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Valneva Receives Optimistic CHMP Opinion for Advertising

Saint Herblain (France), June 23, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine firm, right this moment introduced that the Committee for Medicinal Merchandise for Human Use (CHMP) of the European Medicines Company (EMA) has really helpful advertising and marketing authorization in Europe for Valneva’s inactivated whole-virus COVID-19 vaccine candidate, VLA2001, to be used as main vaccination in folks from 18 to 50 years of age.

The European Fee (EC) will evaluation the CHMP suggestion, and a call on the advertising and marketing authorization utility for VLA2001 is predicted shortly. If granted, this would be the first COVID-19 vaccine to obtain a typical advertising and marketing authorization in Europe.

The CHMP concluded by consensus after a radical analysis that, “the information on the vaccine have been sturdy and met the EU standards for efficacy, security and high quality.”

Thomas Lingelbach, Chief Govt Officer of Valneva, commented, “We’re happy that the CHMP has really helpful VLA2001, the one inactivated COVID-19 vaccine candidate in Europe, for full advertising and marketing authorization and are actually trying ahead to receiving advertising and marketing authorization from the EC. I want to personally thank all those that have supported us on this endeavor, in addition to everybody at Valneva for all their onerous work. We hope that the EC and its member states will acknowledge the potential benefits of an inactivated vaccine and make a significant order, since we’ve clear proof that Europeans are in search of a extra conventional vaccine know-how. Our intention is to additional assist public well being in Europe by offering a brand new possibility for the 15% of Europeans over 18 who aren’t but vaccinated1.”

As soon as granted by the EC, the advertising and marketing authorization can be legitimate in all European Union Member States in addition to in Iceland, Liechtenstein, and Norway.

The EMA’s CHMP opinion follows conditional advertising and marketing authorization in the UK, which was granted in April 20222, and emergency use authorization granted within the United Arab Emirates in Could 2022 and in Bahrain in March 2022.   

About VLA2001
VLA2001 is presently the one entire virus, inactivated, adjuvanted vaccine candidate in medical trials in opposition to COVID-19 in Europe. It’s supposed for lively immunization of at-risk populations to stop carriage and symptomatic an infection with COVID-19 in the course of the pandemic and for routine vaccination together with addressing new variants. VLA2001 can also be suited to boosting, as repeat booster vaccinations have been proven to work nicely with entire virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing know-how for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated entire virus particles of SARS-CoV-2 with excessive S-protein density, together with two adjuvants, alum and CpG 1018. This adjuvant mixture has persistently induced larger antibody ranges in preclinical experiments than alum-only formulations and proven a shift of the immune response in direction of Th1. CpG 1018 adjuvant, equipped by Dynavax Applied sciences Company (Nasdaq: DVAX), is a element of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001’s manufacturing course of, which has already been upscaled to last industrial scale, contains chemical inactivation to protect the native construction of the S-protein. VLA2001 is predicted to evolve with commonplace chilly chain necessities (2 to eight levels Celsius).

About Valneva SE

Valneva is a specialty vaccine firm targeted on the event and commercialization of prophylactic vaccines for infectious ailments with important unmet medical want. The Firm takes a extremely specialised and focused strategy to vaccine growth after which applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these ailments. Valneva has leveraged its experience and capabilities each to efficiently commercialize two vaccines and to quickly advance a broad vary of vaccine candidates into and thru the clinic, together with candidates in opposition to Lyme illness, the chikungunya virus and COVID-19.

Media & Investor Contacts
Laëtitia Bachelot-Fontaine
VP World Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com        
 

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

Ahead-Wanting Statements
This press launch incorporates sure forward-looking statements regarding the enterprise of Valneva, together with with respect topossible regulatory approval of VLA2001. As well as, even when the precise outcomes or growth of Valneva are in step with the forward-looking statements contained on this press launch, these outcomes or developments of Valneva will not be indicative of future outcomes. In some instances, you may establish forward-looking statements by phrases akin to “might,” “ought to,” “might,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “goals,” “targets,” or comparable phrases. These forward-looking statements are primarily based on the present expectations of Valneva as of the date of this press launch and are topic to quite a few identified and unknown dangers and uncertainties and different elements which will trigger precise outcomes, efficiency or achievements to be materially totally different from any future outcomes, efficiency or achievement expressed or implied by these forward-looking statements. Specifically, the expectations of Valneva may very well be affected by, amongst different issues, uncertainties concerned within the growth and manufacture of vaccines, sudden medical trial outcomes, sudden regulatory actions or delays, competitors typically, forex fluctuations, the influence of the worldwide and European credit score disaster, the power to acquire or keep patent or different proprietary mental property safety and the influence of the COVID-19 pandemic. In mild of those dangers and uncertainties, there may be no assurance that the forward-looking statements made throughout this presentation will in actual fact be realized. Valneva is offering the data on this press launch as of the date hereof and disclaims any intention or obligation to publicly replace or revise any forward-looking statements, whether or not on account of new info, future occasions, or in any other case.


1 EMA Press Briefing Could 5, 2022: https://www.youtube.com/watch?v=C5DL66-Fb0Q
2 Valneva Receives Conditional Advertising Authorization from UK MHRA for its Inactivated COVID-19 Vaccine – Valneva

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