Valneva comments: The short interval between the second and booster vaccinations could have an adverse effect on the study

03.12.2021

Valneva comments on the booster study that led to a lower stockpile today: In the recently published COV Boost COVID-19 vaccine study, the interaction and immunogenicity of seven different COVID-19 vaccines at different doses were investigated. The COV Boost study, which began in May 2021 and was overseen by the University of Southampton University Hospital NHS Foundation Trust, included Valneva’s candidate VLA2001 inactivated and adjuvant COVID-19 vaccine. The aim of the COV Boost study was to rapidly generate data to support the recommendations of the UK Joint Committee on Vaccination and Immunization in the Autumn Booster Campaign. Participants received a booster dose relatively early, only two to three months after completing the second dose of the initial series, if they did not need a booster dose either from an immunological standpoint or less than the currently recommended interval for approved COVID-19 vaccines. Valneva believes that it is possible that the short period between the second vaccination and the booster vaccination may have adversely affected the results of VLA2001, as inactivated vaccines generally require a longer period.

More data has already begun to be generated, and results from continuation of existing (homogeneous) clinical studies are expected in the first quarter of 2022. In addition, Valneva is in the process of preparing a heterogeneous booster study. All Valneva studies evaluate a booster dose given at least six months after the initial vaccination at the interval currently recommended for approved COVID-19 vaccines.

The results of the COV Boost study were not intended to be part of the company’s filings with the UK Medicines and Health Products Authority (MHRA) and the European Medicines Agency (EMA), according to Valneva. Juan Carlos Jaramillo, chief medical officer of Valneva, said: “The study environment leads us to believe that COV-Boost does not allow any conclusions to be drawn regarding the use of VLA2001 as a booster in a real environment. The protective antibody threshold has not been established yet, so it should not be considered Relative increase in antibody levels is indicative of efficacy.I agree with Professor Faust’s statements that the data describe an immune response after 28 days, not vaccine efficacy, and that the relationship between this response and long-term protection remains poorly understood.Our requests for approval of VLA2001 remain As part of the initial vaccination on schedule.”

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