Introduction
by Emer Cooke
EMA Executive Director
In 2021, global efforts to tackle the COVID-19 pandemic continued, with the EU medicines network redoubling their efforts and delivering, one by one, the scientific recommendations Europe needed to protect the health of its citizens. Our experts worked extremely hard to ensure that EU citizens had access to much-needed vaccines and therapeutics. As a result of this collective effort, we ended 2021 with more medical tools to fight this pandemic.
After giving its first positive opinion for a COVID-19 vaccine at the end of 2020, EMA recommended four more vaccines for approval in 2021, which enabled the roll-out of the largest mass vaccination campaign ever in the EU. EMA also recommended five new COVID-19 treatments for approval, which brought therapeutic options for people who had contracted the virus. COVID-19 is a new disease and as our understanding of the virus and its effect on people grew, we updated our recommendations accordingly throughout the year: we recommended to extend vaccination to adolescents and children, provided advice on vaccine boosters and monitored closely the impact of each new variant of concern.
In parallel, we kept a very close eye on the safety of the new vaccines and treatments, acting swiftly as and when necessary. Due to the unparalleled extent of the vaccination campaigns - never before had we received such a large volume of safety information on vaccines or any other medicines in such a short time - we were able to build our safety recommendations based on the analysis of an extensive data set. The EU pharmacovigilance system demonstrated its strength, notably when we were the first to identify and immediately put in place measures to mitigate a very rare risk of a specific form of thrombosis with two of the vaccines.
We also worked tirelessly to help increase manufacturing capacity for COVID-19 vaccines. The number of approved manufacturing sites rose from 19 to 52 by the end of 2021, leading to a significant increase in vaccine supply, both in the EU and globally.
Due to its critical role in the global response to the pandemic, EMA found itself in the limelight of public and media attention during 2021. We fully understood the need to provide the public and our stakeholders with high quality, clear information about vaccines and to deliver on our commitment to transparency. We communicated every step of the way and published the full clinical data reviewed as part of the regulatory approval process for COVID-19 products. We also maintained at full speed our close collaboration with global regulators and other international partners through the International Coalition of Medicines Regulatory Authorities (ICMRA) in order to streamline and align regulatory requirements for medicine development and approval.
EMA’s essential role in the COVID-19 pandemic was recognised by the European Commission, Parliament and Council in the form of a legislative proposal to extend the Agency’s mandate developed throughout 2021. The extended mandate will give us new tools to tackle many of the challenges the medicines system in the EU is faced with, from coordinating national responses to shortages of critical medicines, to supporting innovation, particularly in crisis situations, but also in preparation for other emerging health threats. It will be my priority in 2022 to deliver on this ambitious vision.
Despite the focus on COVID-19, I am very proud that we have also made significant progress in other areas. 2021 was a very strong year for human and veterinary medicines overall. EMA recommended for approval 92 medicines for human use, including a first-in-class treatment for an aggressive form of breast cancer and the first cell-based gene therapy to treat multiple myeloma, to name but a few.
In the veterinary area, we recommended 12 new medicines for approval. These include a new vaccine for pigs, which has the potential to reduce the need for antimicrobial treatment in animals and could therefore limit the development of antimicrobial resistance – the ‘silent’ pandemic against which EMA continued to take action in 2021.
Throughout the year, EMA also worked hard to deliver on the implementation of two major legislative tasks by the end of January 2022: the Veterinary Medicines Regulation and the Clinical Trials Information System (CTIS) supporting the go-live of the Clinical Trials Regulation (CTR).
A long time in the making, the CTR and the IT system we have developed, CTIS, will support ambitious plans for clinical trials in the EU that will put Europe back on the map as an important global player in medical research. Concerning the Veterinary Medicines Regulation, EMA developed major new IT systems and supported the European Commission in putting in place a large body of implementing legislation. It will re-shape the regulation of medicines for animals, with a strong emphasis on making innovative medicines available, including for limited markets, and further foster prudent use of antimicrobials.
I would like to sincerely thank all those who have been part of this journey and who are at the heart of EMA’s work: the members of its scientific committees, the working parties and scientific advisory groups, the Management Board and the national experts, our stakeholders and, of course, EMA’s staff.