15/16 June 2023
No other topic is currently as controversial as the research, approval and production of vaccines for COVID-19. The discussion about the necessity, side effects of vaccinations, etc. has been going on for a long time. Due to the accelerated procedures in relation with the Corona pandemic and the uncertainty in the population, these discussions, fueled by a large number of comments and articles in the social media and demonstrations by opponents of the vaccination, have greatly increased.
EMA has now announced that it will organise a public meeting on 11 December 2020 to give all European citizens the opportunity to learn about the EU regulatory procedures for the authorisation of COVID-19 vaccines and the role of the Agency in the development, evaluation, authorisation and safety surveillance of these vaccines.
In its announcement, EMA says: "The COVID 19 pandemic is an unprecedented global crisis with devastating health, social and economic consequences. Safe and effective vaccines for COVID-19 are urgently needed to respond to this crisis and reduce its impact.
EMA, together with the European Network for Drug Regulation, is supporting the development of vaccines against COVID-19 and has taken steps to accelerate the evaluation processes for these vaccines. The Agency and its partners ensure that the same high regulatory standards of quality, safety and efficacy are applied to COVID-19 vaccines".
The activities of the EMA tend to be less in the focus of the public, and its responsibilities are often not known to the citizen. The planned public meeting is intended to inform citizens about the role of EMA in regulation and authorisation. It will also be an opportunity for both the public and stakeholders to communicate their needs, expectations and concerns, which will be taken into account by EMA and the European Network for the Regulation of Medicinal Products in the decision-making process.
Those who wish to contribute actively to the planned public meeting must register by 27 November 2020 using a speaker application form.
EMA will examine all applications and, taking into account the time available, will select a group of people to speak at the meeting. Accordingly, a list of speakers will be published in advance by EMA.
The public meeting will be broadcast live and open to all citizens. In addition to the selected list of speakers, a mailbox will be available for public comments during the meeting via the EMA website. All related information, from the list of speakers to the agenda, will be made available on the EMA website.