Valneva Comments on COV-Boost Clinical Trial Data
Saint Herblain (France), December 3, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today responded to data published from the COV-Boost COVID-19 vaccine trial, which investigated the reactogenicity and immunogenicity of seven different COVID-19 vaccines at different dose levels when administered as a third dose, or booster, to people primed with either Pfizer’s Comirnaty or AstraZeneca’s Vaxzevria.
The COV-Boost trial, which launched in May 2021 and was led by University Hospital Southampton NHS Foundation Trust, included Valneva’s inactivated, adjuvanted, whole virus COVID-19 vaccine candidate VLA2001. The aim of the COV-Boost trial was to quickly generate data to inform advice from the UK’s Joint Committee on Vaccination and Immunization on the autumn booster campaign. Participants were given a booster dose relatively early, only two to three months after completion of the second dose of the primary vaccination series, when they did not need a booster from either an immunological standpoint or under the currently recommended interval for licensed COVID-19 vaccines. Valneva believes it is likely that the short interval between the second shot and booster shot could have adversely impacted the results for VLA2001, given that a longer interval is generally required for inactivated vaccines.
The Company has already begun generating data to inform any regulatory discussions regarding a potential booster indication for VLA2001. The first data from a continuation of existing clinical trials (homologous) are expected in the first quarter of 2022. Additionally, Valneva is in the process of setting up a dedicated heterologous booster trial. All of Valneva’s trials will evaluate a booster shot provided at least six months after primary vaccination, as per the currently recommended interval for licensed COVID-19 vaccines. The results of the COV-Boost trial were never intended to be, nor will they be, part of the Company’s regulatory submissions to the UK Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA), which seek approvals for VLA2001 in the primary vaccination context solely based on the positive data from the pivotal Phase 3 Cov-Compare trial.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, said, “The setting in the study leads us to believe that COV-Boost does not allow any conclusions to be reached regarding the use of VLA2001 as a booster in a real-life setting. The protective antibody threshold has not yet been established therefore relative increases in antibody levels should not be seen as indicative of efficacy. I concur with Professor Faust’s statements that the data describe the immune response at 28 days, not vaccine effectiveness, and that the relationship between that response and long-term protection is still poorly understood, especially since several studies have shown that longer periods between doses improve immune response. Our submissions for authorization of VLA2001 in a primary vaccination context remain on track, with the EMA announcing yesterday that it has started its rolling review of VLA2001, and our teams are working diligently so that we can quickly deploy our vaccine ad ensure it reaches the people who need it.”
On October 18, 2021, Valneva announced positive topline results from Cov-Compare, the pivotal Phase 3 comparative immunogenicity trial of VLA2001. VLA2001 demonstrated superiority in terms of neutralizing antibody titer levels against the active comparator vaccine, AstraZeneca’s AZD1222, as well as non-inferiority in terms of seroconversion rates and a significantly better tolerability profile. The Company commenced rolling submission for initial approval of VLA2001 with the MHRA on August 23, 2021 and rolling review with the EMA on December 2 and will continue to work very closely with those authorities to complete their review process.
Valneva announced on November 23, 2021 that the European Commission signed an agreement for the Company to supply up to 60 million doses of VLA2001 over two years - including 24.3 million doses in 2022. Delivery of the vaccine is currently expected to begin in April 2022, subject to approval by the EMA.
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