In 1998, the first Lyme disease vaccine was introduced by LYMErix but it was pulled from the market after 3 years due to poor sales and possible safety concerns. The FDA was never able to confirm that the vaccine caused harm despite concerns.
Only recently have drug makers resumed researching new human Lyme vaccines.
“But the challenge now is creating vaccines that will protect against the seven globally known strains of Lyme disease,” says Obadiah Plante, who leads the bacteriology team at Moderna.
Pfizer/Valneva candidate: VLA15 and Moderna are both developing vaccines that target the bacterium’s Outer Surface Protein A (OspA). The spirochete that causes Lyme disease produces OspA in the tick. The vaccine is intended to create “antibodies that prevent the organisms from suppressing OspA when the tick next feeds,” the author explains. “This will render them immobile, imprisoned within the tick’s intestine and unable to infect a human host.”
The vaccine is not expected to work after the infection enters humans, as the spirochete changes proteins from OspA to Outer Surface Protein C (OspC).
“The Pfizer/Valneva candidate, VLA15, is farthest along and is being tested in a phase three clinical trial that launched in the summer of 2022,” writes Guynup.
Two study sites (Nantucket and Martha’s Vineyard) were halted due to protocol violations. “In an email, a spokesperson for Pfizer noted that the study is expected to wrap up in December 2025,” Guynup points out.
Moderna, best known for developing a COVID-19 vaccine using mRNA technology, has been working on two Lyme disease vaccines using this same technology.
Moderna will begin human trials this summer with 800 participants in the U.S. between 18 and 70 years old.
The first vaccine, named mRNA-1982, contains a single mRNA that targets the Borrelia bacteria species that causes most cases of Lyme disease in the U.S.
The second vaccine, named mRNA-1975, contains a mixture of seven mRNAs targeting the Borrelia species that cause most cases of Lyme disease in both the U.S. and Europe.
MassBiologics is taking a different approach, using monoclonal antibody targeting OspA.
This vaccine may offer immediate protection, while it can take months for immunity to develop with the Pfizer and Moderna vaccines.
“Within days after you get the subcutaneous injection, you’ve absorbed enough of the antibody so you’re immediately immune,” says Mark Klempner, a professor of medicine and vice chancellor emeritus of MassBiologics at UMass Chan Medical School.
According to Klempner, when 20 infected ticks were placed on nonhuman primates “this antibody treatment provided 100 percent protection.”
The company hopes to apply for approval from the FDA in 2025.
Author’s Note: The safety and efficacy of these vaccines are not yet available for doctors to weigh the pros and cons of offering a vaccine. Furthermore, none of the vaccines is designed for protecting against a co-infections.
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References:
- Lyme disease is spreading fast but a vaccine may be on the way. National Geographic. Guynup, Sharon. May 15, 2023. https://www.nationalgeographic.com/premium/article/vaccine-prevention-lyme-disease-epidemic-tick-treatment
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