The vaccine development process has been made much more efficient (without compromising efficacy and health standards) by conducting clinical trials in parallel, with more volunteers than usual, and by allocating more resources to researchers.
Efficiency was also increased by allowing vaccine developers to present trial results to the EMA cyclically throughout the research and development phase. Clinical trial data is typically only submitted for review by the EMA after the research and development phase has been completed.
EMA therefore needs less time to give its opinion on the vaccine after submitting the marketing authorization application, as most of the evaluation has already been done. The increased speed of the procedure therefore does not compromise its quality.Learn more about EMA’s rules on vaccine trials
Learn more about vaccine approval in the EUEMA website: the calendar of all vaccine trialsMore information from EMA’s public meeting with stakeholders on the development and authorization of safe and effective COVID-19 vaccines in the EUCOVID-19 vaccines, like any other type of vaccine, teach the immune system to protect itself from the virus.
Vaccines introduce a small portion of the inactivated virus into our body so that it can generate immunity without causing infections. They thus protect us from potential future infections of the active virus.
The cells in our body read the genetic code (DNA) and create temporary genetic instructions, in the form of RNA, that tell the body how to make the proteins they need to grow and heal.
Once the proteins are created, the RNA degrades. Vaccines manufactured by Pfizer-BioNTech and Moderna have identified the specific protein (the “spike” protein) that allows the coronavirus to infect healthy cells in humans.
These vaccines provide cells with modified RNA (mRNA) which gives them the task of reproducing the spike protein without the remainder of the virus. Our body then generates an immune response to the spike protein, which can take a long time when the body is first exposed to it.
Thanks to this process, after vaccination, the body learns to identify the protein and, in the event of a real infection, is able to recall and produce the antibodies it needs to eliminate it.There is no evidence that this process can damage our cells.Essential data on COVID-19 vaccinesMicrobiologist Peter Piot explains how vaccines work in 15 seconds
Find out more about how vaccines work on the European Vaccination Information Portal
Watch EMA’s public meeting with stakeholders on the development and authorization of safe and effective COVID-19 vaccines in the EU
Pharmaceutical companies are responsible for any side effects of vaccines purchased under the EU vaccination strategyThe company that holds the marketing authorization for a product always bears responsibility for it.
Businesses are responsible for the safety of their products and have specific obligations, such as implementing a comprehensive risk monitoring plan, reporting any adverse product effects and taking the necessary steps to remedy them.
While it is true that the EU has adapted some vaccine regulations to obtain safe and effective products in a shorter timeframe, safety standards have remained unchanged and the Product Liability Directive continues to apply. In other words, the claims that vaccine manufacturers are not responsible for any side effects in the contracts negotiated by the Commission are simply false.