Encephalitis, Arbovirus

Saint Herblain (France), April 18, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that during its regular meeting on April 16, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) updated its recommendation for use of Valneva’s single-dose chikungunya vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus (CHIKV). ACIP maintained its current recommendation for IXCHIQ® for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak. Additionally, it may be considered for persons aged ≥18 years traveling or taking up residence in a country or territory without an outbreak but with elevated risk for U.S. travelers if planning travel for an extended period of time e.g., six months or more. The ACIP also voted to recommend a precaution related to the use of IXCHIQ® in persons aged ≥65 years. This precaution is a response to an ongoing investigation by the CDC of six cases of serious adverse events (SAEs), including five hospitalizations, among persons aged 67-86 years after vaccination with IXCHIQ®. These SAEs were reported through the Vaccine Adverse Event Reporting System (VAERS), which is intended to be an early warning system to identify potential safety issues but generally cannot determine if adverse events are caused by a vaccine. All of the individuals who were hospitalized had pre-existing comorbidities, and ACIP concluded that while plausible, no causal association with IXCHIQ® could be determined for all cases and that further investigation is warranted. ACIP also noted that for individuals aged ≥65 years, vaccination with IXCHIQ® might be indicated in certain higher-risk settings (e.g., outbreak), given the known risks for severe chikungunya disease and hospitalization in this age group. For example, earlier this month Valneva supplied 40,000 doses of IXCHIQ® to France’s Island of La Réunion where the local public health agency, the Agence Régionale de Santé (ARS), is prioritizing vaccination of adults aged 65 and over, especially those with comorbidities, to protect residents during the ongoing chikungunya outbreak. Valneva recently received confirmation from ARS for an order of 50,000 additional doses of IXCHIQ® as part of its ongoing effort to manage this outbreak. To date, Valneva has supplied approximately 80,000 doses of IXCHIQ® in the United States, Canada and Europe. No further SAEs have been reported since January 2025 globally, and Valneva has not identified any safety signal concerns that are inconsistent with the U.S. product label through its ongoing post-marketing safety monitoring, including its periodic safety reports and routine signal detection activities, which are shared with the U.S. Food and Drug Administration (FDA). Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “Valneva is committed to the highest standards of safety, and the safety profile of IXCHIQ® remains unchanged and positive. We respect the ACIP recommendation and agree on the importance of continuing the stringent safety surveillance protocols that are in place. We encourage providers to assess the benefit/risk of vaccination based on the individual’s medical history and upcoming travel, in line with the current recommendation.” The recommendation from ACIP is pending final approval by the Director of the CDC and the U.S. Department of Health and Human Services. About ChikungunyaChikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years1. In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas2. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas3 and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.4 About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first chikungunya vaccine, as well as certain third-party vaccines.Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com. Media and Investor Relations Contacts Laetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 7099laetitia.bachelot-fontaine@valneva.com Joshua Drumm, Ph.D.VP Global Investor RelationsM +001 917 815 4520joshua.drumm@valneva.com Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to potential product sales and regulatory review of existing products. 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 and delays 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 in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 https://jvi.asm.org/content/jvi/88/20/11644.full.pdf 2 https://cmr.asm.org/content/31/1/e00104-163 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 01 Aug 2023.4 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int) Attachment 2025_04_18_ACIP_PR_EN_Final

WASHINGTON, April 8, 2025 /PRNewswire/ -- Center for Lyme Action, the leading nonprofit dedicated to growing Federal funding for Lyme and tick-borne diseases, honored Members of Congress, current and former administration officials, and Lyme and tick-borne disease community leaders who have demonstrated extraordinary support in the push to cure Lyme Disease – the most prevalent vector-borne illness and the most prevalent tick-borne illness in the United States, with nearly a half million new cases estimated each year. "While we are making some progress, Lyme and tick-borne disease continue to be frustrating and debilitating for millions of patients across the United States," said Bonnie Crater, co-founder of Center for Lyme Action. "We believe this is a problem we can solve, and our award recipients have demonstrated extraordinary leadership in working to find a cure. We are honored to have them as long-term partners in this important fight." Receiving the Center for Lyme Action Lyme and Tick-Borne Disease Champion Award were: U.S. Senator Tammy Baldwin (D-WI), U.S. Senator John Boozman (R-AR), U.S. Senator Shelley Moore Capito (R-WV), U.S. Senator Kirsten Gillibrand (D-NY), U.S. Representative Diana DeGette (D-CO), U.S. Representative Rosa DeLauro (D-CT), U.S. Representative Morgan Griffith (R-VA), U.S. Representative Mark Pocan (D-WI), U.S. Representative Lloyd Smucker (R-PA) and U.S. Representative Jefferson Van Drew (R-NJ). The Center for Lyme Action's awards event builds on the momentum of a 169% increase in federal funding for Lyme and tick-borne disease across Federal agencies to $158M million. Even with these increases, Federal funding for Lyme disease continues to be very low at $90 per patient compared with other less prevalent diseases. Less common diseases West Nile and Malaria have 75 times and 1300 times the amount of per patient funding. "The awards ceremony was all about thanking our supporters," Crater said. "Now we are getting back to work – spending time meeting with Members of Congress to ensure Appropriators understand the gravity of Lyme and tick-borne diseases and the need to fully fund the Kay Hagan Tick Act and grow research funding for Lyme." Kay Hagan Tick Act Delivers National Strategy As directed by the Kay Hagan Tick Act, leaders in HHS Office of the Secretary and CDC Division of Vector-Borne Diseases organized input from over 50 representatives from 17 different Federal agencies to deliver the National Public Health Strategy to Prevent and Control Vector-Borne Diseases in People. Delivered in February 2024, this comprehensive strategy includes dozens of recommendations including: Better understanding when, where, and how people are exposed to and get sick or die; Developing, evaluating, and improving tools, methods, and guidance to diagnose diseases and their pathogens; Developing, evaluating, and improving tools, methods, and guidance to prevent and control disease; Developing and assessing drugs and treatment strategies; and Disseminating and implementing public health tools, programs, and collaborations to prevent, detect, diagnose, and respond to threats. "There wasn't a national strategy for vector-borne disease until the Kay Hagan Tick Act directed HHS to develop one," said Senator Susan Collins in video remarks. "At its core, the National Strategy for strategy sets out goals to better prevent, detect, diagnose, and treat tick-borne illnesses. Now is the time to implement this excellent blueprint for Federal action and not lose momentum in research to combat devastating diseases like Lyme and other tick-borne diseases." To date, Lyme disease has been reported in every state and 65 countries worldwide. For more information, go to centerforlymeaction.org; also follow on Twitter @lyme_action, Instagram @centerforlymeaction, LinkedIn, Facebook. Press Contact Meghan Bradshaw [email protected] SOURCE Center for Lyme Action WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Bharat currently has five products in its personalized medicine pipeline—two in cell culture and three in the gene therapy segment, the Hindu Business Line reported late last week. With a storied history in vaccine development, India's Bharat Biotech is shaking things up and answering the call of advanced therapeutics. Bharat has unveiled plans to set up its first cell and gene therapy manufacturing facility at the Hyderabad, India, life sciences cluster known as Genome Valley. The drugmaker will lay out around $75 million for the project, multiple local news outlets have reported. The move by Bharat represents (PDF) its foray from vaccines into cutting-edge regenerative and personalized therapies, the company said in a Mar. 20 press release. Although a specific date wasn’t disclosed, the 50,000-square-foot plant is expected to begin full operations with the finalization of regulatory approvals and the completion of a build-out phase.Bharat currently has five products in its personalized medicine pipeline—two in cell culture and three in the gene therapy segment, the Hindu Business Line reported late last week, citing comments from Bharat's executive chairman Krishan Ella. The company is working on a range of CAR-T cell, CAR-NK cell and off-the-shelf gene therapies, Bharat's chief development officer Raches Ella added, as quoted by the Times of India. “Bharat Biotech, with its extensive experience and proven excellence in viral vaccine manufacturing, is uniquely positioned to master these complexities and produce human-grade vectors at the scale and consistency needed for clinical trials,” Krishan Ella said in the company's release. Additionally, Bharat has revealed a new collaboration pact with the University of Wisconsin-Madison that has the potential to expand into commercial deals that include in-licensing. The company is also looking ahead to exporting and the potential of medical tourism in the cell and gene therapy segment.Bharat popped up on the global radar in 2019 when it became the largest supplier of rabies vaccines in the world after acquiring Chiron Behring Vaccines from GSK in an all-cash deal. The price of the purchase wasn’t disclosed.At the time, India-based Chiron Behring had just a single product in the rabies vaccine Rabipur, while Bharat Biotech was selling a Vero cell-based rabies vaccine, Indirab. The acquisition boosted Bharat's annual rabies capacity to 25 million doses.During the pandemic, Bharat also rolled out a COVID-19 vaccine, dubbed Covaxin, which won approvals in multiple countries including India, Malaysia and Mexico. Attempts to introduce the shot in the U.S. with partner Ocugen proved less fruitful, however. Bharat currently boasts a portfolio of more than 19 vaccines and 4 biotherapeutics, with shots in influenza H1N1, rotavirus, Japanese encephalitis, rabies and cholera, among multiple others.