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Bell's Palsy and SARS-CoV-2 Vaccines - The Lancet

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  • Bell's Palsy and SARS-CoV-2 Vaccines - The Lancet

    Published:February 24, 2021


    Al Ozonoff, Etsuro Nanishi, Ofer Levy

    In light of the ongoing pandemic, development of vaccines to protect against SARS-CoV-2 infection and COVID-19 disease is an important public health priority. As of February 2021, two SARS-CoV-2 vaccines have received emergency use authorisation by the US Food and Drug Administration (FDA), both of which use mRNA technology. While the safety data are reassuring, phase 3 studies of both vaccines demonstrate an imbalance of cases of Bell's palsy in the vaccine groups compared with the placebo groups. This Comment has three purposes: to briefly review the literature on the association of Bell's palsy with vaccination, and vaccination for respiratory viruses such as influenza in particular, to consider biological mechanisms that might explain observed associations, and to reconsider statistical and epidemiological evidence from the reported safety data of the SARS-CoV-2 vaccine trials.
    Associations between influenza vaccines and Bell's palsy have been studied extensively (table). Elevated incidence of Bell's palsy among recipients of an inactivated intranasal influenza vaccine was reported in a study conducted in 2000–01.1 Since this vaccine contained the Escherichia coli heat-labile toxin as a mucosal adjuvant, which undergoes retrograde neuronal uptake, it was suspected that heat-labile toxin could affect the seventh cranial nerve through such an interaction. Potential signs of Bell's palsy have been reported following parenteral seasonal influenza vaccinations,2 and influenza H1N1 monovalent pandemic vaccinations.3, 4 However, the association between parenteral influenza vaccines and Bell's palsy was not reproducible in other studies.

  • #2
    "Media reports have stated that the incidence of Bell's palsy among participants of the Pfizer-BioNTech and Moderna vaccine trials is comparable to that observed in the general population. The FDA briefing on the Pfizer-BioNTech trial stated “observed frequency of reported Bell's palsy in the vaccine group is consistent with the expected background rate in the general population”, although this statement was removed from the subsequent FDA briefing on the Moderna trial. However, this reporting is based on a misconception, driven by a subtle distinction between rates and proportions, that has persisted in the lay media. The estimated incidence rate of Bell's palsy in the general population ranges from 15 to 30 cases per 100 000 person-years. Since the 40 000 vaccine arm participants were followed for a median of 2 months, the combined safety population receiving vaccine across the two trials represents roughly 6700 person-years of observation time for an expected incidence of Bell's palsy of one to two cases, in line with the single observed case in the combined placebo arms. Therefore, the observed incidence of Bell's palsy in the vaccine arms is between 3·5-times and 7-times higher than would be expected in the general population. This finding signals a potential safety phenomenon and suggests inaccurate reporting of basic epidemiological context to the public.'

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    • #3
      bump this