Real-time analysis of a mass vaccination effort confirms the safety of FDA-authorized mRNA COVID-19 vaccines

McMurry, Reid; Lenehan, Patrick; Awasthi, Samir; Silvert, Eli; Puranik, Arjun; Pawlowski, Colin; Venkatakrishnan, AJ; Agarwal, Vineet; O’Horo, John C.; Gores, Gregory J.; Williams, Amy W.; Badley, Andrew D.; Halamka, John; Virk, Abinash; Swift, Melanie D.; Carlson, Katherine; Doddahonnaiah, Deeksha; Metzger, Anna; Kayal, Nikhil; Berner, Gabriela; Ramudu, Eshwan; Carpenter, Corinne; Wagner, Tyler; Rajasekharan, Ajit; Soundararajan, Venky

doi:10.1016/j.medj.2021.06.006

Cited by 51 publications

(70 citation statements)

References 29 publications

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“…Previous research has shown the importance of active solicitation of information [68] and EMRs are now being used to help evaluate the effectiveness [69] and potential side effects [70,71] of COVID-19 vaccines. Similarly, EMR-based data has been utilized previously in studies looking at the effects of the COVID-19 pandemic as a stressor on people with bipolar disorder [72], the safety of the COVID-19 vaccine in pregnant women [73], the effect of COVID-19 on pregnancy outcomes [74], the effects of clinical characteristics on outcomes of COVID-19 patients [75][76][77], the factors that influence pharmacotherapy for tobacco dependence in the VA system [78], the effect of mental health disorders on COVID-19 mortality [79], COVID-19 vaccine adverse effects [68], and the effects of the COVID-19 pandemic on body mass index in children [80]. Thus, the present study builds upon a growing body of research examining similar effects of the COVID-19 pandemic.…”

Section: Discussionmentioning

confidence: 99%

Changes in Tobacco Use Patterns among Veterans in San Diego during the Recent Peak of the COVID-19 Pandemic

Fatollahi

Bentley

Doran

et al. 2021

IJERPH

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The prevalence of tobacco use increases in times of stress; however, during the initial stage of the COVID-19 pandemic, tobacco use rates stayed the same in most populations. Previous work focused on the initial months of the pandemic, while this study examined the changes in tobacco use during a later peak period of the pandemic. We used data from 61,852 visits to the VA San Diego Healthcare System from November 2019 to February 2021, divided into pre-, early, and peak pandemic periods. Multinomial logistic regression was used to test whether the odds of being a daily or non-daily tobacco user varied over time, by demographic group, or with the presence of specific psychiatric diagnoses. Younger Veterans had a greater reduction in the prevalence of non-daily tobacco use between the early and peak periods, while older Veterans had a rise in daily use from pre- to the early pandemic, which returned to baseline during the peak. Individuals with substance use disorder and serious mental illness diagnoses were more likely to report tobacco use, but psychiatric diagnoses did not predict change over time. These findings demonstrate factors that potentially contribute to changes in tobacco use during a public health crisis and may help guide future targeted cessation efforts.

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Section: Discussionmentioning

confidence: 99%

Changes in Tobacco Use Patterns among Veterans in San Diego during the Recent Peak of the COVID-19 Pandemic

Fatollahi

Bentley

Doran

et al. 2021

IJERPH

View full text Add to dashboard Cite

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“…4 Additional real-world retrospective studies in major health systems in the United States and Israel further support the effectiveness and safety of these vaccines. [5][6][7] However, only about 50% of the United States population is fully vaccinated as of July 2021, with an even lower fraction fully vaccinated across the globe. 2 Further, there have been reports of reduced vaccine effectiveness against emerging variants and local increases in COVID-19 cases despite mass vaccination, raising questions about the potential need to administer vaccine booster doses and to develop variant-targeted vaccines in the future.…”

Section: Introductionmentioning

confidence: 99%

Comparison of two highly-effective mRNA vaccines for COVID-19 during periods of Alpha and Delta variant prevalence

Puranik

Lenehan

Silvert

et al. 2021

Preprint

Self Cite

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Although clinical trials and real-world studies have affirmed the effectiveness and safety of the FDA-authorized COVID-19 vaccines, reports of breakthrough infections and persistent emergence of new variants highlight the need to vigilantly monitor the effectiveness of these vaccines. Here we compare the effectiveness of two full-length Spike protein-encoding mRNA vaccines from Moderna (mRNA-1273) and Pfizer/BioNTech (BNT162b2) in the Mayo Clinic Health System over time from January to July 2021, during which either the Alpha or Delta variant was highly prevalent. We defined cohorts of vaccinated and unvaccinated individuals from Minnesota (n = 25,589 each) matched on age, sex, race, history of prior SARS-CoV-2 PCR testing, and date of full vaccination. Both vaccines were highly effective during this study period against SARS-CoV-2 infection (mRNA-1273: 86%, 95%CI: 81-90.6%; BNT162b2: 76%, 95%CI: 69-81%) and COVID-19 associated hospitalization (mRNA-1273: 91.6%, 95% CI: 81-97%; BNT162b2: 85%, 95% CI: 73-93%). In July, vaccine effectiveness against hospitalization has remained high (mRNA-1273: 81%, 95% CI: 33-96.3%; BNT162b2: 75%, 95% CI: 24-93.9%), but effectiveness against infection was lower for both vaccines (mRNA-1273: 76%, 95% CI: 58-87%; BNT162b2: 42%, 95% CI: 13-62%), with a more pronounced reduction for BNT162b2. Notably, the Delta variant prevalence in Minnesota increased from 0.7% in May to over 70% in July whereas the Alpha variant prevalence decreased from 85% to 13% over the same time period. Comparing rates of infection between matched individuals fully vaccinated with mRNA-1273 versus BNT162b2 across Mayo Clinic Health System sites in multiple states (Minnesota, Wisconsin, Arizona, Florida, and Iowa), mRNA-1273 conferred a two-fold risk reduction against breakthrough infection compared to BNT162b2 (IRR = 0.50, 95% CI: 0.39-0.64). In Florida, which is currently experiencing its largest COVID-19 surge to date, the risk of infection in July after full vaccination with mRNA-1273 was about 60% lower than after full vaccination with BNT162b2 (IRR: 0.39, 95% CI: 0.24-0.62). Our observational study highlights that while both mRNA COVID-19 vaccines strongly protect against infection and severe disease, further evaluation of mechanisms underlying differences in their effectiveness such as dosing regimens and vaccine composition are warranted.

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“…4,5 These advances have enabled the rapid assessment of the real-world effectiveness and safety of the messenger RNA (mRNA) vaccines mRNA-1273 (Moderna) and BNT162b2 (Pfizer/BioNTech) as well as a targeted investigation of the incidence of cerebral venous sinus thrombosis among patients receiving COVID-19 vaccines (including Ad26.COV2.S) within the Mayo Clinic Health System. [6][7][8] We believe such approaches are essential for the development and deployment of vaccines and, most importantly, to build trust and transparency for the public. Here, we expand on this effort to conduct a preliminary assessment of the effectiveness of the Ad26.COV2.S vaccine using EHR data from the Mayo Clinic and Mayo Clinic Health System between February 27 and July 22, 2021.…”

Section: Introductionmentioning

confidence: 99%

Analysis of the Effectiveness of the Ad26.COV2.S Adenoviral Vector Vaccine for Preventing COVID-19

et al. 2021

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IMPORTANCEContinuous assessment of the effectiveness and safety of the US Food and Drug Administration-authorized SARS-CoV-2 vaccines is critical to amplify transparency, build public trust, and ultimately improve overall health outcomes. OBJECTIVE To evaluate the effectiveness of the Johnson & Johnson Ad26.COV2.S vaccine for preventing SARS-CoV-2 infection. DESIGN, SETTING, AND PARTICIPANTS This comparative effectiveness research study used largescale longitudinal curation of electronic health records from the multistate Mayo Clinic Health System (Minnesota, Arizona, Florida, Wisconsin, and Iowa) to identify vaccinated and unvaccinated adults between February 27 and July 22, 2021. The unvaccinated cohort was matched on a propensity score derived from age, sex, zip code, race, ethnicity, and previous number of SARS-CoV-2 polymerase chain reaction tests. The final study cohort consisted of 8889 patients in the vaccinated group and 88 898 unvaccinated matched patients. EXPOSURE Single dose of the Ad26.COV2.S vaccine. MAIN OUTCOMES AND MEASURES The incidence rate ratio of SARS-CoV-2 infection in the vaccinated vs unvaccinated control cohorts, measured by SARS-CoV-2 polymerase chain reaction testing. RESULTS The study was composed of 8889 vaccinated patients (4491 men [50.5%]; mean [SD] age, 52.4 [16.9] years) and 88 898 unvaccinated patients (44 748 men [50.3%]; mean [SD] age, 51.7 [16.7] years). The incidence rate ratio of SARS-CoV-2 infection in the vaccinated vs unvaccinated control cohorts was 0.26 (95% CI, 0.20-0.34) (60 of 8889 vaccinated patients vs 2236 of 88 898 unvaccinated individuals), which corresponds to an effectiveness of 73.6% (95% CI, 65.9%-79.9%) and a 3.73-fold reduction in SARS-CoV-2 infections.CONCLUSIONS AND RELEVANCE This study's findings are consistent with the clinical trialreported efficacy of Ad26.COV2.S and the first retrospective analysis, suggesting that the vaccine is effective at reducing SARS-CoV-2 infection, even with the spread of variants such as Alpha or Delta that were not present in the original studies, and reaffirm the urgent need to continue mass vaccination efforts globally.

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Real-time analysis of a mass vaccination effort confirms the safety of FDA-authorized mRNA COVID-19 vaccines

Cited by 51 publications

References 29 publications

Changes in Tobacco Use Patterns among Veterans in San Diego during the Recent Peak of the COVID-19 Pandemic

Changes in Tobacco Use Patterns among Veterans in San Diego during the Recent Peak of the COVID-19 Pandemic

Comparison of two highly-effective mRNA vaccines for COVID-19 during periods of Alpha and Delta variant prevalence

Analysis of the Effectiveness of the Ad26.COV2.S Adenoviral Vector Vaccine for Preventing COVID-19

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