COVID-19 Commons^™

Association Of Messenger Rna Coronavirus Disease 2019 (Covid-19) Vaccination And Reductions In Post Covid Conditions Following Severe Acute Respiratory Syndrome Coronavirus 2 Infection In A Us Prospective Cohort Of Essential Workers, Josephine Mak, Sana Khan, Amadea Britton, Spencer Rose, Lisa Gwynn, Katherine D Ellingson, Jennifer Meece, Leora R Feldstein, Harmony Tyner, Laura J Edwards, Matthew S Thiese, Allison Naleway, Manjusha Gaglani, Natasha Solle, Jefferey L Burgess, Julie Mayo Lamberte, Meghan Shea, Taryn Hunt-Smith, Alberto Caban-Martinez, Cynthia Porter, Ryan Wiegand, Ramona Rai, Kurt T Hegmann, James Hollister, Ashley Fowlkes, Meredith Wesley, Andrew L Philips, Patrick Rivers, Robin Bloodworth, Gabriella Newes-Adeyi, Lauren E W Olsho, Sarang K Yoon, Sharon Saydah, Karen Lutrick

Center for Medical Ethics and Health Policy Staff Publications

Background: Data are limited on whether vaccination reduces post COVID conditions (PCCs) risk after less severe nonhospitalized coronavirus disease 2019 (COVID-19). This study assessed whether COVID-19 vaccination protected against PCCs in persons with mild initial infections during Delta and Omicron variant predominance.

Methods: This study utilized a case-control design, nested within the HEROES-RECOVER cohort. Participants aged ≥18 years with test-confirmed severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) between 28 June 2021 and 14 September 2022 were surveyed for PCCs, defined by symptoms lasting >4 weeks after initial infection. Cases self-reported PCCs and controls self-reported no PCCs. The exposure was …

Increasing Covid-19 Testing And Vaccination Uptake In The Take Care Texas Community-Based Randomized Trial: Adaptive Geospatial Analysis, Kehe Zhang, Jocelyn V Hunyadi, Marcia C De Oliveira Otto, Miryoung Lee, Zitong Zhang, Ryan Ramphul, Jose-Miguel Yamal, Ashraf Yaseen, Alanna C Morrison, Shreela Sharma, Mohammad Hossein Rahbar, Xu Zhang, Stephen Linder, Dritana Marko, Rachel White Roy, Deborah Banerjee, Esmeralda Guajardo, Michelle Crum, Belinda Reininger, Maria E Fernandez, Cici Bauer

Faculty, Staff and Student Publications

BACKGROUND: Geospatial data science can be a powerful tool to aid the design, reach, efficiency, and impact of community-based intervention trials. The project titled Take Care Texas aims to develop and test an adaptive, multilevel, community-based intervention to increase COVID-19 testing and vaccination uptake among vulnerable populations in 3 Texas regions: Harris County, Cameron County, and Northeast Texas.

OBJECTIVE: We aimed to develop a novel procedure for adaptive selections of census block groups (CBGs) to include in the community-based randomized trial for the Take Care Texas project.

METHODS: CBG selection was conducted across 3 Texas regions over a 17-month period …

Neutralizing Antibody Immune Correlates In Covail Trial Recipients Of An Mrna Second Covid-19 Vaccine Boost, Bo Zhang, Youyi Fong, Lauren Dang, Jonathan Fintzi, Shiyu Chen, Jing Wang, Nadine G Rouphael, Angela R Branche, David J Diemert, Ann R Falsey, Daniel S Graciaa, Lindsey R Baden, Sharon E Frey, Jennifer A Whitaker, Susan J Little, Satoshi Kamidani, Emmanuel B Walter, Richard M Novak, Richard Rupp, Lisa A Jackson, Chenchen Yu, Craig A Magaret, Cindy Molitor, Bhavesh Borate, Sydney Busch, David Benkeser, Antonia Netzl, Derek J Smith, Tara M Babu, Angelica C Kottkamp, Anne F Luetkemeyer, Lilly C Immergluck, Rachel M Presti, Martín Bäcker, Patricia L Winokur, Siham M Mahgoub, Paul A Goepfert, Dahlene N Fusco, Robert L Atmar, Christine M Posavad, Jinjian Mu, Mat Makowski, Mamodikoe K Makhene, Seema U Nayak, Paul C Roberts, Peter B Gilbert, Dean Follmann

Faculty, Staff and Students Publications

Neutralizing antibody titer has been a surrogate endpoint for guiding COVID-19 vaccine approval and use, although the pandemic's evolution and the introduction of variant-adapted vaccine boosters raise questions as to this surrogate's contemporary performance. For 985 recipients of an mRNA second bivalent or monovalent booster containing various Spike inserts [Prototype (Ancestral), Beta, Delta, and/or Omicron BA.1 or BA.4/5] in the COVAIL trial (NCT05289037), titers against 5 strains were assessed as correlates of risk of symptomatic COVID-19 ("COVID-19") and as correlates of relative (Pfizer-BioNTech Omicron vs. Prototype) booster protection against COVID-19 over 6 months of follow-up during the BA.2-BA.5 Omicron-dominant period. …

Covid-19 Vaccine Hesitancy Among Black Women In The Us, Brittany C Slatton, Farrah G Cambrice, Serwaa S Omowale

Faculty, Staff and Student Publications

IMPORTANCE: COVID-19 vaccine hesitancy among Black women is a critical public health concern, potentially exacerbating existing health disparities and impacting community-wide vaccination efforts.

OBJECTIVE: To explore the factors associated with COVID-19 vaccine hesitancy among Black women in the US and identify the specific concerns and experiences shaping hesitant attitudes toward vaccination.

DESIGN, SETTING, AND PARTICIPANTS: Qualitative study using in-depth, semistructured interviews conducted virtually between June and November 2021. Thematic analysis was used to identify key themes from the interview data. Participants were recruited through social media platforms and word-of-mouth referrals from various regions of the US. Interviews were conducted remotely …

Protective Effects Of Psychiatric Medications Against Covid-19 Mortality Before Vaccines, Rodrigo Machado-Vieira, Trudy M Krause, Gregory Jones, Antonio L Teixeira, Lokesh R Shahani, Scott D Lane, Jair C Soares, Chau N Truong

Faculty, Staff and Student Publications

The coronavirus disease pandemic caused by the coronavirus SARS-CoV-2, which emerged in the United States in late 2019 to early 2020 and quickly escalated into a national public health crisis. Research has identified psychiatric conditions as possible risk factors associated with COVID-19 infection and symptom severity. This study aims to determine whether specific classes of psychiatric medications could reduce the likelihood of infection and alleviate the severity of the disease. The objective of this study is to investigate the relationship between neuropsychiatric medication usage and COVID-19 outcomes before the widespread utilization of COVID-19 vaccines. This cross-sectional study used Optum's de-identified …

Effectiveness Of Original Monovalent And Bivalent Covid-19 Vaccines Against Covid-19-Associated Hospitalization And Severe In-Hospital Outcomes Among Adults In The United States, September 2022-August 2023, Jennifer Decuir, Diya Surie, Yuwei Zhu, Adam S Lauring, Manjusha Gaglani, Tresa Mcneal, Shekhar Ghamande, Ithan D Peltan, Samuel M Brown, Adit A Ginde, Aimee Steinwand, Nicholas M Mohr, Kevin W Gibbs, David N Hager, Harith Ali, Anne Frosch, Michelle N Gong, Amira Mohamed, Nicholas J Johnson, Vasisht Srinivasan, Jay S Steingrub, Akram Khan, Laurence W Busse, Abhijit Duggal, Jennifer G Wilson, Nida Qadir, Steven Y Chang, Christopher Mallow, Jennie H Kwon, Matthew C Exline, Nathan I Shapiro, Cristie Columbus, Ivana A Vaughn, Mayur Ramesh, Basmah Safdar, Jarrod M Mosier, Jonathan D Casey, H Keipp Talbot, Todd W Rice, Natasha Halasa, James D Chappell, Carlos G Grijalva, Adrienne Baughman, Kelsey N Womack, Jillian P Rhoads, Sydney A Swan, Cassandra Johnson, Nathaniel Lewis, Sascha Ellington, Fatimah S Dawood, Meredith Mcmorrow, Wesley H Self, Investigating Respiratory Viruses In The Acutely Ill (Ivy) Network

Faculty, Staff and Students Publications

BACKGROUND: Assessments of COVID-19 vaccine effectiveness are needed to monitor the protection provided by updated vaccines against severe COVID-19. We evaluated the effectiveness of original monovalent and bivalent (ancestral strain and Omicron BA.4/5) COVID-19 vaccination against COVID-19-associated hospitalization and severe in-hospital outcomes.

METHODS: During September 8, 2022 to August 31, 2023, adults aged ≥ 18 years hospitalized with COVID-19-like illness were enrolled at 26 hospitals in 20 US states. Using a test-negative case-control design, we estimated vaccine effectiveness (VE) with multivariable logistic regression adjusted for age, sex, race/ethnicity, admission date, and geographic region.

RESULTS: Among 7028 patients, 2924 (41.6%) were …

Neutralization Escape, Infectivity, And Membrane Fusion Of Jn1-Derived Sars-Cov-2 Slip, Flirt, And Kp2 Variants, Pei Li, Julia N Faraone, Cheng Chih Hsu, Michelle Chamblee, Yi-Min Zheng, Claire Carlin, Joseph S Bednash, Jeffrey C Horowitz, Rama K Mallampalli, Linda J Saif, Eugene M Oltz, Daniel Jones, Jianrong Li, Richard J Gumina, Kai Xu, Shan-Lu Liu

Faculty, Staff and Student Publications

We investigate JN.1-derived subvariants SLip, FLiRT, and KP.2 for neutralization by antibodies in vaccinated individuals, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected patients, or class III monoclonal antibody S309. Compared to JN.1, SLip, KP.2, and especially FLiRT exhibit increased resistance to bivalent-vaccinated and BA.2.86/JN.1-wave convalescent human sera. XBB.1.5 monovalent-vaccinated hamster sera robustly neutralize FLiRT and KP.2 but have reduced efficiency for SLip. All subvariants are resistant to S309 and show decreased infectivity, cell-cell fusion, and spike processing relative to JN.1. Modeling reveals that L455S and F456L in SLip reduce spike binding for ACE2, while R346T in FLiRT and KP.2 strengthens …

What Is The Economic Benefit Of Annual Covid-19 Vaccination From The Adult Individual Perspective?, Sarah M Bartsch, Kelly J O'Shea, Colleen Weatherwax, Ulrich Strych, Kavya Velmurugan, Danielle C John, Maria Elena Bottazzi, Mustafa Hussein, Marie F Martinez, Kevin L Chin, Allan Ciciriello, Jessie Heneghan, Alexis Dibbs, Sheryl A Scannell, Peter J Hotez, Bruce Y Lee

Center for Medical Ethics and Health Policy Staff Publications

Background: With coronavirus disease 2019 (COVID-19) vaccination no longer mandated by many businesses/organizations, it is now up to individuals to decide whether to get any new boosters/updated vaccines going forward.

Methods: We developed a Markov model representing the potential clinical/economic outcomes from an individual perspective in the United States of getting versus not getting an annual COVID-19 vaccine.

Results: For an 18-49 year old, getting vaccinated at its current price ($60) can save the individual on average $30-$603 if the individual is uninsured and $4-$437 if the individual has private insurance, as long as the starting vaccine efficacy against severe …

Sars-Cov-2 Viral Load In The Nasopharynx At Time Of First Infection Among Unvaccinated Individuals, Leigh H Fisher, Jia Jin Kee, Albert Liu, Claudia M Espinosa, April K Randhawa, James Ludwig, Craig A Magaret, Samuel T Robinson, Peter B Gilbert, Ollivier Hyrien, James G Kublin, Nadine Rouphael, Ann R Falsey, Magdalena E Sobieszczyk, Hana M El Sahly, Beatriz Grinsztejn, Glenda E Gray, Karen L Kotloff, Cynthia L Gay, Brett Leav, Ian Hirsch, Frank Struyf, Lisa M Dunkle, Kathleen M Neuzil, Lawrence Corey, Yunda Huang, Paul A Goepfert, Stephen R Walsh, Lindsey R Baden, Holly Janes, Covid-19 Prevention Network (Covpn)

Faculty, Staff and Student Publications

Importance: SARS-CoV-2 viral load (VL) in the nasopharynx is difficult to quantify and standardize across settings, but it may inform transmission potential and disease severity.

Objective: To characterize VL at COVID-19 diagnosis among previously uninfected and unvaccinated individuals by evaluating the association of demographic and clinical characteristics, viral variant, and trial with VL, as well as the ability of VL to predict severe disease.

Design, setting, and participants: This secondary cross-protocol analysis used individual-level data from placebo recipients from 4 harmonized, phase 3 COVID-19 vaccine efficacy trials sponsored by Moderna, AstraZeneca, Janssen, and Novavax. Participants were SARS-CoV-2 negative at baseline …

Potential Impact Of Annual Vaccination With Reformulated Covid-19 Vaccines: Lessons From The Us Covid-19 Scenario Modeling Hub, Sung-Mok Jung, Sara L Loo, Emily Howerton, Lucie Contamin, Claire P Smith, Erica C Carcelén, Katie Yan, Samantha J Bents, John Levander, Jessi Espino, Joseph C Lemaitre, Koji Sato, Clifton D Mckee, Alison L Hill, Matteo Chinazzi, Jessica T Davis, Kunpeng Mu, Alessandro Vespignani, Erik T Rosenstrom, Sebastian A Rodriguez-Cartes, Julie S Ivy, Maria E Mayorga, Julie L Swann, Guido España, Sean Cavany, Sean M Moore, T Alex Perkins, Shi Chen, Rajib Paul, Daniel Janies, Jean-Claude Thill, Ajitesh Srivastava, Majd Al Aawar, Kaiming Bi, Shraddha Ramdas Bandekar, Anass Bouchnita, Spencer J Fox, Lauren Ancel Meyers, Przemyslaw Porebski, Srini Venkatramanan, Aniruddha Adiga, Benjamin Hurt, Brian Klahn, Joseph Outten, Jiangzhuo Chen, Henning Mortveit, Amanda Wilson, Stefan Hoops, Parantapa Bhattacharya, Dustin Machi, Anil Vullikanti, Bryan Lewis, Madhav Marathe, Harry Hochheiser, Michael C Runge, Katriona Shea, Shaun Truelove, Cécile Viboud, Justin Lessler

Faculty, Staff and Student Publications

BACKGROUND: Coronavirus Disease 2019 (COVID-19) continues to cause significant hospitalizations and deaths in the United States. Its continued burden and the impact of annually reformulated vaccines remain unclear. Here, we present projections of COVID-19 hospitalizations and deaths in the United States for the next 2 years under 2 plausible assumptions about immune escape (20% per year and 50% per year) and 3 possible CDC recommendations for the use of annually reformulated vaccines (no recommendation, vaccination for those aged 65 years and over, vaccination for all eligible age groups based on FDA approval).

METHODS AND FINDINGS: The COVID-19 Scenario Modeling Hub …

Recombinant Rod Domain Of Vimentin Reduces Sars-Cov-2 Viral Replication By Blocking Spike Protein-Ace2 Interactions, Fong Wilson Lam, Cameron August Brown, Shannon Elizabeth Ronca

Faculty, Staff and Students Publications

Although the SARS-CoV-2 vaccination is the primary preventive intervention, there are still few antiviral therapies available, with current drugs decreasing viral replication once the virus is intracellular. Adding novel drugs to target additional points in the viral life cycle is paramount in preventing future pandemics. The purpose of this study was to create and test a novel protein to decrease SARS-CoV-2 replication. We created the recombinant rod domain of vimentin (rhRod) in E. coli and used biolayer interferometry to measure its affinity to the SARS-CoV-2 S1S2 spike protein and the ability to block the SARS-CoV-2–ACE2 interaction. We performed plaque assays …

Development, Implementation, And Evaluation Of Three Outreach Events To Improve Covid-19 Vaccine Uptake Among Racial And Ethnic Minority Communities In Houston, Texas, 2022, Carmin Munoz-Lavanderos, Abiodun Oluyomi, Omar Rosales, Norvin Hernandez, Nana Mensah-Bonsu, Hoda Badr

Faculty, Staff and Students Publications

OBJECTIVES: Lack of access to timely, accurate, and linguistically appropriate COVID-19 information has complicated the dissemination of evidence-based information and contributed to vaccine hesitancy among racial and ethnic minority groups in the United States. We developed community events that provided outreach, education, and access to COVID-19 vaccination to overcome vaccine hesitancy in these communities.

METHODS: Using spatial analysis techniques, we identified 3 communities with low vaccine uptake in Houston, Texas, in fall 2021; engaged 20 stakeholders from these communities via 4 focus groups to understand barriers to vaccination; and developed and implemented 3 COVID-19 vaccine education and outreach events tailored …

Baseline Characteristics Of Sars-Cov-2 Vaccine Non-Responders In A Large Population-Based Sample, Ashraf Yaseen, Stacia M Desantis, Rachit Sabharwal, Yashar Talebi, Michael D Swartz, Shiming Zhang, Luis Leon Novelo, Cesar L Pinzon-Gomez, Sarah E Messiah, Melissa Valerio-Shewmaker, Harold W Kohl, Jessica Ross, David Lakey, Jennifer A Shuford, Stephen J Pont, Eric Boerwinkle

Faculty, Staff and Student Publications

INTRODUCTION: Studies indicate that individuals with chronic conditions and specific baseline characteristics may not mount a robust humoral antibody response to SARS-CoV-2 vaccines. In this paper, we used data from the Texas Coronavirus Antibody REsponse Survey (Texas CARES), a longitudinal state-wide seroprevalence program that has enrolled more than 90,000 participants, to evaluate the role of chronic diseases as the potential risk factors of non-response to SARS-CoV-2 vaccines in a large epidemiologic cohort.

METHODS: A participant needed to complete an online survey and a blood draw to test for SARS-CoV-2 circulating plasma antibodies at four-time points spaced at least three months …

Exploring The Relationship Between Vaccine Hesitancy And Mothers’ Perspectives On Covid-19 Vaccines For Children Ages 5–11 Years During The Omicron Predominant Period 2021–2022: A Qualitative Study, Tiffany A Suragh, David Adzrago, Marlyn A Allicock, Paul G Yeh, Paula Cuccaro

Faculty, Staff and Student Publications

Background: The United States Food and Drug Administration authorized COVID-19 vaccines for children ages 5-11 years in October 2021 during the Omicron predominant period. Parental vaccine hesitancy was prevalent during this time, resulting in low childhood COVID-19 vaccine uptake. Most studies exploring factors influencing parental vaccine hesitancy have focused on racial and ethnic minorities and lower socioeconomic populations; however, there is little knowledge of the drive drivers of vaccine hesitancy among White parents with higher education and socioeconomic statuses.

Methods: We conducted semi-structured interviews with a sample of 15 White mothers of children ages 5-11 years in Atlanta, GA, between …

Risk Of Covid-19 After Natural Infection Or Vaccination, Anne-Marie Rick, Matthew B Laurens, Ying Huang, Chenchen Yu, Thomas C S Martin, Carina A Rodriguez, Christina A Rostad, Rebone M Maboa, Lindsey R Baden, Hana M El Sahly, Beatriz Grinsztejn, Glenda E Gray, Cynthia L Gay, Peter B Gilbert, Holly E Janes, James G Kublin, Yunda Huang, Brett Leav, Ian Hirsch, Frank Struyf, Lisa M Dunkle, Kathleen M Neuzil, Lawrence Corey, Paul A Goepfert, Stephen R Walsh, Dean Follmann, Karen L Kotloff

Faculty, Staff and Student Publications

BACKGROUND: While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection.

METHODS: In this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection …

Dynamics Of Inflammatory Responses After Sars-Cov-2 Infection By Vaccination Status In The Usa: A Prospective Cohort Study, Xianming Zhu, Kelly A Gebo, Alison G Abraham, Feben Habtehyimer, Eshan U Patel, Oliver Laeyendecker, Thomas J Gniadek, Reinaldo E Fernandez, Owen R Baker, Malathi Ram, Edward R Cachay, Judith S Currier, Yuriko Fukuta, Jonathan M Gerber, Sonya L Heath, Barry Meisenberg, Moises A Huaman, Adam C Levine, Aarthi Shenoy, Shweta Anjan, Janis E Blair, Daniel Cruser, Donald N Forthal, Laura L Hammitt, Seble Kassaye, Giselle S Mosnaim, Bela Patel, James H Paxton, Jay S Raval, Catherine G Sutcliffe, Matthew Abinante, Patrick Broderick, Valerie Cluzet, Marie Elena Cordisco, Benjamin Greenblatt, Joann Petrini, William Rausch, David Shade, Karen Lane, Amy L Gawad, Sabra L Klein, Andrew Pekosz, Shmuel Shoham, Arturo Casadevall, Evan M Bloch, Daniel Hanley, David J Sullivan, Aaron A R Tobian

Faculty, Staff and Student Publications

BACKGROUND: Cytokines and chemokines play a critical role in the response to infection and vaccination. We aimed to assess the longitudinal association of COVID-19 vaccination with cytokine and chemokine concentrations and trajectories among people with SARS-CoV-2 infection.

METHODS: In this longitudinal, prospective cohort study, blood samples were used from participants enrolled in a multi-centre randomised trial assessing the efficacy of convalescent plasma therapy for ambulatory COVID-19. The trial was conducted in 23 outpatient sites in the USA. In this study, participants (aged ≥18 years) were restricted to those with COVID-19 before vaccination or with breakthrough infections who had blood samples …

Comparison Of Bivalent And Monovalent Sars-Cov-2 Variant Vaccines: The Phase 2 Randomized Open-Label Covail Trial, Angela R Branche, Nadine G Rouphael, David J Diemert, Ann R Falsey, Cecilia Losada, Lindsey R Baden, Sharon E Frey, Jennifer A Whitaker, Susan J Little, Evan J Anderson, Emmanuel B Walter, Richard M Novak, Richard Rupp, Lisa A Jackson, Tara M Babu, Angelica C Kottkamp, Anne F Luetkemeyer, Lilly C Immergluck, Rachel M Presti, Martín Bäcker, Patricia L Winokur, Siham M Mahgoub, Paul A Goepfert, Dahlene N Fusco, Elissa Malkin, Jeffrey M Bethony, Edward E Walsh, Daniel S Graciaa, Hady Samaha, Amy C Sherman, Stephen R Walsh, Getahun Abate, Zacharoula Oikonomopoulou, Hana M El Sahly, Thomas C S Martin, Satoshi Kamidani, Michael J Smith, Benjamin G Ladner, Laura Porterfield, Maya Dunstan, Anna Wald, Tamia Davis, Robert L Atmar, Mark J Mulligan, Kirsten E Lyke, Christine M Posavad, Megan A Meagher, David S Stephens, Kathleen M Neuzil, Kuleni Abebe, Heather Hill, Jim Albert, Kalyani Telu, Jinjian Mu, Teri C Lewis, Lisa A Giebeig, Amanda Eaton, Antonia Netzl, Samuel H Wilks, Sina Türeli, Mamodikoe Makhene, Sonja Crandon, David C Montefiori, Mat Makowski, Derek J Smith, Seema U Nayak, Paul C Roberts, John H Beigel, Covail Study Group

Faculty, Staff and Students Publications

Vaccine protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection wanes over time, requiring updated boosters. In a phase 2, open-label, randomized clinical trial with sequentially enrolled stages at 22 US sites, we assessed safety and immunogenicity of a second boost with monovalent or bivalent variant vaccines from mRNA and protein-based platforms targeting wild-type, Beta, Delta and Omicron BA.1 spike antigens. The primary outcome was pseudovirus neutralization titers at 50% inhibitory dilution (ID50 titers) with 95% confidence intervals against different SARS-CoV-2 strains. The secondary outcome assessed safety by solicited local and systemic adverse events (AEs), unsolicited AEs, serious AEs …

Clinical And Demographic Factors Associated With Covid-19, Severe Covid-19, And Sars-Cov-2 Infection In Adults: A Secondary Cross-Protocol Analysis Of 4 Randomized Clinical Trials, Deborah A Theodore, Angela R Branche, Lily Zhang, Daniel S Graciaa, Madhu Choudhary, Timothy J Hatlen, Raadhiya Osman, Tara M Babu, Samuel T Robinson, Peter B Gilbert, Dean Follmann, Holly Janes, James G Kublin, Lindsey R Baden, Paul Goepfert, Glenda E Gray, Beatriz Grinsztejn, Karen L Kotloff, Cynthia L Gay, Brett Leav, Jacqueline Miller, Ian Hirsch, Jerald Sadoff, Lisa M Dunkle, Kathleen M Neuzil, Lawrence Corey, Ann R Falsey, Hana M El Sahly, Magdalena E Sobieszczyk, Yunda Huang

Faculty, Staff and Student Publications

IMPORTANCE: Current data identifying COVID-19 risk factors lack standardized outcomes and insufficiently control for confounders.

OBJECTIVE: To identify risk factors associated with COVID-19, severe COVID-19, and SARS-CoV-2 infection.

DESIGN, SETTING, AND PARTICIPANTS: This secondary cross-protocol analysis included 4 multicenter, international, randomized, blinded, placebo-controlled, COVID-19 vaccine efficacy trials with harmonized protocols established by the COVID-19 Prevention Network. Individual-level data from participants randomized to receive placebo within each trial were combined and analyzed. Enrollment began July 2020 and the last data cutoff was in July 2021. Participants included adults in stable health, at risk for SARS-CoV-2, and assigned to the placebo group …

Factors, Enablers And Challenges For Covid-19 Vaccine Development, Jean-Louis Excler, Melanie Saville, Lois Privor-Dumm, Sarah Gilbert, Peter J Hotez, Didi Thompson, Salim Abdool-Karim, Jerome H Kim

Faculty, Staff and Students Publications

The COVID-19 pandemic triggered a sense of vulnerability and urgency that led to concerted actions by governments, funders, regulators and industry to overcome traditional challenges for the development of vaccine candidates and to reach authorisation. Unprecedented financial investments, massive demand, accelerated clinical development and regulatory reviews were among the key factors that contributed to accelerating the development and approval of COVID-19 vaccines. The rapid development of COVID-19 vaccines benefited of previous scientific innovations such as mRNA and recombinant vectors and proteins. This has created a new era of vaccinology, with powerful platform technologies and a new model for vaccine development. …

Vaccine Access, Equity And Justice: Covid-19 Vaccines And Vaccination, Lois Privor-Dumm, Jean-Louis Excler, Sarah Gilbert, Salim S Abdool Karim, Peter J Hotez, Didi Thompson, Jerome H Kim

Faculty, Staff and Students Publications

Although significant progress has been made in achieving goals for COVID-19 vaccine access, the quest for equity and justice remains an unfinished agenda. Vaccine nationalism has prompted calls for new approaches to achieve equitable access and justice not only for vaccines but also for vaccination. This includes ensuring country and community participation in global discussions and that local needs to strengthen health systems, address issues related to social determinants of health, build trust and leverage acceptance to vaccines, are addressed. Regional vaccine technology and manufacturing hubs are promising approaches to address access challenges and must be integrated with efforts to …

Covid-19 Vaccines And The Pandemic: Lessons Learnt For Other Neglected Diseases And Future Threats, Peter J Hotez, Sarah Gilbert, Melanie Saville, Lois Privor-Dumm, Salim Abdool-Karim, Didi Thompson, Jean-Louis Excler, Jerome H Kim

Faculty, Staff and Students Publications

Through the experiences gained by accelerating new vaccines for both Ebola virus infection and COVID-19 in a public health emergency, vaccine development has benefited from a 'multiple shots on goal' approach to new vaccine targets. This approach embraces simultaneous development of candidates with differing technologies, including, when feasible, vesicular stomatitis virus or adenovirus vectors, messenger RNA (mRNA), whole inactivated virus, nanoparticle and recombinant protein technologies, which led to multiple effective COVID-19 vaccines. The challenge of COVID-19 vaccine inequity, as COVID-19 spread globally, created a situation where cutting-edge mRNA technologies were preferentially supplied by multinational pharmaceutical companies to high-income countries while …

Bovine Lactoferrin For The Prevention Of Covid-19 Infection In Health Care Personnel: A Double-Blinded Randomized Clinical Trial (Lf-Covid), Rafaella Navarro, Jose Luis Paredes, Lourdes Tucto, Carlos Medina, Eddie Angles-Yanqui, Juan Carlos Nario, Jorge Ruiz-Cabrejos, Juan Luis Quintana, Kevin Turpo-Espinoza, Fernando Mejia-Cordero, Meylin Aphang-Lam, Jorge Florez, Gabriel Carrasco-Escobar, Theresa Jean Ochoa

Faculty, Staff and Student Publications

Lactoferrin (LF) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to determine the effect of bovine lactoferrin (bLF) in the prevention of SARS-CoV-2 infection in health care personnel. A randomized, double-blinded, placebo-controlled clinical trial was conducted in two tertiary hospitals that provide care to patients with SARS-CoV-2 infection in Lima, Peru. Daily supplementation with 600 mg of enteral bLF versus placebo for 90 days was compared. Participants were weekly screened for symptoms suggestive of SARS-CoV-2 infection and molecular testing was performed on suspected episodes. A serological test was obtained from all participants …

Higher Risk Of Short Term Covid-19 Vaccine Adverse Events In Myositis Patients With Autoimmune Comorbidities: Results From The Covad Study, Mrinalini Dey, Naveen R, Elena Nikiphorou, Parikshit Sen, Sreoshy Saha, James B Lilleker, Vishwesh Agarwal, Sinan Kardes, Jessica Day, Marcin Milchert, Mrudula Joshi, Tamer Gheita, Babur Salim, Tsvetelina Velikova, Abraham Edgar Gracia-Ramos, Ioannis Parodis, Albert Selva O'Callaghan, Minchul Kim, Tulika Chatterjee, Ai Lyn Tan, Ashima Makol, Arvind Nune, Lorenzo Cavagna, Miguel A Saavedra, Samuel Katsuyuki Shinjo, Nelly Ziade, Johannes Knitza, Masataka Kuwana, Oliver Distler, Bhupen Barman, Yogesh Preet Singh, Rajiv Ranjan, Avinash Jain, Sapan C Pandya, Rakesh Kumar Pilania, Aman Sharma, Manesh M Manoj, Vikas Gupta, Chengappa G Kavadichanda, Pradeepta Sekhar Patro, Sajal Ajmani, Sanat Phatak, Rudra Prosad Goswami, Abhra Chandra Chowdhury, Ashish Jacob Mathew, Padnamabha Shenoy, Ajay Asranna, Keerthi Talari Bommakanti, Anuj Shukla, Arunkumar R Pande, Kunal Chandwar, John D Pauling, Chris Wincup, Döndü Üsküdar Cansu, Erick Adrian Zamora Tehozol, Jorge Rojas Serrano, Ignacio García-De La Torre, Nicoletta Del Papa, Gianluca Sambataro, Atzeni Fabiola, Marcello Govoni, Simone Parisi, Elena Bartoloni Bocci, Gian Domenico Sebastiani, Enrico Fusaro, Marco Sebastiani, Luca Quartuccio, Franco Franceschini, Pier Paolo Sainaghi, Giovanni Orsolini, Rossella De Angelis, Maria Giovanna Danielli, Vincenzo Venerito, Lisa S Traboco, Leonardo Santos Hoff, Suryo Anggoro Kusumo Wibowo, Stylianos Tomaras, Daman Langguth, Vidya Limaye, Merrilee Needham, Nilesh Srivastav, Akira Yoshida, Ran Nakashima, Shinji Sato, Naoki Kimura, Yuko Kaneko, Jesús Loarce-Martos, Sergio Prieto-González, Albert Gil-Vila, Raquel Arànega Gonzalez, Hector Chinoy, Vikas Agarwal, Rohit Aggarwal, Latika Gupta

Faculty, Staff and Student Publications

No abstract provided.

Effect Of Thromboprophylaxis On Clinical Outcomes After Covid-19 Hospitalization, Tracy Y Wang, Abdus S Wahed, Alison Morris, Lisa Baumann Kreuziger, John G Quigley, Gervasio A Lamas, Alexandra J Weissman, Jose Lopez-Sendon, M Margaret Knudson, Deborah M Siegal, Raj S Kasthuri, Andrew J Alexander, Lana Wahid, Bassel Atassi, Peter J Miller, Janice W Lawson, Bela Patel, Jerry A Krishnan, Nancy L Shapiro, Deborah E Martin, Andrei L Kindzelski, Eric S Leifer, Jungnam Joo, Lingyun Lyu, Annie Pennella, Brendan M Everett, Mark W Geraci, Kevin J Anstrom, Thomas L Ortel, Activ-4c Study Group

Faculty, Staff and Student Publications

BACKGROUND: Patients hospitalized with COVID-19 have an increased incidence of thromboembolism. The role of extended thromboprophylaxis after hospital discharge is unclear.

OBJECTIVE: To determine whether anticoagulation is superior to placebo in reducing death and thromboembolic complications among patients discharged after COVID-19 hospitalization.

DESIGN: Prospective, randomized, double-blind, placebo-controlled clinical trial. (ClinicalTrials.gov: NCT04650087).

SETTING: Done during 2021 to 2022 among 127 U.S. hospitals.

PARTICIPANTS: Adults aged 18 years or older hospitalized with COVID-19 for 48 hours or more and ready for discharge, excluding those with a requirement for, or contraindication to, anticoagulation.

INTERVENTION: 2.5 mg of apixaban versus placebo twice daily for …

Shedding Light On Mechanisms Of Myocarditis With Covid-19 Mrna Vaccines, Biykem Bozkurt

Faculty, Staff and Students Publications

No abstract provided.

Evaluation Of Bnt162b2 Covid-19 Vaccine In Children Younger Than 5 Years Of Age, Flor M Muñoz, Lawrence D Sher, Charu Sabharwal, Alejandra Gurtman, Xia Xu, Nicholas Kitchin, Stephen Lockhart, Robert Riesenberg, Joanna M Sexter, Hanna Czajka, Grant C Paulsen, Yvonne Maldonado, Emmanuel B Walter, Kawsar R Talaat, Janet A Englund, Uzma N Sarwar, Caitlin Hansen, Martha Iwamoto, Chris Webber, Luke Cunliffe, Benita Ukkonen, Silvina N Martínez, Barbara A Pahud, Iona Munjal, Joseph B Domachowske, Kena A Swanson, Hua Ma, Kenneth Koury, Susan Mather, Claire Lu, Jing Zou, Xuping Xie, Pei-Yong Shi, David Cooper, Özlem Türeci, Uğur Şahin, Kathrin U Jansen, William C Gruber

Faculty, Staff and Students Publications

BACKGROUND: Safe and effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in young children.

METHODS: We conducted a phase 1 dose-finding study and are conducting an ongoing phase 2-3 safety, immunogenicity, and efficacy trial of the BNT162b2 vaccine in healthy children 6 months to 11 years of age. We present results for children 6 months to less than 2 years of age and those 2 to 4 years of age through the data-cutoff dates (April 29, 2022, for safety and immunogenicity and June 17, 2022, for efficacy). In the phase 2-3 trial, participants were randomly assigned (in a …

Evaluation Of Bnt162b2 Covid-19 Vaccine In Children Younger Than 5 Years Of Age, Flor M Muñoz, Lawrence D Sher, Charu Sabharwal, Alejandra Gurtman, Xia Xu, Nicholas Kitchin, Stephen Lockhart, Robert Riesenberg, Joanna M Sexter, Hanna Czajka, Grant C Paulsen, Yvonne Maldonado, Emmanuel B Walter, Kawsar R Talaat, Janet A Englund, Uzma N Sarwar, Caitlin Hansen, Martha Iwamoto, Chris Webber, Luke Cunliffe, Benita Ukkonen, Silvina N Martínez, Barbara A Pahud, Iona Munjal, Joseph B Domachowske, Kena A Swanson, Hua Ma, Kenneth Koury, Susan Mather, Claire Lu, Jing Zou, Xuping Xie, Pei-Yong Shi, David Cooper, Özlem Türeci, Uğur Şahin, Kathrin U Jansen, William C Gruber, C4591007 Clinical Trial Group

Faculty, Staff and Students Publications

BACKGROUND: Safe and effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in young children.

METHODS: We conducted a phase 1 dose-finding study and are conducting an ongoing phase 2-3 safety, immunogenicity, and efficacy trial of the BNT162b2 vaccine in healthy children 6 months to 11 years of age. We present results for children 6 months to less than 2 years of age and those 2 to 4 years of age through the data-cutoff dates (April 29, 2022, for safety and immunogenicity and June 17, 2022, for efficacy). In the phase 2-3 trial, participants were randomly assigned (in a …

A Longitudinal Seroepidemiology Study To Evaluate Antibody Response To Sars-Cov-2 Virus Infection And Vaccination In Children In Calgary, Canada From July 2020 To April 2022: Alberta Covid-19 Childhood Cohort (Ab3c) Study, Emily J Doucette, Joslyn Gray, Kevin Fonseca, Carmen Charlton, Jamil N Kanji, Graham Tipples, Susan Kuhn, Jessica Dunn, Payton Sayers, Nicola Symonds, Guosong Wu, Stephen B Freedman, James D Kellner

Faculty, Staff and Student Publications

BACKGROUND: Measurement of SARS-CoV-2 antibody seropositivity is important to accurately understand exposure to infection and/or vaccination in specific populations. This study aimed to estimate the serologic response to SARS-CoV-2 virus infection and vaccination in children in Calgary, Alberta over a two-year period.

METHODS: Children with or without prior SARS-CoV-2 infections, were enrolled in Calgary, Canada in 2020. Venous blood was sampled 4 times from July 2020 to April 2022 for SARS-CoV-2 nucleocapsid and spike antibodies. Demographic and clinical information was obtained including SARS-CoV-2 testing results and vaccination records.

RESULTS: 1035 children were enrolled and 88.9% completed all 4 visits; median …

Ethnic And Racial Differences In Self-Reported Symptoms, Health Status, Activity Level, And Missed Work At 3 And 6 Months Following Sars-Cov-2 Infection, Kelli N O'Laughlin, Robin E Klabbers, Imtiaz Ebna Mannan, Nicole L Gentile, Rachel E Geyer, Zihan Zheng, Huihui Yu, Shu-Xia Li, Kwun C G Chan, Erica S Spatz, Ralph C Wang, Michelle L'Hommedieu, Robert A Weinstein, Ian D Plumb, Michael Gottlieb, Ryan M Huebinger, Melissa Hagen, Joann G Elmore, Mandy J Hill, Morgan Kelly, Samuel Mcdonald, Kristin L Rising, Robert M Rodriguez, Arjun Venkatesh, Ahamed H Idris, Michelle Santangelo, Katherine Koo, Sharon Saydah, Graham Nichol, Kari A Stephens

Faculty, Staff and Student Publications

INTRODUCTION: Data on ethnic and racial differences in symptoms and health-related impacts following SARS-CoV-2 infection are limited. We aimed to estimate the ethnic and racial differences in symptoms and health-related impacts 3 and 6 months after the first SARS-CoV-2 infection.

METHODS: Participants included adults with SARS-CoV-2 infection enrolled in a prospective multicenter US study between 12/11/2020 and 7/4/2022 as the primary cohort of interest, as well as a SARS-CoV-2-negative cohort to account for non-SARS-CoV-2-infection impacts, who completed enrollment and 3-month surveys (

RESULTS: Following SARS-CoV-2 infection, the majority of symptoms were similar over time between ethnic and racial groups. At …

From Concept To Delivery: A Yeast-Expressed Recombinant Protein-Based Covid-19 Vaccine Technology Suitable For Global Access, Peter J Hotez, Rakesh Adhikari, Wen-Hsiang Chen, Yi-Lin Chen, Portia Gillespie, Nelufa Y Islam, Brian Keegan, Rakhi Tyagi Kundu, Jungsoon Lee, Zhuyun Liu, Jason T Kimata, Numan Oezguen, Jeroen Pollet, Cristina Poveda, Kay Razavi, Shannon E Ronca, Ulrich Strych, Syamala R Thimmiraju, Leroy Versteeg, Maria Jose Villar-Mondragon, Junfei Wei, Bin Zhan, Maria Elena Bottazzi

Faculty, Staff and Students Publications

Introduction: The development of a yeast-expressed recombinant protein-based vaccine technology co-developed with LMIC vaccine producers and suitable as a COVID-19 vaccine for global access is described. The proof-of-concept for developing a SARS-CoV-2 spike protein receptor-binding domain (RBD) antigen as a yeast-derived recombinant protein vaccine technology is described.

Areas covered: Genetic Engineering: The strategy is presented for the design and genetic modification used during cloning and expression in the yeast system. Process and Assay Development: A summary is presented of how a scalable, reproducible, and robust production process for the recombinant protein COVID-19 vaccine antigen was developed. Formulation and Pre-clinical Strategy: …