ASDS releases guidance on reported cases of adverse events related to the Moderna COVID-19 vaccine and dermal filler patients.
The American Society of Dermatologic Surgery (ASDS) recently released guidance including data from the U.S. Food and Drug Administration (FDA) on reactions associated with the SARS-CoV-2 mRNA vaccine and dermal fillers.
Data from the Moderna vaccine clinical trial show that a total of three participants out of 15,184 who received at least one dose of mRNA-1273 developed an adverse event (AE) of facial or lip swelling. This is presumed to be related to dermal filler placement. Out of the three cases, one case of lip angioedema was classified as medically significant but not as a serious AE (SAE) and study researchers noted the patient had similar reactions after a past influenza vaccine.
All events resolved after treatment.
These AEs have only been reported in the Moderna mRNA trial and no patients in the placebo group reported any filler-related events.
Based on the information from the FDA, ASDS guidance provides information and perspective for aesthetic practitioners and patients regarding such incidence.
The society writes that these dermal filler inflammatory events are rare and can be immunologically triggered by viral and bacterial illness and vaccines such as the influenza vaccine and dental procedures.
Treatment of such AEs respond to oral corticosteroids and hyaluronidase, are temporary, and often resolve without treatment.
ASDS encourages its members to continue current dermal filler practices, including obtaining pertinent medical history. Patients with dermal fillers should not be discouraged from receiving the COVID-19 vaccine. Likewise, patients who have received the vaccine should not be discouraged from future dermal filler treatment.
The society’s Soft-tissue Fillers Guideline Task Force will also be publishing a multi-specialty evidence-based clinical guideline on the prevention and treatment of soft-tissue filler AEs, and ASDS urges members to monitor incoming and scientific data as it develops.
“Patient safety is foremost in the practice of dermatology and board-certified dermatologists take adverse effects seriously,” says Mathew Avram, M.D., J.D., ASDS president, in the press release announcing the guidance. “Although still very early in the vaccination process, this guidance is meant to be informational and helpful as we move forward during pandemic recovery efforts.”