20 years ago, a vaccine against Lyme disease was taken off the market. Now 2 companies are developing one that could be available in 2025.

An illustration of a Borrelia bacteria over red blood cells and a red background.

Some types of Borrelia bacteria, illustrated here, can cause Lyme disease.KATERYNA KON/SCIENTIFIC PHOTO LIBRARY/Getty Images

  • A candidate vaccine against Lyme disease produced antibodies that persisted for at least six months.

  • The vaccine is made by the French biotech company Valneva in collaboration with Pfizer.

  • If approved, Pfizer and Valneva’s vaccine would be the first of its kind available in 20 years.

Valneva, a French vaccine maker, and Pfizer said Thursday in a follow-up to a phase 2 safety trial that the companies’ candidate vaccine for Lyme disease had produced durable immunity.

The phase 2 trial was completed in April, and six months later the companies checked the antibody levels of children and adults who had received two or three injections of the vaccine. The companies found that antibody levels remained higher in the three-shot group compared to the two-shot group.

While these antibody levels decreased over time, they indicated some level of continued protection against Lyme disease. The companies reported no serious side effects or safety concerns and are now in the middle of Phase 3 clinical trials.

Lyme disease is a bacterial disease spread by tick bites. The hallmark symptom is a bull’s-eye-like rash around the bitten area, but symptoms can also include fever, chills, joint pain, and headache. If not treated quickly, it can cause carditis – swelling of the heart – or arthritis. Some people may continue to have symptoms for a long time after treatment, a condition called Lyme disease syndrome after treatment.

A Lyme vaccine was taken off the market 20 years ago

There has already been one U.S. Food and Drug Administration-approved vaccine for Lyme disease. GSK — then called SmithKline Beecham — made a Lyme vaccine that was approved by the FDA in 1998. It was called Lymerix and after three injections it was about 75% effective in preventing Lyme.

But at the time, the Centers for Disease Control and Prevention rarely recommended the vaccine, because the disease was considered easy to treat in the early stages. In addition, patients were reluctant to take the vaccine because they found the dosing schedule inconvenient, and it was not approved for children because it had not been tested in that population.

It was pulled from the market in 2002 after patients said it caused serious side effects such as arthritis and filed a class action lawsuit. The CDC and FDA found no pattern with the vaccine causing these reactions, but this didn’t save Lymerix. Sales dropped so dramatically that GSK pulled the drug off the market.

Valneva and Pfizer hope the new Lyme vaccine gets better public reception. If the results of the Phase 3 trial are positive, the companies aim to receive FDA approval for the vaccine by 2025.

Lyme disease is a growing problem

Lyme disease has become much more concerning since 2002. About 30,000 cases are reported each year, according to the CDC, though the agency says this is likely lower than the true number of cases due to undercounting. This compares to about 24,000 cases reported in 2002. A study of private insurance claims data estimated that between 2010 and 2018, approximately 476,000 patients were diagnosed with and treated for Lyme disease.

In 2022, a study estimated that 15% of the world’s population had contracted Lyme disease at some point in their lives.

One theory for increasing the prevalence of Lyme in the American Northeast involves the emergence of patchy forests, leading to more of a certain species of mouse that is a great reservoir for Lyme-causing bacteria. In addition, the climate crisis is expanding the range of disease-carrying ticks, as warmer temperatures can accelerate tick life cycles and better survive winters.

Read the original article on Business Insider

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