The US Food and Drug Administration (FDA) is warning that the Johnson and Johnson (JNJ) COVID-19 vaccine may be linked to Guillain-Barré syndrome, a relatively rare autoimmune disorder. Unfortunately for the confidence in the vaccine, this follows up on several other missteps and potential cardiovascular issues with the vaccine.
Nevertheless, it is clear that the COVID-19 vaccines’ benefits, preventing the disease, far exceed the extremely rare risks.
Because there is a lot of confusion about Guillain-Barré syndrome and whether there is a causal link to the JNJ vaccine, I will try to present the facts as they are known today. Of course, things change, and the CDC’s Advisory Committee on Immunization Practices (ACIP) will meet on 22 July 2021 to further discuss this issue, so stay tuned for more information.
What is Guillain-Barré syndrome?
The initial symptoms usually develop between a few hours to a few weeks and include weakness or a tingling feeling in your legs. The feeling can spread to your upper body. In severe cases, the patient can become almost paralyzed. This is life-threatening.
The cause of GBS is unknown, although the underlying mechanism involves an autoimmune disorder, which describes a condition where the body’s own immune system mistakenly attacks the peripheral nerves. Sometimes, GBS appears to be triggered by infection, although surgery and, very rarely, vaccination.
Guillain-Barré syndrome can be treated with intravenous immunoglobulins or plasmapheresis, with good chances for full recovery in the majority of individuals. However, recovery may take weeks to years, with about one-third suffering some permanent weakness. Approximately 7.5% of those affected by GBS will die.
Just to be clear, Guillain–Barré syndrome is rare, at one or two cases per 100,000 people every year.
The FDA has issued a revised fact sheet (pdf) for the JNJ COVID-19 vaccine. It includes the following statement about GBS:
The FDA stated that the chances of developing GBS are low, it does appear that it might be 3-5X higher among recipients of the JNJ vaccine than among the general population in the United States.
The CDC has identified approximately 100 suspected cases of Guillain-Barré among recipients of the JNJ one-dose vaccine through the Vaccine Adverse Events Reporting System (VAERS), a Health and Human Services monitoring system that relies on patients and health care providers to report adverse effects of vaccines. About 95% of the cases serious enough to require hospitalization.
Of course, as we discussed recently, VAERS is far from a perfect system, and it cannot establish causality. It is, at best, an observational system that might provide safety signals for adverse events. However, and I cannot stress this enough, until a thorough investigation is completed by infectious disease experts, these signals may or may provide any evidence of causality. A determination of causality is a logical, scientific process, not by data mining a huge database like VAERS.
However, the substantial, 3-5X, increase in the risk of GBS in those who received the JNJ vaccine compared to the general population is troublesome.
Like the myocarditis issue with the COVID-19 mRNA vaccines, Guillain-Barré syndrome can appear to be very scary. And unlike myocarditis, which is almost never a chronic condition, GBS can cause permanent neurological issues along with a small, but significant, risk of death.
However, as of 8 July 2021, about 12.8 million doses of the JNJ COVID-19 vaccines have been given – if we accept all 100 GBS cases as being caused by the vaccine, then the risk of GBS is about 0.78 out of 100,000 people. Of course, it’s possible not all GBS cases have been reported (especially since it could be a few weeks before symptoms appear).
The risk of dying from COVID-19 is still over 1000 out of 100,000 cases – getting COVID-19 is much more dangerous, so the benefit side of the risk-benefit equation is substantially higher.
And one group of neurology researchers has recently written:
Herein lie the statistics: within a population of 1 billion people, one would expect about 17 000 cases of GBS to occur sporadically per annum, of which 1962 would occur in any 6-week period. When considering a more optimistic 4-billion-person immunization programme conducted over 1 year, 68 000 cases of GBS would be expected to occur naturally within this time period, irrespective of any vaccination programme. Of these GBS cases, 13 076 would occur in the 10-week window following double-dose vaccination with injections separated by 4 weeks. It is therefore inevitable that many thousands of sporadic cases of GBS caused by other factors will appear temporally associated with COVID-19 vaccination. But, as any statistician can confirm, this cannot be considered causal.
They are saying that a potential link between the JNJ vaccine and Guillain-Barré probably doesn’t exist. Furthermore, a recent large study has shown no association between COVID-19 and GBS. Why is this important? Because the COVID-19 vaccines utilize the spike protein of the SARS-CoV-2 virus to induce an immune response – if GBS were caused by that virus, and it does not appear to be so, then maybe it would lend some credibility to a causal relationship between the vaccine’s antigens and GBS.
GBS has become a sort of proxy for everything wrong with vaccines – I believe that every vaccine package insert states that there’s a risk of GBS from every vaccine. Except that’s simply not ever been shown.
Lunn et al. state:
Multiple other vaccines including hepatitis B, polio, tetanus, meningococcus, rabies, and importantly, an orally administered adenovirus vaccine, have also previously been alleged to be associated with the occurrence of GBS. No causative links have been conclusively proven despite these individual reports being widely quoted. In a defensive posture, but one that further heightens worries about GBS and vaccines, GBS is recorded as a warning in every vaccination summary of medical product characteristics (SmPC) in the EU or Package Insert (PI) insert in the USA.
We seem to be afraid of GBS and vaccines, yet there is no evidence. Even with the flu vaccine, which even I assumed to be linked to GBS, the incidence appears to be less than 1 out of 1 million doses.
I think the FDA and CDC, institutionally paranoid after years of abuse from the anti-vaccine world, are over-reacting to VAERS data without really trying to establish causality. Humans are awful at weighing risk and benefit, so they think something that may be rare makes it dangerous.
I honestly waver between “it’s not linked, what are these bureaucrats thinking” to “OK, let’s be careful.” However, I think our over exaggeration of these tiny risks are causing a larger problem – COVID-19 vaccinations are plateauing. People will die because of this.
I wish the CDC and FDA could be as snarky and sarcastic as I am, because I just remain unconvinced that there is a link between GBS and the JNJ vaccine. I think the FDA and CDC are wrong. These precautionary tales are causing a larger problem, and it’s causing vaccine hesitancy.
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