(News Bulletin 247) – Pfizer and the French laboratory communicated this Thursday positive data in children and adolescents with the use of a booster dose of their vaccine candidate against Lyme disease.
Good news for Valneva and its partner Pfizer. The infectious disease vaccine specialist is taking a new step in the development of its Lyme disease vaccine candidate, VLA15.
Lyme disease is a systemic infection caused by bacteria transmitted to humans by ticks. It is now considered the most common vector-borne disease in the northern hemisphere. Although the true incidence of this disease is unknown, it affects approximately 476,000 people per year in the United States and 129,000 people per year in Europe.
Pfizer and Valneva thus published this Thursday the safety data (that is to say which show the absence of harmfulness of a treatment) and immunogenicity (immune response induced by vaccination) for the use of a booster dose of their vaccine candidate against Lyme disease, in children and adolescents.
A vaccine well tolerated in all age groups
The results of the Phase II trial (intermediate stage of clinical trials before phase III and then potential commercial authorization) thus showed a strong anamnestic response (immune memory), one month after vaccination with a booster dose of VLA15 in children aged 5 to 11), adolescents (aged 12 to 17) and adults (aged 18 to 65).
“The safety and tolerability profile of VLA15 following a booster dose is consistent with previous studies, with the candidate vaccine being well tolerated across all age groups, regardless of primary vaccination schedule,” Valneva said. . “No serious adverse events (SAEs) linked to the vaccine and no safety problems were observed by the independent safety data monitoring committee (DSMB)”, continues the French group.
The results presented by Valneva and Pfizer follow those reported in December 2022 regarding new six-month data on antibody persistence in children and adults vaccinated with their Lyme disease candidate.
Other studies in progress
In August 2022, Pfizer and Valneva had launched a Phase III clinical study (last stage of clinical trials before possible marketing) and which is still ongoing, aimed at evaluating the efficacy, safety and immunogenicity of VLA152 in participants aged five and older in areas where Lyme disease is highly endemic, including Finland, Germany, the Netherlands, Poland, Sweden and the United States.
Subject to positive Phase III data, Pfizer intends to submit a marketing authorization request (MA) to the American health authority, the Food and Drug Administration (FDA), and a marketing authorization request to of the European Medicines Agency (EMA) in 2026.
On the Paris Stock Exchange, Valneva shares rose 1.5% this Thursday around 10:20 a.m. in response to the announcement of these positive clinical data.
Remember that Valneva has a portfolio of vaccines and vaccine candidates, including that against chikungunya, a viral disease transmitted by certain mosquitoes, resulting in particular in acute fevers and joint pain. And the group has taken many steps to offer a therapeutic solution for this disease for which there is currently no preventive vaccine or effective treatment.
At the end of August, the regulatory agency Health Canada in fact deemed admissible the application for marketing authorization for this vaccine candidate. This review from the Canadian health authority focuses on the use of VLA1553, the vaccine candidate in people 18 years of age or older.
A day earlier, Valneva had been bolstered by the announcement of positive safety data for the vaccine candidate in adolescents.
Valneva’s chikungunya vaccine candidate is already under review by the US health authority, the Food and Drug Administration (FDA). In mid-August, the French company had indicated that this authority had postponed the target date for the end of the treatment review, from the end of August to the end of November, which had weighed on its action. Valneva has nevertheless confirmed that it anticipates the possible approval of its application for authorization of the vaccine this year, as well as its initial launch.
“The VLA1553 is the most advanced product under development in this indication and therefore Valneva has a good chance of being the first and only operator on this market”, had then explained to News Bulletin 247 Mohamed Kaabouni, analyst at Portzamparc. According to a VacZine analytics study cited by Valneva, the global chikungunya vaccine market could exceed $500 million per year by 2032.
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