Wednesday, March 29, 2023
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Health Sciences Clinical Professor of Family Medicine
University of California, Irvine School of Medicine
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This activity is intended for physicians, nurses, pharmacists, physician assistants, and all other members of the healthcare team who advise patients regarding COVID-19 vaccination.
The goal of this activity is for learners to be better able to analyze the risk for Guillain-Barré syndrome (GBS) after COVID-19 vaccination.
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Medscape, LLC requires every individual in a position to control educational content to disclose all financial relationships with ineligible companies that have occurred within the past 24 months. Ineligible companies are organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.
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Health Sciences Clinical Professor of Family Medicine
University of California, Irvine School of Medicine
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Guillain-Barré syndrome (GBS) is a rare but serious complication of vaccinations, and it is most often linked to the influenza vaccine. The risk for GBS was most closely associated with the influenza vaccine during the 1976 "swine flu" outbreak. In that year, more than 45 million people received influenza vaccinations over a short period, and there were almost 500 cases of GBS related to vaccination.[1]
A meta-analysis by Martín Arias and colleagues assessed the overall risk for GBS associated with the influenza vaccine, and their results were published in the July 17, 2015 issue of Vaccine.[2] Overall, the relative risk for GBS associated with influenza vaccination was 1.41 (95% CI: 1.2, 1.66). The risk was particularly increased with pandemic influenza vaccines; the risk for GBS associated with seasonal influenza vaccine was marginally significant. The use of adjuvanted pandemic vaccines did not significantly increase the risk for GBS.
Of course, the risk for GBS is also increased after infection with influenza, so only a history of GBS related to the influenza vaccine is an absolute contraindication to vaccination. Guillain-Barré syndrome has also been reported after application of the COVID-19 vaccines. The current study by Hanson and colleagues analyzes the association, if any, between COVID-19 vaccination and the risk for GBS.
New surveillance data from the Vaccine Safety Datalink confirm a small but statistically significant increased risk for GBS in the 3 weeks after receipt of the Johnson & Johnson/Janssen COVID-19 vaccine.
The Janssen vaccine (Ad.26.COV2.S) is a replication-incompetent adenoviral vector vaccine.
The data show no increased risk for GBS with the Pfizer (BNT162b2) or Moderna (mRNA-1273) shots: both mRNA vaccines.
"Our findings support the current guidance from US health officials that preferentially recommend use of mRNA COVID-19 vaccines for primary and booster doses," Nicola Klein, MD, PhD, with Kaiser Permanente Vaccine Study Center, Oakland, California, told Medscape Medical News.
"Individuals who choose to receive Janssen/J&J COVID-19 vaccine should be informed of the potential safety risks, including GBS," Klein said.
The study was published online April 1 in JAMA Network Open.[2]
11 Cases
Between mid-December 2020 and mid-November 2021, approximately 15.1 million doses of COVID-19 vaccine were administered to nearly 7.9 million adults in the United States.
This includes roughly 483,000 doses of the Janssen vaccine, 8.8 million doses of the Pfizer vaccine, and 5.8 million doses of the Moderna vaccine.
The researchers confirmed 11 cases of GBS after the Janssen vaccine.
The unadjusted incidence of GBS (per 100,000 person-years [PY]) was 32.4 in the first 21 days after the Janssen vaccine: substantially higher than the expected background rate of 1 to 2 cases/100,000 PY.
There were 36 confirmed cases of GBS after mRNA vaccines. The unadjusted incidence in the first 21 days after mRNA vaccination was 1.3/100,000 PY, similar to the overall expected background rate.
In an adjusted head-to-head comparison, GBS incidence during the 21 days after receipt of the Janssen vaccine was 20.6 times higher than the GBS incidence during the 21 days after the Pfizer or Moderna mRNA vaccines, amounting to 15.5 excess cases/1 million Janssen vaccine recipients.
Most cases of GBS after the Janssen vaccine occurred during the 1- to 21-day risk interval, with the period of greatest risk in the 1 to 14 days after vaccination.
The findings of this analysis of surveillance data of COVID-19 vaccines are "consistent with an elevated risk of GBS after primary Ad.26.COV2.S vaccination," the authors wrote.
Novel Presentation?
The researchers noted that nearly all individuals who developed GBS after the Janssen vaccine had facial weakness or paralysis, in addition to weakness and decreased reflexes in the limbs, suggesting that the presentation of GBS after COVID-19 adenoviral vector vaccine may be novel.
"More research is needed to determine if the presentation of GBS after adenoviral vector vaccine differs from GBS after other exposures such as Campylobacter jejuni, and to investigate the mechanism for how adenoviral vector vaccines may cause GBS," Klein and colleagues said.
"The Vaccine Safety Datalink continues to conduct safety surveillance for all COVID-19 vaccines, including monitoring for GBS and other serious health outcomes after vaccination," Klein told Medscape Medical News.
This study was supported by the Centers for Disease Control and Prevention (CDC). Klein reported receiving grants from Pfizer Inc. research support for a COVID-19 vaccine clinical trial as well as other unrelated studies, grants from Merck & Co., Inc.; grants from GlaxoSmithKline, grants from Sanofi Pasteur, and grants from Protein Science (now Sanofi Pasteur) outside the submitted work.
