Is there cause for concern about the use of the mRNA COVID-19 vaccines in patients who have received dermal fillers or Botox within the past 12 months?

Comment by InpharmD Researcher

There have been three dermal filler-related adverse events (<0.001%) reported with the use of the mRNA COVID-19 vaccines. The American Society for Dermatologic Surgery (ASDS) encourages patients with dermal fillers to receive vaccines and patients who have had vaccines should not be precluded from receiving dermal fillers in the future. There is no specific mention regarding the use of the COVID-19 vaccines in patients who have received Botox (onabotulinumtoxina).

Background

The American Society for Dermatologic Surgery (ASDS) has issued a guidance statement on the use of mRNA COVID-19 vaccines in patients who have had dermal fillers. Preliminary data from studies of Moderna's mRNA-1273 vaccine (Moderna COVID-19 vaccine) found three (3) patients of 15.184 (0.0002%) developed facial or lip swelling presumed to be related to dermal filler placement [Table 1], while no subjects in the placebo group reported any filler-related adverse events. All events resolved after treatment. While these adverse events have been reported, it is unknown how many subjects in the trial had previous treatment with dermal fillers and did not experience any events. The Food and Drug Administration (FDA) suggests there may be a potential contribution of dermal filler with the reported facial swelling. [1], [2]

Due to these cases, the ASDS reminds that delayed dermal filler inflammatory events very rarely occur with both hyaluronic acid and non-hyaluronic acid fillers. Evidence suggests these reactions can be immunologically triggered by viral and bacterial illness, vaccinations, and dental procedures. While rare, these adverse events are temporary and respond to treatments (e.g. corticosteroids, hyaluronidase) and often resolve spontaneously. Given currently available data, patients already treated with dermal fillers should not be discouraged or precluded from receiving vaccines of any kind. Similarly, patients who have had vaccines should not be precluded from receiving dermal fillers in the future. [1]

Similarly, The Aesthetic Society issued a statement stating a history of dermal fillers should not bar someone from being vaccinated. The risks from acquiring and being infected with the COVID-19 virus far outweigh the risks from a reaction to one of the vaccines if the patient has a history of using dermal fillers. The reported incidents are very rare, and these facial swelling have been mild and responded quickly to oral steroids and/or oral antihistamines. None of the cases required the use of an EpiPen or hospitalization, none were considered life-threatening, and there were no long-term complications in those who reported having facial swelling after receiving the COVID-19 vaccine. All three reported cases have been in relation to the Moderna COVID-19 vaccine; there have been no reported cases in patients receiving the Pfizer COVID-19 vaccine. [3]

References:

[1] Avram M, Bertucci V, Cox SE, er al. Guidance Regarding SARS-CoV-2 mRNA Vaccine Side Effects in Dermal Filler Patients. https://www.asds.net/Portals/0/PDF/secure/ASDS-SARS-CoV-2-Vaccine-Guidance.pdf. January 6, 2021. Accessed January 14, 2021.
[2] U.S. Food and Drug Administration. FDA Review of Efficacy and Safety of Moderna COVID-19 Vaccine Emergency Use Authorization Request. https://www.fda.gov/media/144585/download. December 17, 2020. Accessed January 14, 2021.
[3] Lund HG. Facial Fillers and COVID-19 Vaccine. https://www.surgery.org/professionals/covid-19/facial-fillers-and-covid-19-vaccine. 2021. Accessed January 14, 2021.
Relevant Prescribing Information

Serious Adverse Events:
There were two serious adverse events of facial swelling in vaccine recipients with a history of injection of dermatological fillers. The onset of swelling was reported 1 and 2 days, respectively, after vaccination and was likely related to vaccination. [4], [5]

References:

[4] U.S. Food and Drug Administration. FDA Briefing Document Moderna COVID-19 Vaccine. https://www.fda.gov/media/144434/download. Published December 17, 2020. Accessed January 12, 2021.
[5] MODERNA COVID-19 VACCINE (cx-024414 injection, suspension) [vaccine label]. Cambridge, MA: Moderna US, Inc.; 2021.
Literature Review

A search of the published medical literature revealed 1 study investigating the researchable question:

Is there cause for concern about the use of the mRNA COVID-19 vaccines in patients who have received dermal fillers or Botox within the past 12 months?

Please see Table 1 for your response.

 

Dermal Filler-related Adverse Events with the Moderna COVID-19 Vaccine
Patient Reported Reaction Time After Vaccine Time of Dermal Filler Placement Resolved

Female, 51 years old

 Facial swelling 2 days 2 weeks prior Yes

Female, 46 years old

 Facial swelling 1 day 6 months prior Yes

Female, 29 years old

 Lip angioedema* 2 days Unknown Yes

*This patient had a similar reaction after an influenza vaccine in the past.

References:

Avram M, Bertucci V, Cox SE, er al. Guidance Regarding SARS-CoV-2 mRNA Vaccine Side Effects in Dermal Filler Patients. https://www.asds.net/Portals/0/PDF/secure/ASDS-SARS-CoV-2-Vaccine-Guidance.pdf. January 6, 2021. Accessed January 14, 2021.