Month: July 2020
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RECOVERY trial from University of Oxford confirms benefits of dexamethasone in Covid-19
The RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial led by the University of Oxford found that the use of dexamethasone resulted in lower 28-day mortality among those receiving either invasive mechanical ventilation or oxygen alone. However, there was “no clear effect” of dexamethasone for patients who were not receiving respiratory support. In the controlled, open-label trial,…
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Vaccination Failure
Despite remarkable success of immunization programmes on a global perspective, vaccines are neither 100% efficacious nor 100% effective. Therefore, vaccination failure, i.e. occurrence of a specific disease in an individual despite previous vaccination, may occur. Vaccination failure may be due to actual vaccine failure or failure to vaccinate appropriately. A. Vaccine failure (1) Vaccine-related(host-related): (a)…
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New study reveals Oxford coronavirus vaccine produces strong immune response
A team of scientists at Oxford University’s Jenner Institute and Oxford Vaccine Group has taken the next step towards the discovery of a safe, effective and accessible vaccine against coronavirus. The results of the Phase I/II trial published today in the scientific journal, The Lancet, indicate no early safety concerns and induces strong immune responses in…
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FDA electronic format submission for medical device
A new guidance finalised by the US Food and Drug Administration (FDA) outlines the framework for electronic submissions for medical devices. The guidance clarifies submissions which can be made electronically: Premarket notifications (501k) Evaluation of automatic class III designation request (De Novos) submissions (513(f)(2)) Premarket approval applications (PMAs) including transitional PMAs and modular PMAs. Product…
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Toxic sanitizer list
Forget protecting youself from Covid-19, the hand sanitisers you use may contain nothing but a lethal chemical, methanol, known to cause life-threatening ailments in pregnant women, the elderly, alcoholics, individuals having poor-quality diet and persons on certain medication. Any hand sanitiser should contain 80 per cent ethanol or 75 per cent isopropyl alcohol, as per…
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Update on Covid-19 vaccine
More than four months into the coronavirus pandemic, how close are the U.S. and the world to a safe and effective vaccine? Scientists say they see steady progress and are expressing cautious optimism that a vaccine could be ready by spring. As of early July, roughly 160 vaccine projects were underway worldwide, according to the…
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Preliminary report of an mRNA Vaccine against SARS-CoV-2
The Phase 1 of the Moderna, SARSCoV2 vaccine results published by NEJM and they are very encouraging for immune response and safety in 45 healthy people, 2 shots, increasing doses. The study is funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461). This phase 1, dose-escalation, open-label trial including…
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Traditional methods of signal detection
Traditional pharmacovigilance approaches are particularly important in the assessment of designated medical events (DMEs – Adverse events which are rare, serious have a high drug attributable risk distributed over multiple distinct pharmacological/therapeutic classes) or rare events for which clinical evaluation of individual cases tends to carry a larger weight and for which there may be…
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EU agencies clarify PV expectations during pandemic
The European Medicines Agency (EMA), European Commission and Heads of Medicines Agencies (HMA) released the guidelines in April to explain regulatory expectations for medicinal products during COVID-19. The three new questions addressed cover corrective and preventive actions management, PV system audits and on-site PV inspections: Is there any impact on corrective and preventive actions management…
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Remdesivir Liver Toxicity – case study
Remdesivir, the only drug cleared to treat Covid-19, sped the recovery time of patients with the disease, but its benefit appeared much more limited in patients who needed mechanical ventilation as part of their treatment. Although the antiviral agent remdesivir has been shown to shorten recovery time in patients with COVID-19, it has also been…