4- Thursday Pharmacotherapy News – 30th September

1 – Effectiveness of the Single-Dose Ad26.COV2.S COVID Vaccine

• Vaccination against the SARS-CoV-2 virus is critical to control the pandemic.
• Randomized trials demonstrated efficacy of the single-dose Ad26.COV2.S COVID vaccine but data on longer-term protection in clinical practice and effectiveness against variants are needed.
• This study aims to assess the effectiveness of Ad26.COV2.S in preventing COVID infections and COVID-related hospitalizations in clinical practice, the longer-term stability of its protective effect and effectiveness against Delta variants.
• These non-randomized data across U.S. clinical practices show high and stable vaccine effectiveness of Ad26.COV2.S over time before the Delta variant emerged to when the Delta variant was dominant.

Source: MedRxiv

2 – Reports of myocarditis and pericarditis following mRNA COVID-19 vaccines: A review of spontaneously reported data from the UK, Europe, and the US

• A signal of myocarditis and pericarditis following mRNA COVID-19 vaccines first emerged in Israel in May 2021.
• Further cases have since been reported in multiple countries.
• The reporting rates of these events indicate that they are very rare given the high numbers of vaccinated persons.
• Males and younger vaccinees appear more frequently affected, more often following the second vaccine dose.
• As vaccine programmes progress with the focus shifting to younger people, it is possible that more cases of myocarditis and pericarditis will be reported.
• This study aims to bring together spontaneously reported data from around the world to estimate the reporting rate in different countries and better understand the risk factors for myocarditis and pericarditis following exposure to COVID-19 mRNA vaccines.
• This study provides evidence that younger vaccinees more frequently report myocarditis and pericarditis following mRNA COVID-19 vaccines compared with older vaccinees.

Source: MedRxiv

3 – An open label, adaptive, phase 1 trial of high-dose oral nitazoxanide in healthy volunteers: an antiviral candidate for SARS-CoV-2

• Repurposing approved drugs may rapidly establish effective interventions during a public health crisis.
• This has yielded immunomodulatory treatments for severe COVID-19, but repurposed antivirals have not been successful to date because of redundancy of the target in vivo or suboptimal exposures at studied doses.
• Nitazoxanide is an FDA approved antiparasitic medicine, that physiologically-based pharmacokinetic (PBPK) modelling has indicated may provide antiviral concentrations across the dosing interval, when repurposed at higher than approved doses.
• Nitazoxanide administered at 1500mg BID with food was safe and well tolerated and a phase 1b/2a study is now being initiated in COVID-19 patients.

Source: MedRxiv

4- Vaccines against Covid-19, venous thromboembolism, and thrombocytopenia. A population-based retrospective cohort study

• This study aimed at estimating the risk of venous thromboembolism (VTE), thrombocytopenia (TCP), and VTE associated with TCP, by age and sex, after the first dose of both adenovirus vector-based and mRNA-based Covid-19 vaccines, and after the second dose of m-RNA vaccines.
• They observed increases of rates of venous thromboembolism in usual and unusual anatomical sites and of thrombocytopenia in recipients of both adenovirus vector and mRNA vaccines against Covid-19.
• Excess rates were higher in men than in women and they were not particularly elevated in any specific age group.

Source: MedRxiv

5 – The efficacy and safety of bamlanivimab treatment against COVID-19: A meta-analysis

• Bamlanivimab is routinely used in the treatment of coronavirus disease 2019 (COVID-19) in worldwide.
• They performed a meta-analysis to investigate the efficacy and safety of bamlanivimab treatment in patients with COVID-19.
• Bamlanivimab has demonstrated clinical efficacy on mild or moderate ill patients with COVID-19 to prevent hospitalization, reduce severity and mortality from the disease.
• Combinations of two or more monoclonal antibody increase the effect.
• Well-designed clinical trials to identify the clinical and biochemical characteristics in COVID-19 patients’ population that could benefit from bamlanivimab are warranted in the future.

Source: MedRxiv

6 – Cardiac Inflammation after COVID-19 mRNA Vaccines: A Global Pharmacovigilance Analysis

• To counter the COVID-19 pandemic, mRNA vaccines, namely tozinameran and elasomeran, have been authorized in several countries.
• These next generation vaccines have shown high efficacy against COVID-19 and demonstrated a favorable safety profile.
• As widespread vaccinations efforts are taking place, incidents of myocarditis and pericarditis cases following vaccination have been reported.
• This safety signal has been recently confirmed by the European Medicine Agency and the U.S. Food and Drug Administration.
• This study aimed to investigate and analyze this safety signal using a dual pharmacovigilance database analysis.
• The inflammatory heart reactions, namely myocarditis and pericarditis, have been reported world-wide shortly following COVID-19 mRNA vaccination.
• An important disproportionate reporting among adolescents and young adults, particularly in males, was observed especially for myocarditis.
• Guidelines must take this specific risk into account and to optimize vaccination protocols according to sex and age.

Source: MedRxiv

• Read more from FADIC Blog, with many articles with evidence based articles.
• Learn More Through FADIC® – Online Programs & Mini-Courses.
• Listen Now to FADIC Podcast focusing on varieties of pharmacist perspectives in specialties.
• Read More Now about FADIC Pharmacy Events to get more Experience.

Course Copyrights:

All Courses is meant for SINGLE user use only.
If more than one person acceced this course, they will be BLOCKED Forever.

Why FADIC 2021 Pharmacotherapy Daily News (FNN) ?

• It helps to keep up with the literature!
• Provide you with the Updated with the latest in your clinical practice. Wherever you are, and Whenever you need!
• Help you to share in the advance in clinical career. In addition to adding an impressive image to the pharmacists all-around!

Subscribe to FADIC 2021 Pharmacotherapy Daily News (FNN), for a publication of E-News

Read & Download FNN Issue 8 of April 2020 FNN News