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

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

Certain types of Borrelia bacteria, shown here, can cause Lyme disease.KATERYNA KON/SCIENCE PHOTO LIBRARY/Getty Images

  • One Lyme disease vaccine candidate produced antibodies that lasted at least six months.

  • The vaccine was created by the French biotech company Valneva in collaboration with Pfizer.

  • If Pfizer and Valneva’s vaccine gets approval, it will 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 study that the companies’ vaccine candidate for Lyme disease had produced lasting immunity.

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

Although these antibody levels decreased over time, they did indicate some level of lasting protection against Lyme disease. The companies have reported no serious side effects or safety issues and are now in the midst of Phase 3 clinical trials.

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

A Lyme vaccine was taken off the market 20 years ago

There is already a vaccine approved by the US Food and Drug Administration for Lyme disease. GSK — then called SmithKline Beecham — produced a Lyme vaccine that was approved by the FDA in 1998. Called Lymerix, it was about 75 percent effective at preventing Lyme after three shots.

But at the time, the Centers for Disease Control and Prevention rarely recommended the vaccine because the disease was considered easily treatable in its early stages. Additionally, patients were reluctant to take the vaccine because they found the dosing schedule inconvenient, and it hadn’t been approved for children because it hadn’t been tested in that population.

It was taken off the market in 2002 after patients claimed it caused serious side effects such as arthritis and filed a class action lawsuit. The CDC and FDA didn’t find a pattern with the vaccine causing these reactions, but that didn’t save Lymerix. Sales fell so sharply that GSK withdrew the drug from the market.

Valneva and Pfizer hope the new Lyme vaccine will get a better reception from the public. If the Phase 3 study results are positive, the companies aim to get the vaccine approved by the FDA in 2025.

Lyme disease is a growing problem

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

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 increasing patchy forests, which leads to more of a particular type of mouse being a large reservoir for Lyme-causing bacteria. Additionally, the climate crisis is expanding the range of disease-carrying ticks because warmer temperatures can speed up the life cycle of ticks and make winters more survivable.

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