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Valneva Reports Further Heterologous Booster Data for its Inactivated COVID-19 Vaccine

30.12.2022

Saint-Herblain (France), December 30, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further heterologous booster data from an exploratory, small clinical study for its inactivated COVID-19 vaccine, VLA2001.

In study VLA2001-307 a subset of participants (three out of nine groups) received VLA2001 following two or three doses of mRNA COVID-19 vaccine, with or without break-through infection (25-50 participants per group).

The data show that a booster dose of VLA2001 was well tolerated in previously BNT162b2 (Pfizer/BioNTech)- or mRNA 1273 (Moderna)-vaccinated participants, confirming the favorable safety profile of VLA2001 seen across all studies – including in homologous or heterologous booster settings. However, in this study, an additional booster dose of VLA2001 elicited only a marginally increased neutralizing antibody response. The Company previously reported positive heterologous booster results following primary vaccination with ChAdOx1-S (AstraZeneca) in August 2022 and positive homologous booster results at the end of December 2021.

Valneva is currently seeking regulatory approval for VLA2001 as a homologous booster as well as heterologous booster in ChAdOx1-S (AstraZeneca) primed individuals which may support the Company in deploying its inventory in international markets.

Juan Carlos Jaramillo, M.D., Valneva’s Chief Medical Officer, commented, “While these latest booster results are not aligned with the encouraging homologous and heterologous booster results seen previously, we are pleased to once again confirm the favorable safety and tolerability profile of VLA2001, which was important for EMA and MHRA approval.”

About Trial VLA2001-307

VLA2001-307 is a multicenter, open-label clinical study investigating the safety, tolerability and immunogenicity of a VLA2001 booster vaccination in participants aged 18 years and older. Approximately 275 participants, either generally healthy or with a stable medical condition, were planned to be enrolled in the trial. The VLA2001 booster will be given to adults at least 6 months after vaccination with an mRNA COVID-19 vaccine, with or without confirmed SARS-CoV-2 infection, or to unvaccinated adults at least four months after confirmation of natural SARS-CoV-2 infection.

About VLA2001

VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001’s manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).

VLA2001 was the first COVID-19 vaccine to receive a standard marketing authorization in Europe and the only whole virus, inactivated, COVID-19 vaccine to receive marketing authorization in Europe for use as primary vaccination in people from 18 to 50 years of age. The vaccine was also granted conditional marketing authorization in the United Kingdom and emergency use authorization in the United Arab Emirates and Kingdom of Bahrain. Valneva signed agreements to supply VLA2001 to certain EU Member States2 and the Kingdom of Bahrain. In August 2022, the World Health Organization (WHO) issued recommendations for use of VLA2001. In light of current order levels and existing inventories, Valneva has suspended manufacturing of the vaccine and is continuing discussions on potential additional supply agreements with various other governments around the world to deploy remaining inventory. VLA2001’s shelf life is expected to be extended to up to 24 months, compared to 18 months currently.

About Valneva SE

Valneva is a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to commercialize three vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and the chikungunya virus.

Valneva Investor and Media Contacts
Laetitia Bachelot-Fontaine
VP, Global Communications and European Investor Relations
M +33 (0)6 4516 7099
investors@valneva.com

Joshua Drumm, Ph.D.
VP, Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com