Vaccine procedures: international and European standards
According to the World Health Organization (WHO) and the EU’s vaccination information portal, vaccination in general is safe and side effects from a vaccine are usually minor and temporary. The vaccines are rigorously tested by their developers and then they undergo a scientific evaluation procedure overseen by regulatory authorities, which includes three phases of clinical trials before being approved for use and licensed. These licensed vaccines are also regularly reassessed. Vaccines are tested in laboratories and in animals and their effects are observed. These tests are then followed by clinical testing programmes in humans that can last for up to 10 years from the initial concept to authorisation.
The European Medicines Agency (EMA) plays an important role in this procedure because it interacts with developers of potential COVID-19 treatments and vaccines and it also makes use of real-world data to monitor the safety and effectiveness of medicines used to treat patients with COVID-19. It also helps Member States and the Commission by taking quick and coordinated regulatory action on the development, authorisation and safety monitoring of COVID-19 treatments.
Marco Cavaleri, Chair of the EMA’s COVID task force : “There are many vaccines undergoing clinical trials at the moment, each using different platform technologies, and all presenting interesting features that could provide a diversified portfolio of options. The mRNA vaccines from Moderna and BioNTech/Pfizer are certainly among the most advanced, and the clinical data on their efficacy and safety is already available. The EMA has started a rolling review of these two mRNA vaccines and could come up with a positive opinion for at least one of them to be approved as early as the end of this year.” – Read the full interview of Marco Cavaleri
The EU’s vaccine standards and approval procedure consists of six major steps: first, vaccines undergo laboratory tests to assess their pharmaceutical quality, then they are tested in non-clinical trials on animals before clinical trials on humans are initiated. After this, the evaluation and manufacturing procedures take place. Once a vaccine has been authorised, further studies are carried out on its safety and efficacy (see Figure 1). After it has received EU-wide marketing authorisation, decisions about pricing and reimbursement take place at national and regional levels: the EMA has no say in these decisions.
Figure 1: Overview of vaccine development and approval stages, source EMA
Marco Cavaleri : “The EMA has started a rolling review of vaccines where data are assessed as soon as they become available, which allows us to save time as the assessment can progress continuously until the last set of data is submitted. This process is rather intense and time-consuming but allows the timelines for assessment to be compressed without any compromise in the quality of the regulatory review.”
Once a vaccine has been authorised for use in the EU, the EMA and the Member States continuously monitor its safety and take action if new information suggests that it is no longer as safe and effective as previously thought.
Industry-independent post-authorisation studies are currently being funded by the Commission and planned by the ECDC and EMA. Such studies should consider the safety and effectiveness of pharmaceutical products.
Dr Kari Johansen, from the ECDC : “Many new vaccines are expected to become available in the Member States, but they may not be equally effective in all age and target groups. We still have a lot to learn, and studies that go beyond the routine safety monitoring available in all EU/EEA countries are therefore needed, and are indeed already planned.” – Read the full interview of Kari Johansen
Chinese and Russian vaccines
China and Russia were the first to approve their COVID-19 vaccines in summer 2020 after working to develop them as quickly as possible, and have faced widespread criticism and scepticism as a result. According to a paper published by Canadian scientists in The Lancet, the lack of data from phase III trials raises concerns about safety. Following the Ebola outbreak in 2013, the WHO put in place a rapid evaluation procedure that speeds up the introduction of a new vaccine. This means instead of waiting years for clinical trials to progress, vaccines can be subject to emergency approval. However, neither the Chinese nor the Russian vaccines were developed in accordance with the WHO’s Emergency Use Listing procedure, so it remains unclear whether they meet its manufacturing quality norms and standards.
Marco Cavaleri : “The EMA has not has not yet assessed the data relating to the quality of these vaccines. The timeframe for their development does not differ much from what we have seen for the vaccines we usually deal with. The speed of development is not a cause for concern, as long as all the required tests have been conducted.”
Dr Kari Johansen : “The Russian and Chinese vaccines have both been recommended and used without there being any results available from the phase III clinical trials currently underway. We are now waiting for those results, but we have no reason to believe that they will be worse than for any other vaccine candidates in development and which use the same type of technology.”
Vaccine confidence and hesitancy
Marco Cavaleri : “Vaccine hesitancy is a threat to vaccination campaigns against many serious pathogens, and could also play a detrimental role in the current pandemic.”
The possible impact of vaccine hesitancy must be considered. According to the recent survey on COVID-19 vaccination intent carried out by Ipsos, a majority of adults in France (54 %), Spain (64 %), Italy (65 %) and Germany (69 %) would get vaccinated if a vaccine were available. On the other hand, 48 % of respondents in Spain worry that rushed clinical trials might compromise a vaccine’s quality.
Figure 2 : If a vaccine for Covid-19 were available, I would get it, source : IPSOS
European institutions are working together to tackle the spread of misinformation around COVID-19 vaccines, and politicians have a role to play in making people feel confident about taking the vaccine.
Marco Cavaleri : “The Commission, the ECDC, and the relevant authorities in Member States need to work together to make sure that there is a proactive approach to communication on vaccines. The EMA is committed to providing accurate and transparent scientific information on the benefits and risks of any vaccine that is approved.”
Dr Kari Johansen : “Politicians can help ensure that adequate human and financial resources are set aside for the required studies at the EU and national levels. Once the vaccines are shown to be safe and effective, each country needs to put adequate resources into rolling them out, including using websites at the governmental, public health, and regional and local levels in the relevant languages, and other reach-out activities may be needed.”
Useful links:
• Member of the European Parliament debated ways to secure a quick and safe supply of COVID-19 vaccines with representatives of pharmaceutical companies, research, and civil society.
• The European Medicines Agency (EMA) latest updates
• European Centre for Disease Prevention and Control (ECDC)
• European Parliamentary Research Service: At a glance on Coronavirus vaccines strategy
• The European Medicines Agency’s EU conditional marketing authorisations for COVID-19 vaccines
Related content:
• A scientist’s opinion : Interview with Dr Kari Johansen about vaccine procedure
• A scientist’s opinion : Interview with Marco Cavaleri about vaccine procedure