In light of increasing COVID-19 cases across the EU and concerns raised by a new variant, members of the Environment, Public Health and Food Safety Committee focused the debate on COVID-19 vaccines, recent developments in COVID-19 therapeutics and the Agency’s capacity to deal with current and future challenges. MEPs asked whether the agency is prepared to deal with new variants, about the use and effectiveness of booster vaccines, clinical trials transparency and coordination with European and international counterparts, including the new Health Emergency Preparedness and Response Authority (HERA).
Emer Cooke, Executive Director of the European Medicines Agency (EMA) reassured MEPs that the EMA is prepared to deal with the current challenges posed by the pandemic. Existing vaccines have remained effective until now, with studies showing that an additional dose or booster ensures extended immunity, she added. Should a scientific decision be taken to adapt them, the Agency already has in place guidance for manufacturers that plan to modify vaccines to address variants. The agency also has a legal framework to authorise adapted vaccines more quickly, which would ensure they are approved within a 3-4 months period.
The EMA recently recommended that a booster dose of the two mRNA-based COVID-19 vaccines (Comirnaty-BioNTech/Pfizer and Spikevax - Moderna) may be given to people with severely weakened immune systems as well as the general population over 18 years old, said Emer Cooke. Member states decide how these boosters should be rolled out depending on their vaccination campaigns and the capacity of their national health systems.
Regarding clinical trials, Ms Cooke confirmed that the EMA is committed to being transparent in publishing data, also in view of the application of the new requirements under the clinical trials regulation from the end of January 2022. On coordination with HERA, the EMA is currently preparing a memorandum of understanding, which will clearly outline the responsibilities of the two bodies and ensure they coordinate effectively.
With regard to the EMA’s capacity to deal with its reinforced role, Ms Cooke informed MEPs that the Agency is still evaluating the impact of its new tasks. However, the general situation is a concern, with the workload constantly growing since 2014 and the needs of human resources not being matched with financial resources.
Background
The Environment, Public Health and Food Safety MEPs hold annual exchanges with leaders of EU agencies within the committee’s fields of expertise. Parliament and Council also recently reached a deal for a stronger role for the Agency following lessons learned from the pandemic.
Ref.: 20211129IPR18310
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