Clinical trial was carried out on almost 10 thousand Europeans and Americans. The vaccine is from Pfizer and Valneva. Disease is transmitted by ticks.
A vaccine experimental against the disease Lyme developed by Pfizer and by Valneva presented results considered promising in an advanced phase clinical trial, demonstrating a 73.2% effectiveness in preventing confirmed cases of infection.
According to the companies, the vaccine candidate PF-07307405 was tested in approximately 9400 healthy participantsaged five or more, recruited in endemic regions of the Europa, do Canada and of USA.
Lyme disease is a bacterial infection transmitted by the bite of a ticks infected and can cause fever, headaches, fatigue and a characteristic skin rash known as erythema migrans.
In some cases, the infection may have more prolonged and disruptive consequences for everyday life and health.
There is no vaccine approved for human use against this disease.
According to the data released, the effectiveness of the vaccine was measured 28 days after the fourth dosehighlights the .
The pharmaceutical companies also emphasize that the product was well tolerated and that, until the moment of analysis, no relevant safety issues were identified.
PF-07307405 is currently the Lyme disease vaccine candidate in the most advanced phase of clinical development, with two phase 3 trials already completed.
The path to these results, however, was not linear. In a first interim analysis, the trial did not fully meet one of the statistical criteria usually required for regulatory approval, due to the number of cases being lower than expected.
In a second analysis, however, the lower limit of the 95% confidence interval rose to 21.7%, above the 20% level generally considered necessary. With these results, Pfizer is now preparing authorization requests from regulatory authorities.
