Lisette Hilton

Part 1: Learning From COVID-19 Vaccine Filler Reactions

Experienced injectors have likely seen these reactions before from other immune system triggers and know how to manage them using antihistamines, anti-inflammatories and, in some cases, systemic steroids in short course, she says.

Additionally, she says, physicians should continue to encourage patients to get vaccinated in accordance with public health needs while continuing to stay vigilant of potential reactions and treatments.

Staying up to date and getting involved in vaccine reaction and adverse event reporting are key.

Currently, dermal filler reactions have been related only to the Moderna COVID-19 vaccine.

This could change as more data emerges during mass vaccination efforts.

Medical knowledge is only as good as the data reported, Kourosh says.

Providers and patients can use the institutional reporting systems in place to report reactions, including CDC’s Vaccine Safety (v-safe)

 website, which helps consumers report adverse reactions to the vaccine with their smartphones. That same page also has links to other vaccine safety reporting resources, including the Vaccine Adverse Event Reporting System (VAERS).

The American Academy of Dermatology also houses a COVID-19 registry on its website.

Joe Niamtu III, DMD, an oral and maxillofacial surgeon in Midlothian, Virginia, says his practice performs many dermal filler injections, but has yet to see a filler reaction from the COVID-19 vaccine.

“My personal take on it is this [reaction] affects a small number of people,” he says. “But we must understand these reactions if filler patients present with inflamed, painful or hardened areas.”

Niamtu explains to patients the potential risk of immunogenic response with the vaccine and recommends they space it, and other immune system triggers, at least 2 weeks before or after having dermal filler injections.

The only course of action Niamtu has doubts about treating filler reactions post–COVID-19 vaccination with oral steroids.

As for treatment options available for these reactions, he is hesitant to use oral steroids.

“I’m skeptical about that,” he says. “Steroids are a potent anti-inflammatory and the whole purpose of this vaccine is to set up an inflammatory response, more or less. You do not want to immunosuppress the vaccine. It has to do its job.”

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Articles

Arianne Shadi Kourosh, MD, MPH, and Joe Niamtu, III, DMD, discuss adverse event reporting resources for COVID-19 vaccine filler reactions and the potential treatments when they occur.

Management and Reporting COVID-19 Vaccine Filler Reactions

The evidence showing instance of 3 patients with a history of dermal filler injections reporting reactions, including facial or lip swelling after getting the Moderna coronavirus disease 2019 (COVID-19) vaccine, is a reminder that immunogenic dermal filler reactions happen.

Investigators studying delayed onset of inflammatory nodules after hyaluronic acid filler injections years before the pandemic, found nodules occurred in 0.5% of patients. Nearly 40% of those patients identified an immunologic trigger, such as flu-like illness, according to a 2015 paper published in 

Recent developments concerning filler reactions related to the vaccine highlight known instances of other vaccines activating the immune system, says dermatologist Arianne Shadi Kourosh, MD, MPH, director of the Community Health at Massachusetts General Hospital.

Aesthetic providers likely already incorporate the concept of immunogenicity when counseling patients for cosmetic procedures, according to Kourosh. The provider might ask, for example, about a history of cold sores, which are due to viral infection, or if a patient was ill in the weeks before a procedure.

“If a person had a recent infection in the mouth, a sinus infection or upper respiratory infection, it could affect their immune reactivity to other stimuli, such as fillers,” says Kourosh, author of The Art of Prevention: COVID-19 Vaccine Preparedness for the Dermatologist,” recently published in the 

International Journal of Women’s Dermatology

Providers and patients should maximize time between events that can activate the immune system.

“It may be advisable to counsel patients to plan their cosmetic procedures with a window of time of at least a few weeks before and after their COVID vaccination,” Kourosh says, continuing that many things can trigger or activate the immune system.

“It is suspected that the reactions to the fillers were actually nonspecific—just immunogenic activation of more than one thing activating the immune system at the same time,” she says.

Kourosh speculates the patient with a reported reaction in the vaccine trial, who had filler 6 months prior, had filler still remaining in the skin.

The body breaks down fillers with time, and some of the breakdown product remains in the skin and can ignite immune activation, according to Kourosh.

NEXT: Management and Reporting COVID-19 Vaccine Filler Reactions

The small incidence of COVID-19 vaccine induced filler reactions have raised new concerns pertaining to immunogenic activation and how to minimize potential risks. 

Learning From COVID-19 Vaccine Filler Reactions

Part 1: 2021 Injectable Updates: Renewed Interest, Positive Stage 3 Trials, New Indications

Allergan, of Botox Cosmetic fame, is in late-stage studies looking at different possible indications for the neuromodulator, including for the platysma and masseter muscles.

 The company is studying microinjections into the skin, as well as using a higher dose Botox for longer duration of effect, he says.

Galderma is conducting studies on Dysport (abobotulinumtoxinA) looking at increased longevity and patient satisfaction. The company’s QM1114 (relabotulinumtoxinA), a ready-to-use liquid botulinum toxin, is in phase 3 trials for treatment of glabellar lines and lateral canthal lines, according to Gold.

Xeomin from Merz is being studied for use in the full upper face, as well as in high-dose trials.

“All are doing well. We just have to wait for the final results,” Gold says. “Xeomin looked at 50, 75, and 100 units in the glabella. They’ve already reported up to 75 units doing really well for a long time.”

Hugel, a South Korean company, may soon have its botulinum toxin type A (Botulax) available in the US. market.

The pivotal neuromodulator approval, however, is Revance’s Daxi (daxibotulinumtoxinA).

“Daxi is presumed to get approval later this year on a longer duration than we’ve had so far,” says Gold. “They tell us they have an excipient protein as part of the molecule that may be leading to that longer duration. We will see how that plays out in the real world. The biggest issue with all the toxins is price. If Daxi comes out priced wrong, they are not going to be as successful as if priced right.”

Evolus’s Jeuveau (prabotulinumtoxinA-xvfs) continues to fight legal troubles from an Allergan-based patent infringement lawsuit.

“Right now, they’re moving along as normal but there’s a lot of work behind the scenes of trying to maintain product availability,” says Gold.

Biesman is a consultant and researcher for Allergan, Galderma, Merz, and Revance. Gold is a consultant for Allergan, Merz, and MTF.

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Teoxane Laboratories - Hyaluronic Acid news

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Galderma receives FDA approval for restylane Defyne for chin augmentation. Galderma. 

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Allergan aesthetics, an abbvie company, acquires innovative luminera dermal filler business. Cision PR Newswire. 

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Safety and efficacy study of the simultaneous treatment of upper facial lines (horizontal forehead lines, glabellar frown lines and lateral canthal lines) in subjects with moderate to severe upper facial lines (ULTRA I). ClinicalTrials.gov. 

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Galderma announces phase 3 trials for liquid neurotoxin. MedEsthetics. 

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Croma-pharma gmbh sets the course for entering the US market. Cision PR Newswire. 

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Abbvie settles botox rival IP lawsuit with Evolus. BioSpace. 

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Physicians discuss 2021 neurotoxin FDA-approvals, phase 3 trials, new indications, and introductions into the U.S. market. 

Neurotoxins to Watch

Expert injectors say one of the big stories in injectables for 2021 is not new but is a practice game-changer.

Brian S. Biesman, MD, assistant clinical professor of ophthalmology, dermatology, and otolaryngology at Vanderbilt University Medical Center in Nashville, Tennessee, and past president of the American Society for Laser Medicine and Surgery, says he wonders why the industry’s renewed interest in the use of biostimulators isn’t making headlines.

Biesman says using hyperdiluted Radiesse (calcium hydroxylapatite [CaHA]; Merz) has been a practice changer for treating skin laxity and improving skin quality on the face, neck, chest, arms, knees, abdomen, and buttocks.

 have published global consensus guidelines for the injection of diluted and hyperdiluted CaHA leading to new interest in the use of hyperdiluted Radiesse and diluted Sculptra Aesthetic (poly-L-lactic acid [PLLA]; Galderma).

“Hyperdiluted Radiesse has allowed me to accomplish things that I just haven’t been able to do with other modalities,” Biesman says. “I use it in the face as well [as] in some patients with certain conditions and am still working on those protocols. I am certain that there is a lot more that we are going to be hearing about biostimulators down the road.”

Michael H. Gold, MD, medical director of Gold Skin Care Center and Tennessee Clinical Research Center, in Nashville, agrees that the expanded role of biostimulator fillers is one of the most exciting developments in today’s filler world.

“We will have to see what happens with those as time goes on,” Gold says.

In 2020, Revance launched 3 FDA-approved dermal fillers in the Teoxane Laboratories portfolio, including Resilient Hyaluronic Acid (RHA) 2, RHA 3, and RHA 4.

Biesman says the RHA line is multipurpose and offers versatility. RHA 2 is ideal for fine lines and can be used in lips, RHA 3 is a workhorse filler, with nice elasticity and a natural look and feel, and RHA 4 is best for contouring.

Gold is interested in a newer filler, Renuva, an adipose matrix from the Musculoskeletal Transplant Foundation (MTF) Biologics.

“We’ve done studies treating the hollows of the temples and are in the midst of finalizing a volumizing treatment study in the cheeks and jowl area,” Gold says. “What we know from histology is that over a 12- to 16-week period this adipose matrix transforms itself into one’s own fat cells. Providers might use Renuva instead of fat transfer or even as a volumizing filler.”

Many filler companies are expanding their indications. In February 2021, Galderma announced the FDA approval of Restylane Defyne (hyaluronic acid gel)for mild to moderate chin retrusion in adults, while Juvéderm Voluma XC (AbbVie) was approved for the chin in June 2020.

Gold says the fact that the big companies are expanding in this way is a good thing and shows the safety and efficacy of their products outside of nasolabial folds and cheeks.

Companies also are looking to launch or expand filler lines in the US.

Allergan Aesthetics recently purchased Israeli company, Luminera, for its filler portfolio, including its HArmonyCa product, a hyaluronic acid (HA) and calcium hydroxylapatite filler.

“This gives you the immediate effect with HA and then a long-lasting effect,” says Gold. “We hope Allergan will start doing trials in the next couple of years to bring the product to the US.”

Algeness, which markets its purified agarose gel (polysaccharide) fillers as the first 100% natural, biocompatible, and biodegradable filler option, according to company literature. It is also in clinical trials to bring its fillers to the US market, Gold says.

Switzerland-based Neauvia will soon start US clinical trials on its HA and calcium hydroxylapatite mix filler.

 The company differentiates its fillers by using a different mechanism for cross linking, Gold says.

Brian S. Biesman, MD; and Michael H. Gold, MD, discuss the state of injectables in 2021, including renewed interest in biostimulators, dermal fillers and neurotoxins hitting the US market, along with a focus on expanding indications. 