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Authorising COVID-19 vaccines: MEPs to debate with European Medicines Agency

EMA Executive Director Emer Cooke will update MEPs on the latest developments concerning the authorisation of vaccines against COVID-19, on Thursday at 14.00.

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This will be followed by a Q&A session, where MEPs from the Committee on Environment, Public Health and Food Safety will quiz her on how close the most advanced vaccines are to receiving authorisation.

The European Medicines Agency (EMA) has recently received two applications for conditional marketing authorisation for two COVID-19 vaccines, one developed by BioNTech and Pfizer and one by Moderna Biotech Spain, S.L. The EMA’s scientific committee for human medicines is expected to conclude its assessments on the Pfizer/BioNTech and on the Moderna vaccines in the coming weeks.

Background

Developing and deploying an effective and safe vaccine against the virus is likely to be the only way to end the pandemic. To this end, the Commission has proposed an EU vaccines strategy for COVID-19. The Commission has already entered into advance purchase agreements with several pharmaceutical laboratories in order to create a portfolio of potential vaccines against COVID-19. Any vaccine will need to be authorised by the European Medicines Agency in accordance with safety and efficacy standards.

On 22 September, Parliament organised a public hearing on “How to secure access to COVID-19 vaccines for EU citizens: clinical trials, production and distribution challenges”.

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