- First conditional market authorisation could be given by 29 December at the latest
- EMA will publish all information to grant conditional market authorisation
- Public meeting on approving COVID-19 vaccines 11 December
MEPs debated the latest developments concerning the authorisation of vaccines against COVID-19 with European Medicines Agency (EMA) Executive Director Emer Cooke.
MEPs from the Committee on Environment, Public Health and Food Safety today quizzed the EMA Executive Director on the status of approving COVID-19 vaccines.
Ms Cooke explained that currently four different COVID-19 vaccines are under an assessment or a rolling review by the EMA. It received on 1/12/2020 two applications for conditional marketing authorisation for COVID-19 vaccines. Both vaccines will be assessed under an accelerated procedure and the EMA will conclude its assessments on the first one by 29 December at the latest which is less than one month after the application was received. This speedy review process is only possible since a rolling review started long before. During this phase, EMA assessed data on the vaccine’s quality (such as information about its ingredients and the way it is produced) as well as results from laboratory studies. While speed is of the essence, safety is paramount, she said, as hundreds of millions of Europeans are going to be given these vaccinations.
Several MEPs took the floor and supported the EMA in only approving vaccines when it was clear that the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine.
The Executive Director also confirmed that it is allowed for a member state under EU law to give a temporary marketing authorisation, as done by the UK, but that all 27 EU member states have chosen to wait for the EMA to give a conditional market authorisation that will be valid in all EU member states at the same time. The EMA is working around the clock to finish the review as soon as possible. Even after the conditional authorisation has been granted, companies will be legally obliged to provide additional information including studies for specific vulnerable groups and children.
The Executive Director of the EMA confirmed that the Agency has been under a cyber attack during the last weeks but stated that this would not affect the timeline of the approval of vaccines.
Transparency on vaccines
MEPs repeated calls for transparency and Ms. Cooke said that all information that the EMA has used to give a conditional market authorisation to a COVID-19 vaccine will be made public as soon as the authorisation is given, including the risk management plan that is normally not released.
She added that there is substantial misinformation about COVID-19 vaccines circulating online and mentioned that the EMA is organising a public meeting 11 December to inform European citizens about the EU regulatory processes for the approval of COVID-19 vaccines and to listen to concerns.
You can watch a recording of the committee meeting here.
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”.