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With the rapid onset of the pandemic, the race to develop a viable vaccine quickly became a race to secure access to the developed vaccines. In this article, Ben Hargreaves examines how wealth determined the winners and what is now underway to help lower-income countries gain access to the available vaccines.
This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. You can read part one of this article here. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and genericmedicines.
A genericmedicine, Diethyl fumarate Accord (dimethyl fumarate), received a positive opinion for the treatment of multiple sclerosis (MS), a chronic disease affecting the central nervous system. The CHMP completed reviews under Article 29(4), following disagreements among EU Member States regarding two medicines authorisations.
Four medicines recommended for approval in the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP)’s latest meeting included a biosimilar for osteoporosis and a novel COVID-19 vaccine. COVID-19 update. 5 in children five to 11 years. CHMP’s safety update.
The race to produce a vaccine which could protect the world against COVID-19 brought the topic of diversity in clinical trials, or lack of it, into sharp focus. Vaccines approved for public use require comprehensive RCTs to establish their safety and efficacy. The pandemic brought imbalances into sharp focus. About the authors.
CHMP’s positive opinions for vaccines In addition, the human medicines committee recommended the vaccine Capvaxive (pneumococcal polysaccharide conjugate vaccine (21-valent)), as a preventative treatment for invasive disease and pneumonia caused by streptococcus pneumoniae bacteria in adults.
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