Regulators in many countries are collecting reports of adverse events that occur after a person receives the covid-19 vaccine. This data collection is crucial to identify side effects that may not have appeared during clinical trials. But, at least in the UK, patients and doctors are reporting a wide range of these events, many of which obviously have nothing to do with a recent vaccination with covid-19.
More European Union countries suspended the launch of the AstraZeneca vaccine Tuesday, citing concerns about a possibly increased risk of blood clotting in people who take it. At the same time, EU health regulators themselves said on Tuesday that there appears to be no clear link between coagulation and the vaccine and that its benefits still outweigh any potential harm. Meanwhile, other countries like the United Kingdom continue to assert their security.
The crux of this ongoing controversy largely comes down to reports of adverse events sent voluntarily by patients and doctors from these various countries. This system is absolutely vital for detecting possible warning signs of a newly launched drug or vaccine. But it is also imperfect, and any conclusions based on these reports must be weighed carefully – just ask people who might think that your case of genital herpes is linked to the vaccine.
Here is a collection of the most complicated claims reported in the UK about the AstraZeneca vaccine:
- Genital herpes (four reports)
- Appendicitis (two reports)
- Diet failure (a report)
- Breast augmentation (a report)
- Moaning or screaming (three reports each)
- Hairy tongue (two reports)
- Clavicle fracture (two reports)
- Arthropod bite, although it is not clear whether it is a spider or a tick (two reports)
- Cracked lips (two reports)
- Flatulence (89 reports)
- Electric shock (two reports)
- Bad breath (five reports)
- Ejaculation failure (a failure)
These claims come from the UK’s Yellow Card System, a system that tracks reports of adverse events from the public and doctors (the UK was the first country to authorize the AstraZeneca vaccine last December). Last week, UK health regulators released the most recent and extensive vaccine report based on data collected from this system. These spontaneous notifications, as they are sometimes also called, were made between January 4 and February 28, 2021. On the UK website configure specifically to send these reports, he asks people to “report suspected side effects to drugs and vaccines” involved in the treatment of covid-19.
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How Gizmodo did approached before, however, “adverse events” and “side effects” are not the same. An adverse event is none health problem or condition that appears after treatment, even if the problem is not really related to it. Sometimes, a headache after taking a cold medicine is just a headache that would have happened anyway. That is why placebo-controlled studies are so important in medicine, because they can help to clarify the real benefits and possible side effects of a treatment versus taking nothing.
Once a drug is released to the public, however, you cannot monitor everyone who takes it the way you do it in a clinical trial. That is why most countries, including the United States, rely on reporting systems in which patients (or their doctors) are encouraged to detail the possible side effects they may have experienced after taking treatment. It is important to note that, although these systems sometimes lead people to report “side effects” that they feel they have experienced, this is still just a collection of adverse event data.
If you travel the UK report, you will see symptoms that were commonly seen in vaccine tests, such as headache, fatigue, and pain at the injection site. But as a Twitter user CTWarriorMonkey pointed out, you will also see many symptoms that are probably not related.
Not all of these more foolish reports are from people who really believe they got a tick or spider bite because of the vaccine. Some reports can be tricky. In other cases, doctors may have felt compelled to send a report just because the event happened after vaccination, even though they do not believe it is actually caused by the vaccine. Some adverse events, such as death, are in fact strongly encouraged (or legally mandatory) to be reported by doctors, no matter how plausible your connection to a treatment is.
That’s because this system is still, with all its warts, one of the fastest ways to collect as much real-world data about a new drug or vaccine as possible. Scientists sometimes miss side effects in clinical trials, often because they are so rare that they only appear in a very large population or because some groups may be especially vulnerable to a complication, but were not studied in the trial (the problem of long-term care with pregnant people).
When assessing the safety of new treatment, health regulators need to separate the least plausible reports and insert those that could be a real sign of a problem. Only then can they try to find out if there is a real additional danger. They generally do this by looking at the rate of any suspicious problems among the treated population and comparing it to the basic rate for the general public.
EU health regulators, the European Medicines Agency, are expected to present the formal conclusions of their investigation into the AstraZeneca vaccine later this week. But on Tuesday, at a news conference, EMA chief Emer Cooke reiterated the agency’s position that “there is no indication” of an increased risk of blood clotting associated with the vaccine, based on the coagulation rates between vaccinated and unvaccinated studied so far. The United Kingdom is also standing vaccine, as well as the World Health Organization. According to AstraZeneca, until last Friday, there were 37 notifications in total blood clotting identified among 17 million people in the EU and the UK who received the vaccine.
In Germany, regulators said they were forced to suspend vaccination after receiving reports of an especially rare form of blood clotting, not just blood clotting alone. Several reports in several countries have been traced for people who received doses of the same batch, which plausibly raised the possibility of contamination.
These are reasonable questions to continue studying. But much of Europe is in danger of a new wave of the pandemic, and the slow implementation of the vaccine in the area is only getting worse because of these suspensions. In an attempt to avoid the possible hidden risks of this vaccine, which probably do not include appendicitis, many of these countries are increasing the well-known risks of a resurgent pandemic.