COVID-19 mRNA Vaccines Preserve Immunogenicity after Re-Freezing.

The massive COVID-19 vaccine purchases made by high-income countries have resulted in important sample losses, mainly due to the complexity of their handling. Here, we evaluated the possibility of preserving the immunogenicity of COVID-19 mRNA vaccines after re-freezing vials, following the extraction of the maximum possible number of samples, as an alternative approach to minimizing their wastage. Thus, we exposed the vaccine vials to different re-freezing conditions and evaluated mRNA integrity and the effects in mice after in vivo administration. We reveal that the mRNA integrity of Comirnaty® and Spikevax® vaccines remained unaffected after re-freezing during 1 month at -20 °C or -80 °C. The immunological responses also remained unchanged in mice after these re-freezing conditions and no apparent side effects were revealed. The preservation of mRNA integrity and immunogenicity under these handling conditions opens the possibility of re-freezing the mRNA COVID-19 vaccine vials to limit their wastage and to facilitate vaccination processes.

SARS-CoV-2 could be spread through hospital medication dispensed to patients: A prospective observational study.

ABSTRACT: Our objective was to analyze in vitro the persistence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in the packaging material of the drugs dispensed to hospital wards. Additionally, to evaluate if the protection with a double plastic bag prevents the contamination of the medication dispensed to an intensive care unit (ICU).On the first part, different materials containing different drugs within an ICU were sampled to confirm the lack of contamination by SARS-CoV-2. The confirmation of the virus was performed using real time reverse transcription polymerase chain reaction. As a control group, in the microbiology laboratory we inoculated the virus into the different surfaces containing the same drugs included in the first part. Samples were obtained with a sterile swab at 3, 6, 8, 10, 14, 21, and 30 days after inoculation and analyzed through real time reverse transcription polymerase chain reaction.None of the studied materials containing the drugs within an ICU was contaminated by SARS-CoV-2. In the second part, SARS-CoV-2 was found in all surfaces for up to 30 days.The use of double-bag unit-dose system to deliver medication in a pandemic seems effective to prevent the potential transmission of SARS-CoV-2. A striking SARS-CoV-2 RNA stability of up to 30 days was found in the surfaces containing the drugs.

Impact of Generic Entry on Hospital Antimicrobial Use: A Retrospective Quasi-Experimental Interrupted Time Series Analysis.

BACKGROUND: The impact of antimicrobials generic entry (GE) is controversial. Their introduction could provide an economic benefit yet may also increase their consumption, leading to a higher risk of resistance. Our aim was to analyze the impact of GE on trends of antimicrobial consumption in an acute-care hospital. METHODS: A retrospective quasi-experimental interrupted time series analysis was conducted at a 400-bed tertiary hospital in Barcelona, Spain. All antimicrobials for systemic use for which a generic product entered the hospital from January 2000 to December 2019 were included. Antimicrobial consumption was expressed as DDD/100 bed days. RESULTS: After GE, the consumption of cefotaxime (0.09, p < 0.001), meropenem (0.54, p < 0.001), and piperacillin-tazobactam (0.13, p < 0.001) increased, whereas the use of clindamycin (-0.03, p < 0.001) and itraconazole (-0.02, p = 0.01) was reduced. An alarming rise in cefepime (0.004), daptomycin (1.02), and cloxacillin (0.05) prescriptions was observed, despite not achieving statistical significance. On the contrary, the use of amoxicillin (-0.07), ampicillin (-0.02), cefixime (-0.06), fluconazole (-0.13), imipenem-cilastatin (-0.50) and levofloxacin (-0.35) decreased. These effects were noticed beyond the first year post GE. CONCLUSIONS: GE led to an increase in the consumption of broad-spectrum molecules. The potential economic benefit of generic antibiotics could be diluted by an increase in resistance. Antimicrobial stewardship should continue to monitor these molecules despite GE.

Reconstituted mRNA COVID-19 vaccines may maintain stability after continuous movement.

OBJECTIVES: There is an urgent need to ameliorate the possibilities of transporting reconstituted mRNA vaccines from the centralized preparation centres to the vaccination sites to improve the efficiency of the vaccination campaign against coronavirus disease 2019 (COVID-19). We have analysed the integrity of the Pfizer-BioNTech and Moderna vaccines under different movement conditions to provide information that may improve the distribution of vaccines to the target population. METHODS: Syringes of reconstituted Pfizer-BioNTech or Moderna COVID-19 vaccines were prepared in a laminar flow chamber to be subjected to a stability analysis in order to evaluate the impact of movement on mRNA integrity. RNA integrity was checked by the lack of RNA peaks under the original mRNA peak in the electropherogram resulting from potential fragments from RNA degradation. Samples were then exposed for 180 min at room temperature (21 ± 1°C, 55 ± 10% humidity) under different movement conditions. RESULTS: We report that the integrity of the mRNA in the reconstituted COVID-19 vaccines after continuous moderate movement at room temperature is maintained for at least 3 hours, with values of fluorescence units (FU) under the original mRNA peak of 0.38 ± 0.06 in the Pfizer-BioNTech vaccine and 0.96 ± 1.18 FU in the Moderna vaccine, equal to the values obtained without movement (0.36 ± 0.08 FU in the Pfizer-BioNTech and 1.12 ± 0.19 FU in the Moderna). In contrast, the integrity of these vaccines exposed to repeated Vortex shaking was significantly impaired (p < 0.001) with values under the original mRNA peak of 1.34 ± 0.31 FU for the Pfizer-BioNTech and 5.03 ± 1.16 FU for the Moderna samples. CONCLUSIONS: The stability of these reconstituted vaccines reported here may improve the efficiency of the ground transportation and distribution of the vaccines, which may lead to shorter and more homogeneous vaccinations in cities and rural areas.

Accidental Interruption of the Cold Chain for the Preservation of the Moderna COVID-19 Vaccine.

Maintenance in restricted cold temperature conditions is a mandatory requirement to preserve the stability of mRNA vaccines [...].

Evolution of Antimicrobial Consumption During the First Wave of COVID-19 Pandemic.

Background: The first wave of COVID-19 pandemic may have significantly impacted antimicrobial consumption in hospitals. The objective of this study was to assess the evolution of antimicrobial consumption during this period. Methods: A retrospective quasi-experimental before-after study was conducted in a Spanish tertiary care hospital. The study compared two periods: pre-pandemic, from January 2018 to February 2020, and during the COVID-19 pandemic from March to June 2020. Antimicrobial consumption was analyzed monthly as defined daily doses (DDD)/100 bed-days and overall hospital and ICU consumption were evaluated. Results: An increase in the hospital consumption was noticed. Although only ceftaroline achieved statistical significance (p = 0.014), a rise was observed in most of the studied antimicrobials. A clear temporal pattern was detected. While an increase in ceftriaxone and azithromycin was observed during March, an increment in the consumption of daptomycin, carbapenems, linezolid, ceftaroline, novel cephalosporin/ß-lactamase inhibitors or triazoles during April-May was noticed. In the ICU, these findings were more evident, namely ceftriaxone (p = 0.029), carbapenems (p = 0.002), daptomycin (p = 0.002), azithromycin (p = 0.030), and linezolid (p = 0.011) but followed a similar temporal pattern. Conclusion: An increase in the antimicrobial consumption during the first wave of COVID-19 pandemic was noticed, especially in the ICU. Availability of updated protocols and antimicrobial stewardship programs are essential to optimize these outcomes.

Azithromycin in the treatment of COVID-19: a review.

INTRODUCTION: SARS-CoV-2 is a novel virus that causes coronavirus disease-19 (COVID-19). Antiviral and immunomodulatory agents have been proposed as potential treatments. Azithromycin exhibits both properties and therefore may play a role. AREAS COVERED: This article reviews the pharmacology, pharmacokinetics, clinical efficacy, and safety of azithromycin in viral infections, with emphasis on COVID-19. A literature search of PUBMED was conducted on May 30th and updated on July 28th. EXPERT OPINION: Azithromycin presents in vitro activity against SARS-CoV-2 and could act in different points of the viral cycle. Its immunomodulatory properties include the ability to downregulate cytokine production, maintain epithelial cell integrity or prevent lung fibrosis. Azithromycin use was associated with a reduction in mortality and ventilation days in other viral infections. These properties could be beneficial throughout the COVID-19. However, the evidence of its use is scarce and of low quality. Azithromycin has been assessed in retrospective observational studies mainly in combination with hydroxychloroquine, which has shown to provide no benefit. This macrolide presents a well-known safety profile. Upcoming clinical trials will determine the role of azithromycin in the COVID-19 (including the stage of the disease where it offers the greatest benefits and the effect of its combination with other drugs).