Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age.

2022

1673-1687

12/2022

1533-4406

BACKGROUND: The safety, reactogenicity, immunogenicity, and efficacy of the mRNA-1273 coronavirus disease 2019 (Covid-19) vaccine in young children are unknown.

METHODS: Part 1 of this ongoing phase 2-3 trial was open label for dose selection; part 2 was an observer-blinded, placebo-controlled evaluation of the selected dose. In part 2, we randomly assigned young children (6 months to 5 years of age) in a 3:1 ratio to receive two 25-μg injections of mRNA-1273 or placebo, administered 28 days apart. The primary objectives were to evaluate the safety and reactogenicity of the vaccine and to determine whether the immune response in these children was noninferior to that in young adults (18 to 25 years of age) in a related phase 3 trial. Secondary objectives were to determine the incidences of Covid-19 and severe acute respiratory syndrome coronavirus 2 infection after administration of mRNA-1273 or placebo.

RESULTS: On the basis of safety and immunogenicity results in part 1 of the trial, the 25-μg dose was evaluated in part 2. In part 2, 3040 children 2 to 5 years of age and 1762 children 6 to 23 months of age were randomly assigned to receive two 25-μg injections of mRNA-1273; 1008 children 2 to 5 years of age and 593 children 6 to 23 months of age were randomly assigned to receive placebo. The median duration of follow-up after the second injection was 71 days in the 2-to-5-year-old cohort and 68 days in the 6-to-23-month-old cohort. Adverse events were mainly low-grade and transient, and no new safety concerns were identified. At day 57, neutralizing antibody geometric mean concentrations were 1410 (95% confidence interval [CI], 1272 to 1563) among 2-to-5-year-olds and 1781 (95% CI, 1616 to 1962) among 6-to-23-month-olds, as compared with 1391 (95% CI, 1263 to 1531) among young adults, who had received 100-μg injections of mRNA-1273, findings that met the noninferiority criteria for immune responses for both age cohorts. The estimated vaccine efficacy against Covid-19 was 36.8% (95% CI, 12.5 to 54.0) among 2-to-5-year-olds and 50.6% (95% CI, 21.4 to 68.6) among 6-to-23-month-olds, at a time when B.1.1.529 (omicron) was the predominant circulating variant.

CONCLUSIONS: Two 25-μg doses of the mRNA-1273 vaccine were found to be safe in children 6 months to 5 years of age and elicited immune responses that were noninferior to those in young adults. (Funded by the Biomedical Advanced Research and Development Authority and National Institute of Allergy and Infectious Diseases; KidCOVE ClinicalTrials.gov number, NCT04796896.).

10.1056/NEJMoa2209367

N Engl J Med

36260859

Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age.

2022

10/2022

1533-4406

BACKGROUND: The safety, reactogenicity, immunogenicity, and efficacy of the mRNA-1273 coronavirus disease 2019 (Covid-19) vaccine in young children are unknown.

METHODS: Part 1 of this ongoing phase 2-3 trial was open label for dose selection; part 2 was an observer-blinded, placebo-controlled evaluation of the selected dose. In part 2, we randomly assigned young children (6 months to 5 years of age) in a 3:1 ratio to receive two 25-μg injections of mRNA-1273 or placebo, administered 28 days apart. The primary objectives were to evaluate the safety and reactogenicity of the vaccine and to determine whether the immune response in these children was noninferior to that in young adults (18 to 25 years of age) in a related phase 3 trial. Secondary objectives were to determine the incidences of Covid-19 and severe acute respiratory syndrome coronavirus 2 infection after administration of mRNA-1273 or placebo.

RESULTS: On the basis of safety and immunogenicity results in part 1 of the trial, the 25-μg dose was evaluated in part 2. In part 2, 3040 children 2 to 5 years of age and 1762 children 6 to 23 months of age were randomly assigned to receive two 25-μg injections of mRNA-1273; 1008 children 2 to 5 years of age and 593 children 6 to 23 months of age were randomly assigned to receive placebo. The median duration of follow-up after the second injection was 71 days in the 2-to-5-year-old cohort and 68 days in the 6-to-23-month-old cohort. Adverse events were mainly low-grade and transient, and no new safety concerns were identified. At day 57, neutralizing antibody geometric mean concentrations were 1410 (95% confidence interval [CI], 1272 to 1563) among 2-to-5-year-olds and 1781 (95% CI, 1616 to 1962) among 6-to-23-month-olds, as compared with 1391 (95% CI, 1263 to 1531) among young adults, who had received 100-μg injections of mRNA-1273, findings that met the noninferiority criteria for immune responses for both age cohorts. The estimated vaccine efficacy against Covid-19 was 36.8% (95% CI, 12.5 to 54.0) among 2-to-5-year-olds and 50.6% (95% CI, 21.4 to 68.6) among 6-to-23-month-olds, at a time when B.1.1.529 (omicron) was the predominant circulating variant.

CONCLUSIONS: Two 25-μg doses of the mRNA-1273 vaccine were found to be safe in children 6 months to 5 years of age and elicited immune responses that were noninferior to those in young adults. (Funded by the Biomedical Advanced Research and Development Authority and National Institute of Allergy and Infectious Diseases; KidCOVE ClinicalTrials.gov number, NCT04796896.).

10.1056/NEJMoa2209367

N Engl J Med

36260859

COVID-19 Vaccine Hesitancy among Physicians, Physician Assistants, Nurse Practitioners, and Nurses in Two Academic Hospitals in Philadelphia.

2021

1-24

2021 Sep 20

1559-6834

<p><strong>OBJECTIVE: </strong>To evaluate COVID-19 vaccine hesitancy among health care personnel (HCP) with significant clinical exposure to COVID-19 at two large, academic hospitals in Philadelphia.</p>

<p><strong>DESIGN, SETTING AND PARTICIPANTS: </strong>HCP were surveyed between November-December 2020 about their intention to receive the COVID-19 vaccine.</p>

<p><strong>METHODS: </strong>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 (MD, NP/PA, RN) 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.</p>

<p><strong>RESULTS: </strong>Among 5,929 HCP (2,253 MDs/DOs, 582 NPs, 158 PAs, and 2,936 nurses), a higher proportion of nurses (47.3%) were COVID-vaccine hesitant compared with 30.0% of PAs/NPs and 13.1% of MDs/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 (OR∼5) and females were more hesitant than males (OR∼2).</p>

<p><strong>CONCLUSION: </strong>Although a majority of 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/ethnicity across all positions. These results underline 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.</p>

10.1017/ice.2021.410

Infect Control Hosp Epidemiol

34538290

Racial/Ethnic Differences in COVID-19 Vaccine Hesitancy Among Health Care Workers in 2 Large Academic Hospitals.

2021

e2121931

2021 Aug 02

2574-3805

<p><strong>Importance: </strong>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.</p>

<p><strong>Objective: </strong>To assess hesitancy to COVID-19 vaccination among HCWs across different racial/ethnic groups and assess factors associated with vaccine hesitancy.</p>

<p><strong>Design, Setting, and Participants: </strong>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.</p>

<p><strong>Main Outcomes and Measures: </strong>Vaccine hesitancy, defined as not planning on, being unsure about, or planning to delay vaccination, served as the outcome.</p>

<p><strong>Results: </strong>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 &lt; .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 &lt; .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 &lt; .001) and being up to date with prior vaccines (aOR, 4.48; 95% CI, 3.62-5.53; P &lt; .001) but not among HCWs with other racial/ethnic backgrounds.</p>

<p><strong>Conclusions and Relevance: </strong>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.</p>

10.1001/jamanetworkopen.2021.21931

JAMA Netw Open

34459907

Perspectives on the receipt of a COVID-19 vaccine: A survey of employees in two large hospitals in Philadelphia.

2021

2021 Feb 16

1873-2518

<p><strong>BACKGROUND: </strong>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.</p>

<p><strong>METHODS: </strong>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.</p>

<p><strong>RESULTS: </strong>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.</p>

<p><strong>CONCLUSIONS: </strong>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.</p>

10.1016/j.vaccine.2021.02.029

Vaccine

33632563