About this position The European Medicines Agency (EMA) defines real-world data (RWD) as routinely collected data relating to patient health status or the delivery of health care from a variety of sources other than clinical trials, and real-world evidence (RWE) as information derived from the analysis of RWD, this information being valid, reliable and appropriate […]
Solution Analyst Position
The European Medicines Agency (EMA) promotes and protects public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality. EMA serves a population of approximately 500 million citizens living in the […]
European Medicines Agency (EMA) gives go-ahead for use of anticovid tablet
The European Medicines Agency (EMA) gives the green light to the use of the anticovid pill that halves the risk of death and hospitalisation. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has endorsed the use of Merk and Ridgeback’s ‘Lagevrio’ (molnupiravir) to treat Covid-19. With this approval, Merk takes the lead in the […]
First COVID-19 vaccine approved for children aged 12 to 15 in EU
EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 12 to 15. The vaccine is already approved for use in adults and adolescents aged 16 and above. Comirnaty is a vaccine for preventing COVID-19. It contains a molecule called messenger RNA (mRNA) with instructions for […]
Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues
EMA’s safety committee (PRAC) is reviewing very rare cases of unusual blood clots that occurred in the United States following the use of Janssen’s COVID-19 vaccine. The type of blood clot reported, cerebral venous sinus thrombosis (CVST), occurred in most cases in combination with low levels of blood platelets (thrombocytopenia). The US FDA and CDC […]
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V. EMA’s human medicines committee (CHMP) will assess the vaccine, known as COVID-19 Vaccine Janssen, under an accelerated timetable. The Committee could issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety […]
EMA preparing guidance to tackle COVID-19 variants
EMA is developing guidance for manufacturers planning changes to the existing COVID-19 vaccines to tackle the new virus variants. In order to consider options for additional testing and development of vaccines that are effective against new virus mutations, the Agency has requested all vaccine developers to investigate if their vaccine can offer protection against any […]