The Commission has authorised the Spikevax XBB.1.5-adapted COVID-19 vaccine, developed by Moderna. This is another important step in the fight against the disease. It is the third adaptation of this vaccine to respond to new COVID-19 variants. The European Medicines Agency (EMA) carried out a stringent evaluation of the vaccine under the accelerated assessment mechanism. Following this […]
EU steps up action to prevent shortages of antibiotics for next winter
The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) are today issuing recommendations for actions to avoid shortages of key antibiotics used to treat respiratory infections for European patients in the next winter season. These recommendations, which have been developed through the Executive Steering Group on Shortages and Safety […]
European Health Union: building a stronger EU health response
Today, the Council has adopted the final building blocks of the European Health Union: the Regulation on Serious cross-border health threats, the Regulation on the extended mandate of the European Centre for Disease Prevention and Control (ECDC) and the Emergency Framework Regulation to provide extra powers to the European Health Emergency Preparedness and Response Authority (HERA). These new rules complete […]
EMA advises on intradermal use of Imvanex / Jynneos against monkeypox
The European Medicines Agency (EMA) has advised on intradermal use of monkeypox vaccine. EMA’s Emergency Task Force (ETF) has reviewed data showing that people who receive the monkeypox vaccine as an intradermal injection (injection into the skin) produce similar levels of antibodies to those who receive it as a subcutaneous injection (injection under the skin). As only […]
EMA response to the monkeypox public health emergency
The European Medicines Agency (EMA) has initiated a series of actions to respond to the ongoing monkeypox outbreak, which has been escalated by the World Health Organization (WHO) to a Public Health Emergency of International Concern (PHEIC) on Saturday 23 July. This is the first new PHEIC to be declared since the regulation reinforcing EMA’s role in crisis preparedness and […]
EMA and ECDC recommend fourth dose vaccination for those over 60 years of age
The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have updated public health recommendations on the use of additional booster doses of COVID-19 vaccines this summer and in the upcoming autumn and winter seasons. The updated recommendations come amid increasing rates of COVID-19 reporting and rates of hospital and […]
European Health Union: a stronger role for the European Medicines Agency
As part of the on-going work to build a strong European Health Union, the Council has adopted the Regulation revising the mandate of the European Medicines Agency (EMA), taking an important step towards EMA’s reinforcement in crisis preparedness and management for medicinal products and medical devices. The new rules will allow the Agency to closely […]
Europe recommends Covid-19 vaccination for children 5 to 11 years of age
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 […]