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Concomitant administration of Menveo, other vaccines linked to Bell’s palsy
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Researchers detected a temporal association between occurrences of Bell’s palsy and concomitant administration of Menveo vaccine with HPV, influenza or Tdap vaccines among young adolescents and adults, according to recent findings.
“The [CDC]’s Advisory Committee on Immunization Practices recommends routine vaccination with meningococcal vaccines for persons 11 through 18 years of age, as well as for children and adults who are at an increased risk of invasive meningococcal infection,” Hung-Fu Tseng, PhD, from the department of research and evaluation at Kaiser Permanente Southern California, and colleagues wrote. “Although the safety of both of these vaccines has been evaluated in clinical trials in mainly healthy populations, post-licensure safety data have been lacking.”
To gain insight into the safety profile of Menveo (MenACWY-CRM, GlaxoSmithKline), Tseng and colleagues conducted a post-licensure safety study among a cohort of 48,899 adolescents and young adults aged 11 to 21 years who received MenACWY-CRM at three medical centers affiliated with Kaiser Permanente between September 30, 2011 through June 2013. Researchers tracked 26 prespecified events of interest during the study, including neurologic, rheumatologic, hematologic, pediatric infectious diseases and others. The researchers used specific risk and comparison windows after MenACWY-CRM vaccinations to identify the relative risk for an event of interest.
Results showed the relative incidence (RI) for Bell’s palsy was statistically significant among patients who received combinations of HPV, influenza or Tdap vaccines simultaneously with MenACWY-CRM (RI = 5; 95% CI, 1.4-17.8). In contrast, patients who received only MenACWY-CRM did not exhibit an increased risk of Bell’s palsy (RI = 1.1; 95% CI, 0.2-5.5).
Additionally, the most frequent events of interest occurring at any time throughout the study period was asthma (n = 841) and seizure (n = 81). Further, multiple sclerosis, transverse myelitis, rheumatoid arthritis, Henoch-Schönlein purpura, nephrotic syndrome, autoimmune hemolytic anemia and aseptic meningitis occurred at least once within the comparison window but never in the risk window.
“With nearly 50,000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bell’s palsy and receipt of MenACWY-CRM concomitantly with other vaccines,” Tseng and researchers wrote. “The association needs further investigation because it could be due to chance, concomitant vaccination or underlying medical history predisposing to Bell’s palsy.” – by Kate Sherrer
Disclosure: Haag, Miao and Cunnington were employees of the sponsor during the conduct of this study, and all other authors received research support from Novartis Vaccines.
Perspective
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Gerald B. Whitman, MD
The study was impressive because of both the size of it — with nearly 50,000 adolescents and children enrolled — and demonstrating the general safety of vaccines. While Tseng et al pointed out a supposed increased risk for Bell’s palsy if patients received concomitant vaccines, statistically, this is more borderline than we think.
If you look at the numbers, the majority of people who received the vaccine had concomitant vaccines administered. When examining patients with Bell's palsy, researchers considered it significant when they did receive a concomitant vaccine, yet not significant when they did not receive them.
I was impressed with the safety aspects of the study and the results would not change what I am doing for several reasons: pediatricians are administering the second vaccine is for the benefit of the additional MenACWY-CRM vaccine; the incidence of Bell’s palsy was so marginal that the researchers removed potential complications throughout the whole study except for this one complication; Bell’s palsy was a temporary – and borderline – event and eventually went away, so there is no long-term consequence.
The study is reassuring to me, but the title refers to the possible risk of administering concomitant vaccines, and this can scare people. There are certainly enough people concerned about vaccines that if they even see a study title or research that indicates that there may be a problem with administering vaccines at the same time, it makes it more difficult for pediatricians to get vaccine series accomplished, and thus does more harm than good.
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