The results of the third phase of Lyme disease vaccine trials will most likely be available at the end of 2025, says the president of the Office for Registration of Medicinal Products. If this is confirmed, this long-awaited vaccine could be registered and available in the European Union no earlier than 2026.
The number of cases of Lyme disease in Poland has continued to grow in recent years. According to data from the National Institute of Public Health - National Institute of Hygiene in Warsaw, 9,134 infections were confirmed in the first half of this year (by the end of June). A year earlier, in the same period, there were 7,714 cases of this infection. Researchers suspect that there may be even more cases in the coming years.
An effective vaccine could protect many people from Lyme disease, which is an insidious disease that can develop in secret over many years. So far, advanced research is being conducted on one such preparation, marked with the symbol VLA15.
'The candidate for a Lyme disease vaccine, VLA15, is a multivalent vaccine based on the recombinant OspA surface protein of Borrelia spirochetes', Grzegorz Cessak, president of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, explained on X.
'The data from the clinical trial published in 2023 showed the immunogenicity of the vaccine against all serotypes of the OspA surface protein of the bacteria and confirmed the safety profile. The vaccine was well tolerated, and most of the adverse events were mild or moderate', he added.
'The most important data from the third phase of the clinical trial are expected to be published at the end of 2025. Then, it is planned to submit an application for a marketing authorization, provided that positive data from the third phase of the trial are obtained', he continued.
A vaccine against Lyme disease is awaited in many countries, especially in Europe and the USA. Lyme disease is a bacterial multi-system disease transmitted to humans by infected ticks. 'About 14 percent of the world's population suffer is or have suffered from Lyme disease transmitted by ticks, it is the most common vector disease in the northern hemisphere', Cessak said.
Not all ticks are carriers of Lyme disease bacteria; they can also transmit other pathogens, for example viruses causing tick-borne encephalitis. However, an effective vaccine for this infection has been available for many years.
A worrying sign that an infection may have occurred is a painless redness around the site of the tick bite. Such redness, in the shape of a ring or oval, usually appears after a few days to a week. However, it does not have to appear. Therefore attention needs to be paid to other symptoms, such as fatigue, dizziness and headaches, because these are usually trivialized. More serious ailments that may be associated with Lyme disease include paralysis of one half of the face, inflammation of the joint (most often the knee), heart disorders and meningitis.
Lyme disease is treated with antibiotics, but it can be detected late, even several years after infection, and in such cases it is difficult to treat. It is also possible to get infected with it multiple times, because having the disease does not immunise against it.
'Let's hope that a Lyme disease vaccine will be available soon', virologist Professor Krzysztof Pyrć wrote on X. In his opinion, the goal is not only to reduce the number of infections. 'Not only will it protect our health, but it will also (hopefully) cut down the pathological pseudo-medical underground', he added.
This concerns the so-called ILADS method used in the treatment of Lyme disease, which is inconsistent with medical knowledge, because its effectiveness has not been confirmed by clinical studies. It involves long-term, many months of use of more than just one antibiotic. According to the adopted therapy standards, also recommended by the Polish Society of Epidemiologists and Infectious Disease Physicians, in the treatment of Lyme disease it is enough to use one, but appropriate antibiotic for a period of up to 30 days. (PAP)
Zbigniew Wojtasiński
zbw/ bar/ kap/
tr. RL