to Participate in the World's First COVID-19 Vaccine Booster Trial in the UK

to Participate in the World's First COVID-19 Vaccine Booster Trial in the UK

Saint-Herblain (France), May 19, 2021 - Valneva SE, a specialty vaccine company

focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical

need, today announced it will participate in a UK government-funded clinical trial looking at different COVID-19 booster'

vaccines that launches today.

Cov-Boost trial, led by University Hospital Southampton NHS Foundation Trust, will look

at seven different COVID-19 vaccines, including Valneva's inactivated vaccine VLA2001,

as potential boosters. It will be the first trial in the world to provide vital data

on how effective a booster of each vaccine is in protecting individuals from the virus.

vaccines will be given at least three months after a second dose as part of the ongoing

vaccination programme. One booster will be provided to each volunteer and could be a

different brand to the one they were originally vaccinated with. The trial will also

include a control group.

results from the trial, expected in September, will help inform decisions by the UK Joint

Committee on Vaccination and Immunisation (JCVI) on any potential booster programme from

autumn this year, ensuring the UK's most vulnerable people are given the strongest

possible protection over the winter period.

Lingelbach, Chief Executive Officer of Valneva, commented, "We are pleased

to be involved in this new Cov-Boost trial. Valneva has the only whole virus, inactivated,

adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe and we believe

our VLA2001 vaccine has an important role to play in the ongoing pandemic, including

as a booster. We remain fully committed to completing development and bringing our inactivated

vaccine solution to the market."

parallel to the Cov-Boost trial, Valneva will continue working on its pivotal Phase 3

clinical trial "Cov-Compare", (VLA2001-301) which the Company launched in

April 20211. This trial compares Valneva's SARS-CoV-2 vaccine candidate,

VLA2001, against AstraZeneca's conditionally approved vaccine, Vaxzevria2.

Recruitment for the trial, conducted in the U.K. and supported by the National Institute

for Health Research (NIHR), is ongoing (https://www.ukcovid19study.com/). Subject

to successful Phase 3 data, Valneva aims to make regulatory submissions for initial approval

in the autumn of 2021.

VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine

candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization

of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during

the ongoing pandemic and potentially later for routine vaccination including addressing

new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations

have been shown to work well with whole virus inactivated vaccines. 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. The manufacturing process

for VLA2001, which has already been upscaled to final industrial scale, includes inactivation

with BPL to preserve the native structure of the S-protein. VLA2001 is expected to conform

with standard cold chain requirements (2 degrees to 8 degrees Celsius).

Valneva is a specialty vaccine company focused on the development

and commercialization of prophylactic vaccines for infectious diseases with significant

unmet medical need. We take a highly specialized and targeted approach to vaccine development,

beginning with the identification of deadly and debilitating infectious diseases that

lack a prophylactic vaccine solution and for which there are limited therapeutic treatment

options. We then apply our deep understanding of vaccine science, including our expertise

across multiple vaccine modalities, as well as our established vaccine development capabilities,

to develop prophylactic vaccines to address these diseases. We have leveraged our expertise

and capabilities both to successfully commercialize two vaccines and to rapidly advance

a broad range of vaccine candidates into and through the clinic, including candidates

against Lyme disease, the chikungunya virus and COVID-19.

Forward-Looking Statements

This press release contains certain forward-looking

statements relating to the business of Valneva, including with respect to the progress,

timing, results and completion of research, development and clinical trials for product

candidates and estimates for future performance. In addition, even if the actual results

or development of Valneva are consistent with the forward-looking statements contained

in this press release, those results or developments of Valneva may not be sustained

in the future. In some cases, you can identify forward-looking statements by words such

as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates,"

"aims," "targets," or similar words. These forward-looking statements are based largely

on the current expectations of Valneva as of the date of this press release and are subject

to a number of known and unknown risks and uncertainties and other factors that may cause

actual results, performance or achievements to be materially different from any future

results, performance or achievement expressed or implied by these forward-looking statements.

In particular, the expectations of Valneva could be affected by, among other things,

uncertainties involved in the development and manufacture of vaccines, unexpected clinical

trial results, unexpected regulatory actions or delays, competition in general, currency

fluctuations, the impact of the global and European credit crisis, and the ability to

obtain or maintain patent or other proprietary intellectual property protection. Success

in preclinical studies or earlier clinical trials may not be indicative of results in

future clinical trials. In light of these risks and uncertainties, there can be no assurance

that the forward-looking statements made during this presentation will in fact be realized.

Valneva is providing the information in these materials as of this press release, and

disclaim any intention or obligation to publicly update or revise any forward-looking

statements, whether as a result of new information, future events, or otherwise.

Valneva Initiates Phase 3 Clinical Trial for its Inactivated, Adjuvanted COVID-19 Vaccine

2 Approved by MHRA under reg. 174 and by the European

Commission as conditional approval