Studies investigating serious side effects associated with the COVID-19 vaccines are beginning to give us a better sense of how safe the shots are. Despite what you may see on Twitter, the evidence continues to show that vaccination poses minimal risk to the vast majority of people.
If you want to find “evidence” that the COVID-19 vaccines are deadly, you don't have to look very hard. New blog posts, videos, news stories, and social media posts hit Google every day, and they all follow the same formula. Here's a typical example from Twitter:
Weekly update of the RARE serious vaccine adverse events reported to US VAERS. Up 10% overall (+10k), +5k hospitalised (41k total), +1.6k permanently disabled (13k total), +500 deaths (12k total). Don't worry though, these vaccines are SAFE and all events are reported.
VAERS stands for the Vaccine Adverse Event Reporting System, and it is beloved by folks like Joel Smalley who, for whatever reason, find value in scaring people away from generally safe, effective shots. This is amusing because the VAERS database has for many years helped public health agencies perform post-marketing surveillance to ensure that licensed vaccines are safe. As I wrote in a June story:
The irony in all this is that VAERS actually underscores just how safe FDA-approved vaccines are. And when used as intended, the system helps regulators update vaccine labels, restrict who should get certain shots, and, rarely, modify a vaccine or remove it from the market. In other words, VAERS mitigates the risk of vaccine injury.
VAERS during the pandemic
So, how has VAERS performed during the pandemic? Despite allegations that the COVID shots have caused an unprecedented number of adverse events, published studies that verify reports to the federal database show that the vaccines are safe for most people, and when side effects are reported, they are generally mild and easily treated, if they require treatment at all. We'll look at reports related to blood-clotting disorders in this story. In the next article, we'll examine some other widely reported side effects.
Keep in mind as we go that the peer-reviewed evidence always lags behind VAERS reports by two months or so because scientists have to evaluate cases submitted to the database. Vaccine skeptics will continue to point to more recent adverse events until they are investigated. That isn't a point in their favor; it just means that doing good science takes time.
Vaccines and blood-clotting disorders
Shortly after the Pfizer-BioNTech and Moderna vaccines were authorized in late 2020, reports of Thrombocytopenia (low blood platelet count) began to trickle into VAERS, and the media amplified individual cases. Here's a February report from Fox News, for example:
The condition was rarely reported in clinical trials for both vaccines (in the experimental and control groups), so it's not implausible that it might be linked to immunization in the real world. What did the FDA find when it investigated these cases? According to a June study:
Fifteen cases of thrombocytopenia were identified among 18,841,309 doses of Pfizer-BioNTech COVID-19 Vaccine and 13 cases among 16,260,102 doses of Moderna COVID-19 Vaccine. The reporting rate of thrombocytopenia was 0.80 per million doses for both vaccines.
Based on an annual incidence rate of 3.3 ITP [immune thrombocytopenia] cases per 100,000 adults, the observed number of all thrombocytopenia cases, which includes ITP, following administration of mRNA COVID-19 vaccines is not greater than the number of ITP cases expected.
Not only were these cases extremely rare, but the researchers weren't able to determine the mechanism by which immunization could cause thrombocytopenia because “an immune-mediated mechanism would be expected to have a longer onset interval than observed in most cases in this series ...” This doesn't mean the mRNA vaccines can't cause ITP; indeed other researchers have speculated that they could. Crucially, though, SARS-COV-2 infection is much more likely than immunization to cause thrombocytopenia.
Our own Dr. Chuck Dinerstein wrote a helpful primer on the relationship between COVID-19 and blood clotting disorders I encourage everyone to read: Why Are COVID-19 Patients Dying From Blood Clots?
On a related note, both the Pfizer-BioNTech and AstraZeneca shots pose a similarly low risk of thrombocytopenia and several related blood-clotting disorders, according to a June study of 1,372,213 vaccinated individuals in Europe. “In summary,” the researchers wrote, “in this study of over a million people vaccinated against SARS-CoV-2 in Catalonia, Spain, the BNT162b2 [Pfizer] and ChAdOx1 [AstraZeneca] vaccines have been seen to have similar safety profiles.” They added:
Safety signals for both venous thromboembolic events and thrombocytopenia following BNT162b2 vaccination have been identified, with their magnitude similar to these same events among people vaccinated with ChAdOx1.
These safety signals must be interpreted with caution with further investigation required to confirm causality. Regardless of the vaccine used, the increase in rates of thrombosis among persons with COVID-19 is far higher than those seen among persons vaccinated [emphasis mine].
Similar results have been reported for J&J's shot, an adenoviral vector vaccine similar to AstraZeneca's. A May 2021 study found that 7.98 million doses of the vaccine generated 13,725 VAERS reports, of which “97% were classified as nonserious and 3% as serious,” including three reports in women of thrombosis accompanied by thrombocytopenia during the second week after vaccination.
Ask questions and seek answers
Before we move on to part two, there are a few points worth stressing here in conclusion. The media has vacillated between downplaying the efficacy of COVID vaccines and chastising Americans for refusing to get immunized. Giving this conflicting information, the public is asking reasonable questions about serious side effects linked to the shots. Fortunately, severe adverse events appear to be quite rare and may not even be related to the vaccines themselves.
It's important to remember that we know all this because scientists around the world are actively investigating these cases and reporting the results in generally open-access venues. You don't have to take statements from public health agencies, pharmaceutical companies, and reporters at face value. The data they rely on are out there on Google for all of us to see. If the COVID vaccines were actually injuring or killing people left and right, there'd be no way to hide it.
