(Boursier.com) — Valneva fall of almost 10% this Friday, back to 5.75 euros, while Pfizer And Valneva announced that Pfizer, as the study sponsor, has decided to exclude a significant percentage of participants who had been recruited in the United States for the Phase 3 clinical study VALOR (NCT05477524), evaluating the efficacy, the safety and immunogenicity of a Lyme disease vaccine candidate, VLA15. Vaccination of these participants, representing approximately half of all study participants, will be discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial centers operated by a clinical trial company third party. The exclusion of these participants is not linked to problems of safety of the candidate vaccine and is not motivated by adverse effects that would be reported by participants.
The GCPs are the international standard for the ethical and scientific quality of clinical trials and should be followed by all clinicians. These standards are designed to put the interests of participants first and ensure a high level of scientific integrity. After being made aware of possible GCP violations, Pfizer conducted a thorough review of practices and data collection at clinical trial centers operated by this third-party company and applied standardized safeguards to determine the plan most appropriate course of action.
Third party
The clinical study continues at other sites not under the responsibility of this third party, and Pfizer continues to recruit new participants there. The companies intend to work with regulatory authorities and, as previously announced, aim for Pfizer to be able to submit marketing authorization applications to the US health authority, the Food and Drug Administration ( FDA), and the European health authority, the European Medicines Agency (EMA), in 2025, subject to the success of the Phase 3 study and the agreement of these regulatory agencies on the modifications to the plan of clinical development that will be offered to them.
Affected study participants are being notified. Pfizer has also notified the FDA and other regulatory authorities as well as the independent ethics committee in charge of this study.
The integrity of the data collected in the context of a clinical study is essential to demonstrate the potential safety and efficacy of a candidate vaccine or a drug candidate and to provide confidence in its use. Pfizer and Valneva are committed to collecting robust data, necessary for an eventual regulatory submission of VLA15. While VLA15 is still being evaluated, the companies are encouraged by the Phase 2 clinical study data collected to date, which have demonstrated strong immunogenicity and acceptable safety and tolerability profiles…
setback
Portzamparc speaks of “hiccups” in the development of VLA15 “whose impact on Valneva remains difficult to measure at this stage”…”We understand that Pfizer intends to maintain an identical schedule despite the time lost (submission in 2025), however the financial impact remains to be determined,” continues the analyst. “At this stage, discussions with the regulatory authorities are ongoing to find an agreement around a new development plan for VALOR… The question that remains is whether the regulatory authorities will be able to accept a file which only includes data from half of the participants initially planned (3000 vs 6000).The company will communicate as soon as the FDA returns on this subject “…We are maintaining our scenarios at this stage” concludes Portzamparc. What always aim for a course of 10.70 euros, remaining in the purchase on the file.
For its part, Oddo BHF reduced its target from 10 to 9 euros while remaining to ‘outperform’.