AstraZeneca ChAdOx1-S COVID-19 Vaccine Can Be Safely Administered in Patients with EDTA Allergy

Background: Immediate hypersensitivity reactions to COVID-19 vaccines have been postulated to be linked to their excipients, such as polyethylene glycol (PEG) in Pfizer Comirnaty, or polysorbate 80 and ethylenediaminetetracetic acid (EDTA) in AstraZeneca ChAdOx1-S [recombinant] (Vaxzevria). These excipients are potentially found in a range of other products, including injectable and oral medications as well as intravenous radiocontrast media (RCM) and various cosmetic products.Currently patients with proven excipient allergy may be advised to avoid a COVID-19 vaccine containing that excipient and/or potentially cross-reactive excipients. We present two cases of previously confirmed EDTA anaphylaxis, who had negative Vaxzevria vaccine in-vivo testing and subsequently tolerated the vaccine.Case 1: A patient with history of anaphylaxis to RCM and local anaesthetics (LA) had positive intradermal test (IDT) to EDTA nine years earlier. Skin testing to Vaxzeria vaccine (up to 1:10 IDT), Comirnaty vaccine (up to 1:10 IDT) and EDTA 0.3mg/mL IDT were negative. However, following EDTA 3mg/ml IDT, he developed immediate generalised urticaria without anaphylaxis. Basophil activation testing was negative to disodium EDTA, Vaxzevria and Cominarty vaccines. Given the negative in-vitro and in-vivo testing to Vaxzevria vaccine, he proceeded to Vaxzevria immunisation and tolerated both doses.Case 2: A patient with history of anaphylaxis to RCM had positive skin testing to EDTA and RCM containing EDTA six years earlier. Following referral to COVID19 vaccine clinic, Vaxzevria vaccine (1:10 IDT) and Cominarty vaccine (1:10 IDT) were negative whilst EDTA was positive at 0.3mg/mL IDT. He subsequently tolerated both Vaxzevria vaccinations.Conclusion: Excipient allergy does not necessarily preclude a patient from receiving a vaccine containing that excipient. Allergy testing can help identify excipient-allergic patients who may still tolerate vaccination, which is important in situations where COVID-19 vaccination options are limited.

Hypothesis: disodium EDTA and vitamin C combination therapy for COVID -19

COVID.19 Pandemic represent major problem facing research community worldwide. Based on information mentioned in book entitled; COVID-19: Man-made pandemic, Lead AND Cadmium mutate influenza virus produce: SARS COV-2 we suggest Disodium EDTA Vitamin C combination therapy successful protocol to overcome this lethal health condition. This protocol need pre-clinical experiments to a prove it.

Excipients of inhaled medications with potential to cause adverse reactions

Introduction: In addition to the active pharmaceutical ingredient (API), the composition of the medicines also includes excipients which are only ideally completely pharmacologically inactive. It has been shown that excipients in inhaled preparations can cause effects opposite to the pharmacological effect of the medicine. Aim: The Aim of the study was to identify potentially harmful excipients in inhaled medicines approved in the Republic of Serbia. Material and Methods: The academic study was conducted during April 2021 and included the analysis of medicines that received a marketing authorization from the Medicines and Medical Devices Agency of Serbia (ALIMS). Qualitative compositions of inhaled medicines available in Summaries of product characteristics (SmPC) on the ALIMS's official website were observed. Excipients considered potentially harmful if they are recognised as excipients with known effect (EKE) in Serbian and European regulations. Results: Total of 46 inhalation preparations that are approved in Serbia were analyzed. In their composition were found 17 different excipients. By comparing appropriate domestic and European regulations three excipients from examined preparations that represent potential causative agents of adverse drug reactions (ADRs) were identified: lactose-monohydrate, ethanol and benzalkonium chloride. It has been shown that disodium EDTA is also a potential causative agent of ADRs, but it is not classified as EKE. Conclusion: Neither domestic nor international regulations have classified EDTA and its salts as EKE and they should be given special attention in the future as potential causative agents of ADRs. It has been shown that benzalkonium chloride is the only excipient that can lead to bronchospasm and it was found in two inhaled medicines.

A review on known and unknown facts of EDTA

Edetate disodium (EDTA) is a chelating (KEE-late-ing) agent. A chelating agent is capable of removing a heavy metal, such as lead or mercury, from the blood. Ethylenediaminetetraacetic acid (EDTA) is a chelating agent can bind to metals via four carboxylate and two amine groups. It is a polyamino carboxylic acid and a colorless, water-soluble solid, which is widely used to dissolve lime scale. It is produced as several salts, notably disodium EDTA and calcium disodium EDTA. EDTA reacts with the calcium ions in dentine and forms soluble calcium chelates. A review on EDTA’s known and unknown facts are presented in this article.

Ceftriaxone+Sulbactam+Disodium EDTA Versus Meropenem for the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis: PLEA, a Double-Blind, Randomized Noninferiority Trial

Background CSE is a novel combination of ceftriaxone, sulbactam, and disodium ethylenediaminetetraacetic acid (EDTA) with activity against multidrug-resistant Gram-negative pathogens. Methods Adult patients aged ≥18 years with a diagnosis of complicated urinary tract infections (cUTIs), including acute pyelonephritis (AP), were randomized 1:1 to receive either intravenous CSE (1000 mg ceftriaxone/500 mg sulbactam/37 mg disodium EDTA) every 12 hours or intravenous meropenem (1000 mg) every 8 hours for up to 14 days. The primary objective was to show the noninferiority of CSE to meropenem at the test-of-cure visit (8–12 days after the end of therapy), with a noninferiority margin of 10%. Results Of 230 randomized patients, 74 of 143 and 69 of 143 were treated with CSE and meropenem, respectively. Of these, 98% were ceftriaxone nonsusceptible and 83% were ESBL-positive at baseline. Noninferiority of CSE to meropenem was demonstrated for both the US Food and Drug Administration-defined coprimary endpoints of (1) symptomatic resolution at test-of-cure (71 of 74 [95.9%] patients vs 62 of 69 [89.9%]; treatment difference, 6%; 95% confidence interval [CI] −2.6% to 16%) and (2) symptomatic resolution as well as microbiological eradication at test-of-cure (70 of 74 [94.6%] vs 60 of 69 [87.0%]; treatment difference, 7.6%; 95% CI, −2.0% to 18.4%). Microbiological eradication at test-of-cure (European Medical Agency’s primary endpoint) was observed in 70 of 74 (94.6%) vs 61 of 69 (88.4%) (treatment difference, 6.2%; 95% CI, −3.2% to 16.6%) patients treated with CSE and meropenem, respectively. Safety profile of CSE was consistent with that of ceftriaxone alone. Conclusions The results support the use of CSE as a carbapenem-sparing treatment for patients suffering from cUTI/AP caused by resistant Gram-negative pathogens.

Formation and Application of High Reflectivity Controllable Barium Sulfate Microspheres

This paper investigated the influence of reaction conditions on particle morphology. X-ray powder diffraction (XRD), particle size distribution (PSD), and scanning electron microscopy (SEM) were used to characterize the morphology of barium sulfate. The barium sulfate microspheres were synthesized with BaCl2, Na2SO4, and ethylenediaminetetraacetic acid disodium (EDTA·2Na). The reflectivity of the synthesized barium sulfate microspheres was greater than 99% in the range of 400–700 nm, which was characterized by a reflectance spectrometer. The morphology of the barium sulfate particles and their cross-section were observed by SEM. The prepared microspheres were applied to high-density lipoprotein dry tablets due to their high reflectivity, and the results showed that the prepared tablets had high sensitivity and good repeatability.