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Article: COVID-19 Epidemiology, Immunity, and Vaccine Development in Children: A Review.

Fergie, Jaime / Moran, Mary M / Cane, Alejandro / Pather, Shanti / Türeci, Ӧzlem / Srivastava, Amit

2022 Volume 10, Issue 12

Abstract: Although pediatric populations experienced lower COVID-19 severity and mortality than adults, the epidemiology of this disease continues to evolve. COVID-19 clinical manifestations in pediatrics commonly include fever and cough, but may differ from ... ...

Abstract	Although pediatric populations experienced lower COVID-19 severity and mortality than adults, the epidemiology of this disease continues to evolve. COVID-19 clinical manifestations in pediatrics commonly include fever and cough, but may differ from adults and by variant. Serious complications, including MIS-C, rarely occur. Although early data showed a decreased likelihood of COVID-19 transmission from children versus adults, outbreaks and viral shedding studies support pediatric transmission potential. Children may mount more robust initial immune responses to SARS-CoV-2 versus adults. COVID-19 vaccines with available pediatric data include BNT162b2, mRNA-1273, CoronaVac, and BBIBP-CorV. Depending on age group and jurisdiction, BNT162b2 and mRNA-1273 have received full approval or emergency/conditional authorization in the United States and European Union from 6 months of age. Clinical trials have shown BNT162b2 and mRNA-1273 safety and high efficacy in pediatric populations, with demonstrably noninferior immune responses versus young adults. Real-world studies further support BNT162b2 safety and effectiveness against the Delta variant. mRNA vaccination benefits are considered to outweigh risks, including myocarditis; however, pediatric vaccination rates remain relatively low. Given a growing body of clinical trial and real-world data showing vaccine safety and effectiveness, pediatric vaccination should be prioritized as an important strategy to control the pandemic.
Language	English
Publishing date	2022-11-29
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines10122039
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Article ; Online: The Cost of Seasonal Influenza: A Systematic Literature Review on the Humanistic and Economic Burden of Influenza in Older (≥ 65 Years Old) Adults.

Langer, Jakob / Welch, Verna L / Moran, Mary M / Cane, Alejandro / Lopez, Santiago M C / Srivastava, Amit / Enstone, Ashley / Sears, Amy / Markus, Kristen / Heuser, Maria / Kewley, Rachel / Whittle, Isabelle

Advances in therapy

2024 Volume 41, Issue 3, Page(s) 945–966

Abstract: Introduction: Adults aged ≥ 65 years contribute a large proportion of influenza-related hospitalizations and deaths due to increased risk of complications, which result in high medical costs and reduced health-related quality of life (HRQoL). Although ... ...

Abstract	Introduction: Adults aged ≥ 65 years contribute a large proportion of influenza-related hospitalizations and deaths due to increased risk of complications, which result in high medical costs and reduced health-related quality of life (HRQoL). Although seasonal influenza vaccines are recommended for older adults, the effectiveness of current vaccines is dependent on several factors including strain matching and recipient demographic factors. This systemic literature review aimed to explore the economic and humanistic burden of influenza in adults aged ≥ 65 years. Methods: An electronic database search was conducted to identify studies assessing the economic and humanistic burden of influenza, including influenza symptoms that impact the HRQoL and patient-related outcomes in adults aged ≥ 65 years. Studies were to be published in English and conducted in Germany, France, Spain, and Italy, the UK, USA, Canada, China, Japan, Brazil, Saudi Arabia, and South Africa. Results: Thirty-eight studies reported on the economic and humanistic burden of influenza in adults aged ≥ 65 years. Higher direct costs were reported for people at increased risk of influenza-related complications compared to those at low risk. Lower influenza-related total costs were found in those vaccinated with adjuvanted inactivated trivalent influenza vaccine (aTIV) compared to high-dose trivalent influenza vaccine (TIV-HD). Older age was associated with an increased occurrence and longer duration of certain influenza symptoms. Conclusion: Despite the limited data identified, results show that influenza exerts a high humanistic and economic burden in older adults. Further research is required to confirm findings and to identify the unmet needs of current vaccines.
MeSH term(s)	Humans ; Aged ; Influenza Vaccines ; Influenza, Human/prevention & control ; Quality of Life ; Financial Stress ; Seasons ; Cost-Benefit Analysis
Chemical Substances	Influenza Vaccines
Language	English
Publishing date	2024-01-23
Publishing country	United States
Document type	Systematic Review ; Journal Article ; Review
ZDB-ID	632651-1
ISSN	1865-8652 ; 0741-238X
ISSN (online)	1865-8652
ISSN	0741-238X
DOI	10.1007/s12325-023-02770-0
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Article ; Online: Meningococcal vaccination: a discussion with all adolescents, whether college-bound or not.

Alderfer, Justine T / Moran, Mary M / Srivastava, Amit / Isturiz, Raul E

Postgraduate medicine

2019 Volume 131, Issue 8, Page(s) 551–554

Abstract: ... ...

Abstract	Introduction
MeSH term(s)	Adolescent ; Decision Making ; Female ; Humans ; Male ; Meningococcal Infections/epidemiology ; Meningococcal Infections/prevention & control ; Meningococcal Vaccines/administration & dosage ; Neisseria meningitidis ; Patient Participation ; Practice Patterns, Physicians' ; United States ; Vaccination Coverage/statistics & numerical data ; Young Adult
Chemical Substances	Meningococcal Vaccines
Language	English
Publishing date	2019-10-14
Publishing country	England
Document type	Editorial
ZDB-ID	410138-8
ISSN	1941-9260 ; 0032-5481
ISSN (online)	1941-9260
ISSN	0032-5481
DOI	10.1080/00325481.2019.1671667
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Article ; Online: Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in patients with immunocompromising conditions: a review of available evidence.

Chilson, Erica / Scott, Daniel A / Schmoele-Thoma, Beate / Watson, Wendy / Moran, Mary M / Isturiz, Raul

Human vaccines & immunotherapeutics

2020 Volume 16, Issue 11, Page(s) 2758–2772

Abstract: Immunocompromising conditions increase the risk of invasive pneumococcal disease (IPD). Vaccine uptake in patients with these conditions may be low in part because of concerns about decreased immunogenicity and safety in these high-risk groups. We ... ...

Abstract	Immunocompromising conditions increase the risk of invasive pneumococcal disease (IPD). Vaccine uptake in patients with these conditions may be low in part because of concerns about decreased immunogenicity and safety in these high-risk groups. We conducted a literature search to identify publications describing antibody responses to 13-valent pneumococcal conjugate vaccine (PCV13) in immunocompromised individuals recommended for PCV13 vaccination by the US Advisory Committee on Immunization Practices (ACIP). This review summarizes immunogenicity data from 30 publications regarding the use of PCV13 comprising 2406 individuals considered at high risk for IPD by the ACIP. Although antibody responses to PCV13 in individuals with immunocompromising and high-risk conditions were variable and generally lower compared with healthy controls, the vaccine was immunogenic and was largely well tolerated. Based on these findings, concerns regarding immunogenicity and safety of PCV13 are not supported and should not be barriers to vaccination in high-risk populations.
MeSH term(s)	Advisory Committees ; Humans ; Immunocompromised Host ; Immunogenicity, Vaccine ; Pneumococcal Infections/prevention & control ; Pneumococcal Vaccines/adverse effects ; Vaccination ; Vaccines, Conjugate/adverse effects
Chemical Substances	Pneumococcal Vaccines ; Vaccines, Conjugate
Keywords	covid19
Language	English
Publishing date	2020-06-12
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2664176-8
ISSN	2164-554X ; 2164-5515
ISSN (online)	2164-554X
ISSN	2164-5515
DOI	10.1080/21645515.2020.1735224
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Article ; Online: The impact of COVID-19 vaccination in the US: Averted burden of SARS-COV-2-related cases, hospitalizations and deaths.

Yamana, Teresa K / Galanti, Marta / Pei, Sen / Di Fusco, Manuela / Angulo, Frederick J / Moran, Mary M / Khan, Farid / Swerdlow, David L / Shaman, Jeffrey

PloS one

2023 Volume 18, Issue 4, Page(s) e0275699

Abstract: By August 1, 2022, the SARS-CoV-2 virus had caused over 90 million cases of COVID-19 and one million deaths in the United States. Since December 2020, SARS-CoV-2 vaccines have been a key component of US pandemic response; however, the impacts of ... ...

Abstract	By August 1, 2022, the SARS-CoV-2 virus had caused over 90 million cases of COVID-19 and one million deaths in the United States. Since December 2020, SARS-CoV-2 vaccines have been a key component of US pandemic response; however, the impacts of vaccination are not easily quantified. Here, we use a dynamic county-scale metapopulation model to estimate the number of cases, hospitalizations, and deaths averted due to vaccination during the first six months of vaccine availability. We estimate that COVID-19 vaccination was associated with over 8 million fewer confirmed cases, over 120 thousand fewer deaths, and 700 thousand fewer hospitalizations during the first six months of the campaign.
MeSH term(s)	Humans ; SARS-CoV-2 ; COVID-19 Vaccines ; COVID-19/epidemiology ; COVID-19/prevention & control ; Vaccination ; Hospitalization
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2023-04-25
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0275699
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Article: Clinical outcomes of COVID-19 and influenza in hospitalized children <5 years in the US.

McGrath, Leah J / Moran, Mary M / Alfred, Tamuno / Reimbaeva, Maya / Di Fusco, Manuela / Khan, Farid / Welch, Verna L / Malhotra, Deepa / Cane, Alejandro / Lopez, Santiago M C

Frontiers in pediatrics

2023 Volume 11, Page(s) 1261046

Abstract: Introduction: We compared hospitalization outcomes of young children hospitalized with COVID-19 to those hospitalized with influenza in the United States.: Methods: Patients aged 0-<5 years hospitalized with an admission diagnosis of acute COVID-19 ( ... ...

Abstract	Introduction: We compared hospitalization outcomes of young children hospitalized with COVID-19 to those hospitalized with influenza in the United States. Methods: Patients aged 0-<5 years hospitalized with an admission diagnosis of acute COVID-19 (April 2021-March 2022) or influenza (April 2019-March 2020) were selected from the PINC AI Healthcare Database Special Release. Hospitalization outcomes included length of stay (LOS), intensive care unit (ICU) admission, oxygen supplementation, and mechanical ventilation (MV). Inverse probability of treatment weighting was used to adjust for confounders in logistic regression analyses. Results: Among children hospitalized with COVID-19 ( Conclusions: Hospitalized children with either SARS-CoV-2 or influenza had severe complications including ICU admission and oxygen supplementation. Nearly 10% received MV support. Both SARS-CoV-2 and influenza have the potential to cause severe illness in young children.
Language	English
Publishing date	2023-09-11
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2711999-3
ISSN	2296-2360
ISSN	2296-2360
DOI	10.3389/fped.2023.1261046
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Article ; Online: Impact of COVID-19 and effects of booster vaccination with BNT162b2 on six-month long COVID symptoms, quality of life, work productivity and activity impairment during Omicron.

Di Fusco, Manuela / Sun, Xiaowu / Moran, Mary M / Coetzer, Henriette / Zamparo, Joann M / Alvarez, Mary B / Puzniak, Laura / Tabak, Ying P / Cappelleri, Joseph C

Journal of patient-reported outcomes

2023 Volume 7, Issue 1, Page(s) 77

Abstract: Background: Longitudinal estimates of long COVID burden during Omicron remain limited. This study characterized long-term impacts of COVID-19 and booster vaccination on symptoms, Health-Related Quality of Life (HRQoL), and Work Productivity Activity ... ...

Abstract	Background: Longitudinal estimates of long COVID burden during Omicron remain limited. This study characterized long-term impacts of COVID-19 and booster vaccination on symptoms, Health-Related Quality of Life (HRQoL), and Work Productivity Activity Impairment (WPAI). Methods: Outpatients with ≥ 1 self-reported symptom and positive SARS-CoV-2 test at CVS Health United States test sites were recruited between 01/31 and 04/30/2022. Symptoms, EQ-5D and WPAI were collected via online surveys until 6 months following infection. Both observed and model-based estimates were analyzed. Effect sizes based on Cohen's d quantified the magnitude of outcome changes over time, within and between vaccination groups. Mixed models for repeated measures were conducted for multivariable analyses, adjusting for covariates. Logistic regression assessed odds ratio (OR) of long COVID between vaccination groups. Results: At long COVID start (Week 4), 328 participants included 87 (27%) Boosted with BNT162b2, 86 (26%) with a BNT162b2 primary series (Primed), and 155 (47%) Unvaccinated. Mean age was 42.0 years, 73.8% were female, 26.5% had ≥ 1 comorbidity, 36.9% prior infection, and 39.6% reported ≥ 3 symptoms (mean: 3.1 symptoms). At Month 6, among 260 participants, Boosted reported a mean of 1.1 symptoms versus 3.4 and 2.8 in Unvaccinated and Primed, respectively (p < 0.001). Boosted had reduced risks of ≥ 3 symptoms versus Unvaccinated (observed: OR 0.22, 95% CI 0.10-0.47, p < 0.001; model-based: OR 0.36, 95% CI 0.15-0.87, p = 0.019) and Primed (observed: OR 0.29, 95% CI 0.13-0.67, p = 0.003; model-based: OR 0.59, 95% CI 0.21-1.65, p = 0.459). Results were consistent using ≥ 2 symptoms. Regarding HRQoL, among those with long COVID, Boosted had higher EQ-5D Utility Index (UI) than Unvaccinated (observed: 0.922 vs. 0.731, p = 0.014; model-based: 0.910 vs. 0.758, p-value = 0.038) and Primed (0.922 vs. 0.648, p = 0.014; model-based: 0.910 vs. 0.708, p-value = 0.008). Observed and model-based estimates for EQ-VAS and UI among Boosted were comparable with pre-COVID since Month 3. Subjects vaccinated generally reported better WPAI scores. Conclusions: Long COVID negatively impacted HRQoL and WPAI. The BNT162b2 booster could have a beneficial effect in reducing the risk and burden of long COVID. Boosted participants reported fewer and less durable symptoms, which contributed to improve HRQoL and maintain WPAI levels. Limitations included self-reported data and small sample size for WPAI.
MeSH term(s)	Female ; Humans ; Adult ; Male ; Post-Acute COVID-19 Syndrome ; COVID-19/prevention & control ; BNT162 Vaccine ; Quality of Life ; SARS-CoV-2 ; Vaccination
Chemical Substances	BNT162 Vaccine
Language	English
Publishing date	2023-07-24
Publishing country	Germany
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2509-8020
ISSN (online)	2509-8020
DOI	10.1186/s41687-023-00616-5
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Article ; Online: High Clinical Burden of Influenza Disease in Adults Aged ≥ 65 Years: Can We Do Better? A Systematic Literature Review.

Langer, Jakob / Welch, Verna L / Moran, Mary M / Cane, Alejandro / Lopez, Santiago M C / Srivastava, Amit / Enstone, Ashley L / Sears, Amy / Markus, Kristen J / Heuser, Maria / Kewley, Rachel M / Whittle, Isabelle J

Advances in therapy

2023 Volume 40, Issue 4, Page(s) 1601–1627

Abstract: Introduction: Influenza is a respiratory infection associated with a significant clinical burden globally. Adults aged ≥ 65 years are at increased risk of severe influenza-related symptoms and complications due to chronic comorbidity and ... ...

Abstract	Introduction: Influenza is a respiratory infection associated with a significant clinical burden globally. Adults aged ≥ 65 years are at increased risk of severe influenza-related symptoms and complications due to chronic comorbidity and immunosenescence. Annual influenza vaccination is recommended; however, current influenza vaccines confer suboptimal protection, in part due to antigen mismatch and poor durability. This systematic literature review characterizes the global clinical burden of seasonal influenza among adults aged ≥ 65 years. Methods: An electronic database search was conducted and supplemented with a conference abstract search. Included studies described clinical outcomes in the ≥ 65 years population across several global regions and were published in English between January 1, 2012 and February 9, 2022. Results: Ninety-nine publications were included (accounting for > 156,198,287 total participants globally). Clinical burden was evident across regions, with most studies conducted in the USA and Europe. Risk of influenza-associated hospitalization increased with age, particularly in those aged ≥ 65 years living in long-term care facilities, with underlying comorbidities, and infected with A(H3N2) strains. Seasons dominated by circulating A(H3N2) strains saw increased risk of influenza-associated hospitalization, intensive care unit admission, and mortality within the ≥ 65 years population. Seasonal differences in clinical burden were linked to differences in circulating strains. Conclusions: Influenza exerts a considerable burden on adults aged ≥ 65 years and healthcare systems, with high incidence of hospitalization and mortality. Substantial influenza-associated clinical burden persists despite increasing vaccination coverage among adults aged ≥ 65 years across regions included in this review, which suggests limited effectiveness of currently available seasonal influenza vaccines. To reduce influenza-associated clinical burden, influenza vaccine effectiveness must be improved. Next generation vaccine production using mRNA technology has demonstrated high effectiveness against another respiratory virus-SARS-CoV-2-and may overcome the practical limitations associated with traditional influenza vaccine production.
MeSH term(s)	Adult ; Humans ; Aged ; Influenza, Human/epidemiology ; Influenza, Human/prevention & control ; Influenza Vaccines/therapeutic use ; Influenza A Virus, H3N2 Subtype ; COVID-19 ; SARS-CoV-2 ; Vaccination
Chemical Substances	Influenza Vaccines
Language	English
Publishing date	2023-02-15
Publishing country	United States
Document type	Systematic Review ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	632651-1
ISSN	1865-8652 ; 0741-238X
ISSN (online)	1865-8652
ISSN	0741-238X
DOI	10.1007/s12325-023-02432-1
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Article ; Online: The impact of vaccination and outpatient treatment on the economic burden of Covid-19 in the United States omicron era: a systematic literature review.

Pierre, Vicki / Draica, Florin / Di Fusco, Manuela / Yang, Jingyan / Nunez-Gonzalez, Solange / Kamar, Joanna / Lopez, Santiago / Moran, Mary M / Nguyen, Jennifer / Alvarez, Piedad / Cha-Silva, Ashley / Gavaghan, Meghan / Yehoshua, Alon / Stapleton, Naomi / Burnett, Heather

Journal of medical economics

2023 Volume 26, Issue 1, Page(s) 1519–1531

Abstract: Aims: To identify and synthesize evidence regarding how coronavirus disease 2019 (COVID-19) interventions, including vaccines and outpatient treatments, have impacted healthcare resource use (HCRU) and costs in the United States (US) during the Omicron ... ...

Abstract	Aims: To identify and synthesize evidence regarding how coronavirus disease 2019 (COVID-19) interventions, including vaccines and outpatient treatments, have impacted healthcare resource use (HCRU) and costs in the United States (US) during the Omicron era. Materials and methods: A systematic literature review (SLR) was performed to identify articles published between 1 January 2021 and 10 March 2023 that assessed the impact of vaccination and outpatient treatment on costs and HCRU outcomes associated with COVID-19. Screening was performed by two independent researchers using predefined inclusion/exclusion criteria. Results: Fifty-eight unique studies were included in the SLR, of which all reported HCRU outcomes, and one reported costs. Overall, there was a significant reduction in the risk of COVID-19-related hospitalization for patients who received an original monovalent primary series vaccine plus booster dose vs. no vaccination. Moreover, receipt of a booster vaccine was associated with a lower risk of hospitalization vs. primary series vaccination. Evidence also indicated a significantly reduced risk of hospitalizations among recipients of nirmatrelvir/ritonavir (NMV/r), remdesivir, sotrovimab, and molnupiravir compared to non-recipients. Treated and/or vaccinated patients also experienced reductions in intensive care unit (ICU) admissions, length of stay, and emergency department (ED)/urgent care clinic encounters. Limitations: The identified studies may not represent unique patient populations as many utilized the same regional/national data sources. Synthesis of the evidence was also limited by differences in populations, outcome definitions, and varying duration of follow-up across studies. Additionally, significant gaps, including HCRU associated with long COVID and various high-risk populations and cost data, were observed. Conclusions: Despite evidence gaps, findings from the SLR highlight the significant positive impact that vaccination and outpatient treatment have had on HCRU in the US, including periods of Omicron predominance. Continued research is needed to inform clinical and policy decision-making in the US as COVID-19 continues to evolve as an endemic disease.
MeSH term(s)	Humans ; COVID-19/prevention & control ; Financial Stress ; Post-Acute COVID-19 Syndrome ; Outpatients ; Vaccination ; Vaccines
Chemical Substances	Vaccines
Language	English
Publishing date	2023-11-27
Publishing country	England
Document type	Systematic Review ; Journal Article ; Review
ZDB-ID	2270945-9
ISSN	1941-837X ; 1369-6998
ISSN (online)	1941-837X
ISSN	1369-6998
DOI	10.1080/13696998.2023.2281882
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Article ; Online: Public health impact of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in the first year of rollout in the United States.

Di Fusco, Manuela / Marczell, Kinga / Deger, Kristen A / Moran, Mary M / Wiemken, Timothy L / Cane, Alejandro / de Boisvilliers, Solène / Yang, Jingyan / Vaghela, Shailja / Roiz, Julie

Journal of medical economics

2022 Volume 25, Issue 1, Page(s) 605–617

Abstract: Background: As the body of evidence on COVID-19 and post-vaccination outcomes continues to expand, this analysis sought to evaluate the public health impact of the Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, during the first year of its rollout in the ... ...

Abstract	Background: As the body of evidence on COVID-19 and post-vaccination outcomes continues to expand, this analysis sought to evaluate the public health impact of the Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, during the first year of its rollout in the US. Methods: A combined Markov decision tree model compared clinical and economic outcomes of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) versus no vaccination in individuals aged ≥12 years. Age-stratified epidemiological, clinical, economic, and humanistic parameters were derived from existing data and published literature. Scenario analysis explored the impact of using lower and upper bounds of parameters on the results. The health benefits were estimated as the number of COVID-19 symptomatic cases, hospitalizations and deaths averted, and Quality Adjusted Life Years (QALYs) saved. The economic benefits were estimated as the amount of healthcare and societal cost savings associated with the vaccine-preventable health outcomes. Results: It was estimated that, in 2021, the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) contributed to averting almost 9 million symptomatic cases, close to 700,000 hospitalizations, and over 110,000 deaths, resulting in an estimated $30.4 billion direct healthcare cost savings, $43.7 billion indirect cost savings related to productivity loss, as well as discounted gains of 1.1 million QALYs. Scenario analyses showed that these results were robust; the use of alternative plausible ranges of parameters did not change the interpretation of the findings. Conclusions: The Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) contributed to generate substantial public health impact and vaccine-preventable cost savings in the first year of its rollout in the US. The vaccine was estimated to prevent millions of COVID-19 symptomatic cases and thousands of hospitalizations and deaths, and these averted outcomes translated into cost-savings in the billions of US dollars and thousands of QALYs saved. As only direct impacts of vaccination were considered, these estimates may be conservative.
MeSH term(s)	BNT162 Vaccine ; COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19 Vaccines ; Cost Savings ; Humans ; Public Health ; United States/epidemiology
Chemical Substances	COVID-19 Vaccines ; BNT162 Vaccine (N38TVC63NU)
Language	English
Publishing date	2022-05-09
Publishing country	England
Document type	Journal Article
ZDB-ID	2270945-9
ISSN	1941-837X ; 1369-6998
ISSN (online)	1941-837X
ISSN	1369-6998
DOI	10.1080/13696998.2022.2071427
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