Facial nerve palsy as a possible adverse drug reaction of the modified vaccinia ankara-bavarian nordic (MVA-BN) smallpox vaccine: A pharmacovigilance analysis

Adverse drug reaction profile of third-generation smallpox vaccines used in France during the 2022 monkeypox epidemic

“…Facial paralysis and vaccination failure were considered as adverse events of special interest (AESI) and benefited from reinforced monitoring, in agreement with the French 'Agence Nationale des M edicaments et des produits de sant e' (ANSM). In addition to the three cases of facial paralysis that were published [2], we observed two cases of vaccination failure in nonimmunocompromised patients that did not require hospitalization. The first occurred 4 months after a complete vaccination with Imvanex (dose 1) and Jynneos (dose 2), with no further documented outcome.…”

“…The results of our pharmacovigilance survey in 2022 are consistent with the study from VAERS [3] and the results from the Netherlands Pharmacovigilance Centre Lareb [4], as they also reported a majority of nonserious reactogenicity ADRs. Regarding facial paralysis, three French cases were published [2] and one in the Netherlands [4]. This ADR is still under monitoring at the time of our article, but no confirmed safety signals has emerged so far.…”

Progress and prospects on vaccine development against monkeypox infection

“…Without the intrinsic mutations associated with serial replication, the clonally purified master seed ensures a more uniform vaccine, and the cell culture restricts accidental and bacterial contamination in vaccine manufacture. [ 82 , 83 ] Lister strain isolate of vaccinia in rabbit kidney cells (RIVM) Thus, using rabbit kidney cells, the first second-generation Lister-based vaccine, RIVM, was created in 1960. No additional passages were carried out during the creation of this vaccine; the virus was transferred directly from the calf lymph vaccine to cells.…”

“…Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) is given subcutaneously via injection and is often well tolerated. It may induce injection site responses (such as discomfort, redness, and swelling) and minor systemic adverse effects similar to other vaccinations (e.g., nausea, headache, and chills) [ 82 ]. The FDA has given the JYNNEOS vaccine nonreplicating vaccine protection against smallpox and MPOX.…”