Merck and Ridgeback’s Molnupiravir, an Oral COVID-19 Antiviral Medicine, receives first authorization in the world with trade name of Lagevrio (molnupiravir), by MHRA. Lagevrio is not intended to be used as a substitute for vaccination against COVID-19 but for the treatment of Mild-to-Moderate COVID-19 in adults with a positive SARS-CoV-2 …
EMA had released its first safety update on a COVID-19 vaccine — Comirnaty. It concludes that safety data collected on Comirnaty use in vaccination campaigns is consistent with the known safety profile of the vaccine, and no new side effects were identified. Summary points: The latest safety data for this vaccine are …
The phase 1 results for Covaxin are now in the Lancet. Covaxin is the inactivated vaccine by Bharat Biotech, India. Covaxin – BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) or alum (Algel). The study was conducted at 11 …
MHRA has authorized use of Oxford/AstraZeneca vaccine, goal to “give as many people in at-risk groups their first dose” but recommending a 2nd up to 3 months later. Safety information from the trials: The most frequently reported adverse reactions were injection site tenderness (>60%); injection site pain, headache, fatigue (>50%); …
FDA released breifing document on Moderna covid19 vaccine. Below are the highlights on safety from the document: Efficacy of the vaccine to prevent COVID-19 occurring at least 14 days after dose 2 was 94.5%, (95% CI 86.5%; 97.8%) in participants without prior evidence of SARS-CoV-2 infection. VE was >93% in …
Today University of Oxford and AstraZeneca researchers present a pooled analysis of Phase 3 trials of a vaccine against SARS-CoV-2 across two different dose regimens, resulting in an average efficacy of 70.4%. The new study published in the Lancet is the first peer-reviewed publication of phase 3 data from studies …
COVAXINTM, India’s indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility. Covaxin is an inactivated vaccine. That …
A safe and effective vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will be an important tool in controlling the global COVID-19 pandemic. Although there are no licensed vaccines against COVID-19, 48 potential vaccine candidates based on a variety of platforms including lipid nanoparticle mRNA, DNA, adjuvanted protein, inactivated …
On 30-October-2020, EMA had released detailed guidance on ICSRs in the context of COVID 19 – validity and coding of ICSRs. This detailed guidance document provides recommendations relevant to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of …
Developing a vaccine takes a long time (usually 15 years). The general stages of the development cycle of a vaccine are: Exploratory stage Pre-clinical stage Clinical development Regulatory review and approval Manufacturing Quality control Different versions of vaccines will be created during exploratory stage and they are tested in iterative …
