There is promising news on the horizon for people living in areas where Lyme disease is common. Pfizer and Valneva, two pharmaceutical giants, are in Phase 2 trials to develop a vaccine that prevents Lyme disease. This potentially serious, systemic infection transmitted by bacteria-infected ticks is considered the most common vector-born illness in the Northern Hemisphere.
According to BioPharma-Reporter, the Centers for Disease Control and Prevention estimates 476,000 Americans are diagnosed and treated for Lyme disease each year. The pharmaceutical companies note that climate change, specifically warmer winters, has increased the prevalence of ticks, prompting the need for a vaccine.
Scientists have been working for decades to reduce the numbers of blacklegged, or deer, ticks that carry the Lyme disease bacterium, and to slow the spread of the disease, says Mark Klempner, M.D., professor of medicine at the University of Massachusetts Medical School, according to The Conversation.
Klempner says that the U.S. Food and Drug Administration approved a vaccine called LYMErix against Lyme in 1998, but it was pulled off the market three years later by the manufacturer due to controversy over its side effects.
Lyme disease is characterized by a red, bull’s-eye shaped rash that develops around the site of the tick bite. Between 70% to 80% of patients have this symptom, according to experts.
“Lyme, like other tick-borne diseases, is associated with general flu-like symptoms, such as fever, head and body ache, and fatigue,” Jory Brinkerhoff, an associate professor of biology at the University of Richmond, told Healthline. If left untreated, the disease can cause chronic inflammation, neurological problems, such as facial palsy and neuropathy, impaired memory and irregular heart rhythms, says the Mayo Clinic. While Lyme disease is seldom fatal, it can make life very challenging.
While a Lyme vaccine has been approved for dogs since 1992, humans are still waiting their turn. According to TIME, research from the Johns Hopkins Bloomberg School of Public Health found that Lyme disease costs the U.S. healthcare system between $712 million and $1.3 billion every year. People with Lyme disease had 87% more doctors’ visits and 71% more visits to the emergency room in the year after their diagnosis compared to those without Lyme.
In 2020 and 2021, the National Institutes of Health poured more than $6 million into tick disease-prevention projects including vaccine developments. Several new vaccines are in the works, but the one manufactured by Pfizer and its partner Valneva, a French biotech company, is furthest along in its research. In March, the companies launched Phase 2 trials in 600 people ages five to 65, says TIME. The vaccine is similar to its predecessor, LYMErix, but targets six strains of Lyme bacteria instead of the single strain that LYMErix attacked.
Industry experts predict that the new vaccine may be available by 2025. In the meantime, Klempner and his colleagues at University of Massachusetts Medical School’s MassBiologics, the only non-profit, FDA-licensed manufacturer of vaccines and biologics in the U.S., have developed a monoclonal antibody shot called Lyme PrEP to prevent Lyme disease.
Although it is not a vaccine, the seasonal shot appears to protect against many forms of Lyme disease-carrying bacteria and “makes you immune to Lyme disease the day you receive the injection,” said Klempner, executive vice chancellor for MassBiologics. He explained that his shot delivers an anti-Lyme antibody directly into a person rather than triggering the person’s own immune system to make antibodies, as vaccines do.
“In February 2021, we received approval from the FDA to proceed with the first human clinical trial of Lyme PrEP, and all of the volunteers in this trial have been enrolled and received the shot,” said Klempner. So far, the preliminary results from this trial have been encouraging, according to The Conversation. They show the drug is safe and should be effective during the entire nine-month season when most Americans are vulnerable to Lyme disease.