Preventing COVID-19 outweighs ‘theoretical’ risk for Guillain-Barré syndrome with vaccine
Two patients enrolled in a COVID-19 vaccine trial — including one who received the vaccine and one who received placebo — developed Guillain-Barré syndrome 10 days after the injection, according to a case report published in Neurology.
The researchers urged neurologists “to avoid misattributing adverse events to the vaccination program” and to “educate and reassure their patients, the public and policy makers” about the safety of, and need for, COVID-19 vaccines, given that more reports of Guillain-Barré syndrome and other autoimmune diseases “will likely emerge.”
“COVID-19 vaccines currently being administered in the United States have been shown to be safe and effective at reducing risk of severe illness and death and are saving lives,” Anthony A. Amato, MD, professor of neurology at Brigham and Women’s Hospital and Harvard Medical School, said in a press release. “With approximately one billion people worldwide expected to be vaccinated against COVID-19, we anticipate there could be thousands of cases of Guillain-Barré syndrome that will occur around the time of the vaccination only by coincidence.”
Amato and colleagues described the timing of onset of Guillain-Barré syndrome in the patient who received the vaccine, a 60-year-old woman with a history of migraines who was “in her usual state of health” when she entered the trial, according to the case report. The patient began having pain in her back and legs 10 days after the vaccine, followed by headache, nausea, vomiting and diplopia 5 days after symptom onset, for which she went to the hospital. Two days later, she was readmitted to the hospital’s neurology service and began exhibiting “the earliest electrophysiological abnormalities” observed with Guillain-Barré syndrome, according to the researchers.
Coincidental, not causal, association
The patient received IV immunoglobulin 2g/kg over the course of 2 days and also underwent reverse-transcriptase polymerase chain reaction for SARS-CoV-2 twice during her admission, with negative results both times. The patient’s strength “slowly improved” and she was discharged to a rehabilitation facility 10 days after her initial admission, according to the case report.
“Temporal associations do not imply causality,” the researchers wrote. “The fact that one other participant in the Johnson & Johnson vaccine trial also developed [Guillain-Barré syndrome] 10 days after being injected with placebo supports the argument for a coincidental rather than a causal association.”
Amato pointed to “the momentous task” of vaccinating people throughout the world against COVID-19 and highlighted the need to closely monitor side effects, in addition to conducting larger studies to see if the risk for Guillain-Barré syndrome with COVID-19 vaccines “is similar to or different from the small risk” associated with vaccines such as the influenza vaccine.
“Such monitoring will also help avoid incorrectly attributing side effects that are not scientifically linked to the vaccine,” he said. “Based on experience with other vaccination initiatives and the data in the adverse monitoring systems of the COVID-19 vaccines gathered so far, we are certain that the benefits of vaccination outweigh the risks of COVID-19 infection.”
‘All adults should be vaccinated’
In a related editorial, Dennis Bourdette, MD, FANA, FAAN, professor emeritus of neurology in the School of Medicine at Oregon Health & Science University, and Joep Killestein, MD, PhD, of Amsterdam University Medical Center and Vrije University Amsterdam, emphasized many of the points made by Amato and colleagues, including the fact that, “importantly,” Guillain-Barré syndrome occurred in a patient who received placebo, that this temporal association “does not establish causation,” and that additional studies are needed to determine if COVID-19 vaccination increases the risk for Guillain-Barré syndrome “above background rates.”
“Given that the annual incidence of [Guillain-Barré syndrome] is about 10 to 20 cases per million among adults and hundreds of millions of people are to be vaccinated in North America and Europe and hopefully billions worldwide, many cases of [Guillain-Barré syndrome] will occur in temporal relationship to vaccination coincidentally,” Bourdette and Killestein wrote. “Indeed, a second case of [Guillain-Barré syndrome] in association with the mRNA Pfizer COVID-19 vaccination was reported in February 2021.”
Bourdette and Killestein noted that “numerous adverse events following vaccination will be reported” as worldwide COVID-19 vaccinations occur, but the majority of these “will be without evidence of causality.” While it is important to complete reporting of these events, the researchers emphasized the consensus that “the benefits of recommended vaccinations outweigh possible risks, even of [Guillain-Barré syndrome] and other autoimmune diseases.” They also emphasized that, “in general, all adults should be vaccinated against COVID-19” given the severity of the disease.
“Neurologists should be prepared to address concerns expressed by their patients and others when reports of [Guillain-Barré syndrome] temporally associated with COVID-19 vaccines appear in the news and online. Our position should be that such associations are most likely coincidental and that it is unlikely that COVID-19 vaccination causes [Guillain-Barré syndrome],” Bourdette and Killestein wrote. “We should also provide reassurances that there is ongoing monitoring of serious health problems, including [Guillain-Barré syndrome], occurring following COVID-19 vaccinations. Finally, we should emphasize that preventing COVID-19 with its proven risks of serious consequences outweigh any theoretical risks of [Guillain-Barré syndrome] following vaccination.”
American Academy of Neurology. COVID-19 trial: One case of Guillain-Barré after vaccine, but also one after placebo. Available at: https://www.aan.com/PressRoom/Home/PressRelease/4878. Accessed April 7, 2021.