On 11 March 2020, the World Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a global pandemic. On 30 January 2020, the WHO had declared COVID-19 a public health emergency of international concern (PHEIC).
Within its first two years, more than 450 million cases were reported worldwide, with 100 million in the European Union (EU) alone.
The pandemic caused millions of deaths worldwide and disrupted the lives of people across the globe.
In response, the EU and its health authorities deployed a range of public health counter-measures to contain the spread of the coronavirus, protect citizens, and save lives.
Throughout the crisis, the European Medicines Agency (EMA) along with national competent authorities (NCAs):
Such responsibilities are part of EMA's extended mandate which recognises the Agency's role in preparing for and helping deal with public health emergencies.
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A report is available summarising the European medicines regulatory network's response to the COVID-19 public health emergency, which highlights lessons for future health crises.
Among its findings, it suggests that more can be done in the areas of rapidly setting up large clinical studies and gathering multiple real-world data sources to generate useful evidence for regulatory assessments.
EMA and the Heads of Medicines Agencies (HMA) published this joint report in December 2023.
The pandemic required regulatory agility to adapt processes and speed up the development of vaccines and therapeutics while maintaining EU standards for safety, efficacy and quality.
EMA, through the Emergency Task Force (ETF), offered developers early scientific advice on the best methods and study designs to generate robust data enabling them to fast-track the development of COVID-19 vaccines and therapeutics.
It also introduced rolling reviews to speed up the assessment of data and reach an authorisation recommendation sooner.
Additionally, EMA was involved in approving new manufacturing sites to increase manufacturing capacity and supply
of COVID-19 vaccines in the EU.
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In preparation for the large-scale roll-out of COVID-19 vaccines and treatments, EMA put in place a comprehensive plan for enhanced safety monitoring.
It continuously monitored and evaluated vaccines and therapeutics to ensure that any possible risks were detected and managed as early as possible.
One of the largest vaccination programmes in history provided regulators with an unprecedented amount of data which confirmed the safety and efficacy of COVID-19 vaccines.
EMA coordinated closely with NCAs to collect and analyse information on suspected side effects. The Agency also investigated any potential safety concerns and took regulatory actions.
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Collaboration between EU and international partners was essential to address pressing public health needs and solve the many scientific and regulatory challenges that COVID-19 presented.
Under the framework of the European Health Union, EMA collaborated with regulatory and public health authorities including the:
On a global level, EMA worked closely with international regulators under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), the WHO and other stakeholders.
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The success of public health measures such as the roll-out of vaccines relies on the trust citizens have in the systems that make these vaccines available.
Communicating regularly about the importance, safety and efficacy of medicines in an open and easily understandable manner became an important part of EMA’s response to the threat of COVID-19.
EMA gave regular updates on the evaluation and authorisation processes of COVID-19 vaccines and treatments, ensuring that reliable, science-based information was accessible to everyone.
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