The Therapeutic Goods Administration (TGA) is investigating the link between the Comirnaty (Pfizer) vaccine and lip and/or dermal filler swelling following a number of viral TikTok videos.
In an exclusive statement to Gizmodo Australia, the TGA confirmed it is aware of Pharmacovigilance Risk Assessment Committee (PRAC) findings released by the European Medicines Agency and is currently investigating the issue.
“The TGA is aware of the PRAC finding and is currently investigating the issue of facial swelling following Comirnaty vaccination in people with a history of injections with dermal fillers,” a spokesperson said.
If you frequently find yourself perusing the platform you’ve probably come across one of these videos, which shows what appears to be intense swelling of filler-injected areas following the Pfizer vaccine.
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While we know all too well not to believe everything we see on the internet, especially when it comes to medical advice on TikTok, there’s some legitimate evidence to back this one up.
The European Medicines Agency (EMA) met to discuss the side effect back in May, and concluded that there “is at least a reasonable possibility of a causal association between the vaccine and the reported cases of facial swelling in people with a history of injections with dermal fillers.”
“PRAC has recommended a change to Comirnaty’s product information. After reviewing all the available evidence, including cases reported to the European database for suspected side effects (EudraVigilance) and data from the scientific literature, PRAC considered that there is at least a reasonable possibility of a causal association between the vaccine and the reported cases of facial swelling in people with a history of injections with dermal fillers (soft, gel-like substances injected under the skin),” the meeting notes from the PRAC meeting said.
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However, the EMA also stressed that the benefits of the vaccine still outweigh any risk associated with swollen filler.
“Therefore, PRAC concluded that facial swelling in people with a history of injections with dermal fillers should be included as a side effect in section 4.8 of the summary of product characteristics (SmPC) and in section 4 of the patient information leaflet (PIL) for Comirnaty. The benefit-risk balance of the vaccine remains unchanged.”
But despite what the now-viral TikTok videos may suggest, filler swelling as a result of the Pfizer vaccine is extremely rare, which is why it isn’t included in the list of common Pfizer side effects released by the TGA.
Despite the EMA releasing its findings back in May, information regarding the side effect has not been listed anywhere on the Australian Government’s COVID websites.
The TGA asserted that the side effect – which is extremely rare – is a result of an immunological response.
“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 such as the influenza vaccine, and dental procedures. These rare adverse events are temporary and respond to treatments such as oral corticosteroids and hyaluronidase, and often resolve without treatment,” the TGA told Gizmodo Australia.
Much like the EMA, which stressed that the potential side effect should not be a deterrent for people looking to receive the vaccine, the TGA stated that the two types of injections need not be mutually exclusive.
“Each person should seek specific medical advice for their situation, however the benefit-risk balance of the Comirnaty vaccine remains unchanged in patients with dermal fillers. At this stage, patients already treated with dermal fillers should not be precluded from receiving COVID-19 vaccination on this basis alone. Similarly, patients who have had COVID-19 vaccination should not be precluded from receiving dermal fillers in the future.”
Basically, there is some risk of filler swelling after receiving the Pfizer vaccine, but this is easily treatable and shouldn’t be a reason to stop you getting the jab.