The national COVID-19 vaccination campaign targeting the extremely vulnerable: the Florence Medical Oncology Unit experience in patients with cancer

Pino, Maria Simona; Cheli, Simone; Perna, Marco; Fabbroni, Valentina; Giordano, Clara; Martella, Francesca; Lanini, Fabio; Ribecco, Angela Stefania; Scoccianti, Silvia; Bacci, Carlotta; Bassareo, Valentina; Bertolini, Ilaria; Leonardo, Greta Di; Fulignati, C; Grifoni, Raffaella; Molinara, Elena; Rangan, Sheila; Tassi, Renato; Furlan, Federica; Goldzweig, Gil; Bassetti, Andrea; Fioretto, Luisa

doi:10.1016/j.ejca.2022.04.008

Cited by 4 publications

(5 citation statements)

References 27 publications

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“…Overall, 178,298 and 170,760 patients received mRNA-1273 and BNT162b2, respectively. Studies included mostly US populations (n=12) ( 18 , 44 , 46 , 55 – 59 , 61 , 64 , 65 , 67 ), with the remaining trials reporting data on patients from Spain (n=2) ( 45 , 62 ), Italy (n=1) ( 63 ), Singapore (n=1) ( 66 ), and multiple countries (n=1) ( 60 ). Specific at-risk and IC conditions included solid organ transplant (n=5) ( 44 , 45 , 55 , 61 , 67 ), cancer (n=5) ( 18 , 44 , 58 , 63 , 64 ), hemodialysis (n=2) ( 56 , 65 ), rheumatologic disease (n=3) ( 18 , 46 , 60 ), multiple sclerosis or other neurologic autoimmune disease (n=2) ( 57 , 66 ), inflammatory bowel disease (n=1) ( 59 ), and hematologic disorders (n=1) ( 62 ).…”

Section: Resultsmentioning

confidence: 99%

“…Individuals received ≥2 doses of mRNA-1273 or BNT162b2. Data on 2-dose regimens were considered if reported (n=13) ( 18 , 44 , 45 , 55 – 57 , 59 – 62 , 64 , 65 , 67 ); otherwise, data from 3- or 4-dose regimens (n=4) ( 46 , 58 , 63 , 66 ) were used. Outcomes were assessed ≥14 days after the second dose (n=13) ( 18 , 44 , 45 , 55 , 56 , 58 , 60 – 64 , 66 , 67 ), other timepoints (n=2) ( 46 , 65 ), and ≥7 days after the second dose (n=1) ( 59 ).…”

Section: Resultsmentioning

confidence: 99%

“…Variants of concern were delta (n=6) ( 18 , 44 , 45 , 62 , 64 , 67 ), delta and omicron (n=2) ( 58 , 66 ), delta and beta (n=1) ( 56 ), and pre-omicron variants (n=1) ( 46 ). Seven studies did not directly specify the variant assessed ( 55 , 57 , 59 – 61 , 63 , 65 ).…”

Section: Resultsmentioning

confidence: 99%

“…Analysis of 5 studies reporting SARS-CoV-2 infection in patients with cancer (18,44,(62)(63)(64) (18,46,57,59,66). No association between mRNA vaccine type and risk of infection was found for the 4 studies reporting SARS-CoV-2 infection in solid organ transplant recipients (RR, 1.05 [95% CI, 0.87-1.26]; RD, −93 [95% CI, −573 to 386]) (44,55,61,67).…”

Section: Sars-cov-2 Infectionmentioning

confidence: 99%

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Comparative effectiveness of mRNA-1273 and BNT162b2 COVID-19 vaccines in immunocompromised individuals: a systematic review and meta-analysis using the GRADE framework

Wang,

Haeussler,

Spellman

et al. 2023

Front. Immunol.

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IntroductionDespite representing only 3% of the US population, immunocompromised (IC) individuals account for nearly half of the COVID-19 breakthrough hospitalizations. IC individuals generate a lower immune response after vaccination in general, and the US CDC recommended a third dose of either mRNA-1273 or BNT162b2 COVID-19 vaccines as part of their primary series. Influenza vaccine trials have shown that increasing dosage could improve effectiveness in IC populations. The objective of this systematic literature review and pairwise meta-analysis was to evaluate the clinical effectiveness of mRNA-1273 (50 or 100 mcg/dose) vs BNT162b2 (30 mcg/dose) in IC populations using the GRADE framework.MethodsThe systematic literature search was conducted in the World Health Organization COVID-19 Research Database. Studies were included in the pairwise meta-analysis if they reported comparisons of mRNA-1273 and BNT162b2 in IC individuals ≥18 years of age; outcomes of interest were symptomatic, laboratory-confirmed SARS-CoV-2 infection, SARS-CoV-2 infection, severe SARS-CoV-2 infection, hospitalization due to COVID-19, and mortality due to COVID-19. Risk ratios (RR) were pooled across studies using random-effects meta-analysis models. Outcomes were also analyzed in subgroups of patients with cancer, autoimmune disease, and solid organ transplant. Risk of bias was assessed using the Newcastle-Ottawa Scale for observational studies. Evidence was evaluated using the GRADE framework.ResultsOverall, 17 studies were included in the pairwise meta-analysis. Compared with BNT162b2, mRNA-1273 was associated with significantly reduced risk of SARS-CoV-2 infection (RR, 0.85 [95% CI, 0.75–0.97]; P=0.0151; I2 = 67.7%), severe SARS-CoV-2 infection (RR, 0.85 [95% CI, 0.77–0.93]; P=0.0009; I2 = 0%), COVID-19–associated hospitalization (RR, 0.88 [95% CI, 0.79–0.97]; P<0.0001; I2 = 0%), and COVID-19–associated mortality (RR, 0.63 [95% CI, 0.44–0.90]; P=0.0119; I2 = 0%) in IC populations. Results were consistent across subgroups. Because of sample size limitations, relative effectiveness of COVID-19 mRNA vaccines in IC populations cannot be studied in randomized trials. Based on nonrandomized studies, evidence certainty among comparisons was type 3 (low) and 4 (very low), reflecting potential biases in observational studies.ConclusionThis GRADE meta-analysis based on a large number of consistent observational studies showed that the mRNA-1273 COVID-19 vaccine is associated with improved clinical effectiveness in IC populations compared with BNT162b2.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Sars-cov-2 Infectionmentioning

confidence: 99%

See 2 more Smart Citations

Comparative effectiveness of mRNA-1273 and BNT162b2 COVID-19 vaccines in immunocompromised individuals: a systematic review and meta-analysis using the GRADE framework

Wang,

Haeussler,

Spellman

et al. 2023

Front. Immunol.

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show abstract

“…However, there is an increase in the risk of morbidity and mortality in paediatric cancer patients, particularly from low-and middle-income countries (LMIC) 3 . In this regard, the clinical value of SARS-CoV-2 vaccination in adult oncology patients has been ascertained as a vital measure to reduce hospitalisation, development of severe disease and death [4][5][6] . Although trial data in paediatric oncology groups is lacking, data demonstrating high efficacy of vaccines in children 7,8 have led to recommendations from global healthcare authorities to vaccinate paediatric oncology children, with formal guidance issued alongside vaccination protocols 6,[9][10][11] .…”

Section: Introductionmentioning

confidence: 99%

Global caregiver concerns of SARS-CoV-2 vaccination in children with cancer: a cross-sectional mixed-methods study

Gumy

Silverstein

Kaye

et al. 2022

Pediatric Hematology and Oncology

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The objective of this study was to understand global caregiver about SARS-CoV-2 vaccination for children with cancer and to provide healthcare providers with guidance to support parental decision-making. A co-designed cross-sectional mixed-methods survey was distributed to primary caregivers of children with cancer globally between April and May 2021 via several media. Caregivers were asked to rate the importance of vaccine-related questions and the median scores were ranked. Principal Component Analysis was conducted to identify underlying dimensions of caregiver concerns by World Bank income groups. Content analysis of free-text responses was conducted and triangulated with the quantitative findings. 627 caregivers from 22 countries responded to the survey with 5.3% (n = 67) responses from low-and-middle-income countries (LMIC). 184 caregivers (29%) provided free-text responses. Side effects and vaccine safety were caregivers' primary concerns in all countries. Questions related to logistics were of concern for caregivers in LMIC. A small minority of caregivers (n = 17) did not consider the survey questions important; free-text analysis identified these parents as vaccine hesitant, some of them quoting safety and side effects as main reasons for hesitancy. Healthcare providers and other community organizations globally need to provide tailored information about vaccine safety and effectiveness in pediatric oncology settings. Importantly, continued efforts are imperative to reduce global inequities in logistical access to vaccines, particularly in LMIC.

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Comparative Effectiveness of mRNA-1273 and BNT162b2 COVID-19 Vaccines in Immunocompromised Individuals: A Systematic Review and Meta-Analysis Using the GRADE Framework

Wang¹,

Haeussler²,

Spellman

et al. 2023

Preprint

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Introduction: Despite representing only 3% of the US population, immunocompromised (IC) individuals account for nearly half of the COVID-19 breakthrough hospitalizations. IC individuals generate a lower immune response following vaccination in general, and the US CDC recommended a third dose of either mRNA-1273 or BNT162b2 COVID-19 vaccines as part of their primary series. Influenza vaccine trials have shown that increasing dosage could improve effectiveness in IC populations. The objective of this systematic literature review and pairwise meta-analysis was to evaluate the clinical effectiveness of mRNA-1273 (50 or 100 mcg/dose) versus BNT162b2 (30 mcg/dose) in IC populations using the GRADE framework. Methods: The systematic literature search was conducted in the World Health Organization COVID-19 Research Database. Studies were included in the pairwise meta-analysis if they reported comparisons of mRNA-1273 and BNT162b2 in IC individuals ≥18 years of age; outcomes of interest were SARS-CoV-2 infection, hospitalization due to COVID-19, and mortality due to COVID-19. Risk ratios (RR) were pooled across studies using random-effects meta-analysis models. Outcomes were also analyzed in subgroups of patients with cancer, autoimmune disease, and solid organ transplant. Risk of bias was assessed for randomized and observational studies using the Risk of Bias 2 tool and the Newcastle-Ottawa Scale, respectively. Evidence was evaluated using the GRADE framework. Results: Overall, 22 studies were included in the pairwise meta-analysis. Compared with BNT162b2, mRNA-1273 was associated with significantly reduced risk of SARS-CoV-2 infection (RR 0.87, 95% CI 0.79-0.96; P=0.0054; I2=61.9%), COVID-19-associated hospitalization (RR 0.83, 95% CI 0.76-0.90; P<0.0001; I2=0%), and COVID-19-associated mortality (RR 0.62, 95% CI 0.43-0.89; P=0.011; I2=0%) in IC populations. Results were consistent across subgroups. Because of sample size limitations, relative effectiveness of COVID-19 mRNA vaccines in IC populations cannot be studied in randomized trials and evidence certainty among comparisons was type 3 (low) and 4 (very low), reflecting potential biases in observational studies. Conclusion: This GRADE meta-analysis based on a large number of consistent observational studies showed that the mRNA-1273 COVID-19 vaccine is associated with improved clinical effectiveness in IC populations compared with BNT162b2.

show abstract

The national COVID-19 vaccination campaign targeting the extremely vulnerable: the Florence Medical Oncology Unit experience in patients with cancer

Cited by 4 publications

References 27 publications

Comparative effectiveness of mRNA-1273 and BNT162b2 COVID-19 vaccines in immunocompromised individuals: a systematic review and meta-analysis using the GRADE framework

Comparative effectiveness of mRNA-1273 and BNT162b2 COVID-19 vaccines in immunocompromised individuals: a systematic review and meta-analysis using the GRADE framework

Global caregiver concerns of SARS-CoV-2 vaccination in children with cancer: a cross-sectional mixed-methods study

Comparative Effectiveness of mRNA-1273 and BNT162b2 COVID-19 Vaccines in Immunocompromised Individuals: A Systematic Review and Meta-Analysis Using the GRADE Framework

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