First Lyme disease vaccine in 20 years begins final clinical trial: ‘People are worried, now is the time’

The Lyme disease vaccine, created by Pfizer and Valneva, is called VLA15 and is the only one in clinical development. If all goes well, the companies could seek approval for this new vaccine in 2025.

The first vaccine against Lyme disease in the last 20 years begins the final clinical trial PHOTO: ARCHIVE

Manufacturers Pfizer and Valneva have announced that a new vaccine to prevent Lyme disease is entering the final phase of clinical trials. It would provide an additional level of protection against the tick-borne disease, writes the Health publication.

The VLA15 vaccine is being tested in four doses (three primary doses plus a booster dose) in humans and has shown promising results so far. In the upcoming Phase 3 clinical trial, researchers will further investigate the vaccine’s efficacy and safety.

“With global rates of Lyme disease on the rise, providing a new option for people to help protect against the disease is more important than ever”Annaliesa Anderson, PhD, senior vice president and head of vaccine research and development at Pfizer, said in a press release.

Lyme disease is the most common vector-borne disease in the US and is usually caused by the bacterium Borrelia burgdorferi. It is transmitted to humans through ticks.

“I think it’s finally gotten to a point where it’s something a lot of people have heard about. They’re worried, they’re worried about Lyme disease, and so the timing is right, and we certainly have the science to be able to create a vaccine against Lyme disease.”Bobbi Pritt, MD, chair of the division of clinical microbiology at Mayo Clinic, told Health.

If approved, VLA15 will be the only vaccine against Lyme disease in the US, but it will not be the first vaccine used to prevent the disease. Another vaccine, LYMERix, was used for a short time in the early 2000s and reduced infections by nearly 80 percent.

However, complaints about arthritis and other adverse effects of the vaccine decimated demand for LYMERix, and the FDA discontinued it in 2002.

With climate change, people are at greater risk of coming into contact with ticks due to earlier springs and longer summers.

When will the new vaccine be available?

The new vaccine, VLA15, is a multivalent protein subunit vaccine that works by targeting the external surface protein A (OspA) of Borrelia burgdorferi.

“The protein that the vaccine targets is called OspA and it is a protein that is very very abundant on bacteria. (…)If the body has already been exposed (to OspA) through a vaccine and has generated a very strong immune response, then the body can fight the bacteria as soon as it possibly actually enters the body”said Dr. Pritt.

There is no official timeline for when data on VLA15 could be published, although a Pfizer spokesperson told Health that the study will take just under two and a half years.

Given the public’s mistrust of the latest Lyme disease vaccine, Dr. Pritt added, the clinical trial will certainly be on the lookout for any specific side effects or dangers associated with it.