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Concomitant administration of Menveo, other vaccines increases risk for Bell’s palsy

BALTIMORE — Concomitant administration of Menveo vaccine with HPV, influenza or Tdap vaccines demonstrated an increased the risk for Bell’s palsy among adolescents and young adults, according to research presented at the Annual Conference on Vaccine Research.

“Out of the 26 events of interest [studied], we found only one increased risk associated with Menveo, and the risk was only found with those who received other concomitant vaccines,” Hung Fu Tseng, PhD, MPH, of the department of research and evaluation at Kaiser Permanente, Southern California, said during a presentation. “These could be real associations or this could simply be due to chance, because of the multiple comparisons we have done.”

The researchers studied a cohort of 48,899 children and young adults aged 11 to 21 years who received Menveo (MenACWY-CRM, GlaxoSmithKline) at three medical centers from Sept. 30, 2011 through June 2013. During the study, the researchers tracked 26 events of interest including Bell’s palsy, multiple sclerosis, Guillain-Barré syndrome, seizures, anaphylaxis and others. The researchers used a self-controlled case series to identify the relative risk for an event of interest during a specific risk window compared with the risk in a comparison window.

According to Tseng, study results showed there was a relative incidence of Bell’s palsy of 5 (95% CI, 1.4-17.8) for patients who received combinations of HPV, influenza or Tdap vaccine in tandem with MenACWY-CRM, compared with a relative incidence of 1.1 (95% CI, 0.2-55) among participants who received only MenACWY-CRM. Tseng said all cases of Bell’s palsy resolved.

Results also showed associations with seizures, iridocyclitis, Hashimoto’s disease and anaphylaxis; however, after further analysis these associations were determined not to be vaccine-related.

According to Tseng, the limitations of the observational study design need to be considered. The results do not conclude a causal link between the vaccine and Bell’s palsy.

“This association needs further investigation,” Tseng said. “In the meantime, the facial paresis is already mentioned in the adverse reactions section of the U.S. product packaging.” 

Reference:
Tseng HF, et al. Abstract S12. Presented at: Annual Conference on Vaccine Research; April 18-20, 2016; Baltimore.

Disclosure: This study was funded by Novartis Vaccines and Diagnostics (now GlaxoSmithKline Vaccines).