Are the COVID-19 vaccines safe, even though they have been developed so quickly?
The short development time for the current COVID-19 vaccine candidates was possible thanks to a number of factors:
- Knowledge of the potentially protective antigen from previous work on vaccines for SARS-CoV in 2002/2003 and MERS-CoV
- Application and further development of new vaccine technologies
- Some otherwise preclinical trials were carried out in parallel to clinical trials
- Performance of overlapping phase 1/2 and phase 2/3 trials
- Regulatory guidance through intensive and in some cases repeated scientific advice
- Rolling review at the Paul-Ehrlich-Institut and at the European Medicines Agency (EMA)
- High level of focus and generous financial support from the German Federal Government, the European Commission and global charitable foundations which also enabled large-scale manufacture to commence prior to marketing authorisation
- Worldwide cooperation, e.g. at the level of the WHO and the International Coalition of Medicines Regulatory Agencies (ICMRA)
- For the marketing authorisation of the COVID-19 vaccines, data was evaluated from between 20,000 and almost 40,000 study participants. This allowed extensive information to be gained on the safety and efficacy of the vaccines.
The follow-up monitoring of the study participants does not end with marketing authorisation. They will be actively monitored over a period of up to two years as part of the ongoing clinical trials tied to the authorisation process. One of the reasons for doing this is to evaluate how long the efficacy of the vaccination will last.
In general, however, it is the case with COVID-19 vaccines, as with all other new vaccines and therapeutic medicinal products, that not all very rare adverse reactions can be recorded at the time of marketing authorisation. For this reason, the safety of vaccines, like that of other newly authorised medicinal products, continues to be checked after marketing authorisation. One element of this follow-up monitoring (surveillance) is, for example, the analysis of spontaneous reports of suspected adverse reactions or vaccination complications. For the pandemic COVID-19 vaccines, other studies are also being carried out, including active safety studies.
Updated: 01.06.2022
Do we need to fear long-term effects of vaccines that occur years after vaccination?
Decades of experience has shown that most vaccine side effects occur within a few hours or a few days after a vaccination. In rare cases, vaccine side effects occur or are recognised only after weeks or a few months.
The first available COVID-19 vaccines in Europe were authorised in late 2020 or early 2021 and have been in general use since. The first clinical trials began several months before authorisation. Since then, the vaccines have been administrated millions or even billions of times. These vaccines and their side effects are now well known - including very rare side effects.
Further Information
Updated: 01.06.2022
What are long-term effects anyway?
There are two possibilities of what is meant by the term "long-term effects". Something that only occurs after a long time, or something that lasts over a long period of time.
A desirable long-term consequence of vaccination in the sense of a long-lasting effect is protection against infection or serious illness. For some people, this protection even lasts for life - for example, with the measles vaccination. For other vaccinations, such as against influenza - and according to the current status also against COVID-19 - booster vaccinations are necessary. Together, however, the vaccinations lead to continuous protection against the pathogen.
In individual cases, even very rare vaccination complications can last a long time, possibly years. However, this is the absolute exception. An example of such an extremely rare side effect with a long-term effect is the very rare occurrence of narcolepsy after vaccination against swine flu in 2009/2010 and is an absolute exception. Here, too, the first indications of this vaccination complication occurred only a few months after the start of the vaccinations.
Concerned citizens understand long-term consequences - often also called late effects - to mean side effects that occur only after a delay of many months or years after vaccination. These concerns are unjustified. We are not aware of such very late-onset side effects of vaccines.
Tl;dr: Serious adverse effects happen, tough rarely. A large majority of them appear shortly after the shot (hours to a few days) and are therefore often recorded and followed up.
Things
can go wrong (like with all vaccines), but the risk from the disease is more dangerous for the vast majority of people. Even now, when the mutations have made the symptoms milder, there's a lot of people in hospitals, and a few unlucky (or very old) people take months to years to recuperate completely. Compare that with the amount of people in hospitals or needing long term care for the vaccine and it's pretty clear what is more likely to cause harm.
