Risk Of Facial Paralysis Low With MRNA COVID-19 Vaccines: WH
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Facial paralysis risk is very low in people administered with mRNA COVID-19 vaccines as compared to those given other viral vaccines, according to a recent research letter. The study found that mRNA vaccines showed no higher safety signal for either narrowly or broadly defined facial paralysis in VigiBase.

During the pivotal phase 3 clinical trials of mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna COVID-19 vaccines), the researchers observed several cases of facial paralysis in the vaccine groups (7 of 35654) compared with 1 case among people who received placebo (1 of 35611).

Although from clinical trials, a casual relationship could not be established, the US FDA recommended monitoring of vaccine recipients for facial paralysis. The team thus explored this potential safety signal through a disproportionality analysis using the World Health Organization pharmacovigilance database, VigiBase. For the purpose, the researchers performed 4 analyses with 2 control groups and 2 facial paralysis definitions.

Key findings of the study include:

• Among the 133883 cases of adverse drug reactions reported with mRNA COVID-19 vaccines in the World Health Organization pharmacovigilance database, a total of 844 (0.6%) facial paralysis-related events were identified, including 683 cases of facial paralysis, 168 cases of facial paresis, 25 cases of facial spasms, and 13 cases of facial nerve disorders.

• A total of 749 cases were reported with the Pfizer-BioNTech vaccine, and 95 cases were reported with the Moderna vaccine. Of the 844 patients, 572 were female, and the median age was 49 years.

• The researchers identified 5734 and 2087 cases of facial paralysis among the 1265182 cases of adverse drug reactions reported with other viral vaccines and the 314980 cases reported with influenza vaccines, respectively.

• The researchers did not detect any signal of disproportionality of facial paralysis for broad and narrow definitions vs other viral vaccines or influenza vaccines alone.

"mRNA COVID-19 vaccines did not display a signal of facial paralysis when compared with other viral vaccines," wrote the authors. "Despite selective reporting and a potential delay in reporting and transferring cases among pharmacovigilance databases, the reporting rate of facial paralysis after mRNA COVID-19 vaccination found in the present study is not higher than that observed with other viral vaccines."

"To conclude, if an association between facial paralysis and mRNA COVID-19 vaccines exists, the risk is likely very low, as with other viral vaccines."

Source:
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2779389
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