The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given the green light on Thursday to EU countries to vaccinate children between 5 and 11 years of age against Covid, considering that the benefits outweigh the risks, especially in children with health problems that increase the risk of serious disease. The Comirnaty vaccine, […]
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 […]
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January during the meeting of EMA’s scientific committee for human […]