Low risk of Guillain-Barré after COVID-19 vaccination, surveillance data show

The overall risk of Guillain-Barré syndrome after COVID-19 vaccination was low, but was abnormally high after Johnson & Johnson injection, monitoring data showed.

Of the 15.1 million COVID-19 vaccines included in the Vaccine Safety Datalink, the unadjusted incidence of Guillain-Barré syndrome observed 1-21 days after Johnson & Johnson vaccination was 32.4 per 100,000 person-years. Yes, it was significantly higher than the background. Rate reported Kaiser Permanente in Oakland, Nicola Klein, MD, PhD, and colleagues in Northern California.

The confirmed unadjusted incidence of Guillain-Barré 1-21 days after mRNA vaccination was 1.3 per 100,000 man-years, similar to the background rate. JAMA network open..

“The background rate for Guillain-Barré syndrome is known to be about 1-2 cases per 100,000 person-years,” Klein said. Today’s MedPage..

Findings confirm data seen in the Vaccine Adverse Event Reporting System (VAERS) It led to FDA warning About Johnson & Johnson Vaccine in July 2021.

“Vaccine safety data links are an active monitoring system for vaccine safety events and complement VAERS, but they are quite different,” Klein said.

“At Vaccine Safety Datalink, eight integrative medicine systems work with the CDC to provide data,” she said. “We have full access to complete medical records and can actively investigate all types of medical encounters and health events after vaccination. We know the underlying population. Who is in the denominator? You don’t need to make an estimate because you know. “

In this study, data from 7.9 million people aged 12 years and older who received either Johnson & Johnson Shot or Pfizer BioNTech or Moderna vaccines (including mRNA vaccine doses 1 and 2) from December 2020 to November 2021. Was evaluated. The result was Giran. -Bale syndrome that develops symptoms after vaccination. Confirmed in a review of medical records.

“We pre-designated to see charts for all cases of Guillain-Barré syndrome after vaccination,” Klein said. “All charts have been reviewed and ruled by neurologists and other medical professionals.”

Overall, 15,120,073 COVID-19 vaccine doses were given to 7,894,989 patients. This includes 483,053 Johnson & Johnson, 8,806,595 Pfizer, and 5,830,425 Moderna doses. The average age of the patients was 46.5 years and 53.8% of the dose was received by women. The rate ratio (RR) comparing Guillain-Barré risk after vaccination was adjusted by age, gender, race, ethnicity, location, and calendar day.

After the Johnson & Johnson firing, 11 cases of Guillain-Barré syndrome were identified. Adjusted RR from 1 to 21 days compared to 22 to 42 days after Johnson & Johnson vaccination was 6.03 (95% CI 0.79-147.79).

36 cases of Guillain-Barré syndrome after confirmation of mRNA vaccine. The adjusted RR from days 1 to 21 and days 22 to 42 was 0.56 (95% CI 0.21-1.48) with the mRNA vaccine.

A direct comparison showed that the Johnson & Johnson vaccine had a 20% higher risk of Guillain-Barré than mRNA shots (adjusted RR 20.56, 95% CI 6.94-64.66). Using a risk interval of 1-42 days, the adjusted RR is 11.46 (95% CI 4.83-26.16, P<0.001).

The researchers admitted that the study had some limitations. Johnson & Johnson vaccine doses were much lower, statistical power was reduced, and confidence intervals were widened. People who received Johnson & Johnson shots may have been different from others in that they could affect the risk of Guillain-Barré. In addition, the Guillain-Barré incidence observed during the COVID-19 pandemic has not been established and may differ from the pre-pandemic background rate.

Klein said surveillance for Guillain-Barré syndrome in the vaccine safety datalink is underway. December 2021, CDC recommended The Pfizer and Modana COVID-19 vaccine is intended for all Johnson & Johnson adults.