2 Minute Medicine Rewind August 2, 2021

Safety Evaluation of the Second Dose of Messenger RNA COVID-19 Vaccines in Patients With Immediate Reactions to the First Dose

1. Allergic reactions and anaphylaxis following first dose of mRNA COVID-19 vaccines were not associated with immediate, adverse reactions following second dose.

2. Antihistamine premedication may further mitigate risk of allergic reactions.

Evidence Rating Level: 2 (Good)

After several months of messenger RNA (mRNA) COVID-19 vaccines being available in the US, allergic reactions have been reported in up to 2% of people. Anaphylaxis, on the other hand, has occurred in approximately 2.5 per 100,000 persons. This raises a question regarding safety of a second dose for those who had allergic reactions to the first dose, which would entail the two-dose regimen associated with Pfizer-BioNTech and Moderna vaccines. This multicenter, retrospective study at Brigham and Women’s Hospital, Massachusetts General Hospital, Yale School of Medicine, Vanderbilt University Medical Center, and University of Texas Southwestern Medical Center analyzed patient data from January 1, 2021 to March 31, 2021. Included patients were those with an immediate allergic reaction to a vaccine, defined as (1) symptoms within 4 hours of first dose; (2) at least 1 allergic symptom; and, (3) referral for an immunology/allergy consultation. Occurrences of anaphylaxis were scored using the Brighton and the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria, one of which must have been met for anaphylaxis to be confirmed. Primary outcomes were related to tolerance of second vaccine dose, including no immediate symptoms or mild, transient symptoms resolved with antihistamines. A total of 189 patients experienced immediate reactions to dose one of the two possible vaccines and were included in this study (M [SD] age = 43 [14] years, 86% female). Of these, 69% reacted to the Moderna vaccine and 31% to the Pfizer-BioNTech vaccine. Reactions across vaccines were erythema (28%), lightheadedness or dizziness (26%), tingling (24%), tightness in throat (22%), hives (21%), and shortness of breath or wheezing (21%). A total of 17% met criteria for anaphylaxis. Of the 189 patients included, 84% received a second dose and 30% of these people were premedicated with antihistamine. All of these patients tolerated the second vaccine dose, including those who initially experienced anaphylaxis. Approximately 20% reported mild, transient symptoms that resolved with antihistamines. Overall, this study demonstrates that allergic reactions and anaphylaxis do not necessarily predict reactions to a second dose of the mRNA vaccines. Though this retrospective study is limited, potential risks can be mitigated with antihistamine premedication and careful monitoring immediately following vaccine dose.

 

Association of High Screen-Time Use With School-Age Cognitive, Executive Function, and Behavior Outcomes in Extremely Preterm Children

1. Increased computer and television screen time were associated with childhood declines in cognitive function among extremely preterm children.

Evidence Rating Level: 2 (Good)

Developmental delays and childhood behavioral concerns are associated with preterm birth as well as increased television and computer screen time. The associations between these variables and childhood cognitive ability among extremely preterm children (EPT), however, are less understood. This secondary analysis of a cohort study of 414 EPT children evaluated between 2012 and 2016 sought to evaluated the relation between screen time and cognitive function among EPT children 6 to 7 years of age (45% female, M [SD] birth weight = 870.6 [191] g). Approximately 57% of EPT children had high screen time and 64% had a computer or television located in their bedrooms. All multivariable linear regression models were adjusted for study center, gestational age, male sex, and social determinants of health. High screen time was found to be independently associated with mean test score changes in full-scale IQ (M [SD] change = -3.92 [1.64], p = .02), metacognition (8.18 [3.01], p = .007), global executive function (7.49 [2.99], p = .01), inhibition (-.79 [.38), p = .03), and the Conners Parent Short-Form (Third Edition) inattention (3.32 [1.67], p = .047). Having a computer or television located in the bedroom was associated with an increase in impulsivity and hyperactivity (3.50 [1.75], p = .046), as well as inhibition (-.80, [.39], = .04). Overall, this study suggests that increased screen time negatively impacts cognitive function, particularly in the context of executive functions, among EPT children.

 

Association of Alcohol Consumption With Morbidity and Mortality in Patients With Cardiovascular Disease: Original Data and Meta-Analysis of 48,423 Men and Women

1. Mild-to-moderate alcohol consumption among those with cardiovascular disease does not appear to increase risk of mortality or future cardiovascular events.

2. Lower levels of alcohol consumption are associated with best outcomes.

Evidence Rating Level: 2 (Good)

The relation between alcohol and adverse cardiovascular outcomes is not fully clear, with variability between types of alcohol and frequency and quantity of use. Mild consumption is thought to be protective against cardiovascular concerns in otherwise healthy individuals. However, among those with cardiovascular disease (CVD), this protective capacity is unknown. This retrospective study investigated the association between alcohol consumption and prognosis in those with CVD through a series of meta-analyses of new data from three-large scale cohorts. A total of 14,386 patients with angina, myocardial infarction, or stroke in the UK Biobank Study were assessed, along with 12 published studies that added 31,235 participants. A combined sample of 48,423 was used based on availability of each outcome measure to determine the best-fitting dose-response association. Alcohol consumption was associated with all outcomes, with a risk reduction peaking at 6g/day (relative risk = .50, 95% CI .26 to .96) for cardiovascular events, 7g/day (RR = .79, 95% CI .73 to .85) for all-cause mortality, and 8g/day (RR = .73, 95% CI .64 to .83) for cardiovascular mortality. These associations remained significant up to 15g/day, 62g/day, and 50g/day, respectively, adjusting for age, sex, and smoking status. Overall, this study of individuals with CVD suggests that abstinence from alcohol may not be necessary for secondary prevention. However, it should be noted that lower drinking is likely to be associated with the lowest risk of mortality and having a future cardiovascular event (<105g/day).

 

Immunogenicity and Safety of the CoronaVac Inactivated Vaccine in Patients With Autoimmune Rheumatic Diseases: A Phase 4 Trial

1. CoronaVac, an inactivated SARS-CoV-2 vaccine, offers reduced but adequate short-term immunogenicity among people with autoimmune rheumatic diseases.

Evidence Rating Level: 2 (Good)

In the context of an ongoing COVID-19 pandemic, several vaccines have been approved for emergency use in the hope of reducing the spread of infection. Several countries have approved CoronaVac, an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. Similar to some other vaccines, immunogenicity is largely unclear as it relates to specific populations of people. Specifically, this study sought to investigate the immunogenicity of CoronaVac among adults with autoimmune rheumatic diseases (ARD). Excluded individuals included those with acute febrile illness or symptoms, demyelinating disease, positive baseline IgG serology, and previous COVID-19 vaccination. This prospective, phase 4 trial included 910 adults with ARD and 182 sex- and age-frequency-matched healthy controls (CG), both groups receiving two doses of CoronaVac. Median ages were not significantly different between groups (51 vs. 50 years, p = .985) nor was the number of female participants (76.9% vs. 76.9%, p>.999). The most common ARD diagnoses were chronic inflammatory arthritis (CIA; 49.6%), rheumatoid arthritis (RA; 28.1%), axial spondyloarthritis (axSpA; 11.6%), psoriatic arthritis (PsA; 9.8%), systemic lupus erythematosus (SLE; 25.5%), and primary vasculitis (7.3%). The ARD group had a significantly high frequency of comorbidities, such as systematic arterial hypertension (difference 13.8%, p = .001), dyslipidemia (difference 12.3%, p<.001), interstitial lung disease (difference 8.6%, p<.001), cardiomyopathy (difference 4.1%, p = .024), and chronic renal disease (difference 4.8%, p = .001). At Day 28, ARD group had lower IgG frequency (difference -15.9%, p<.001) and NAb positivity (difference -15.7, p<.001) than the CG. At Day 69, lower Nab positivity (difference -23.0, p<.001) and anti-SARS-CoV-2 IgG SC (-25.1, p<.001) were found in the ARD group than the CG. Median neutralization activity (difference -5.8, p = .013) and IgG titers (difference -17.6, p<.001) were also lower in ARD group at Day 69, compared to the CG. Overall, this phase 4 trial suggests that CoronaVac use among ARD patients results in reduced but adequate short-term immunogenicity. Long-term effectiveness of CoronaVac is still being studied.

 

Association Between Age-Related Macular Degeneration and Risk of Heart Failure: A Population-Based Nested Case-Control Study

1. Age-related macular degeneration was significantly associated with heart failure (HF), with odds of HF varying by comorbidity.

Evidence Rating Level: 2 (Good)

Due to the high mortality and morbidity associated with heart failure (HF), increased efforts have recently been put forth to better understand its risk factors. Microvasculature is one particular area in which there may be promise in predicting and preventing HF. Age-related macular degeneration (AMD) in the context of HF has been largely unexplored, though AMD manifests through development of neovascularization or geographic atrophy. This population-based cohort study sought to investigate this association. Using the Taiwan National Health Insurance Research Database, a nested case-control study of adults over 50 years of age was conducted with newly diagnosed HF cases (N=13,721) and controls (N=54,884) matched by age, sex, polypharmacy, and comorbidities (M [SD] age = 63.15 [8.1] years, 49.02% female). All participants had at least two clinical visits and a diagnosis of AMD a minimum of one year prior to HF diagnosis. This study found that AMD was associated with a significantly increased risk of HF (OR = 1.58, 95% CI 1.16 to 1.87, p<.001) after adjusting for age, sex, propensity score, and number of outpatient visits. Odds of HF varied by comorbidity: diabetes mellitus (OR = 1.56, 95% CI 1.18 to 1.84, p<.001), hypertension (OR = 1.48, 95% CI 1.12 to 1.68, p<.001), and coronary artery disease (OR = 1.28, 95% CI 1.08 to 1.53, p = .002). Among those without these comorbidities, no significant associations between HF and AMD were observed. Overall, this study found a significant association between HF and AMD, suggesting a need for future studies on the pathophysiology that may underly this relation.

Image: PD

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