The incidence of Guillain-Barré syndrome (GBS) was elevated following vaccination with the Janssen COVID-19 vaccine Ad.26.COV2.5, according to study findings published in JAMA Network Open.
In the US, there are 3 available COVID-19 vaccines, the replication-incompetent adenoviral vector vaccine Ad.26.COV2.5 or the mRNA vaccines BNT162b2 from Pfizer-BioNTech and mRNA-1273 from Moderna. In April 2021, use of Ad.26.COV2.5 was paused due to concerns about thrombosis with thrombocytopenia syndrome and in July 2021, a report from the Vaccine Adverse Event Reporting System (VAERS) raised concerns about GBS after Ad.26.COV2.5.
The researchers sought to evaluate the rate of GBS after receiving any COVID-19 vaccine. Data were sourced from the Vaccine Safety Datalink which included records from 10,158,003 people in the US as of November 2021. Incidence rates of GBS up to 84 days after vaccination were evaluated for each of the 3 vaccines.
The study population had received Ad.26.COV2.5 (n=483,053) or 1 of the 2 mRNA vaccines (n=14,637,020) and comprised 53.9% and 45.9% men or boys, 53.9% and 47.0% were aged 18-49 years, and 8.9% and 7.5% had a history of COVID-19, respectively.
Among the Ad.26.COV2.5 cohort, 22 potential GBS cases were identified within 84 days of vaccination, of which 50% were confirmed. Symptoms onset between 1 and 21 days (82%), 22 and 42 days (9%), or 43 and 84 days (9%), with a significant cluster of symptom onset between 1 and 14 days (P =.003).
Confirmed GBS after Ad.26.COV2.5 occurred among patients aged mean 50 (range, 32-63) years, 82% were men, 91% were White, and 91% had facial weakness or paralysis. All received intravenous immune globulin treatment, the median length of stay at the hospital was 5 (interquartile range [IQR], 4-13) days, and 100% had ongoing illness.
Compared with unvaccinated comparators, GBS incidence was elevated 1-21 days (adjusted rate ratio [aRR], 10.57; 95% CI, 5.15-20.16; P <.001) and 1-42 days (aRR, 10.05; 95% CI, 5.75-16.96; P <.001) after receiving the Ad.26.COV2.5 vaccine.
For the mRNA vaccines, there were 78 potential cases identified within 84 days of vaccination, of which 46% were confirmed. More occurred after BNT162b2 (n=23) than mRNA-1273 (n=13). Symptoms onset between 1 and 21 days (31%), 22 and 42 days (42%), or 43 and 84 days (25%).
Confirmed GBS after mRNA occurred among patients aged mean 53 (range, 14-92) years, 50% were men or boys, 42% were White, and 33% had facial weakness or paralysis. Most (97%) received intravenous immune globulin treatment, the median length of stay at the hospital was 6 (interquartile range [IQR], 5-10) days, 83% had ongoing illness, 11% recovered with no neurologic sequelae, and 6% died.
In a head-to-head comparison, the Ad.26.COV2.5 vaccine was associated with increased incidence of GBS at 1-21 (aRR, 20.56; 95% CI, 6.94-64.66; P <.001) and 1-42 (aRR, 11.46; 95% CI, 4.83-26.16; P <.001) days postvaccination compared with the mRNA vaccines.
This study may have been limited by the imbalance in cohort sizes.
“In this cohort study of COVID-19 vaccines, the incidence of GBS was elevated after receiving the Ad.26.COV2.S vaccine. Surveillance is ongoing,” the researchers concluded.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Hanson KE, Goddard K, Lewis N, et al. Incidence of Guillain-Barré Syndrome After COVID-19 Vaccination in the Vaccine Safety Datalink. JAMA Netw Open. 2022;5(4):e228879. doi:10.1001/jamanetworkopen.2022.8879