Early clinical trial data and real‐world assessment of COVID‐19 vaccines: Insights from the Society of Infectious Diseases Pharmacists

Patel, Nimish; Bouchard, Jeannette; Oliver, Meredith B; Badowski, Melissa E; Carreno, Joseph J.

doi:10.1002/phar.2622

Cited by 5 publications

(7 citation statements)

References 46 publications

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“…In terms of sex, 56.2% (n = 6506) were female, while 43.8% (n = 5067) were male. The mean age (standard deviation) of the patients was 57.71 (12.07), and the median (interquartile range) was 58 (50)(51)(52)(53)(54)(55)(56)(57)(58)(59)(60)(61)(62)(63)(64)(65).…”

Section: Sociodemographic Characteristicsmentioning

confidence: 99%

“…Considering that effective pharmacological treatment to combat COVID-19 is still emerging, vaccination has become an important pillar for controlling the COVID-19 pandemic [43][44][45]. As different types of vaccines have shown positive results and are now available for clinical use [3,[46][47][48][49][50], it is quite important for patients with diabetes to receive vaccinations to avoid serious debilitating COVID-19 infection [51][52][53]. Pfizer-BioNtech was the first COVID-19 vaccine approved by the Saudi Food and Drug Authority (SFDA) on 10 December 2020 and was subsequently introduced in Saudi Arabia [54].…”

Section: Introductionmentioning

confidence: 99%

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Prevalence of COVID-19 Infection among Patients with Diabetes and Their Vaccination Coverage Status in Saudi Arabia: A Cross-Sectional Analysis from a Hospital-Based Diabetes Registry

et al. 2022

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Patients with diabetes have a higher risk of severe infection and mortality due to COVID-19. Considering the current limited effective pharmacological treatments, vaccination remains one of the most effective means to control the pandemic. The current study aimed to determine the prevalence of COVID-19 infection and the rate of COVID-19 vaccination coverage among patients with type 2 diabetes mellitus. The patients were identified from a diabetes hospital registry at Prince Sultan Military Medical City, Riyadh, Saudi Arabia in July 2021. The history of COVID-19 infection and the vaccination status were retrieved from the National Health Electronic Surveillance Network (HESN) program and the Seha platform, respectively. A total of 11,573 patients were included in this study (representing 99.5% of all patients in the registry). A total of 1981 patients (17.1%) had a history of confirmed COVID-19 infection. The rate of vaccination with a 1st dose was 84.8% (n = 9811), while the rate of full vaccination with the 2nd dose was 55.5% (n = 6422). The analysis showed that a higher proportion of male patients were fully vaccinated than female patients (61.0% versus 51.2%, p < 0.001). There were statistically significant differences among the age groups, with the full vaccination rate ranging from 59.0% for the 61–70-year-old age group to 49.0% for the > 80-year-old age group (p < 0.001). The patients with no previous history of COVID-19 infection were more likely to get fully vaccinated than those with a previous history of the infection (63.9% versus 14.6%, respectively, p < 0.001). The factors associated with a higher likelihood of unvaccinated status included the female gender (adjusted odds ratio (aOR) = 1.705 (95% confidence interval (CI): 1.528–1.902)), elderly patients in the age group of 61–70 (aOR (95% CI) = 1.390 (1.102–1.753)), the age group of 71–80 (aOR (95% CI) = 1.924 (1.499–2.470)) and the age group of >80 (aOR (95% CI) = 3.081 (2.252–4.214), and prior history of COVID-19 infection (aOR (95% CI) = 2.501 (2.223–2.813)). In conclusion, a considerable proportion of patients with type 2 diabetes had confirmed COVID-19 infection. Continued targeted efforts are needed to accelerate vaccination coverage rates among patients with diabetes in general and the particular subgroups identified in this study.

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Section: Sociodemographic Characteristicsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Prevalence of COVID-19 Infection among Patients with Diabetes and Their Vaccination Coverage Status in Saudi Arabia: A Cross-Sectional Analysis from a Hospital-Based Diabetes Registry

et al. 2022

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“…In addition, although we were unable to measure the complete immune response, the methods we used were sufficiently efficient to assess immune response for the purposes of this study. 32 The main strength of this study is that it included a cohort of patients with MG taking a wide range of immunosuppressive therapies. Also this study gathered important information about the immune response after the COVID-19 vaccination protocol and adds new evidence to support the safety and efficacy of mRNA vaccines in patients with MG.…”

Section: Discussionmentioning

confidence: 99%

Immune Response and Safety of SARS-CoV-2 mRNA-1273 Vaccine in Patients With Myasthenia Gravis

Reyes‐Leiva

López-Contreras

Moga

et al. 2022

Neurol Neuroimmunol Neuroinflamm

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Background and ObjectivesEvidence regarding the safety and efficacy of messenger RNA (mRNA) vaccines in patients with myasthenia gravis (MG) after immunosuppressive therapies is scarce. Our aim is to determine whether the mRNA-1273 vaccine is safe and able to induce humoral and cellular responses in patients with MG.MethodsWe performed an observational, longitudinal, prospective study including 100 patients with MG of a referral center for MG in our country, conducted from April 2021 to November 2021 during the vaccination campaign. The mRNA-1273 vaccine was scheduled for all participants. Blood samples were collected before vaccination and 3 months after a second dose. Clinical changes in MG were measured using the MG activities of daily life score at baseline and 1 week after the first and second doses. A surveillance of all symptoms of coronavirus disease 2019 (COVID-19) was conducted throughout the study. Humoral and cellular immune responses after vaccination were assessed using a spike-antibody ELISA and interferon gamma release assay in plasma. The primary outcomes were clinically significant changes in MG symptoms after vaccination, adverse events (AEs), and seroconversion and T-cell immune response rates.ResultsNinety-nine patients completed the full vaccination schedule, and 98 had 2 blood samples taken. A statistically significant worsening of symptoms was identified after the first and second doses of the mRNA-1273 vaccine, but this was not clinically relevant. Mild AEs occurred in 14 patients after the first dose and in 21 patients after the second dose. Eighty-seven patients developed a humoral response and 72 patients showed a T-cell response after vaccination. A combined therapy with prednisone and other immunosuppressive drugs correlated with a lower seroconversion ratio (OR = 5.97, 95% CI 1.46–24.09, p = 0.015) and a lower T-cell response ratio (OR = 2.83, 95% CI 1.13–7.13, p = 0.024).DiscussionOur findings indicate that the mRNA vaccination against COVID-19 is safe in patients with MG and show no negative impact on the disease course. Patients achieved high humoral and cellular immune response levels.Classification of EvidenceThis study provides Class IV evidence that patients with MG receiving the mRNA-1273 vaccine did not show clinical worsening after vaccination and that most of the patients achieved high cellular or immune response levels.

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“…The current coronavirus (COVID-19) pandemic has resulted in several FDA approved emergency use authorizations (EUA) to slow the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [1 -3]. Messenger ribonucleic acid (mRNA) vaccines were at the forefront of these EUAs based on their efficacy and how they could be formulated to enter cells after intramuscular injection [4][5][6]. RNA delivery to cells had been a challenge for decades, however, the development of lipid nanoparticles and the modification with N1-methylpseudouridine greatly enhanced the efficacy of both Moderna's (Spikevax) and Pfizer-BioNTech's (Comirnaty) mRNA vaccines [7].…”

Section: Introductionmentioning

confidence: 99%

In vitro Characterization of SARS-CoV-2 Protein Translated from the Moderna mRNA-1273 Vaccine

Veenstra

Injeti

Pauley

2022

Preprint

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Extensive research around mRNA vaccines and their proposed utility during the current COVID-19 pandemic resulted in many publications concerning the SARS-Cov-2 spike protein and angiotensin converting enzyme-2 receptor-binding domain of the virus, but none describe the characteristics of the full-length protein obtained from the modified/synthetic mRNA that is part of the Moderna and Pfizer-BioNTech vaccines. In this paper, we provide the first data characterizing the actual proteins produced by mouse and human cells in culture that had been incubated up to 30 minutes with the commercial vaccine produced by Moderna (i.e., Spikevax). The mRNA vaccine continues to produce proteins up to 12-14 days after introduction to the cells. The molecular weight of the SARS-CoV-2 encoded protein ranges from 135-200 kilodaltons depending on the extent of glycosylation.

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Early clinical trial data and real‐world assessment of COVID‐19 vaccines: Insights from the Society of Infectious Diseases Pharmacists

Cited by 5 publications

References 46 publications

Prevalence of COVID-19 Infection among Patients with Diabetes and Their Vaccination Coverage Status in Saudi Arabia: A Cross-Sectional Analysis from a Hospital-Based Diabetes Registry

Prevalence of COVID-19 Infection among Patients with Diabetes and Their Vaccination Coverage Status in Saudi Arabia: A Cross-Sectional Analysis from a Hospital-Based Diabetes Registry

Immune Response and Safety of SARS-CoV-2 mRNA-1273 Vaccine in Patients With Myasthenia Gravis

In vitro Characterization of SARS-CoV-2 Protein Translated from the Moderna mRNA-1273 Vaccine

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