EMA: Development and authorisation of safe and effective COVID-19 vaccines in the EU
The meeting also gave the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns. This feedback will be considered by EMA and the European medicines regulatory network in the decision-making process.
Please note that some issues of high public interest, such as patient access to COVID-19 vaccines and national vaccination campaigns, lie outside EMA’s remit and were not covered at this event.
The European Medicines Agency (EMA) plays an important role in enabling the development, scientific evaluation, approval and monitoring of COVID-19 vaccines in the European Union (EU).
Vaccines for COVID-19 are being developed, evaluated and approved according to current regulatory guidelines and legal requirements.
Like all medicines, COVID-19 vaccines are first tested in the laboratory (e.g. studies on their pharmaceutical quality and studies to check first the effects in laboratory tests and animals).
Then vaccines are tested in human volunteers in studies called clinical trials. These tests help confirm how the vaccines work and, importantly, to evaluate their safety and protective efficacy.
Standard vaccine development
Standard vaccine development is a long process and studies are done in sequential steps.
Companies first make small batches and do small scale studies to characterise and optimise the production process. They perform studies to determinate a suitable formulation that can keep vaccine components stable to the end of its shelf life.
Then the company decides whether to continue development and scale up production. To assure that the vaccine meets its intended quality profile and complies with regulatory standards, the company develops a suitable and effective quality control strategy.
Studies on pharmaceutical quality look at the individual vaccine components, the final formulation to be used and at the whole manufacturing process in detail.
The vaccine developer conducts more studies in laboratory models, using in vitro studies or animal models (in vivo studies), to show how the vaccine triggers an immune response and works to prevent infection.
Finally, the vaccine developer studies the vaccine in three phases of clinical trials, with larger numbers of volunteers in each phase.
Emer Cooke, the executive director of the European Medicines Agency (EMA), stressed that Europeans are much “better protected” if the COVID-19 vaccine is authorised by the EU agency.
All COVID-19 vaccines – including the new ones to come – must be analysed before giving a “consistent authorisation that can be implemented at the beginning of the year (2021)”, said Cooke, adding that the EMA has no specific preference with regard to a COVID-19 vaccine in particular.
On the UK being the first country in Europe to have already started started its COVID-19 vaccination programme, Cooke did not want to be more explicit. It would be better to wait until EMA’s “certification” of safety and quality, she added.
‘We work very hard to meet citizen’s expectations’
The fact that, so far, the majority of COVID-19 vaccines have an efficiency rate of around 90% is “very good news”, said Cooke. The EMA chief pointed out, however, that this is “the analysis of the companies”. EU authorities “must confirm” that the studies carried out so far are sufficient.
“We are working very hard to meet the expectations of the European population,” she said.
Before starting work in her new position last October in Amsterdam, Cooke was director of the Department of Regulation and Prequalification of the World Health Organisation (WHO) in Geneva, and has almost three decades of experience in matters of international health regulation which is now being implemented by the EMA.
Data from Pfizer, BionNTech and Moderna to be carefully reviewed
A week ago, the EMA received formal requests for a conditional authorisation from pharmaceutical companies Pfizer/BionNTech and Moderna for the use of their vaccines in the EU, after the UK began vaccinating its citizens on Tuesday without having to wait for the review.
The EMA chief expects her team to finish reviewing Pfizer’s application before 29 December. The team will only be able to review Moderna’s application by 12 January because it has received less clinical tests and necessary information is still being exchanged.