Controversial Launch of ‘Cavity Vaccine’ Stirs Safety Concerns

According to a recent article in Undark by Christina Szalinski, a company called Lantern Bioworks has launched a genetically modified oral bacteria called Lumina Probiotic, touted as a potential “cavity vaccine” that could prevent tooth decay indefinitely after a single application. The product’s origins date back to research conducted in the 1980s and 2000s by oral biologist Jeffrey Hillman, who discovered a strain of Streptococcus mutans that secretes a protective antibiotic.

Hillman genetically engineered this strain to avoid producing tooth-damaging acid, with hopes it could outcompete harmful cavity-causing bacteria. As Szalinski reports, Aaron Silverbook, founder of Lantern Bioworks, stumbled upon Hillman’s research in 2017 and obtained the rights to commercialize the modified bacteria.

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Product Launch and Claims

While earlier marketing materials suggested Lumina could “indefinitely prevent dental cavities,” the company has recently toned down claims, with Silverbook telling Undark: “If anything I said sounded like a medical claim, it wasn’t.” Lumina is being sold as a cosmetic product to avoid stringent drug trials.

Silverbook stated the company has provided the bacteria to around 60 people so far, including offering it for $20,000 at a biotechnology conference earlier this year. It is now available for $250 pre-order. However, the launch has raised significant safety and ethical concerns among experts interviewed by SZALINSKI:

“Without human trials, you really can’t determine whether it’s safe or efficacious,” said Jennifer Kuzma, professor at North Carolina State University.

Kuzma highlighted risks of unintended impacts on the oral microbiome that could increase cavities or other problems. Jonathon Baker from Oregon Health & Science University warned the antibiotic could wipe out beneficial bacteria too.

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“I don’t think I would take it,” said Baker.

There are also fears the modified bacteria could spread person-to-person without consent, particularly to children whose oral microbiomes develop from caregivers.

Regulatory Ambiguity

The regulatory status of Lumina is ambiguous, potentially falling between cosmetic and drug categories according to Kuzma. The FDA did not directly address the product but stated mismarketing violates the law.

While Silverbook believes proceeding as a cosmetic avoids costly drug trials, Jeff Banas from the University of Iowa argues replacing oral bacteria has proven very challenging, despite earlier optimism.

As Lantern Bioworks begins distributing this controversial product across a nebulous regulatory landscape, dental experts caution thorough human safety studies are still urgently needed.