety during pregnancy is urgently needed. METHODS: We conducted a rapid systematic review, to evaluate the safety of COVID-19 vaccines selected by the COVID-19 Vaccines Global Access-Maternal Immunization Working Group in August 2020, including their components and their technological platforms used in other vaccines for pregnant persons. We searched literature databases, COVID-19 vaccine pregnancy registries, and explored reference lists from the inception date to February 2021 without language restriction. Pairs of reviewers independently selected studies through COVIDENCE, and performed the data extraction and the risk of bias assessment. Discrepancies were resolved by consensus. Registered on PROSPERO (CRD42021234185). RESULTS: We retrieved 6757 records and 12 COVID-19 pregnancy registries from the search strategy; 38 clinical and non-clinical studies (involving 2,398,855 pregnant persons and 56 pregnant animals) were included. Most studies (89%) were conducted in high-income countries and were cohort studies (57%). Most studies (76%) compared vaccine exposures with no exposure during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant, in the context of A/H1N1 pandemic influenza vaccines, (n = 24) and aluminum-based adjuvants (n = 11). Only one study reported exposure to messenger RNA in lipid nanoparticles COVID-19 vaccines. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03), corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns. CONCLUSION: This rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted, given their novelty. Our findings support current WHO guidelines recommending that pregnant persons may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.


Assuntos
COVID-19 , Vírus da Influenza A Subtipo H1N1 , Vacinas contra Influenza , Influenza Humana , Animais , Vacinas contra COVID-19 , Feminino , Humanos , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Gravidez , SARS-CoV-2 , Vacinação
3.
Pediatrics ; 148(4)2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34493538

RESUMO

This technical report accompanies the recommendations of the American Academy of Pediatrics for the routine use of the influenza vaccine and antiviral medications in the prevention and treatment of influenza in children during the 2021-2022 season. Influenza vaccination is an important intervention to protect vulnerable populations and reduce the burden of respiratory illnesses during circulation of severe acute respiratory syndrome coronavirus 2, which is expected to continue during this influenza season. In this technical report, we summarize recent influenza seasons, morbidity and mortality in children, vaccine effectiveness, vaccination coverage, and detailed guidance on storage, administration, and implementation. We also provide background on inactivated and live attenuated influenza vaccine recommendations, vaccination during pregnancy and breastfeeding, diagnostic testing, and antiviral medications for treatment and chemoprophylaxis.


Assuntos
Vacinas contra Influenza , Influenza Humana/prevenção & controle , Antivirais/uso terapêutico , Aleitamento Materno , Criança , Contraindicações de Medicamentos , Farmacorresistência Viral , Armazenamento de Medicamentos , Feminino , Hospitalização , Humanos , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/efeitos adversos , Influenza Humana/tratamento farmacológico , Influenza Humana/epidemiologia , Influenza Humana/mortalidade , Vacinação em Massa , Fatores de Risco , Estados Unidos/epidemiologia , Vacinas Atenuadas/administração & dosagem , Vacinas Atenuadas/efeitos adversos , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos
5.
Medicine (Baltimore) ; 100(31): e26744, 2021 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-34397815

RESUMO

ABSTRACT: Cured leprosy patients have special physical conditions, which could pose challenges for safety and immunogenicity after immunization. We performed an observational clinical study aimed to identify the safety and immunogenicity of influenza vaccine in cured leprosy patients. A total of 65 participants from a leprosarium were recruited into leprosy cured group or control group, and received a 0.5 ml dose of the inactivated split-virion trivalent influenza vaccine and a follow-up 28 days proactive observation of any adverse events. Hemagglutination and hemagglutination inhibition test was performed to evaluate serum antibody titer, flow cytometry was conducted to screen of cytokines level. The total rate of reactogenicity was 0.0% [0/41] in leprosy cured group and 37.5% [9/24] in control group. The seroconversion rate for H1N1 was difference between leprosy cured group and control group (41.83% vs 79.17%, P = .0082), but not for H3N2 (34.25% vs 50.00%, P = .4468). At day 0, leprosy cured group have relatively high concentration of interleukin-6, interleukin-10, tumor necrosis factor, interferon-γ, and interleukin-17 compared to control group. The interleukin-2 concentration increased 2 weeks after vaccination compared to pre-vaccination in leprosy cured group, but declined in control group (0.92 pg/ml vs -0.02 pg/ml, P = .0147). Leprosy cured group showed a more rapid down-regulation of interleukin-6 when influenza virus was challenged compared to control group (-144.38 pg/ml vs -11.52 pg/ml, P < .0001). Subgroup analysis revealed that the immunization administration declined interleukin-17 concentration in Tuberculoid type subgroup, but not in Lepromatous type subgroup or control group. Clinically cured leprosy patients are relatively safe for influenza vaccine. Leprosy cured patient have immune deficit in producing antibody. Interleukin-6 and interleukin-17 were 2 sensitive indicators in immune response for leprosy affected patients. The identification of indicators might be help management of leprosy and used as predictive markers in leprosy early symptom monitoring.


Assuntos
Imunidade/efeitos dos fármacos , Imunogenicidade da Vacina , Vacinas contra Influenza/normas , Hanseníase/tratamento farmacológico , Formação de Anticorpos/efeitos dos fármacos , Humanos , Vírus da Influenza A Subtipo H1N1/efeitos dos fármacos , Vírus da Influenza A Subtipo H1N1/imunologia , Vírus da Influenza A Subtipo H3N2/efeitos dos fármacos , Vírus da Influenza A Subtipo H3N2/imunologia , Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/uso terapêutico , Hanseníase/imunologia , Mycobacterium/efeitos dos fármacos , Mycobacterium/patogenicidade , Mycobacterium leprae/efeitos dos fármacos , Mycobacterium leprae/patogenicidade
6.
Vaccine ; 39(40): 5968-5981, 2021 09 24.
Artigo em Inglês | MEDLINE | ID: mdl-34376308

RESUMO

BACKGROUND: In 2010, the Australian seasonal influenza vaccination program for children under 5 years of age was suspended due to an unexpected increase in fever and febrile convulsions causally associated with one particular influenza vaccine brand. A subsequent national review made seven recommendations to improve vaccine pharmacovigilance. Ten years on, in advance of implementing the COVID-19 immunisation program, we evaluated views on the capacity of Australia's vaccine pharmacovigilance system to promptly detect, examine and communicate a signal. METHODS: Semi-structured interviews were conducted between July and October 2020 with individuals with expertise in vaccine safety in Australia using an interview guide informed by key Australian and international frameworks. Interviews were digitally recorded and transcribed verbatim. Thematic analysis was used to code data using a deductive approach. RESULTS: Interviews with seventeen participants enabled six themes to be identified. Participants described improvement and significant innovation within Australia's vaccine pharmacovigilance system over the decade since 2010, particularly through establishment of a new active, cohort event monitoring system using short message service surveys. Participants thought Australia had a good foundation for COVID-19 vaccine safety surveillance; implementation of the COVID-19 immunisation program was seen as a potential driver for ongoing enhancement through: a) improved integration of the active surveillance and spontaneous reporting systems, and; b) development of population-level active surveillance, including through data linkage. Transparent communication was considered essential to address the unprecedented challenges of COVID-19 and broader vaccine safety concerns. CONCLUSIONS: Vaccine safety experts in Australia convey confidence in the innovative pharmacovigilance systems implemented over the past 10 years. While Australia has a multifaceted system incorporating both active surveillance and spontaneous reporting systems, COVID-19 vaccine implementation represents an opportunity to enhance current systems and to develop new, systematic approaches to vaccine pharmacovigilance that should make both a local and global contribution.


Assuntos
COVID-19 , Vacinas contra Influenza , Austrália , Vacinas contra COVID-19 , Criança , Pré-Escolar , Humanos , Vacinas contra Influenza/efeitos adversos , Pandemias/prevenção & controle , Farmacovigilância , SARS-CoV-2 , Vacinação
7.
J Infect ; 83(4): 444-451, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34425161

RESUMO

OBJECTIVES: Influenza is associated with significant morbidity and mortality, especially in older and immunocompromised patients. Few data are available on the clinical benefit of high dose trivalent influenza vaccine (TIV). We aimed to assess the clinical efficacy and safety of high dose TIV. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs), evaluating high dose versus standard dose TIV for prevention of seasonal influenza in adult population. Primary outcome was laboratory-confirmed influenza. Subgroups analyses included older adults and immunocompromised patients. RESULTS: We included 16 trials, 47,857 patients; 10 included older adults and three immunocompromised patients. Laboratory confirmed influenza was significantly reduced with high dose TIV (relative risk 0.76, 95% confidence interval 0.64 to 0.9). This outcome stemmed mainly from one trial in older adults. Specifically, A(H3N2) laboratory confirmed influenza, but not A(H1N1) or B lineages, was reduced. No difference in mortality or hospitalizations was demonstrated. Immunological response was significantly higher with high dose vaccine. Serious adverse events were significantly less common in the high dose group. CONCLUSIONS: High dose TIV lowers the rates of laboratory confirmed influenza, mainly A (H3N2), in older adults vs. standard dose. Further studies should address immunocompromised patients and report clinical outcomes.


Assuntos
Vacinas contra Influenza , Influenza Humana , Idoso , Anticorpos Antivirais , Humanos , Hospedeiro Imunocomprometido , Vírus da Influenza A Subtipo H3N2 , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Resultado do Tratamento , Vacinas de Produtos Inativados
8.
BMJ Case Rep ; 14(7)2021 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-34330729

RESUMO

We report a case of Guillain-Barré syndrome (GBS) occurring soon after the first dose of Vaxzevria (previously known as COVID-19 vaccine AstraZeneca). Thus far, there has been no evidence of an increased risk of GBS resulting from either COVID-19 infection nor from COVID-19 vaccines; however, individual cases and population cohorts should be scrutinised, in order to ensure the constant evaluation of such risks. It is as yet not possible to draw conclusions about any significant association between COVID-19 vaccination and GBS. A temporal correlation does not imply, and should not be deemed to signify, causality. However, it is important to remain vigilant, so that any potential increased risk is properly evaluated. The specific presentation of bifacial weakness as the initial symptom may be a characteristic feature of GBS in the context of recent COVID-19 vaccination.


Assuntos
COVID-19 , Síndrome de Guillain-Barré , Vacinas contra Influenza , Vacinas contra COVID-19 , Síndrome de Guillain-Barré/etiologia , Humanos , Vacinas contra Influenza/efeitos adversos , SARS-CoV-2 , Vacinação/efeitos adversos
9.
Viruses ; 13(6)2021 05 24.
Artigo em Inglês | MEDLINE | ID: mdl-34073843

RESUMO

Despite seasonal influenza vaccines having been routinely used for many decades, influenza A virus continues to pose a global threat to humans, causing high morbidity and mortality each year. The effectiveness of the vaccine is largely dependent on how well matched the vaccine strains are with the circulating influenza virus strains. Furthermore, low vaccine efficacy in naïve populations such as young children, or in the elderly, who possess weakened immune systems, indicates that influenza vaccines need to be more personalized to provide broader community protection. Advances in both vaccine technologies and our understanding of influenza virus infection and immunity have led to the design of a variety of alternate vaccine strategies to extend population protection against influenza, some of which are now in use. In this review, we summarize the progress in the field of influenza vaccines, including the advantages and disadvantages of different strategies, and discuss future prospects. We also highlight some of the challenges to be faced in the ongoing effort to control influenza through vaccination.


Assuntos
Vírus da Influenza A/imunologia , Vacinas contra Influenza/imunologia , Influenza Humana/prevenção & controle , Medicina de Precisão , Adjuvantes Imunológicos , Tomada de Decisão Clínica , Gerenciamento Clínico , Humanos , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/classificação , Influenza Humana/epidemiologia , Medicina de Precisão/métodos , Vigilância em Saúde Pública , Pesquisa , Vacinação
10.
Therapie ; 76(4): 305-309, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34119319

RESUMO

The marketing authorization granted to SARS-Cov-2 vaccines was accompanied by reinforced safety monitoring plans. These plans' implementation was part of the usual logic of post-marketing surveillance of new and innovative health products. It was especially adapted to the context of post-marketing monitoring of drugs developed according to the usual scientific quality standards but in an accelerated schedule. In Europe, the reinforced surveillance system relies on the complementary strengths of pharmacovigilance and pharmacoepidemiology. If the performances of pharmacovigilance monitoring are incomparable for the detection of safety signals relating to rare events of atypical presentation, it needs to be completed with pharmacoepidemiology activities for more common events, either multifactorial or frequently classified as idiopathic. The pharmacoepidemiological monitoring developed in Europe was elaborated before the first SARS-Cov-2 vaccines where marketed, taking into account the lessons learned from the vaccination campaign against 2009 A (H1N1) influenza. It includes numerous academic studies as well as studies performed within vaccines risk management plans. In terms of safety, those defined a priori mostly concerns a list of pre-established health events of specific interest. Aside of these planned activities, ad-hoc studies will be latter developed on purpose to investigate safety signals or potential signals that could be identified as the result of pharmacovigilance activities. Aside of these regulated activities, as for today, very few studies have been published regarding SARS-Cov-2 vaccines; most of the existing consist in preprints that should be considered with caution. Pharmacoepidemiology of vaccines is thought to allow near-real time monitoring that needs sufficient time to provide with valid results. In the constant urge for information that accompanies COVID-related science, it is important not to make haste the enemy of speed and to let pharmacoepidemiology provides with what it is expected to do: rock-solid scientific information contributing to evidence-based decision-making.


Assuntos
Vacinas contra COVID-19 , COVID-19/epidemiologia , COVID-19/prevenção & controle , Programas de Imunização , Farmacoepidemiologia , COVID-19/imunologia , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/imunologia , Europa (Continente)/epidemiologia , Humanos , Vírus da Influenza A Subtipo H1N1/imunologia , Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/imunologia , SARS-CoV-2/imunologia
11.
Vaccine ; 39(29): 3871-3878, 2021 06 29.
Artigo em Inglês | MEDLINE | ID: mdl-34088505

RESUMO

Quadrivalent influenza inactivated vaccine (IIV4) is more likely to provide wider protection against yearly circulating influenza viruses than trivalent inactivated influenza vaccine (IIV3). In this study, a total of 320 participants were allocated to four age cohorts (6-35 months, 3-8 years, 9-17 years, and ≥ 18 years; 80 participants/cohort) according to their actual date of birth. Participants in each cohort were randomly assigned to two groups to receive intramuscular injection of the trial vaccine or the comparative vaccine in a one-dose (3-8 years, 9-17 years,and ≥ 18 years) schedule on day 0 or two-dose (6-35 months cohort) schedule on day 0 and 28. The first objective is to evaluate the safety and immunogenicity of the full-dose subunit non-adjuvanted IIV4 (FD-subunit NAIIV4) we developed versus an active-control, China-licensed split-virion NAIIV4, in people ≥ 3 years. The second objective is to evaluate the safety and immunogenicity of FD-subunit NAIIV4 versus the half-dose (HD-subunit NAIIV4) in toddlers aged 6-35 months. Results showed that all adverse reactions noted were rare, mild, and self-limited. In ≥ 3 years cohorts, systemic adverse reactions in FD-subunit NAIIV4 groups were less than the active control split-virion NAIIV4 groups ([Systemic adverse reaction rates (95%CI)], 15.0 (8.6-21.4) versus 19.2(12.1-26.2), p = 0.391). The overall seroprotection efficacy after vaccination were comparable between FD-subunit NAIIV4 and the active control split-virion NAIIV4([Seroprotection rates (95%CI)], H1N1, 99.2(81.3-100.0) versus 94.9(90.9-98.9), p = 0.117; H3N2, 81.7(74.7-88.6) versus 82.1(75.1-89.0), p = 0.939; BV, 75.8(68.2-83.5) versus 74.4(66.4-82.3), p = 0.793; BY, 94.2(90.0-98.4) versus 92.3(87.5-97.1), p = 0.568). Additionally, FD-subunit NAIIV4 has comparable safety and better seroprotection versus that of the half-dose in 6-35 months toddlers groups ([Total adverse reaction rates (95%CI)], 37.5(18.5-56.5) versus 47.5(26.1-68.9), p = 0.366) ([Seroprotection rates (95%CI)], H1N1, 85(56.4-100.0) versus 75.7(47.6-100.0), p = 0.117; H3N2, 50(28.1-71.9) versus 29.7(12.2-47.3), p = 0.070; BV, 75(48.2-100.0) versus 29.7(12.2-47.3), p < 0.001; BY, 75(48.2-100.0) versus 56.8(32.5-81.0), p = 0.091). As a result, the FD-subunit NAIIV4 we developed is safe and effective to provide broader and adequate protection against the circulating influenza viruses during 2018-2019, which could be an essential component of the global preventive strategy for influenza pandemic.


Assuntos
Vírus da Influenza A Subtipo H1N1 , Vacinas contra Influenza , Influenza Humana , Anticorpos Antivirais , China , Método Duplo-Cego , Testes de Inibição da Hemaglutinação , Humanos , Imunogenicidade da Vacina , Lactente , Vírus da Influenza A Subtipo H3N2 , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Vacinas de Produtos Inativados/efeitos adversos
12.
Vaccine ; 39(31): 4250-4255, 2021 07 13.
Artigo em Inglês | MEDLINE | ID: mdl-34167835

RESUMO

The Centers for Disease Control and Prevention explored use of emergency department (ED) visit data, during 2018-2020, from the National Syndromic Surveillance Program to monitor vaccine-associated adverse events (VAE) among all age groups. A combination of chief complaint terms and administrative diagnosis codes were used to detect VAE-related ED visits. Postvaccination fever was among the top 10 most frequently noted diagnoses. VAE annual trends demonstrated seasonality; visits trended upward starting in September of each year, coinciding with the administration of seasonal influenza vaccines. The 2020 VAE-related visit trend declined below the 2018 and 2019 baselines during March 22-September 5, 2020, before returning to the seasonal pattern. VAE-related visits declined in children aged 3-18 years in 2020 compared with 2018-2019, especially in the back-to-school months. These findings demonstrate that syndromic surveillance can complement traditional VAE reporting systems without an additional demand on data collection resources.


Assuntos
Vacinas contra Influenza , Vigilância de Evento Sentinela , Criança , Coleta de Dados , Serviço Hospitalar de Emergência , Humanos , Vacinas contra Influenza/efeitos adversos , Vigilância da População , Estados Unidos/epidemiologia
13.
Vaccine ; 39(29): 3814-3824, 2021 06 29.
Artigo em Inglês | MEDLINE | ID: mdl-34090699

RESUMO

OBJECTIVE: This scoping review mapped studies using real-world data (RWD) to measure pediatric safety and effectiveness of vaccines administered to pregnant women. INTRODUCTION: In the US, two vaccines are recommended for all pregnant women to prevent illness in the infant: inactivated influenza vaccine (recommended since 2004), and the combined tetanus-diphtheria-acellular pertussis (Tdap) vaccine (recommended since 2013). This scoping review maps the studies conducted to date that address questions about pediatric safety and effectiveness of vaccines administered during pregnancy and provides a knowledge base for evaluating the use of RWD to study this issue. METHODS: The scoping review was conducted following a published protocol. Methods included an electronic search of PubMed and Embase, screening of titles and abstracts by two reviewers, and double extraction of data for summary and synthesis. Studies that reported on pregnant women and the effectiveness or safety outcomes in their infants were included. RESULTS: Forty-eight studies met the inclusion criteria of the scoping review protocol using RWD to assess safety or effectiveness of influenza or pertussis vaccinations administered to pregnant women with respect to pregnancy, infant or child outcomes. Detailed information about data sources, linkage of maternal and infant data, and operational definitions for gestational age were largely absent from the majority of studies raising concerns about reproducibility and validity of study findings. CONCLUSIONS: A body of literature is available from which to plan and design future studies of vaccination in pregnant women using RWD. This is of intense importance as new vaccines, such as those for COVID-19, become available to the general population via approval or authorization without inclusion of pregnant women in the clinical trials.


Assuntos
COVID-19 , Vacinas contra Difteria, Tétano e Coqueluche Acelular , Vacinas contra Influenza , Coqueluche , Criança , Feminino , Humanos , Lactente , Vacinas contra Influenza/efeitos adversos , Gravidez , Gestantes , Reprodutibilidade dos Testes , SARS-CoV-2 , Vacinação
14.
BMJ Open ; 11(6): e048109, 2021 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-34103321

RESUMO

OBJECTIVES: We integrated an established participant-centred active vaccine safety surveillance system with a cloud-based pharmacy immunisation-recording program in order to measure adverse events following immunisation (AEFI) reported via the new surveillance system in pharmacies, compared with AEFI reported via an existing surveillance system in non-pharmacy sites (general practice and other clinics). DESIGN: A prospective cohort study. PARTICIPANTS AND SETTING: Individuals >10 years receiving influenza immunisations from 22 pharmacies and 90 non-pharmacy (general practice and other clinic) sites between March and October 2020 in Western Australia. Active vaccine safety surveillance was conducted using short message service and smartphone technology, via an opt-out system. OUTCOME MEASURES: Multivariable logistic regression was used to assess the primary outcome: differences in proportions of AEFI between participants immunised in pharmacies compared with non-pharmacy sites, adjusting for confounders of age, sex and influenza vaccine brand. A subgroup analysis of participants over 65 years was also performed. RESULTS: Of 101 440 participants (6992 from pharmacies; 94 448 from non-pharmacy sites), 77 498 (76.4%) responded; 96.1% (n=74 448) within 24 hours. Overall, 4.8% (n=247) pharmacy participants reported any AEFI, compared with 6% (n=4356) non-pharmacy participants (adjusted OR: 0.87; 95% CI: 0.76 to 0.99; p=0.039). Similar proportions of AEFIs were reported in pharmacy (5.8%; n=31) and non-pharmacy participants (6; n=1617) aged over 65 years (adjusted OR: 0.94; 95% CI: 0.65 to 1.35; p=0.725). The most common AEFIs in pharmacy were: pain (2%; n=104), tiredness (1.9%; n=95) and headache (1.7%; n=88); and in non-pharmacy sites: pain (2.3%; n=1660), tiredness (1.9%; n=1362) and swelling (1.5%; n=1121). CONCLUSIONS: High and rapid response rates demonstrate good participant engagement with active surveillance in both pharmacy and non-pharmacy participants. Significantly fewer AEFIs reported after pharmacist immunisations compared with non-pharmacy immunisations, with no difference in older adults, may suggest different cohorts attend pharmacy versus non-pharmacy immunisers. The integrated pharmacy system is rapidly scalable across Australia with global potential.


Assuntos
Vacinas contra Influenza , Influenza Humana , Farmácias , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , Austrália/epidemiologia , Humanos , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Estudos Prospectivos , Estações do Ano , Vacinação , Austrália Ocidental/epidemiologia
15.
JAMA ; 325(22): 2285-2293, 2021 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-34100870

RESUMO

Importance: Seasonal influenza vaccination in pregnancy can reduce influenza illness among pregnant women and newborns. Evidence is limited on whether seasonal influenza vaccination in pregnancy is associated with adverse childhood health outcomes. Objective: To assess the association between maternal influenza vaccination during pregnancy and early childhood health outcomes. Design, Setting, and Participants: Retrospective cohort study, using a birth registry linked with health administrative data. All live births in Nova Scotia, Canada, between October 1, 2010, and March 31, 2014, were included, with follow-up until March 31, 2016. Adjusted hazard ratios (HRs) and incidence rate ratios (IRRs) with 95% confidence intervals were estimated while controlling for maternal medical history and other potential confounders using inverse probability of treatment weighting. Exposures: Seasonal influenza vaccination during pregnancy. Main Outcomes and Measures: Childhood outcomes studied were immune-related (eg, asthma, infections), non-immune-related (eg, neoplasms, sensory impairment), and nonspecific (eg, urgent or inpatient health care utilization), measured from emergency department and hospitalization databases. Results: Among 28 255 children (49% female, 92% born at ≥37 weeks' gestation), 10 227 (36.2%) were born to women who received seasonal influenza vaccination during pregnancy. During a mean follow-up of 3.6 years, there was no significant association between maternal influenza vaccination and childhood asthma (incidence rate, 3.0 vs 2.5 per 1000 person-years; difference, 0.53 per 1000 person-years [95% CI, -0.15 to 1.21]; adjusted HR, 1.22 [95% CI, 0.94 to 1.59]), neoplasms (0.32 vs 0.26 per 1000 person-years; difference, 0.06 per 1000 person-years [95% CI, -0.16 to 0.28]; adjusted HR, 1.26 [95% CI, 0.57 to 2.78]), or sensory impairment (0.80 vs 0.97 per 1000 person-years; difference, -0.17 per 1000 person-years [95% CI, -0.54 to 0.21]; adjusted HR, 0.82 [95% CI, 0.49 to 1.37]). Maternal influenza vaccination in pregnancy was not significantly associated with infections in early childhood (incidence rate, 184.6 vs 179.1 per 1000 person-years; difference, 5.44 per 1000 person-years [95% CI, 0.01 to 10.9]; adjusted IRR, 1.07 [95% CI, 0.99 to 1.15]) or with urgent and inpatient health services utilization (511.7 vs 477.8 per 1000 person-years; difference, 33.9 per 1000 person-years [95% CI, 24.9 to 42.9]; adjusted IRR, 1.05 [95% CI, 0.99 to 1.16]). Conclusions and Relevance: In this population-based cohort study with mean follow-up duration of 3.6 years, maternal influenza vaccination during pregnancy was not significantly associated with an increased risk of adverse early childhood health outcomes.


Assuntos
Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Complicações Infecciosas na Gravidez/prevenção & controle , Vacinação/efeitos adversos , Adulto , Asma/epidemiologia , Pré-Escolar , Intervalos de Confiança , Feminino , Seguimentos , Necessidades e Demandas de Serviços de Saúde/estatística & dados numéricos , Humanos , Incidência , Lactente , Recém-Nascido , Infecções/epidemiologia , Vacinas contra Influenza/administração & dosagem , Nascido Vivo/epidemiologia , Masculino , Idade Materna , Neoplasias/epidemiologia , Nova Escócia/epidemiologia , Avaliação de Resultados em Cuidados de Saúde , Gravidez , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Estações do Ano , Transtornos das Sensações/epidemiologia , Vacinação/estatística & dados numéricos , Adulto Jovem
16.
Vaccine ; 39(27): 3621-3625, 2021 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-33992436

RESUMO

BACKGROUND: Seasonal Influenza is still considered associated with seasonal morbidity and hospitalization in the elderly population. The World Health Organization (WHO) recommended seasonal quadrivalent influenza vaccine (QIV) to reduce burden of two currently circulating influenza B lineages. Until 2019 Korean National Immunization Program (NIP) recommended trivalent influenza vaccine (TIV) after ongoing debates on cost effectiveness of QIV for elderly population. Although influenza vaccine only showed modest effect on reducing influenza in elderly, this study aimed to evaluate the immunogenicity and safety of inactivated QIV in healthy participants ≥ 65 years of age. METHODS: A total of 274 healthy participants aged ≥ 65 years received a QIV. Seroconversion-based vaccine efficacy of 4 strains of seasonal influenza was assessed 21 days after vaccination and adverse events were monitored until 180 days after vaccination. RESULTS: The percentages of participants seroconverted after vaccination on HI antibody against each strain were 36.5% (99/271) to A/H1N1, 47.6% (129/271) to A/H3N2, 40.6% (110/271) to B Yamagata, and 49.1% (133/271) to B Victoria. The percentages of participants seroprotected after vaccination on HI antibody against each strain were 81.2% (220/271) to A/H1N1, 98.5% (267/271) to A/H3N2, 95.2% (258/271) to B Yamagata, and 93.7% (254/271) to B Victoria. There was no serious adverse event (SAE) related with the study vaccine. CONCLUSION: The quadrivalent split influenza vaccine is expected to offer seroprotection against influenza A and both influenza B lineages even in the elderly population.


Assuntos
Vírus da Influenza A Subtipo H1N1 , Vacinas contra Influenza , Influenza Humana , Idoso , Anticorpos Antivirais , Voluntários Saudáveis , Testes de Inibição da Hemaglutinação , Humanos , Imunogenicidade da Vacina , Vírus da Influenza A Subtipo H3N2 , Vírus da Influenza B , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Estações do Ano , Vacinas de Produtos Inativados/efeitos adversos
18.
Cad Saude Publica ; 37(4): e00084820, 2021.
Artigo em Português | MEDLINE | ID: mdl-33978110

RESUMO

Vaccination is one of the public health measures that has most contributed to decreasing the incidence of vaccine-preventable diseases. However, vaccines can lead to post-vaccination adverse events. This study thus aimed to analyze the prevalence of post-vaccination adverse events in elderly persons, determine the reported post-vaccination adverse events, identify the vaccines that cause post-vaccination adverse events, and verify the post-vaccination adverse events and vaccines that lead to hospitalizations in the State of São Paulo, Brazil, from 2015 to 2017. This was a descriptive cross-sectional study with a quantitative approach based on notifications of post-vaccination adverse events recorded in the Information System of the National Immunization Program. The results showed that of the 15,196,080 elderly persons that were immunized, there were 207 reports of post-vaccination adverse events, of which 187 (89%) were non-serious adverse events and 15 (8%) due to immunization errors (IE). The majority of the patients were female (86%), white (49%), and from 60 to 69 years of age (70%). Clinical manifestations featured local reactions at the injection site (84%). There were 131 cases (64%) that evolved to cure without sequelae. Two individuals (2%) were hospitalized due to serious adverse events. The first had received adult diphtheria/tetanus (dT), pneumococcal (Pn23), and influenza vaccines, and the second had received Pn23. The post-vaccination adverse events notifications showed incomplete information. In conclusion, notification of post-vaccination adverse events is essential. Health professionals need to be committed to adequate completion of the notification forms, with health surveillance supervision aimed at quality of care for elderly persons with post-vaccination adverse events.


Assuntos
Vacinas contra Influenza , Vacinação , Adulto , Idoso , Brasil/epidemiologia , Estudos Transversais , Feminino , Humanos , Programas de Imunização , Vacinas contra Influenza/efeitos adversos , Masculino , Vacinação/efeitos adversos
19.
Viruses ; 13(3)2021 03 18.
Artigo em Inglês | MEDLINE | ID: mdl-33803680

RESUMO

BACKGROUND: Data suggest that pediatric patients might react differently to influenza vaccination, both in terms of immunity and side effects. We have recently shown that using a whole virion vaccine with aluminum phosphate adjuvants, reduced dose vaccines containing 6 µg of viral hemagglutinin (HA) per strain are immunogenic, and well tolerated in adult and elderly patients. Here we show the results of a multicenter clinical trial of pediatric patients, using reduced doses of a new, whole virion, aluminum phosphate adjuvanted vaccine (FluArt, Budapest, Hungary). METHODS: A total of 120 healthy volunteers were included in two age groups (3-11 years, receiving 3 µg of HA per strain, and 12-18 years, receiving 6 µg of HA per strain). We used hemagglutination inhibition testing to assess immunogenicity, based on EMA and FDA licensing criteria, including post/pre-vaccination geometric mean titer ratios, seroconversion and seropositivity rates. Safety and tolerability were assessed using CHMP guidelines. RESULTS: All subjects entered the study and were vaccinated (ITT population). All 120 subjects attended the control visit on Day 21 (PP population). All immunogenicity licensing criteria were met in both age groups for all three vaccine virus strains. No serious adverse events were detected and the vaccine was well tolerated by both age groups. DISCUSSION: Using a whole virion vaccine and aluminum phosphate adjuvants, a reduction in the amount of the viral hemmaglutinin is possible while maintaining immunogenicity, safety and tolerability in pediatric and adolescent patients.


Assuntos
Adjuvantes Imunológicos , Compostos de Alumínio , Vacinas contra Influenza , Influenza Humana/prevenção & controle , Fosfatos , Adjuvantes Imunológicos/administração & dosagem , Adjuvantes Imunológicos/efeitos adversos , Adolescente , Compostos de Alumínio/administração & dosagem , Compostos de Alumínio/efeitos adversos , Criança , Pré-Escolar , Feminino , Humanos , Hungria/epidemiologia , Vírus da Influenza A Subtipo H1N1/imunologia , Vírus da Influenza A Subtipo H3N2/imunologia , Vírus da Influenza B/imunologia , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/efeitos adversos , Masculino , Fosfatos/administração & dosagem , Fosfatos/efeitos adversos , Estudos Prospectivos , Vírion/imunologia
20.
Hosp Pract (1995) ; 49(4): 245-251, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33826433

RESUMO

Background: Hospitalists, comprised of nurse practitioners and physician assistants (collectively, advanced practice providers [APPs]) and physicians, have opportunities to counsel patients and reduce SARS-CoV-2 related coronavirus disease 2019 (COVID-19) vaccine hesitancy. However, hospitalist perspectives on the COVID-19 vaccine and potential differences between APPs and physicians are unknown. Understanding hospitalist perspectives could help to address vaccine hesitancy among patients.Methods: We conducted an online survey of hospitalists at Mayo Clinic sites in Arizona, Florida, Minnesota, and Wisconsin from 14 December 2020 through 4 January 2021. We collected demographic information and assessed perspectives on the COVID-19 vaccine and, for comparison, on the influenza vaccine. Descriptive statistics were used to compare responses between APPs and physicians.Results: The overall response rate was 42.7% (n = 128/300) and comprised of 53.9% women (n = 69/128) and 41.4% APPs (n = 53/128). Most hospitalists reported receiving or planning to receive vaccination against COVID-19 (93.7%; n = 119/128) and influenza (97.7%; n = 125/128). Most hospitalists reported they would advise 100% of patients to receive the COVID-19 vaccine (66% for APPs; 74.7% for physicians) and influenza vaccine (83% for APPs; 80% for physicians). Barriers to recommending the COVID-19 vaccine included patient health status and vaccine safety profile. Hospitalists reported that patients and coworkers receiving the COVID-19 vaccine would reduce their anxiety (~80% of hospitalists), social isolation (~64% of hospitalists), and improve their emotional support (~40% of hospitalists). APP and physician responses were similar. The possible reduction in social isolation was associated with higher odds of hospitalists advising all patients to receive the COVID-19 vaccine (adjusted odds ratio 2.95 [95% confidence interval, 1.32-6.59]; P< .008), whereas hospitalist age, gender, and profession showed no association.Conclusion: Most hospitalists would reportedly advise patients to receive the COVID-19 vaccine. Barriers to this recommendation included patient health status and vaccine safety. Hospitalists are an important resource to provide patient education and reduce COVID-19 vaccine hesitancy.


Assuntos
Vacinas contra COVID-19/administração & dosagem , COVID-19/prevenção & controle , Médicos Hospitalares/psicologia , Vacinas contra Influenza/administração & dosagem , Influenza Humana/prevenção & controle , Adulto , Vacinas contra COVID-19/efeitos adversos , Feminino , Nível de Saúde , Humanos , Vacinas contra Influenza/efeitos adversos , Masculino , Pessoa de Meia-Idade , Profissionais de Enfermagem/psicologia , Assistentes Médicos/psicologia , Médicos/psicologia , SARS-CoV-2 , Isolamento Social , Fatores Socioeconômicos
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