Updated January 20, 2021 at 11:19 pm
- “ The re are no long-term data for this vaccine, nobody can estimate the side effects,” is an objection to the COVID-19 vaccination.
- A specialist explains why a lack of long-term data is not the problem – especially in the case of the COVID-19 vaccine.
In the long history of vaccination, vaccine development has taken ten to 20 years. The re is more than It is understandable that many people are now asking themselves: Can the COVID-19 vaccine be just as safe?when it came to market in record time? What many fear are long-term consequences that we cannot yet know about. For the term “long-term” there is no definition at all in the approval, and there is a reason for that.
The word ‘long-term damage’ has established itself here in everyday language and is often incorrectly interpreted – applied to the current situation – as ‘damage that the vaccination only causes after a long time'”, explains Petra Falb, expert in the approval for Vaccines at the Austrian Federal Office for Health Safety, in their blog. Such “Late side effects” that occur suddenly about five years after the vaccination cannot exist for biological reasons.
The scientific explanation: In contrast to pharmaceuticals such as antibiotics, antihistamines or cortisone, you don’t get a vaccine as a long-term therapy: “You get it once, maybe a second or third time as part of a basic immunization, but even that at intervals of weeks or months, then maybe never more or maybe every five or ten years, “writes Falb.
The pharmaceuticals mentionedAccording to the expert, they can accumulate in the body during prolonged therapy, are broken down, creating intermediate products – so-called metabolites. In science this process is called “pharmacokinetics”. “A vaccine has no pharmacokinetics because nothing is metabolized here,” she explains.
So no new metabolites would be produced in the body, nothing corresponding would accumulate in the body through a vaccination, so the following applies: “Side effects appear within a few hours to one or two days after the vaccination”.
Allergic reactions also occurred soon after administration. “Various autoimmune reactions are possible as very rare side effects, but even these occur after a few weeks at the latest,” she adds.
Common mistake: damage that only occurs years after vaccination?
It is important to collect data on vaccines over a longer period of time. However, the reviewer counters a common mistake:
- In the case of vaccines, “long-term” does not refer to the time after which a side effect occurs, “but to the time after which enough people have been vaccinated to be able to reliably assign them to the vaccine!”
The re is Side effects that are so rare that they only become known after a long time. However, this does not mean that a person did not experience a side effect until years after the vaccination: “If a certain side effect only occurs in one in 20,000 or one in 50,000 or 100,000 people, we need a very large number of people who have been vaccinated to get it at all – and until enough people have been vaccinated, it usually takes a long time. Even a large clinical study cannot generally show very rare side effects. “
The same cannot be ruled out with the COVID-19 vaccination. Statistically, however, such side effects would be negligible due to their rarity.
Famous example: swine flu
The misleading term “long term side effects” could have been popularly originated through Long-term vaccine damage that is actually possible. In very rare cases, for example, the smallpox vaccination resulted in a vaccination-related meningitis, explains Falb. But this occurred “on average within a week after the vaccination”, not years later.
The expert notes that the vaccines from that time would no longer make it through the approval process according to today’s criteria.
The frequency of this side effect is about 1: 20,000, the occurrence happened on average within a few weeks after vaccination, in some individual cases about four months later“, Schilder Falb. Due to its rarity, this side effect was only noticed after about a year.
The role of the pandemic in the development of narcolepsy is still being investigated.
The damage itself occurred much earlier.
Corona: Lots of data “dream for the authorities”
The number of subjects already in the clinical studies before approval was strikingly large”she explains. For other, also newly approved vaccines in Europe, it was mostly between 10,000 and 15,000. At Pfizer / Biontech there were more than 43,000.
Second: Because millions of people have already been vaccinated, very rare side effects would also be recognized very quickly: “Since the vaccination campaigns are now running worldwide, the number of people is very high data are available quickly, i.e. extremely high here – a dream that could not be fulfilled under normal circumstances, even for the authorities. “
Those who get vaccinated have to expect a reaction from the body
The experts consider a connection with immunization to be unlikely. “Based on the data that we have, we assume that the patients died of their underlying disease – in a coincidental time connection with the vaccination,” said Brigitte Keller-Stanislawski, the department head responsible for the safety of drugs and medical devices.
The frequency of such reactions in the approved COVID-19 vaccines was compared with a placebo group (who received only a dummy vaccine) in vaccinated persons within up to 14 weeks after. According to the Robert Koch Institute (RKI), these were the most common reactions:
- Injection site pain (BioNTech / Pfizer: 83 percent (in the placebo group: 14 percent), Moderna: 88 percent (placebo: 17 percent).
- Exhaustion: BioNTech / Pfizer: 47 percent (placebo: 23 percent), Moderna: 65 percent (placebo: 33 percent).
- A headache: BioNTech / Pfizer: 42 percent (placebo: 23 percent), Moderna: 59 percent (placebo: 34 percent).
- fever occurred less frequently after the first dose (four percent for BionTech, 0.8 percent for Moderna, and one percent and 0.3 percent in the placebo groups) than after the second dose (16 and 15.5 percent after vaccination; zero and 0.3 percent in the placebo groups).
Paul Ehrlich Institute confirms: Vaccines carefully checked
The “rolling review process” was used for approval – in the EU it was not an emergency, but a so-called conditional marketing authorization. Pharmaceutical manufacturers can submit individual reports on the quality, harmlessness and effectiveness of their preparation before the complete application for approval – the findings are therefore checked in parallel with development, not right at the end.
That did that Procedure faster, but not less secure: “A rolling review and an accelerated evaluation process do not mean that there will be compromises in terms of the care taken during testing,” writes the Paul Ehrlich Institute responsible for vaccines and drugs.
The re, too, there is reassurance about the side effects feared by many: “Long-term side effects that only occur after years are generally not known with vaccines”, explained Susanne Stöcker, press spokeswoman for the Paul Ehrlich Institute in an interview with ZDF. “Most side effects of vaccinations occur within a few hours or days. In rare cases after weeks.”
- “This is how it works! Complex topics simply explained”, blog by Petra Falb, reviewer in the approval of vaccines at the Austrian Federal Office for Safety in Health Care
- Robert Koch Institute
- Paul Ehrlich Institute