Dysentery

A large Phase 3 trial will evaluate whether the M72/AS01E vaccine candidate can protect adolescents and adults from pulmonary tuberculosis Clinical trial site at University of the Witwatersrand, Johannesburg, South Africa, is first of up to 60 sites in seven countries The M72/AS01E vaccine candidate could be the first new TB vaccine in 100 years if proven effective CAMBRIDGE, Mass., March 19, 2024 /PRNewswire/ -- The Bill & Melinda Gates Medical Research Institute (Gates MRI) today announced that a Phase 3 clinical trial to assess the efficacy of the M72/AS01E tuberculosis (TB) vaccine candidate is now underway, with first doses given in South Africa, where TB takes a heavy toll. If shown to be well-tolerated and effective, M72/AS01E could potentially become the first vaccine to help prevent pulmonary TB in adolescents and adults, the most common form of the disease, and the first new TB vaccine in over a century. Globally, according to the World Health Organization, an estimated 10.6 million people fell ill with TB in 2022 and 1.3 million died — over 3,500 people per day. The disease primarily affects people in low- and middle-income countries, and those at highest risk are often living in poverty, with poor living and working conditions and undernutrition. In South Africa alone, around 280,000 people are diagnosed with TB each year. "The launch of this pivotal Phase 3 trial demonstrates our commitment to harnessing the power of medical innovation to fight diseases like TB that are particularly devastating for low- and middle-income countries," said Emilio A. Emini, Ph.D., CEO of the Gates MRI. "Clinical study of the vaccine will still require years, but our incredible partners in South Africa and elsewhere who have come together for the Phase 3 study share our hope in the vaccine's potential." The Gates MRI, a nonprofit organization and subsidiary of the Bill & Melinda Gates Foundation, is sponsoring the trial, which is supported by funding from the Gates Foundation and Wellcome. The M72/AS01E vaccine candidate has been in development since the early 2000s. It was originally designed and clinically evaluated by the biopharma company GSK up to the proof-of-concept phase (Phase 2b), in partnership with Aeras and the International AIDS Vaccine Initiative (IAVI) and was funded by GSK and in part by the Gates Foundation. In 2020, GSK announced a partnership with the Gates MRI for further development of M72/AS01E. GSK continues to provide technical assistance to the Gates MRI, supplies the adjuvant component of the vaccine for the Phase 3 trial and will provide the adjuvant post licensure should the trial be successful. An adjuvant is an ingredient used in some vaccines that can help create a stronger immune response. Making vaccines accessible and affordable for communities in areas of high disease burden in the long-term is a priority for all trial partners. The Gates MRI has worked with a wide range of stakeholders, including communities around clinical trial sites, to guide the TB candidate vaccine to Phase 3. To this end, the Gates MRI, GSK, Wellcome and the Gates Foundation are working together to understand the potential demand for the vaccine and build an end-to-end plan to ensure long-term sustainable access, should the trial be successful; from supporting research and building an evidence-base for the potential impact of the vaccine and community requirements for uptake, to collaborating with multilateral, regional and country partners required to introduce the vaccine. Additionally, the trial funders are planning to establish an international advisory group comprised of representatives from all these groups to provide input on the overall program. Developing and ensuring access to global health products is a complex task. As such, global collaboration and strong partnerships are a core component of planning for future access to the candidate vaccine. "Reaching Phase 3 with an urgently needed TB vaccine candidate is an important moment for South Africans because it demonstrates that there is a strong local and global commitment to fight a disease that remains distressingly common in our communities," said Dr. Lee Fairlie, Director of Maternal and Child Health at Wits RHI at University of the Witwatersrand, Johannesburg, South Africa, and national principal investigator for the trial in South Africa. "South Africa also has considerable experience with TB- and vaccine-related clinical trials and a strong track record for protecting patient safety and generating high quality data essential for regulatory approvals." At full capacity, the trial will include up to 20,000 participants, including people living with HIV, at up to 60 trial sites in seven countries — South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam. Participants will receive either the investigational M72/AS01E vaccine or a placebo in what is known as a double-blind trial, meaning neither the trial participant nor the clinical investigators will know who receives vaccine or placebo. This approach is considered the gold standard for evaluating the safety and efficacy of an investigational vaccine. "After dedicating over 20 years to developing this essential candidate vaccine, we at GSK are delighted that the Phase 3 trial is underway. Developing and ensuring access to global health products is complex but our collaboration with the Gates MRI, Wellcome and the Gates Foundation exemplifies the transformative power of leveraging diverse partners' expertise to change the trajectory of challenging diseases, like TB, which place a huge burden on communities around the world," said Deborah Waterhouse, CEO, ViiV Healthcare and President, Global Health, GSK. While TB is one of the world's deadliest infectious diseases — and the leading cause of death amongst people living with HIV — the only available TB vaccine, BCG, dates back to 1921. It protects babies and young children against severe forms of TB, but it offers inadequate protection for adolescents and adults against the pulmonary form of the disease, which is primarily responsible for transmission of the TB bacterium. "If effective, M72/AS01E could reinvigorate a global fight against TB that has been weakened by the COVID-19 pandemic," said Alemnew Dagnew, M.D., who leads development of M72/AS01E at the Gates MRI. "I am particularly excited to see this trial get underway because when I was working as a physician in Ethiopia, I saw first-hand what pulmonary TB does to communities — and a vaccine that could help prevent that from happening would be transformative." Dagnew noted that TB is both a health problem and a socioeconomic problem. He said the disease primarily affects people during their prime working years, leaving families without income and children without parents. Almost half of TB-affected households face costs higher than 20% of their household income. "We must continue to move with urgency to develop and equitably deliver innovative tools with the potential to transform the prevention, diagnosis, and treatment of TB. The start of the Gates MRI's M72 TB vaccine candidate Phase 3 clinical trial marks a pivotal moment in the fight to end TB, which devastatingly afflicts the world's most vulnerable communities. We think this trial marks the beginning of a series of opportunities that will usher in the most promising pipeline ever of new TB tools. The Gates Foundation remains committed to supporting local and global partners to accelerate the solutions needed to save lives and reduce suffering from this preventable disease," said Trevor Mundel, President, Global Health, Bill & Melinda Gates Foundation. Alex Pym, Director of Infectious Disease at Wellcome, said: "While it is a long journey to results, the start of this trial in South Africa brings us a critical step closer to having an effective vaccine to protect those most at risk of TB. Global collaboration with regulators, in-country decision makers and communities affected is crucial if those who need it most are to benefit from this vaccine, should the trial be successful." It is anticipated that it will take up to five years to complete the trial, followed by data analysis and then preparation for submission of data to regulatory authorities. In GSK's Phase 2b trial, M72/AS01E provided approximately 50% protection (13/1626 versus 26/1663) against progression to active pulmonary tuberculosis for three years in Mycobacterium tuberculosis-infected HIV-negative adults, which was unprecedented in decades of TB vaccine research. The World Health Organization estimates that over a 25-year time span, that level of protection could save 8.5 million lives, prevent 76 million new TB cases and save $41.5 billion for TB affected households. About the Bill & Melinda Gates Medical Research Institute (Gates MRI) The Bill & Melinda Gates Medical Research Institute is a non-profit medical research organization dedicated to the development and effective use of novel biomedical interventions addressing substantial global health concerns, for which investment incentives are limited, including malaria, tuberculosis, enteric and diarrheal diseases, and diseases that impact maternal, newborn, and child health. For further information please visit . For more information, contact: [email protected] Logo -

Immuron proceeding to Phase 3 registration strategy with the FDA Travelan® topline clinical trial results demonstrate protective efficacy with single daily dose 36.4% protective efficacy against Enterotoxigenic Escherichia coli (ETEC) induced moderate to severe diarrhea was observed in the Travelan® group compared to the placebo group (primary endpoint) 66.7% protective efficacy against ETEC induced severe diarrhea was observed in the Travelan® group compared to the placebo group (secondary endpoint) 83.3% statistically significant reduction in the number of subjects in the Travelan® group requiring early antibiotic treatment post challenge compared to the placebo (secondary endpoint) 100% of the subjects requiring IV fluids post challenge were in the placebo (secondary endpoint) 55.6% reduction in the number of subjects experiencing adverse events associated with the ETEC challenge observed in the Travelan® group compared to the placebo group (secondary endpoint) Phase 2 clinical study data supports the excellent safety and tolerability pro Travelan® MELBOURNE, Australia, March 07, 2024 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce the interim topline results confirming that a single daily dose of Travelan® is effective in prevention of moderate to severe diarrhea following challenge with enterotoxigenic Escherichia coli (ETEC). Immuron was awarded AU $4.8 (USD $3.43) million funding by the U.S. Department of Defense (ASX Announcement 12 January 2022) to perform a randomized double-blind placebo-controlled phase 2 controlled human infection model (CHIM) study to assist with evaluating a dosing regimen that is most suited to deployed US troops visiting developing countries. Healthy volunteers were recruited and randomly assigned to receive a single daily oral dose of 1200 mg of Travelan® or placebo. Dosing commenced 2 days prior to challenge with ETEC strain H10407 and continued for 7 days. ClinicalTrials.gov Identifier: NCT05933525. This interim analysis summarizes the data for a total of 60 subjects who have completed the inpatient challenge component of this current clinical study. Last patients last visits are anticipated to commence in April this year and final clinical study report will be completed in H2 2024. Having demonstrated protective efficacy in two published clinical studies (Otto et al., 2011), this Phase 2 study was designed to compare the preventative effects of once daily dosing to the current standard recommended treatment of three times daily dosing. To learn more about Phase 2 study design, read: U.S. Food and Drug Administration Step 3: Clinical Research IMM-124E (Travelan®) will be the first product developed with Immuron’s platform technology to proceed into Phase 3 clinical trials. The underlying nature of Immuron’s platform technology enables the development of medicines across a large range of infectious diseases. The platform can be used to block viruses or bacteria at mucosal surfaces such as the Gastrointestinal tract and neutralize the toxins they produce. More information on Immuron’s platform technology can be found below. Travelan® demonstrated clinical efficacy in preventing ETEC-attributable diarrhea in two previous CHIM studies (Table 1). These studies showed dosing 400 mg three times daily, resulted in 76.7% (p=0.007) to 90.9% (p=0.0005) protection (Otto et al., 2011). This trial demonstrated protective efficacy* with once daily dosing even though the attack rate for this study was much lower than planned. The intended attack rate (percentage of subjects with ETEC-induced moderate- severe diarrhea) for this study was approximately 70%. The attack rate for the Placebo group of this study was only 37% (Table 2). Given the lower than planned attack rate, this current study is underpowered to appropriately detect a significant difference in moderate to severe ETEC attributed diarrhea in the Placebo group compared to the Treatment group. This makes the demonstration of protective efficacy and reduction in adverse events and diarrheal symptoms particularly noteworthy. The company will now proceed to hold an end of Phase 2 meeting with the U.S Food and Drug Administration to discuss the pivotal Phase 3 registration strategy and planned clinical trials including recommended dosing to support a Biologics License Application (BLA) for Travelan® as a prophylactic medicine for Travelers’ Diarrhea. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the U.S. Military. Immuron is in the process of exploring non-dilutive funding opportunities for these Phase 3 clinical trials. Topline results: Travelan®, a first-in-class, oral antibody therapy, dosed once daily resulted in a reduction ETEC-induced moderate-severe diarrhea compared to placebo. ETEC-induced moderate to severe diarrhea was reduced by 36.4% in the Travelan® group compared to the placebo group Protective efficacy of once daily dosing shown to be approx. 50% as effective as the current recommended three times daily dosing regimen; this is a strong result given the lower than expected attack rate 66.7% protective efficacy against ETEC induced severe diarrhea was observed in the Travelan® group compared to the placebo group Statistically significant reduction of 83.3% in the subjects in the Travelan® group requiring early antibiotic treatment post challenge compared to the placebo For the subjects requiring intravenous rehydration post challenge 100% were in the placebo group and none were in the Travelan® group 55.6% reduction in the number of subjects experiencing adverse events post the ETEC challenge was observed in the Travelan® group compared to the Placebo group Studies using the CHIM for a variety of different enteric pathogens suggest the greatest protection may be against more severe disease and in studies where the disease appears to be predominately mild, which appears to be the case in this study, the efficacy estimates can be lower than anticipated. Table 1: Summary of current clinical study data Event post challenge Travelan® n = 30 n (%) Placebo n = 30 n (%) Reduction in AEs or Symptoms (%) P value Primary Endpoint Number (n) of subjects with ETEC-induced moderate- severe diarrhea 7 (23.3%) 11 (36.7%) NA 0.399 Protective efficacy [%]1 95% 2-sided Confidence Interval2 36.4%* (-79.8%, 79.1%) Secondary Endpoints - Safety and tolerability Number of subjects with an adverse event (AE) 95% 2-sided Confidence Interval2 4 (13.3%) (-3.8%, 37.1%) 9 (30.0%) 55.6% 0.1172 Number of subjects with (AEs) fever, nausea, anorexia, or abdominal pain/cramps rated as moderate to severe 95% 2-sided Confidence Interval2 3 (10.0%) (-5.2%, 31.9%) 7 (23.3%) 57.1% 0.1659 Secondary Endpoints – Degree to which a participant experiences diarrheal symptoms Number of subjects who experienced severe diarrhea 95% 2-sided Confidence Interval2 1 (3.3%) (-5.8%, 19.2%) 3 (10.0%) 66.7% 0.3006 Number of subjects requiring early antibiotic treatment 95% 2-sided Confidence Interval2 1 (3.3%) (1.0%, 32.4%) 6 (20.0%) 83.3% 0.0444 Number of subjects requiring IV fluids 95% 2-sided Confidence Interval2 0 (-0.7%, 20.7%) 3 (10.0%) 100.0% 0.0756 1 Fishers exact test and binomial distribution 2 Chi-square test AE = Adverse event associated with the ETEC challenge * Intent-to-treat analysis set defined as randomized subjects who received study medication and were challenged Table 2: Comparison of clinical study data attack rates Event post challenge Otto3 Study 1 Placebo n = 15 n (%) Otto3 Study 2 Placebo n = 14 n (%) Current Travelan® Study n = 30 n (%) Number (n) of subjects with ETEC-induced moderate- severe diarrhea 11 (73%) 12 (86%) 11 (37%) 3Otto et al., 2011 Immuron is investigating the impact of the lower than expected attack rate. Immuron has filed a provisional patent application with the U.S. Patent Office including results from this trial. This release has been authorized by the directors of Immuron Limited. COMPANY CONTACT: Steven Lydeamore Chief Executive Officer steve@immuron.com About Immuron Immuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases. For more information visit: and Subscribe for Immuron News: Here

-- Company Expects to Announce Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series by the End of the First Quarter of 2025, Followed by Topline Data from Booster Dose by the End of 2025 -- -- VAX-24, a 24-Valent Pneumococcal Conjugate Vaccine (PCV), is Designed to Cover More Serotypes Than Any Infant Pneumococcal Vaccine On-Market or in U.S. Clinics Today -- -- Company’s Potential Best-in-Class, Carrier-Sparing PCV Programs, VAX-24 and VAX-31, Intended to Deliver the Broadest-Spectrum of Coverage Against IPD -- SAN CARLOS, Calif., March 04, 2024 (GLOBE NEWSWIRE) --Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced the completion of enrollment in its Phase 2 study evaluating VAX-24, a broad-spectrum, carrier-sparing 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD), in healthy infants. Vaxcyte expects to announce topline safety, tolerability and immunogenicity data from the Phase 2 study primary three-dose immunization series by the end of the first quarter of 2025, followed by topline data from the booster dose by the end of 2025. “Completing enrollment of the VAX-24 study with more than 800 healthy infants demonstrates yet another significant milestone in the development of our VAX-24 and VAX-31 PCV candidates,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “We believe VAX-24 has a potential best-in-class pro this vital population and is designed to cover more serotypes than any infant pneumococcal vaccine on-market or in U.S. clinics today. We look forward to announcing the expected topline safety, tolerability and immunogenicity data from the primary immunization series by the end of the first quarter of 2025, which will follow participants receiving all three doses in this series, as well as the serology and data analsysis.” “Despite the effectiveness of current vaccines, IPD, which includes meningitis and bacteremia, remains persistent in the first years of life and is a leading cause of invasive disease in children two years of age and under,” said Jim Wassil, Executive Vice President and Chief Operating Officer of Vaxcyte. “Given the significant burden of disease in young children, there remains a need for broader-spectrum vaccines like VAX-24 and VAX-31, our next-generation 31-valent PCV candidate, that are designed to provide greater protection than the current standard-of-care.” About the VAX-24 Infant Phase 2 Study The VAX-24 infant Phase 2 clinical study, which is now fully enrolled with 802 healthy infants, is a randomized, observer-blind, dose-finding two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-24. The Stage 1 portion of the study evaluated the safety and tolerability of a single injection of VAX-24 at three dose levels (low dose/1.1mcg, middle dose/2.2mcg, mixed dose/2.2mcg or 4.4mcg) and compared to VAXNEUVANCE™ (PCV15), which was the broadest-spectrum PCV at the time of study initiation, in 48 infants. The Stage 2 portion is evaluating the safety, tolerability and immunogenicity of VAX-24 at the same three dose levels and compared to Prevnar 20® (PCV20), currently the broadest-spectrum PCV recommended by the Advisory Committee on Immunization Practices (ACIP), in 754 infants. Participants who received VAX-24 in Stage 1 will continue the standard dosing regimen as part of Stage 2 and will be included in the safety, tolerability and immunogenicity analysis of the study. In line with recommendations from the ACIP, the study design includes a primary immunization series consisting of three doses given at two months, four months and six months of age, followed by a subsequent booster dose at 12-15 months of age, in conjunction with the other routinely recommended non-PCV vaccines on the infant immunization schedule. The key prespecified immunogenicity study endpoints include an assessment of immune responses for all three VAX-24 doses and compared to PCV20 on the shared serotypes measured at 30 days post-dose three (PD3) and post-dose four (PD4). Immune responses will be assessed based on anti-pneumococcal polysaccharide serotype-specific immunoglobulin G (IgG) responses (proportion of participants achieving the accepted IgG threshold value of ≥0.35mcg/mL) at 30 days PD3 and IgG geometric mean titer ratios at 30 days PD4, among other immunogenicity endpoints. All participants in the study will be evaluated for safety through six months following the booster dose. The study is being conducted at 32 sites in the United States. Additional information about the study can be found at under the identifier NCT05844423. About Pneumococcal Disease Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae (pneumococcus) bacteria. It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. In the United States, approximately 320,000 people get pneumococcal pneumonia each year, which is estimated to result in approximately 150,000 hospitalizations and 5,000 deaths. Pneumococci also cause over 50% of all cases of bacterial meningitis in the United States. Antibiotics are used to treat PD, but some strains of the bacteria have developed resistance to treatments. The morbidity and mortality due to PD are significant, particularly for young children and older adults, underscoring the need for a more broad-spectrum vaccine. About Vaxcyte’s PCV Franchise Candidates: VAX-24 and VAX-31 Vaxcyte’s carrier-sparing PCV franchise candidates, including VAX-24, a Phase 3-ready 24-valent PCV, and VAX-31, the Company’s next-generation 31-valent PCV currently being evaluated in a Phase 1/2 study, are being studied for the prevention of IPD. The public health community continues to affirm the need for vaccines that offer broader protection to prevent IPD, which can be most serious for infants, young children, older adults and those with immune deficiencies or certain chronic health conditions. Both VAX-24 and VAX-31 are designed to improve upon the standard-of-care PCVs for both children and adults by covering the serotypes that are responsible for a significant portion of IPD in circulation 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 aims to efficiently create and deliver high-fidelity, broad-spectrum carrier-sparing conjugate vaccines in order to add coverage without compromising overall immune responses by using modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform. Vaxcyte is deploying this approach with VAX-24 and VAX-31, the latter of which has the potential to provide the broadest coverage of any PCV to reach the clinic with approximately 95 percent coverage of circulating IPD strains in the U.S. adult population. In January 2023, Vaxcyte announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to VAX-24 for the prevention of IPD in adults based on positive topline results from the Phase 1/2 proof-of-concept study, which evaluated the safety, tolerability and immunogenicity of VAX-24 in adults 18 to 64 years of age. The Breakthrough Therapy designation process is designed to expedite the development and review of drugs and biologics that are intended to treat a serious or life-threatening condition, where preliminary clinical evidence indicates that the drug or biologic may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. 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. Vaxcyte’s lead candidate, VAX-24, is a Phase 3-ready 24-valent, broad-spectrum, carrier-sparing PCV being developed for the prevention of IPD. VAX-31, the Company’s next-generation 31-valent PCV, is the broadest-spectrum PCV candidate in the clinic today. 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 . 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 VAX-24 and VAX-31, including breadth of coverage, the ability to deliver a potentially best-in-class PCV franchise and the improvement upon the standard-of-care; the timing and availability of data for the VAX-24 infant Phase 2 study; the demand for Vaxcyte’s vaccine candidates; the potential benefits and opportunities available as a result of the Breakthrough Therapy designation for VAX-24 in adults; 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 Annual Report on Form 10-K filed with the SEC on February 27, 2024 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: Janet Graesser, Vice President, Corporate Communications and Investor Relations Vaxcyte, Inc. 917-685-8799 media@vaxcyte.com Jennifer Zibuda, Senior Director, Investor Relations Vaxcyte, Inc. 860-729-8902 investors@vaxcyte.com