Meningitis

SAN CARLOS, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced it has appointed Dr. Olivier Brandicourt, a veteran biopharmaceutical industry executive and the former Chief Executive Officer of Sanofi S.A., to its Board of Directors. “We are thrilled to welcome Olivier to Vaxcyte’s Board of Directors,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “He brings a wealth of biopharmaceutical expertise, with significant experience in commercial strategy and execution within the global vaccine market. During his time as the CEO of Sanofi, he further bolstered the company’s standing as one of the world’s leading commercial vaccine companies. His strategic insight and operational leadership will be instrumental as we advance toward the potential global commercialization of our pneumococcal conjugate vaccine (PCV) candidates. Separately, I would like to extend our sincere thanks to Dr. Peter Hirth, who has served on the Board since 2016 and will conclude his tenure in June. We are deeply grateful for his years of dedicated service and myriad contributions to Vaxcyte during a defining period in our growth.” “Vaxcyte’s carrier-sparing platform represents a highly differentiated and scientifically compelling approach, with the potential to address some of the most pressing unmet needs in the prevention of bacterial diseases,” said Dr. Brandicourt. “I’m honored to join the Board at such a pivotal time and look forward to working with the team as the Company continues to advance its PCV candidates toward potential commercialization. By broadening protection against invasive pneumococcal disease, Vaxcyte is not only aiming to set a new standard of care—it is also contributing to the global effort to combat antimicrobial resistance, a pervasive public health threat driven by the overuse of antibiotics.” About Dr. BrandicourtDr. Brandicourt is a distinguished executive in the biopharmaceutical industry. He is currently a Senior Advisor at Blackstone Life Sciences and serves on the boards of Alnylam Pharmaceuticals, Inc., AvenCell Therapeutics, Inc., BeOne Medicines Ltd. and Dewpoint Therapeutics, Inc. He was the CEO of Sanofi S.A. from 2015 to 2019, where he was instrumental in advancing the company’s vaccine portfolio through the acquisition of Protein Sciences and its recombinant influenza vaccine, and the CEO of Bayer HealthCare AG from 2013 to 2015. Dr. Brandicourt also spent 13 years at Pfizer Inc., including as a member of the Executive Leadership Team and as President and General Manager of the Emerging Markets and Established Products business units. Additionally, he served in a series of leadership positions, including heading Pfizer’s Global Specialty and Global Primary Care business units. Dr. Brandicourt studied medicine in Paris where he specialized in Infectious Diseases and Tropical Medicine and holds a Master’s Degree in Biology and an Advanced Degree in Cellular and Immunological Pathophysiology. He is an Honorary Fellow of the Royal College of Physicians in London and has been a director of the National Committee on U.S.-China Relations since 2012. About Vaxcyte Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. VAX-31, a 31-valent PCV candidate advancing to a Phase 3 adult clinical program and currently being evaluated in a Phase 2 infant clinical program, is being developed for the prevention of invasive pneumococcal disease (IPD) in adults and infants and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, the Company’s 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market and is currently being evaluated in a Phase 2 infant study. Both VAX-31 and VAX-24 are designed to improve upon the standard-of-care PCVs by covering the serotypes in circulation that are responsible for a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice. Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine candidate designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of Vaxcyte’s carrier-sparing platform and PCV candidates; the potential global commercialization of its PCV candidates; the ability to improve upon the standard-of-care and combat antimicrobial resistance; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Yearly Report on Form 10-K filed with the SEC on February 25, 2025 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date. Contacts: Patrick Ryan, Executive Director, Corporate AffairsVaxcyte, Inc.415-606-5135media@vaxcyte.com Jennifer Zibuda, Senior Director, Investor RelationsVaxcyte, Inc.860-729-8902investors@vaxcyte.com

Amneal cautioned of a “reasonable probability” that particulate matter in the epidural space could damage the spinal cord or set off an epidural inflammatory process to meningitis. Particulate contamination has sparked the recalls of numerous injectable drugs over the years, with Amneal’s hospital med ropivacaine now the latest to fall victim to the trend.Amneal is recalling two lots of ropivacaine hydrocholoride injection on the risk that the anesthetic could contain inert “fibers” that leeched into the product from its IV bag, according to a notice on the FDA’s website.The recall, which covers a 500-mg/100-ml dose of the drug packaged in infusion bags, is specifically concerned with particulate contamination by the common thermoplastic polymer polypropylene.Patients could suffer serious side effects if the contaminated drug is delivered epidurally or inadvertently administered to the intrathecal space via the spinal canal, Amneal warned in its recall notice.The company cautioned of a “reasonable probability” that particulate matter in the epidural space could damage the spinal cord or set off an epidural inflammatory process to meningitis. When administered intrathecally, the particulates in the tainted drug also have the potential to cause inflammation and water on the brain, which can lead to embolization and organ damage.As of Friday, Amneal had not received any side effect or injury reports tied to the suspect drug batch. Ropivacaine is used as both regional anesthesia for surgery and as a tool for acute pain management in hospitals.Amneal’s product pull covers hospital meds shipped across the U.S. between April and November last year.Amneal triggered a separate recall last March when it pulled four batches of the antibacterial oral solution vancomycin hydrochloride, which is used to treat intestine and colon inflammation. At the time, the company noted that it may have “overfilled” certain bottles during a manual portion of the manufacturing process.That error could have led to patients receiving more of the medication than intended, putting them at risk of worsening kidney function, Amneal warned at the time.Particulate contamination, when bits of a drug’s packaging or components from the manufacturing process worm their way into the product itself, has sparked multiple recalls in recent years, often accompanied by warnings of serious potential complications for those who take the polluted meds. Last April, Aurobindo’s Eugia unit yanked one lot of injectable methocarbamol after a customer complaint flagged the presence of white particles in a product vial. And, a month before that, Endo’s Par Pharmaceutical recalled one batch of treprostinil injection over fears that silicone particles had made their way into certain vials.Injecting particulate matter can cause a range of side effects, from the aggravating but ultimately benign—like irritation at the injection site—to the severe, such as stroke or death, Par cautioned in its recall alert.

GSK’s five-in-one meningococcal vaccine has been recommended by the US Centers for Disease Control and Prevention’s (CDC) immunisation panel as part of the adolescent meningococcal vaccination schedule. Penmenvy combines the antigenic components of GSK’s approved Bexsero and Menveo meningococcal vaccines to target five common invasive meningococcal disease (IMD)-causing serotypes (A, B, C, W and Y). The Advisory Committee on Immunization Practices (ACIP) has recommended that individuals aged over ten years be given a single dose of Penmenvy as an alternative to the separate administration of MenACWY and MenB vaccinations when both vaccines would be given in the same visit, typically at age 16. It is hoped that this will simplify meningococcal vaccine delivery and lead to higher uptake. The CDC will now review ACIP’s recommendation as it makes a final decision on Penmenvy. IMD is an uncommon but serious illness caused by the bacterium Neisseria meningitidis. It is a major cause of meningitis and septicaemia, and can result in long-term consequences such as neurological damage, amputations and hearing loss. Babies, young children and those who are in their late teens and early adulthood are among those at the highest risk. GSK’s chief scientific officer, Tony Wood, said: “We welcome this positive recommendation that can help strengthen disease prevention efforts in the US. “Pentavalent vaccines can reduce the number of injections required to help protect against invasive meningococcal disease – especially disease caused by serogroup B. Their use could improve immunisation rates among adolescents and young adults in the US, who are at an age with increased risk.” The recommendation comes just two months after the US Food and Drug Administration (FDA) approved Penmenvy for use in individuals aged from ten to 25 years. The regulator’s decision was supported by positive results from two late-stage trials, which evaluated Penmenvy’s safety, tolerability and immune response in over 4,800 people in this age population. Judy Klein, president and founder of Unity Consortium, a non-profit organisation focused on adolescent health and immunisation in the US, welcomed the FDA’s decision: “The consequences of IMD can be devastating for those who contract it, for their families and friends… Pentavalent menABCWY vaccines could help address the disease by providing protection against the five vaccine-preventable serogroups in one vaccine and making it easier for adolescents to get the coverage they need.”