ASPS Guidance Concerning FDA Reported Adverse Events in Patients with Dermal Fillers Receiving the SARS-CoV-2 mRNA Vaccine
In light of recent media coverage of the Moderna COVID-19 vaccine's associated side-effects noted in patients with dermal fillers, it is important for physicians and patients to understand the self-limited nature of these reported events. The following guidance is solely intended to counsel patients who may have – or be considering – dermal fillers and receiving the COVID-19 vaccine.
The December 17, 2020, FDA briefing document of the Vaccines and Related Biological Products Advisory Committee for the Moderna COVID-19 Vaccine states that 3 patients out of 15,184 receiving the MODERNA SARS-CoV-2 mRNA vaccine had developed facial swelling after vaccination. The three patients were in Moderna's Phase Three trial and developed (2) facial and (1) lip swelling. Two of the patients had a history of dermal filler placement 6 months (46-F) and 2 weeks (51-F) prior to vaccination. There was one incident of lip angioedema in a patient (29-F) with a history of lip dermal filler (unknown how long prior to vaccine). All events occurred within two days of receiving the vaccine dose. All patients reported complete resolution of these effects. There were no reported reactions in the placebo group.
The following recommendations are to serve as guidance from ASPS when discussing the administration of dermal fillers in patients who are anticipating receiving the Moderna COVID-19 vaccine and have a history of having received dermal filler injections.
- The current reported side effects have only been observed in the Moderna vaccine trial in 3 out of 15,184 recipients; it is currently unknown how many participants had a history of dermal filler usage.
- Patients should NOT be discouraged from receiving the COVID-19 vaccine; all reports of facial swelling were noted to be self-limited and resolved with oral antihistamines or corticosteroids.
- Patients should be educated with the current data available, prior to receiving dermal fillers
- A complete medical history should be obtained prior to any medical intervention.
- Dermal filler-associated delayed hypersensitivity immunologically based reactions have been reported for both hyaluronic acid and non-hyaluronic acid-based fillers; these reactions have specifically been demonstrated after influenza-like illness (3).
The American Society of Plastic Surgeons will continue to monitor the scientific literature and update membership as more data is made available.
- Moderna COVID-19 vaccine might cause facial swelling for people with dermal fillers
Drug Discovery & Development
- Late-Onset Inflammatory Response to Hyaluronic Acid Dermal Fillers
PRS Global Open
- FDA Review of Efficacy and Safety of Moderna COVID-19 Vaccine Emergency Use Authorization Request
- Moderna's COVID-19 vaccine may cause swelling, inflammation in those with facial fillers
Plastic Surgery News
- Guidance issued for COVID-19 vaccine side effects in dermal filler patients
Approved by the Executive Committee: January 2021