Regulators in many countries collect reports of adverse events that occur after a person receives a vaccine against covid-19. This data collection is crucial to be able to identify side effects that may not have occurred during clinical trials. But at least in the UK, patients and doctors report a wide range of these events, many of which obviously have nothing to do with a recent vaccination against covid-19.
More countries in the European Union suspended its launch of the AstraZeneca vaccine on Tuesday, alleging concerns about a possibly higher 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 the potential harms. Meanwhile, other countries such as the United Kingdom continue to assert their security.
The core of this ongoing controversy is largely due to the voluntary reporting of adverse events by patients and physicians in these various countries. This system is absolutely vital for capturing possible red flags from a newly released drug or vaccine. But it is also imperfect and the conclusions based on these reports must be carefully weighed; just ask people who might think their genital herpes case is tied to the vaccine.
Below is a compilation of the UK’s most terrifying claims about the AstraZeneca vaccine:
- Genital herpes (four reports)
- Appendicitis (two reports)
- Dietary failure (a report)
- Breast enlargement (a report)
- Moans or shouts (three reports each)
- Hairy tongue (two reports)
- Clavicle fracture (two reports)
- Arthropod bite, though unclear whether spider or 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 yellow card system, a system that tracks adverse event reports 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 latest and longest report on the vaccine based on data collected from this system. These spontaneous reports, as they are sometimes called, were made between 4 January and 28 February 2021. On the UK website specifically configured for the submission of these reports, people are asked to “report suspected side effects to drugs and vaccines” involved in covid-19 treatment.
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As Gizmodo has done covered before, however, the “adverse events” and “side effects” are not the same. An adverse event is cap health problem or condition that appears after taking 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 independently. This is why placebo-controlled trials are so important in medicine, as they can help clarify the real benefits and possible side effects of a treatment rather than taking nothing.
Once a drug is released to the public, however, not all people who take it can be controlled as best they can in a clinical trial. This is why most countries, including the United States, rely on information systems that encourage patients (or their doctors) to detail possible side effects they may have experienced after taking treatment. It is important to note that while these systems will sometimes ask people to report the “side effects” they feel they have experienced, it still collects data from adverse events.
If you travel around the UK report, you will see symptoms that were commonly noticed in vaccine trials, such as headache, fatigue, and pain at the injection site. But as a Twitter user CTWarriorMonkey noted, you will also see many symptoms that are probably not connected.
Not all of these seemingly absurd reports come from people who actually believe they were bitten by a tick or a spider because of their vaccine. Some reports can be jokes. In other cases, doctors might have felt compelled to file a report just because the event happened after the vaccination, even if they don’t believe it was actually caused by the vaccine. In fact, some adverse events, such as death, are strongly encouraged (or with legal mandate) that will need to be reported by physicians, no matter how plausible their relationship to treatment is.
This is because this system remains, for all its warts, one of the fastest ways to collect as much real-world data on a new drug or vaccine as possible. Scientists sometimes miss the 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 only be vulnerable to a complication, but have not been studied during the trial. (a long-term problem with pregnant women).
When assessing the safety of a new treatment, health regulators need to separate the less plausible reports and introduce others that could be a real sign of problems. Only then can they try to find out if there is a real added danger. They often do so by looking at the rate of suspicious problems among the treated population and comparing it to the reference rate of the general public.
EU health regulators, the European Medicines Agency, are expected to present the formal results of their research on the AstraZeneca vaccine later this week. But on Tuesday, at a press conference, the head of the EMA, Emer Cooke reiterated the agency’s stance that there is “no evidence” of an increased risk of vaccine-related blood clotting, based on the clotting rates between vaccinated and unvaccinated people studied so far. The UK is also standing for the vaccine, as is the World Health Organization. According to AstraZeneca, since last Friday there were 37 total reports of blood clotting identified between 17 million people in the EU and the UK who received the vaccine.
In Germany, regulators dit they were forced to discontinue vaccination after receiving reports of a particularly rare form of blood clotting, not just blood clotting. There have been several reports in several countries layout to people who received doses from 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 renewed wave of pandemics, and the launch of the vaccine in the area only gets worse because of these suspensions. In trying to avoid the possible hidden risks of this vaccine, which probably do not include appendicitis, many of these countries are now increasing the well-known risks of a resurgent pandemic.