The EMA recently issued an Explanatory note on the withdrawal of the interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU. The interim guidance focused on the requirements for annual enhanced...
EMA’s Emergency Task Force (ETF) is improving its approach to scientific advice for the most promising medicines and vaccines under development for public health threats. Under the new process, developers of medicines falling within the...
This meeting between European Medicines Agency (EMA) and Vaccines Europe was organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations. The purpose of the meeting was to exchange views and...
This meeting between European Medicines Agency (EMA) and Vaccines Europe is organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations. The purpose of the meeting is to exchange views and...
This reflection paper covers SARS-CoV-2 vaccines and medicinal products intended to prevent or treat COVID-19 and its complications. It focuses on the non-clinical scientific considerations for pivotal, non-clinical data used to support clinical development, marketing authorisation and patient safety in the...
Thousands of gonorrhoea cases could be prevented over the next decade thanks to the NHS’ world-first vaccination programme against the infection.* Eligible patients, which includes gay and bisexual men who have a recent history of...
The EU strategy on COVID-19 therapeutics aims to support the development and increase the availability of much-needed COVID-19 therapeutics, notably through quicker authorisation. It covers the full lifecycle of medicines: from research, development and manufacturing...
A study found that around 4 months after vaccination, people who received the RSV vaccine had a 79% reduction in their risk of getting lower respiratory tract disease caused by RSV, compared with those who...
The EMA is currently developing a guideline on the quality aspects of mRNA vaccines and recently published a draft version of the guideline for consultation until 30 September 2025. It addresses specific aspects regarding the manufacturing...
The Guideline on clinical evaluation of vaccines EMEA/CHMP/VWP/164653/05 Rev. 1 does not provide detailed guidance on the design of clinical trials to assess the safety, immunogenicity and efficacy of vaccines in immunocompromised individuals. This Addendum...
