COVID-19

As part of its health threat plan activated to fight COVID-19, the Agency has finalised and published the  composition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF), which assists Member States and the European Commission in dealing with development, authorisation and safety monitoring of therapeutics and vaccines intended for treatment or prevention of COVID-19.

The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients.

The continued availability of medicines is one of the most important priorities for EU authorities that are adopting measures to mitigate possible disruptions to the supply of medicines caused by the ongoing COVID-19 pandemic. The EU Executive Steering Group on Shortages of Medicines Caused by Major Events met virtually on 8 April to discuss ongoing activities aimed at ensuring a coordinated response to the challenges posed by the COVID-19 pandemic.

BioNTech SE and Pfizer Inc disclosed additional details of their collaboration to advance candidates from BioNTech’s mRNA vaccine program, previously announced on March 17, 2020.

The U.S. Food and Drug Administration issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.