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1.
Lancet Infect Dis ; 2024 Mar 19.
Artigo em Inglês | MEDLINE | ID: mdl-38518789

RESUMO

BACKGROUND: Variant-containing mRNA vaccines for COVID-19 to broaden protection against SARS-CoV-2 variants are recommended based on findings in adults. We report interim safety and immunogenicity of an omicron BA.1 variant-containing (mRNA-1273.214) primary vaccination series and booster dose in paediatric populations. METHODS: This open-label, two-part, non-randomised phase 3 trial enrolled participants aged 6 months to 5 years at 24 US study sites. Eligible participants were generally healthy or had stable chronic conditions, without known SARS-CoV-2 infection in the previous 90 days. Individuals who were acutely ill or febrile 1 day before or at the screening visit or those who previously received other COVID-19 vaccines (except mRNA-1273 for part 2) were excluded. In part 1, SARS-CoV-2-vaccine-naive participants received two-dose mRNA-1273.214 (25 µg; omicron BA.1 and ancestral Wuhan-Hu-1 mRNA) primary series. In part 2, participants who previously completed the two-dose mRNA-1273 (25 µg) primary series in KidCOVE (NCT04796896) received a mRNA-1273.214 (10 µg) booster dose. Primary study outcomes were safety and reactogenicity of the mRNA-1273.214 primary series (part 1) or booster dose (part 2) as well as the inferred effectiveness of mRNA-1273.214 based on immune responses against ancestral SARS-CoV-2 (D614G) and omicron BA.1 variant at 28 days post-primary series (part 1) or post-booster dose (part 2). The safety set included participants who received at least one dose of the study vaccine; the immunogenicity set included those who provided immunogenicity samples. Interim safety and immunogenicity are summarised in this analysis as of the data cutoff date (Dec 5, 2022). This trial is registered with ClinicalTrials.gov, NCT05436834. FINDINGS: Between June 21, 2022, and Dec 5, 2022, 179 participants received one or more doses of mRNA-1273.214 primary series (part 1) and 539 received a mRNA-1273.214 booster dose (part 2). The safety profile within 28 days after either dose of the mRNA-1273.214 primary series and the booster dose was consistent with that of the mRNA-1273 primary series in this age group, with no new safety concerns or vaccine-related serious adverse events observed. At 28 days after primary series dose 2 and the booster dose, both mRNA-1273.214 primary series (day 57, including all participants with or without evidence of prior SARS-CoV-2 infection at baseline) and booster (day 29, including participants without evidence of prior SARS-CoV-2 infection at baseline) elicited responses that were superior against omicron-BA.1 (geometric mean ratio part 1: 25·4 [95% CI 20·1-32·1] and part 2: 12·5 [11·0-14·3]) and non-inferior against D614G (part 1: 0·8 [0·7-1·0] and part 2: 3·1 [2·8-3·5]), compared with neutralising antibody responses induced by the mRNA-1273 primary series (in a historical comparator group). INTERPRETATION: mRNA-1273.214 was immunogenic against BA.1 and D614G in children aged 6 months to 5 years, with a comparable safety profile to mRNA-1273, when given as a two-dose primary series or a booster dose. These results are aligned with the US Centers for Disease Control and Prevention recommendations for the use of variant-containing vaccines for continued protection against the emerging variants of SARS-CoV-2. FUNDING: Moderna.

2.
Vaccine ; 42(7): 1745-1756, 2024 Mar 07.
Artigo em Inglês | MEDLINE | ID: mdl-38365478

RESUMO

BACKGROUND: University students have been uniquely impacted by the COVID-19 pandemic for the past three years (2020-2023). Understanding their COVID-19 perspectives, beliefs, and vaccine uptake may help to improve future vaccine initiatives and education. METHODS: A cross sectional, confidential, online survey was conducted at four universities in Pennsylvania in spring 2023 to assess undergraduate, graduate, and professional students' perspectives regarding their knowledge of COVID-19 vaccines, importance of COVID-19 vaccines and mandates, number of doses of COVID-19 vaccine received including the recent BA.4/BA.5 bivalent booster, where they were vaccinated, receipt of influenza vaccine, and sources of information used to make decisions about COVID-19 vaccine. RESULTS: Vaccination for COVID-19 was considered important by 75 % of 2223 students surveyed; 68 % agreed with mandating COVID-19 vaccine. Over 89 % were fully COVID-19 vaccinated (≥2 doses), 65 % were up-to-date (≥3 doses), but only 35 % had received the BA.4/BA.5 booster. Students who considered COVID-19 vaccine important were generally older, female, and non-business majors. Higher rates of up-to-date COVID-19 vaccination were found in those who received influenza vaccine in 2022-2023, females, Asians, doctoral or professional students, those attending larger universities, non-US residents, and those interested in learning more about COVID-19 vaccines. Most trusted sources of information on COVID-19 vaccines were the Centers for Disease Control and Prevention, healthcare providers, and parents; the least trusted sources were social media, television, and the internet. CONCLUSIONS: The majority of university students agreed that COVID-19 vaccination is important and supported COVID-19 mandates. While the rate of fully vaccinated and up-to-date students was similar to the US adult population, the latter rate needs improvement. Receipt of the BA.4/BA.5 booster was particularly low. Further education is needed to improve vaccine knowledge, especially as we move to periodic boosters. Business majors, males, and younger students may benefit from increased on-campus vaccine education initiatives.


Assuntos
COVID-19 , Vacinas contra Influenza , Adulto , Masculino , Humanos , Feminino , Vacinas contra COVID-19 , COVID-19/epidemiologia , COVID-19/prevenção & controle , Pandemias/prevenção & controle , Estudos Transversais , Universidades , Estudantes , Vacinação
3.
N Engl J Med ; 389(24): 2233-2244, 2023 Dec 14.
Artigo em Inglês | MEDLINE | ID: mdl-38091530

RESUMO

BACKGROUND: Respiratory syncytial virus (RSV) can cause substantial morbidity and mortality among older adults. An mRNA-based RSV vaccine, mRNA-1345, encoding the stabilized RSV prefusion F glycoprotein, is under clinical investigation. METHODS: In this ongoing, randomized, double-blind, placebo-controlled, phase 2-3 trial, we randomly assigned, in a 1:1 ratio, adults 60 years of age or older to receive one dose of mRNA-1345 (50 µg) or placebo. The two primary efficacy end points were the prevention of RSV-associated lower respiratory tract disease with at least two signs or symptoms and with at least three signs or symptoms. A key secondary efficacy end point was the prevention of RSV-associated acute respiratory disease. Safety was also assessed. RESULTS: Overall, 35,541 participants were assigned to receive the mRNA-1345 vaccine (17,793 participants) or placebo (17,748). The median follow-up was 112 days (range, 1 to 379). The primary analyses were conducted when at least 50% of the anticipated cases of RSV-associated lower respiratory tract disease had occurred. Vaccine efficacy was 83.7% (95.88% confidence interval [CI], 66.0 to 92.2) against RSV-associated lower respiratory tract disease with at least two signs or symptoms and 82.4% (96.36% CI, 34.8 to 95.3) against the disease with at least three signs or symptoms. Vaccine efficacy was 68.4% (95% CI, 50.9 to 79.7) against RSV-associated acute respiratory disease. Protection was observed against both RSV subtypes (A and B) and was generally consistent across subgroups defined according to age and coexisting conditions. Participants in the mRNA-1345 group had a higher incidence than those in the placebo group of solicited local adverse reactions (58.7% vs. 16.2%) and of systemic adverse reactions (47.7% vs. 32.9%); most reactions were mild to moderate in severity and were transient. Serious adverse events occurred in 2.8% of the participants in each trial group. CONCLUSIONS: A single dose of the mRNA-1345 vaccine resulted in no evident safety concerns and led to a lower incidence of RSV-associated lower respiratory tract disease and of RSV-associated acute respiratory disease than placebo among adults 60 years of age or older. (Funded by Moderna; ConquerRSV ClinicalTrials.gov number, NCT05127434.).


Assuntos
Infecções por Vírus Respiratório Sincicial , Vacinas contra Vírus Sincicial Respiratório , Vírus Sincicial Respiratório Humano , Vacinas de mRNA , Idoso , Humanos , Anticorpos Antivirais , Método Duplo-Cego , Infecções por Vírus Respiratório Sincicial/epidemiologia , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Vírus Sincicial Respiratório Humano/genética , Doenças Respiratórias/diagnóstico , Doenças Respiratórias/epidemiologia , Doenças Respiratórias/prevenção & controle , Resultado do Tratamento , Vacinas de mRNA/efeitos adversos , Vacinas de mRNA/uso terapêutico , Vacinas contra Vírus Sincicial Respiratório/efeitos adversos , Vacinas contra Vírus Sincicial Respiratório/uso terapêutico , Pessoa de Meia-Idade
4.
J Occup Environ Med ; 65(10): e619-e625, 2023 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-37464275

RESUMO

OBJECTIVE: The aim of the study is to explore associations among personal protective equipment (PPE) availability, workplace environment, and burnout among US healthcare personnel during the COVID-19 pandemic. METHODS: The study used an online healthcare provider (HCP) survey (December 2020-February 2021) regarding PPE confidence, availability, burnout, and workplace environment. RESULTS: Lack of appropriate PPE was reported by 27% of 799 US HCP surveyed. Burnout, reported by 77% of HCP, was more likely among females, those with fewer years of professional experience, and those with a higher desire to quit, and less likely for those who perceived PPE was adequate or their employer took all steps to minimize workplace risks. CONCLUSIONS: This study suggests that lack of adequate PPE can lead to HCP burnout, which may result in employees quitting. A pandemic preparedness plan that includes adequate PPE is essential for HCP well-being, patient health, and employer fiscal health.


Assuntos
COVID-19 , SARS-CoV-2 , Feminino , Humanos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Pandemias/prevenção & controle , Transmissão de Doença Infecciosa do Paciente para o Profissional , Equipamento de Proteção Individual , Pessoal de Saúde , Esgotamento Psicológico , Atenção à Saúde
5.
Vaccine ; 41(37): 5441-5446, 2023 08 23.
Artigo em Inglês | MEDLINE | ID: mdl-37517911

RESUMO

OBJECTIVES: To assess vaccine coverage rates before and after implementation of a COVID-19 vaccine mandate among Health care Personnel (HCP) and demographic characteristics associated with vaccine uptake Design, Setting, and Participants: Cohort study conducted among 10,889 hospital employees followed from Dec 16, 2020 - October 31, 2021, at a large academic hospital in Philadelphia. MAIN OUTCOME AND MEASURES: Time to COVID-19 vaccination and vaccine series completion rates before and after implementation of a COVID-19 vaccine mandate based on age, gender, race/ethnicity, and level of patient contact/occupational group. RESULTS: The vaccination series completion rate was 86.0% prior to mandate announcement, and increased to 98.7% after mandate implementation. Rates before mandate announcement were highest among Asians (96.2%), Whites (94.0%), males (89.7%), employees ≥ 65 years of age (95.2%), and employees with direct patient care (physicians, 99.0%, and nurses, 93.3%). Hospital educational initiatives (including Town Halls and discussions with Black and Hispanic employees with the lowest vaccination rates) appeared to improve uptake. The largest increase in series completion after mandate announcement occurred among Blacks, those of other/multiracial backgrounds, and Hispanics (35.6%, 22.4%, and 10.8%, respectively) as well as those with some or no direct patient contact (24.5% and 18.3%, respectively). Medical or religious exemptions were approved for 64 (<0.6%) employees and 38 (<0.4%) left their positions (8 voluntary, 30 involuntary) specifically due to the COVID-19 vaccine mandate. No clinically meaningful differences by age, gender, or race/ethnicity for those who were vaccinated under the mandate versus those who left their positions were noted. CONCLUSIONS AND RELEVANCE: These results suggest that while mandates may be challenging to institutions and enforcement unpopular, they play an important role in reducing hesitancy and securing high vaccination rates among HCP, a group at high risk of COVID-19 given their employment and who can be a source of disease transmission to patients.


Assuntos
COVID-19 , Vacinas , Masculino , Humanos , Vacinas contra COVID-19 , Etnicidade , Estudos de Coortes , COVID-19/prevenção & controle , Vacinação , Hospitais de Ensino
7.
J Occup Environ Med ; 65(8): 621-626, 2023 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-37043395

RESUMO

OBJECTIVES: The aims of the study are to determine best practices from two large-scale, academic medical centers' employee coronavirus 2019 (COVID-19) vaccination clinics and to apply them to create scalable modules for rapid administration of 10,000 vaccinations. METHODS: The weekly number of COVID-19 vaccine doses administered was captured. Processes were compared to determine best practices, which informed the scalable financial model. RESULTS: Within the first 3 months, more than 60,000 COVID-19 vaccine doses were administered, and 70% of employees were fully vaccinated in 4 months with more than 95% by the vaccine mandate deadline. The estimated cost of delivering one dose was $29.95 ($299,505/10,000) compared with $35-$39 per dose when delivered by an on-site retail pharmacy. CONCLUSIONS: Successful, safe, and rapid delivery of more than 60,000 COVID-19 vaccine doses in 3 months is practical and scalable. Learnings go beyond COVID-19 and can be applied to future outbreaks/pandemics.


Assuntos
COVID-19 , Saúde Ocupacional , Humanos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Pandemias/prevenção & controle , Vacinação
8.
Hum Vaccin Immunother ; 19(1): 2153532, 2023 12 31.
Artigo em Inglês | MEDLINE | ID: mdl-36629006

RESUMO

Messenger RNA (mRNA)-based vaccine platforms used for the development of mRNA-1273 and BNT162b2 have provided a robust adaptable approach to offer protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, as variants of concern (VoCs), such as omicron and associated sub-variants, emerge, boosting strategies must also adapt to keep pace with the changing landscape. Heterologous vaccination regimens involving the administration of booster vaccines different than the primary vaccination series offer a practical, effective, and safe approach to continue to reduce the global burden of coronavirus disease 2019 (COVID-19). To understand the immunogenicity, effectiveness, and safety of heterologous mRNA-based vaccination strategies, relevant clinical and real-world observational studies were identified and summarized. Overall, heterologous boosting strategies with mRNA-based vaccines that are currently available and those in development will play an important global role in protecting individuals from COVID-19 caused by emerging VoCs.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Humanos , COVID-19/prevenção & controle , Vacina BNT162 , SARS-CoV-2 , RNA Mensageiro , Anticorpos Antivirais , Anticorpos Neutralizantes
9.
Vaccines (Basel) ; 12(1)2023 Dec 22.
Artigo em Inglês | MEDLINE | ID: mdl-38250826

RESUMO

Cancer patients are at an increased risk of morbidity and mortality from SARS-CoV-2 infection and have a decreased immune response to vaccination. We conducted a study measuring both the neutralizing and total antibodies in cancer patients following a third dose of the mRNA-1273 COVID-19 vaccine. Immune responses were measured with an enzyme-linked immunosorbent assay (ELISA) and neutralization assays. Kruskal-Wallis tests were used to evaluate the association between patient characteristics and neutralization geometric mean titers (GMTs), and paired t-tests were used to compare the GMTs between different timepoints. Spearman correlation coefficients were calculated to determine the correlation between total antibody and neutralization GMTs. Among 238 adults diagnosed with cancer, a third dose of mRNA-1273 resulted in a 37-fold increase in neutralization GMT 28 days post-vaccination and maintained a 14.6-fold increase at 6 months. Patients with solid tumors or lymphoid cancer had the highest and lowest neutralization GMTs, respectively, at both 28 days and 6 months post-dose 3. While total antibody GMTs in lymphoid patients continued to increase, other cancer types showed decreases in titers between 28 days and 6 months post-dose 3. A strong correlation (p < 0.001) was found between total antibody and neutralization GMTs. The third dose of mRNA-1273 was able to elicit a robust neutralizing antibody response in cancer patients, which remained for 6 months after administration. Lymphoid cancer patients can benefit most from this third dose, as it was shown to continue to increase total antibody GMTs 6 months after vaccination.

11.
Infect Control Hosp Epidemiol ; 43(10): 1424-1432, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-34538290

RESUMO

OBJECTIVE: To evaluate coronavirus disease 2019 (COVID-19) vaccine hesitancy among healthcare personnel (HCP) with significant clinical exposure to COVID-19 at 2 large, academic hospitals in Philadelphia, Pennsylvania. DESIGN, SETTING, AND PARTICIPANTS: HCP were surveyed in November-December 2020 about their intention to receive the COVID-19 vaccine. METHODS: The survey measured the intent among HCP to receive a COVID-19 vaccine, timing of vaccination, and reasons for or against vaccination. Among patient-facing HCP, multivariate regression evaluated the associations between healthcare positions (medical doctor, nurse practitioner or physician assistant, and registered nurse) and vaccine hesitancy (intending to decline, delay, or were unsure about vaccination), adjusting for demographic characteristics, reasons why or why not to receive the vaccine, and prior receipt of routine vaccines. RESULTS: Among 5,929 HCP (2,253 medical doctors [MDs] and doctors of osteopathy [DOs], 582 nurse practitioners [NPs], 158 physician assistants [PAs], and 2,936 nurses), a higher proportion of nurses (47.3%) were COVID-vaccine hesitant compared with 30.0% of PAs and NPs and 13.1% of MDs and DOs. The most common reasons for vaccine hesitancy included concerns about side effects, the newness of the vaccines, and lack of vaccine knowledge. Regardless of position, Black HCP were more hesitant than White HCP (odds ratio [OR], ∼5) and females were more hesitant than males (OR, ∼2). CONCLUSIONS: Although most clinical HCP intended to receive a COVID-19 vaccine, intention varied by healthcare position. Consistent with other studies, hesitancy was also significantly associated with race or ethnicity across all positions. These results highlight the importance of understanding and effectively addressing reasons for hesitancy, especially among frontline HCP who are at increased risk of COVID exposure and play a critical role in recommending vaccines to patients.


Assuntos
COVID-19 , Profissionais de Enfermagem , Assistentes Médicos , Médicos , Humanos , Masculino , Feminino , Vacinas contra COVID-19 , COVID-19/prevenção & controle , Philadelphia/epidemiologia , Hesitação Vacinal , Vacinação , Hospitais
12.
JAMA Netw Open ; 4(12): e2136582, 2021 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-34851399

RESUMO

Importance: Several COVID-19 vaccines have been authorized in the US, yet preliminary evidence suggests high levels of vaccine hesitancy and wide racial, ethnic, and socioeconomic disparities in uptake. Objective: To assess COVID-19 vaccine acceptance among health care personnel (HCP) during the first 4 months of availability in a large academic hospital, compare acceptance with previously measured vaccine hesitancy, and describe racial, ethnic, and socioeconomic disparities in vaccine uptake. Design, Setting, and Participants: This cross-sectional study included 12 610 HCP who were offered COVID-19 vaccination at a major academic hospital in Philadelphia between December 16, 2020, and April 16, 2021. Exposures: For each HCP, data were collected on occupational category, age, sex, race and ethnicity (Asian or Pacific Islander, Black or African American [Black], Hispanic, White, and multiracial), and social vulnerability index (SVI) at the zip code of residence. Main Outcomes and Measures: Vaccine uptake by HCP at the employee vaccination clinic. Results: The study population included 4173 men (34.8%) and 7814 women (65.2%) (623 without data). A total of 1480 were Asian or Pacific Islander (12.4%); 2563 (21.6%), Black; 452 (3.8%), Hispanic; 7086 (59.6%), White; and 192 (1.6%), multiracial; 717 had no data for race and ethnicity. The mean (SD) age was 40.9 (12.4) years, and 9573 (76.0%) received at least 1 vaccine dose during the first 4 months of vaccine availability. Adjusted for age, sex, job position, and SVI, Black (relative risk [RR], 0.69; 95% CI, 0.66-0.72) and multiracial (RR, 0.80; 95% CI, 0.73-0.89) HCP were less likely to receive vaccine compared with White HCP. When stratified by job position, Black nurses (n = 189; 62.8%), Black HCP with some patient contact (n = 466; 49.9%), and Black HCP with no patient contact (n = 636; 56.3%) all had lower vaccine uptake compared with their White and Asian or Pacific Islander counterparts. Similarly, multiracial HCP with some (n = 26; 52.0%) or no (n = 48; 58.5%) patient contact had lower vaccine uptake. In contrast, Black physicians were just as likely to receive the vaccine as physicians of other racial and ethnic groups. Conclusions and Relevance: In this cross-sectional study, more than two-thirds of HCP at a large academic hospital in Philadelphia received a COVID-19 vaccine within 4 months of vaccine availability. Although racial, ethnic, and socioeconomic disparities were seen in vaccine uptake, no such disparities were found among physicians. Better understanding of factors driving these disparities may help improve uptake.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Aceitação pelo Paciente de Cuidados de Saúde , Recursos Humanos em Hospital , Hesitação Vacinal , Vacinação , Adulto , Negro ou Afro-Americano , Povo Asiático , Estudos Transversais , Etnicidade , Feminino , Hispânico ou Latino , Hospitais , Humanos , Masculino , Pessoa de Meia-Idade , Havaiano Nativo ou Outro Ilhéu do Pacífico , Enfermeiras e Enfermeiros , Philadelphia , Médicos , Grupos Raciais , SARS-CoV-2 , Classe Social , Hesitação Vacinal/etnologia , População Branca
13.
JAMA Netw Open ; 4(8): e2121931, 2021 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-34459907

RESUMO

IMPORTANCE: Significant differences in hesitancy to receive COVID-19 vaccination by race/ethnicity have been observed in several settings. Racial/ethnic differences in COVID-19 vaccine hesitancy among health care workers (HCWs), who face occupational and community exposure to COVID-19, have not been well described. OBJECTIVE: To assess hesitancy to COVID-19 vaccination among HCWs across different racial/ethnic groups and assess factors associated with vaccine hesitancy. DESIGN, SETTING, AND PARTICIPANTS: This survey study was conducted among HCWs from 2 large academic hospitals (ie, a children's hospital and an adult hospital) over a 3-week period in November and December 2020. Eligible participants were HCWs with and without direct patient contact. A 3-step hierarchical multivariable logistic regression was used to evaluate associations between race/ethnicity and vaccine hesitancy controlling for demographic characteristics, employment characteristics, COVID-19 exposure risk, and being up to date with routine vaccinations. Data were analyzed from February through March 2021. MAIN OUTCOMES AND MEASURES: Vaccine hesitancy, defined as not planning on, being unsure about, or planning to delay vaccination, served as the outcome. RESULTS: Among 34 865 HCWs eligible for this study, 12 034 individuals (34.5%) completed the survey and 10 871 individuals (32.2%) completed the survey and reported their race/ethnicity. Among 10 866 of these HCWs with data on sex, 8362 individuals (76.9%) were women, and among 10 833 HCWs with age data, 5923 individuals (54.5%) were younger than age 40 years. (Percentages for demographic and clinical characteristics are among the number of respondents for each type of question.) There were 8388 White individuals (77.2%), 882 Black individuals (8.1%), 845 Asian individuals (7.8%), and 449 individuals with other or mixed race/ethnicity (4.1%), and there were 307 Hispanic or Latino individuals (2.8%). Vaccine hesitancy was highest among Black HCWs (732 individuals [83.0%]) and Hispanic or Latino HCWs (195 individuals [63.5%]) (P < .001). Among 5440 HCWs with vaccine hesitancy, reasons given for hesitancy included concerns about side effects (4737 individuals [87.1%]), newness of the vaccine (4306 individuals [79.2%]), and lack of vaccine knowledge (4091 individuals [75.2%]). The adjusted odds ratio (aOR) for vaccine hesitancy was 4.98 (95% CI, 4.11-6.03) among Black HCWs, 2.10 (95% CI, 1.63-2.70) among Hispanic or Latino HCWs, 1.48 (95% CI, 1.21-1.82) among HCWs with other or mixed race/ethnicity, and 1.47 (95% CI, 1.26-1.71) among Asian HCWs compared with White HCWs (P < .001). The aOR was decreased among Black HCWs when adjusting for employment characteristics and COVID-19 exposure risk (aOR, 4.87; 95% CI, 3.96-6.00; P < .001) and being up to date with prior vaccines (aOR, 4.48; 95% CI, 3.62-5.53; P < .001) but not among HCWs with other racial/ethnic backgrounds. CONCLUSIONS AND RELEVANCE: This study found that vaccine hesitancy before the authorization of the COVID-19 vaccine was increased among Black, Hispanic or Latino, and Asian HCWs compared with White HCWs. These findings suggest that interventions focused on addressing vaccine hesitancy among HCWs are needed.


Assuntos
Vacinas contra COVID-19 , COVID-19/prevenção & controle , Etnicidade , Pessoal de Saúde , Hospitais de Ensino , Aceitação pelo Paciente de Cuidados de Saúde/etnologia , Grupos Raciais , Adulto , Negro ou Afro-Americano , Povo Asiático , Criança , Feminino , Hispânico ou Latino , Humanos , Masculino , Motivação , SARS-CoV-2 , População Branca
15.
Pediatr Infect Dis J ; 40(11): 1046-1054, 2021 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-34310506

RESUMO

BACKGROUND: The safety and immunogenicity of M-M-RII (measles, mumps and rubella virus vaccine live, Merck & Co., Inc., West Point, PA)-the only combined measles, mumps and rubella vaccine licensed for use in the United States-were previously reported in pre- and postlicensure clinical trials conducted from 1988 to 2009. M-M-RII continues to be evaluated as a comparator in clinical trials of other vaccines. Here, we review safety and efficacy data from more recent clinical trials of M-M-RII. METHODS: We performed a systematic literature review of trials using M-M-RII published from 2010 to 2019. RESULTS: In the 15 studies that met the inclusion criteria, a total of 12,032 subjects were vaccinated: 7667 persons received a first dose only, 2137 participated in 2-dose studies (128 received 1 dose and 2009 received both) and 2063 received a single dose of M-M-RII as their second dose. Dose number was not specified for 165 participants, ≥6 years old, in 2 studies in which a single dose of M-M-RII was administered. Similar to previous reports, M-M-RII was well tolerated and immunogenic when administered alone or concomitantly with other routinely recommended vaccinations. The most common adverse events included transient injection site pain and fever. Serious adverse events were extremely rare, with only 4 probable or potential vaccine-related events reported among the 12,032 participating subjects. CONCLUSIONS: In trials published from 2010 to 2019, M-M-RII continued to be safe and immunogenic in all age groups studied. These data, along with the results of earlier trials, indicate that the performance of the vaccine has been consistent across more than 30 years of postlicensure studies.


Assuntos
Anticorpos Antivirais/sangue , Ensaios Clínicos como Assunto , Imunogenicidade da Vacina , Vacina contra Sarampo-Caxumba-Rubéola/imunologia , Vacinação/estatística & dados numéricos , Vacinas Combinadas/imunologia , Vacinas Combinadas/normas , Humanos , Esquemas de Imunização , Sarampo/prevenção & controle , Vacina contra Sarampo-Caxumba-Rubéola/efeitos adversos , Caxumba/prevenção & controle , Relatório de Pesquisa , Rubéola (Sarampo Alemão)/prevenção & controle , Vacinação/métodos , Vacinação/normas
17.
Prev Med ; 144: 106321, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33678229

RESUMO

Prophylactic HPV vaccination has been a great public health success. For >20 years, clinical trials were conducted with the 2-, 4-, and/or 9-valent vaccines in young-adult females, mid-adult women, males, and adolescents. In all studies, the vaccines were highly efficacious, immunogenic, and well tolerated. Following vaccine licensure and utilization in national vaccine programs globally (real-world settings primarily in high income countries), numerous studies demonstrated that the vaccines continue to have an excellent safety profile and have dramatically reduced the incidence of genital warts, HPV vaccine-type prevalence, and precancerous lesions. Thirty-eight clinical trials with the currently licensed HPV vaccines are ongoing. Key questions being addressed in new trials include: efficacy against persistent infection and immunogenicity of a 1-dose regimen; efficacy of 3 doses in 20-45-year-old females; use in postpartum women and immunocompromised individuals (HIV, liver and kidney transplants); dose sparing via intradermal administration; use in combination with a PD1 monoclonal antibody in patients with cervical cancer; impact on recurrent disease in women undergoing cervical conization; persistence of protection; and use to prevent oropharyngeal cancer. Additional clinical research that should be conducted includes: long-term follow-up, particularly of 1- and 2-dose regimens; further evaluation of flexible 2-dose regimens; immunogenicity of 1- or 2-dose regimens in persons ≥15 years old and immunocompromised populations; safety and immunogenicity of 1 or 2 doses in children <9 years old; assessment of the vaccine in the prevention of transmission; interchangeability with newer HPV vaccines; additional concomitant use studies; and prevention of penile cancer and recurrent respiratory papillomatosis.


Assuntos
Infecções por Papillomavirus , Vacinas contra Papillomavirus , Infecções Respiratórias , Neoplasias do Colo do Útero , Adolescente , Adulto , Criança , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infecções por Papillomavirus/prevenção & controle , Saúde Pública , Neoplasias do Colo do Útero/prevenção & controle , Adulto Jovem
18.
Vaccine ; 39(12): 1693-1700, 2021 03 19.
Artigo em Inglês | MEDLINE | ID: mdl-33632563

RESUMO

BACKGROUND: Health care personnel have been identified by the ACIP as a priority group for COVID-19 vaccination. We conducted a survey in November-December 2020 at two large, academic hospitals in Philadelphia to evaluate the intention of hospital employees to be vaccinated. METHODS: The survey was sent electronically to all employees (clinical and nonclinical staff) at a children's hospital and an adult hospital. The survey was voluntary and confidential. Questions focused on plans to receive a COVID-19 vaccine when available, reasons why employees would/would not get vaccinated, when employees planned to be vaccinated, vaccine safety and efficacy features that would be acceptable, and past history of receipt of other vaccines by the employee and family. Responses were analyzed using univariate and multiple logistic regression methods. RESULTS: A total of 12,034 hospital employees completed the survey (a 34.5% response rate). Overall, 63.7% of employees reported that they planned to receive a COVID-19 vaccine, 26.3% were unsure, and 10.0% did not plan to be vaccinated. Over 80% of those unsure or unwilling to be vaccinated expressed concerns about vaccine side effects and the vaccines' newness. In multivariable logistic regression, persons planning to take a COVID-19 vaccine were more likely to be older, male, more educated, Asian or White, up-to-date on vaccinations, without direct patient contact, and tested for COVID-19 in the past. No significant difference in intention to be vaccinated was found between those with higher versus lower levels of exposure to COVID-19 patients or the number of previous exposures to patients with COVID-19. CONCLUSIONS: While the majority of hospital employees are planning to receive a COVID-19 vaccine, many are unsure or not planning to do so. Further education of hospital employees about the safety, efficacy, and value of the currently available COVID-19 vaccines is critical to vaccine acceptance in this population.


Assuntos
Vacinas contra COVID-19/administração & dosagem , COVID-19/prevenção & controle , Pessoal de Saúde/psicologia , Vacinação/psicologia , Adulto , Idoso , Teste para COVID-19 , Feminino , Hospitais , Humanos , Intenção , Masculino , Pessoa de Meia-Idade , Philadelphia , Inquéritos e Questionários
19.
Hum Vaccin Immunother ; 17(12): 5372-5383, 2021 12 02.
Artigo em Inglês | MEDLINE | ID: mdl-35130794

RESUMO

Measles, mumps, and rubella are highly contagious diseases that caused significant global mortality and morbidity in the pre-vaccine era. Since its first approval in the United States over 40 years ago, M-M-RII has been used in >75 countries for prevention of these diseases. The vaccine has been part of immunization programs that have achieved dramatic global reductions in case numbers and mortality rates, as well as the elimination of measles and rubella in several countries and regions. This report summarizes over four decades of global safety, immunogenicity, efficacy, and effectiveness data for the vaccine. We include studies on the use of M-M-RII in different age groups, concomitant use with other routine childhood vaccines, administration via different routes, persistence of immunity, and vaccine effectiveness during outbreaks of measles and mumps. We conclude that M-M-RII is well tolerated and has shown consistently high performance during routine use in multiple countries, in randomized controlled trials with diverse designs, and in outbreak settings, including use as measles postexposure prophylaxis. Physicians, parents, and the public can continue to have a high degree of confidence in the use of M-M-RII as a vital part of global public health programs.


Assuntos
Sarampo , Caxumba , Rubéola (Sarampo Alemão) , Anticorpos Antivirais , Antígenos Virais , Criança , Humanos , Lactente , Sarampo/epidemiologia , Sarampo/prevenção & controle , Vacina contra Sarampo-Caxumba-Rubéola , Caxumba/epidemiologia , Caxumba/prevenção & controle , Rubéola (Sarampo Alemão)/epidemiologia , Rubéola (Sarampo Alemão)/prevenção & controle , Estados Unidos/epidemiologia , Vacinação
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