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Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine

Falsey, Ann R; Sobieszczyk, Magdalena E; Hirsch, Ian; Sproule, Stephanie; Robb, Merlin L; Corey, Lawrence; Neuzil, Kathleen M; Hahn, William; Hunt, Julie; Mulligan, Mark J; McEvoy, Charlene; DeJesus, Edwin; Hassman, Michael; Little, Susan J; Pahud, Barbara A; Durbin, Anna; Pickrell, Paul; Daar, Eric S; Bush, Larry; Solis, Joel; Carr, Quito Osuna; Oyedele, Temitope; Buchbinder, Susan; Cowden, Jessica; Vargas, Sergio L; Guerreros Benavides, Alfredo; Call, Robert; Keefer, Michael C; Kirkpatrick, Beth D; Pullman, John; Tong, Tina; Brewinski Isaacs, Margaret; Benkeser, David; Janes, Holly E; Nason, Martha C; Green, Justin A; Kelly, Elizabeth J; Maaske, Jill; Mueller, Nancy; Shoemaker, Kathryn; Takas, Therese; Marshall, Richard P; Pangalos, Menelas N; Villafana, Tonya; Gonzalez-Lopez, Antonio; ,
BACKGROUND:The safety and efficacy of the AZD1222 (ChAdOx1 nCoV-19) vaccine in a large, diverse population at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the United States, Chile, and Peru has not been known. METHODS:In this ongoing, double-blind, randomized, placebo-controlled, phase 3 clinical trial, we investigated the safety, vaccine efficacy, and immunogenicity of two doses of AZD1222 as compared with placebo in preventing the onset of symptomatic and severe coronavirus disease 2019 (Covid-19) 15 days or more after the second dose in adults, including older adults, in the United States, Chile, and Peru. RESULTS:A total of 32,451 participants underwent randomization, in a 2:1 ratio, to receive AZD1222 (21,635 participants) or placebo (10,816 participants). AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest; the incidences were similar to those observed in the placebo group. Solicited local and systemic reactions were generally mild or moderate in both groups. Overall estimated vaccine efficacy was 74.0% (95% confidence interval [CI], 65.3 to 80.5; P<0.001) and estimated vaccine efficacy was 83.5% (95% CI, 54.2 to 94.1) in participants 65 years of age or older. High vaccine efficacy was consistent across a range of demographic subgroups. In the fully vaccinated analysis subgroup, no severe or critical symptomatic Covid-19 cases were observed among the 17,662 participants in the AZD1222 group; 8 cases were noted among the 8550 participants in the placebo group (<0.1%). The estimated vaccine efficacy for preventing SARS-CoV-2 infection (nucleocapsid antibody seroconversion) was 64.3% (95% CI, 56.1 to 71.0; P<0.001). SARS-CoV-2 spike protein binding and neutralizing antibodies increased after the first dose and increased further when measured 28 days after the second dose. CONCLUSIONS:AZD1222 was safe and efficacious in preventing symptomatic and severe Covid-19 across diverse populations that included older adults. (Funded by AstraZeneca and others; number, NCT04516746.).
PMID: 34587382
ISSN: 1533-4406
CID: 5605342

Delayed SARS-COV-2 leukoencephalopathy without Severe Hypoxia [Letter]

Kumar, Arooshi; Olivera, Anlys; Mueller, Nancy; Howard, Jonathan; Lewis, Ariane
PMID: 32977227
ISSN: 1878-5883
CID: 4615762

Evaluation of participant recruitment methods to a rare disease online registry

Johnson, Kimberly J; Mueller, Nancy L; Williams, Katherine; Gutmann, David H
Internet communication advances provide new opportunities to assemble individuals with rare diseases to online patient registries from wide geographic areas for research. However, there is little published information on the efficacy of different recruitment methods. Here we describe recruitment patterns and the characteristics of individuals with the self-identified autosomal dominant genetic disorder neurofibromatosis type 1 (NF1) who participated in an online patient registry during the 1-year period from 1/1/2012 to 12/31/2012. We employed four main mechanisms to alert potential participants to the registry: (1) Facebook and Google advertising, (2) government and academic websites, (3) patient advocacy groups, and (4) healthcare providers. Participants reported how they first heard about the registry through an online questionnaire. During the 1-year period, 880 individuals participated in the registry from all 50 U.S. States, the District of Columbia, Puerto Rico, and 39 countries. Facebook and Google were reported as referral sources by the highest number of participants (n=550, 72% Facebook), followed by healthcare providers (n=74), and government and academic websites (n=71). The mean participant age was 29+/-18 years and most participants reported White race (73%) and female sex (62%) irrespective of reported referral source. Internet advertising, especially through Facebook, resulted in efficient enrollment of large numbers of individuals with NF1. Our study demonstrates the potential utility of this approach to assemble individuals with a rare disease from across the world for research studies.
PMID: 24700441
ISSN: 1552-4825
CID: 1314552

Social media adoption in local health departments nationwide

Harris, Jenine K; Mueller, Nancy L; Snider, Doneisha
OBJECTIVES: We examined whether characteristics of local health departments (LHD) and their geographic region were associated with using Facebook and Twitter. We also examined the number of tweets per month for Twitter accounts as an indicator of social media use by LHDs. METHODS: In 2012, we searched for Facebook and Twitter accounts for 2565 LHDs nationwide, and collected adoption date and number of connections for each account. Number of tweets sent indicated LHD use of social media. LHDs were classified as innovators, early adopters, or nonadopters. Characteristics of LHDs were compared across adoption categories, and we examined geographic characteristics, connections, and use. RESULTS: Twenty-four percent of LHDs had Facebook, 8% had Twitter, and 7% had both. LHDs serving larger populations were more likely to be innovators, tweeted more often, and had more social media connections. Frequency of tweeting was not associated with adoption category. There were differences in adoption across geographic regions, with western states more likely to be innovators. Innovation was also higher in states where the state health department adopted social media. CONCLUSIONS: Social media has the potential to aid LHDs in disseminating information across the public health system. More evidence is needed to develop best practices for this emerging tool.
PMID: 23865660
ISSN: 0090-0036
CID: 1314562

Local health department use of twitter to disseminate diabetes information, United States

Harris, Jenine K; Mueller, Nancy L; Snider, Doneisha; Haire-Joshu, Debra
INTRODUCTION: Diabetes may affect one-third of US adults by 2050. Adopting a healthful diet and increasing physical activity are effective in preventing type 2 diabetes and decreasing the severity of diabetes-related complications. Educating and informing the public about health problems is a service provided by local health departments (LHDs). The objective of this study was to examine how LHDs are using social media to educate and inform the public about diabetes. METHODS: In June 2012 we used NVivo 10 to collect all tweets ever posted from every LHD with a Twitter account and identified tweets about diabetes. We used a 2010 National Association of County and City Health Officials survey to compare characteristics of LHDs that tweeted about diabetes with those that did not. Content analysis was used to classify each tweet topic. RESULTS: Of 217 LHDs with Twitter accounts, 126 had ever tweeted about diabetes, with 3 diabetes tweets being the median since adopting Twitter. LHDs tweeting about diabetes were in jurisdictions with larger populations and had more staff and higher spending than LHDs not tweeting about diabetes. They were significantly more likely to employ a public information specialist and provide programs in diabetes-related areas. There was also a weak positive association between jurisdiction diabetes rate and the percentage of all tweets that were about diabetes (r = .16; P = .049). CONCLUSION: LHDs are beginning to use social media to educate and inform their constituents about diabetes. An understanding of the reach and effectiveness of social media could enable public health practitioners to use them more effectively.
PMID: 23639765
ISSN: 1545-1151
CID: 1314572

Development of an international internet-based neurofibromatosis Type 1 patient registry

Johnson, Kimberly J; Hussain, Ibrahim; Williams, Katherine; Santens, Ryan; Mueller, Nancy L; Gutmann, David H
Internet technology provides unprecedented opportunities to assemble large numbers of individuals with rare diseases from across the world to conduct clinical research studies. One such rare disease is Neurofibromatosis Type 1 (NF1), a cancer predisposition syndrome affecting ~1/3000-4000 individuals worldwide. To enable large epidemiological research studies on NF1, we developed an online NF1 Patient Registry Initiative (NPRI) ( Our objective is to describe the methods for registry development and implementation as well as the characteristics of participants during the first year of registry operation. Following electronic consent, participants completed a 30-45 minute questionnaire with 11 sections that asked about demographic, health, and social information. During the first year, 308 individuals from 44 U.S. states, the District of Columbia, and 19 countries participated. Of these, 98% provided demographic information and ~85% completed all questionnaire sections, of which 95% reported the presence of at least two NF1 diagnostic criteria. Most participants who completed the questionnaire indicated willingness for future contact (99%) and for providing biological samples (94%). Based on this first year of experience, we conclude that online registries provide a valuable tool for assembling individuals with a rare disease from across the world for research studies.
PMID: 23246715
ISSN: 1551-7144
CID: 1314582

Policy activity and policy adoption in rural, suburban, and urban local health departments

Harris, Jenine K; Mueller, Nancy L
Public health policy is among the most effective and cost-effective interventions in some areas of public health and is emerging as effective in others. Policy may be especially important for rural communities, where residents face serious health and economic disparities and local health departments (LHDs) lack resources to provide necessary services. Data from the 2008 National Association of County and City Health Officials National Profile of Local Health Departments were used to examine policy activity (eg, policy development; communication with policymakers) and policy adoption in a sample of 454 LHDs. Results indicate policy activity was low in some policy areas for all LHDs and lowest in all policy areas for rural departments. Policy activities had significant positive relationships with policy adoption for land use (phi = 0.31; P < .05); tobacco prevention and control (phi = 0.37; P < .05); indoor air quality (phi = 0.28; P < .05); and nutrition and physical activity (phi = 0.21; P < .05). These relationships differed for rural, suburban, and urban LHDs. Significant positive correlations were also identified between overall levels of policy activity and any policy adoption (r = 0.16-0.27; P < .05). Local health departments should increase participation in policy activity to facilitate public health policy adoption nationwide.
PMID: 23358301
ISSN: 1078-4659
CID: 1314592