Regulators in many countries collect reports of adverse events that occur after a person receives a covid-19 vaccine. This data collection is crucial in order 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 events, many of which obviously have nothing to do with a recent covid-19 vaccination.
Several countries in the European Union suspend The launch of the AstraZeneca vaccine on Tuesday, raising concerns about a possible higher risk of blood clotting in people who take it. At the same time, European health regulators said on Tuesday that there appears to be no clear link between coagulation and the vaccine and that its benefits still outweigh any potential harms. Meanwhile, other countries such as the United Kingdom continue to assert their security.
The focus of this ongoing controversy is largely reduced to reports of adverse events submitted voluntarily from patients and doctors in these different countries. This system is absolutely vital for catching the potential red flags of a newly released 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 their case of genital herpes is related to the vaccine.
Here is a collection of the loudest statements reported in the UK about the AstraZeneca vaccine:
- Genital herpes (four reports)
- Appendicitis (two reports)
- Diet failure (a report)
- Breast augmentation (one report)
- Voices or shouts (three reports each)
- Fur tongue (two reports)
- Clavicle fracture (two reports)
- Arthropod bite, although it is unclear whether the spider or the tick (two reports)
- Cracked lips (two reports)
- Flatulence (89 reports)
- Electric shock (two reports)
- Bad breath (five reports)
- Ejaculation failure (a failure)
These allegations come from the UK’s yellow card scheme, a system that keeps track of adverse event reports from the public and doctors (the UK was the first country to authorize the AstraZeneca vaccine in December last year). Last week, UK health regulators freed the most recent and very long 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 United Kingdom’s website specially configured for the submission of these reports, calls on people to ‘report suspected adverse reactions to medicines and vaccines’ involved in the treatment of covid-19.
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As Gizmodo did covered before, however, “adverse events” and “side effects” are not the same. An adverse event is anything health problem or condition that occurs after treatment, even if the problem is not actually related to it. Sometimes a headache after taking a cold medicine is just a headache that would have happened no matter what. This is why placebo-controlled studies are so important in medicine because they can help clarify the real benefits and possible side effects of a treatment compared to taking nothing at all.
Once a drug is released to the public, however, you cannot monitor every person who takes it as best you can in a clinical trial. Therefore, most countries, including the US, rely on reporting systems in which patients (or their doctors) are encouraged to detail possible side effects they may have experienced after receiving treatment. Importantly, although these systems will sometimes cause people to report “side effects” that they feel they experience, they still only collect data on adverse events.
If you travel the UK report, you will see symptoms that were commonly seen in vaccine studies, such as headache, fatigue, and pain at the injection site. But as a Twitter user CTWarriorMonkey pointed out, you will also see a lot of symptoms that are probably not connected at all.
Not all of these sounding reports are from people who truly believe they have received a tick or spider bite because of their vaccine. Some reports could be farcical. In other cases, doctors may have felt compelled to report only because the event occurred after vaccination, even if they do not believe it is caused by the vaccine. Some adverse events, such as death, are actually strongly encouraged (or legal mandate) to be reported by doctors, no matter how plausible their connection to a treatment is.
This is because this system is still, 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 will only occur in a very large population or because some groups may be uniquely vulnerable to a complication, but have not been studied. in the study (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 those that could be a real signal of problems. Only then can I try to figure out if there is an added danger. They often do this by analyzing the rate of any suspected problems among the treated population and comparing it with the initial rate of the general public.
EU health regulators, the European Medicines Agency, are expected to present the formal findings of their investigation into the AstraZeneca vaccine later this week. But on Tuesday, at a press conference, the head of EMA, Emer Cooke he reiterated the Agency’s position that there is “no indication” of an increased risk of vaccine-related blood clotting, based on the coagulation rates between vaccinated and unvaccinated individuals studied so far. The UK is also standing of the vaccine, just as it is World Health Organization. According to AstraZeneca, since last Friday, there have been 37 total reports of blood clotting identified among 17 million people in the EU and the UK who received the vaccine.
In Germany, regulators SAPS they were forced to stop vaccination after receiving reports of a particularly rare form of blood clotting, not just blood clotting. There have been several reports in several countries Marking people who received doses from the same batch, which plausibly raised the possibility of contamination.
These are reasonable problems to continue studying. But much of Europe is in danger as a result of a renewed wave of pandemics, and the launch of the vaccine camp 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 now increasing the well-known risks of a recurring pandemic.