{"success":true,"data":{"pressRelease":{"id":"118972","rtpr_id":"nGNXbcryXk","ticker":"PFE","exchange":"NYSE","all_tickers":["PFE","VALN","VLS"],"title":"Pfizer and Valneva’s Lyme Disease Vaccine Candidate Marketing Authorization Application Validated by European Medicines Agency","author":"Globe Newswire","published_at":"2026-08-14T05:00:00.417Z","article_body":"* Submission based on favorable efficacy and safety results from Phase 3 VALOR\ntrial\nNEW YORK & LYON, France, August, 14, 2026 Pfizer Inc. (NYSE: PFE) and Valneva\nSE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the European\nMedicines Agency (EMA) has validated the Marketing Authorization Application\n(MAA) for PF-07307405, the companies’ 6-valent outer surface protein A\n(OspA)-based Lyme disease vaccine candidate and will begin its assessment of\nthe application.\n\nThe application is based on encouraging efficacy of more than 70% observed in\nthe Phase 3 VALOR\n(https://www.globenewswire.com/Tracker?data=94NMu-Ed2WJO2C0bL8thnlJhIOVZiX3ychd_AnC4qadVvaZeE4bN0j641mIYwIvERswiJL0fFY-ENd2VeUZkKJFFBe2j7zYzCv3g7Pzq8JF-A5P1Adf-7e8sOfl6uKTsYzbUNGg_eC751rMS1KgF6WPppxx0BM1hqEn46Yqd2SQYnSg3SJ2_QAt6X36YVo_bvmsAY514PiIRX1mir2lEJrPZvZLLpVT47Gfj0JZ5hQg=)\n“Vaccine Against Lyme for Outdoor Recreationists” clinical trial\n(NCT05477524\n(https://www.globenewswire.com/Tracker?data=KnjRNkcdmDo__qTfXe714JNSjcGNn7QNsvvbdZYMLb4cHiaa6bFi3HPymw0Hdbe4Wc-l3JA39tLk4UaMi4ji3AC-R9YT_tI-ucqMH8dQ6kVFvayXivch_HVYBSGn6x0PW99DFbTIGfR4HEeJIO5Ke_6TL50xt8n79bO6WVnmcBgvtjVaKb2Wmh4TdQjFToEzeSlCFCD1HegNdEwr9NMCb-dByAZ8wzOhG68tykLU8tGYWOXhhj3aQ801vo8erUooXBFyaR4NkhTTKFd53x66eC6wrpX8uhryA9nw7qWsibAOmhpb-bv4hHShmW3iTaipBkra44bJX1wOsyifv35gcqxpB3v5etjEqHR-_52Br2w=)),\nwhich investigated whether the vaccine candidate, PF-07307405, prevented Lyme\ndisease cases in individuals aged five years and older. The vaccine was well\ntolerated in the trial, with no safety concerns identified.0F(1)\n\n“I’m proud of the progress we have made with our Lyme disease vaccine\ncandidate and excited about the opportunity to potentially bring the first\nvaccine of its kind to Europe. I look forward to collaborating with the EMA as\nthis vaccine candidate advances through the review cycle,” said Annaliesa\nAnderson, Ph.D., Senior Vice President and Chief Vaccines Officer, Pfizer.\n“Lyme disease remains the most common vector-borne illness in Europe,\naffecting more than 100,000 people each year. When left untreated, it can lead\nto serious and potentially long-lasting complications involving the skin,\njoints, nervous system, and heart. We believe vaccination has the potential to\nprovide an important new layer of protection against this debilitating disease\nand help people continue to enjoy the outdoors with greater confidence.”\n\n“We would like to thank and congratulate our partner Pfizer for the\nsignificant progress achieved towards delivering a potential vaccine solution\nin the fight against Lyme disease. MAA acceptance represents a major\nmilestone, especially considering that more than 200 million people live in\nLyme disease risk areas in Europe,” said Thomas Lingelbach, CEO and Board\nmember of Valneva.\n\nDeveloped in collaboration between Pfizer and Valneva,1F(2)(,)2F(3) the\ninvestigational 6-valent OspA-based Lyme disease vaccine has been evaluated\nfor its efficacy, safety, tolerability, immunogenicity, and manufacturing lot\nconsistency.(4) The companies entered into a collaboration and license\nagreement in April 2020 for the co-development of PF-07307405 and for Pfizer\nto exclusively manufacture and commercialize PF-07307405, assuming regulatory\nsuccess.(2)(,)(3)\n\nAbout Lyme disease vaccine candidate, PF-07307405\nThere are currently no approved human vaccines for Lyme disease. PF-07307405\nis the current Lyme disease vaccine candidate which has advanced the furthest\nalong the clinical development timeline, with two pivotal Phase 3 trials\ncompleted. This investigational multivalent protein subunit vaccine uses an\nestablished mechanism of action for a Lyme disease vaccine that targets the\nouter surface protein A (OspA) of Borrelia burgdorferi, the bacteria that\ncause Lyme disease. When a person is immunized with PF-07307405, their body\ncreates antibodies against six Borrelia OspA serotypes. As the tick feeds on\nthe vaccinated person, these antibodies are ingested by the tick as part of\nits blood meal. Binding of vaccine-induced antibodies to OspA\non Borrelia inside the tick inhibits the bacterium’s ability to leave the\ntick, preventing it from being transmitted to the human host. The vaccine\ncandidate covers the six most prevalent OspA serotypes expressed by\nthe Borrelia burgdorferi sensu lato species in North America and Europe.\n\nAbout VALOR \nThe VALOR trial was a multicenter, placebo-controlled, randomized,\nobserver-blinded trial conducted at sites in areas of high incidence of Lyme\ndisease across the U.S., Canada, and Europe.3F(4) 9,437 trial participants\naged 5 years and older were randomized 1:1 into two trial groups and received\nfour doses of either PF-07307405 or a saline placebo – one dose administered\nat months 0, 2, and 5-9, followed by a fourth dose one year later, shortly\nbefore the start of the following Lyme disease season (season 2).(4)\n\nAbout Lyme Disease\nLyme disease is a systemic infection caused by Borrelia burgdorferi sensu\nlato bacteria that are transmitted to humans by the bite of\ninfected Ixodes ticks.4F(5) It is considered the most common vector-borne\nillness in the Northern Hemisphere.5F(6)(,)6F(7) The U.S. Centers for Disease\nControl and Prevention (CDC) has estimated that approximately 476,000 people\nin the U.S. are diagnosed and treated each year and 132,000 cases are reported\nannually in Europe from countries with surveillance systems.7F(8) Early\nsymptoms of Lyme disease (such as a gradually expanding erythematous rash\ncalled erythema migrans or other nonspecific symptoms like fatigue, fever,\nheadache, mild stiff neck, muscle and joint pains) are often overlooked or\nmisinterpreted. Left untreated, the disease can disseminate and cause more\nserious chronic complications affecting the skin, joints (arthritis), the\nheart (carditis), or the nervous system.(7)(,)8F(9) The medical need for\nvaccination against Lyme disease is steadily increasing as the geographic\nfootprint of the disease widens.9F(10)\n\nAbout Pfizer: Breakthroughs That Change Patients’ Lives \nAt Pfizer, we apply science and our global resources to bring therapies to\npeople that extend and significantly improve their lives. We strive to set the\nstandard for quality, safety and value in the discovery, development, and\nmanufacture of health care products, including innovative medicines and\nvaccines. Every day, Pfizer colleagues work across developed and emerging\nmarkets to advance wellness, prevention, treatments and cures that challenge\nthe most feared diseases of our time. Consistent with our responsibility as\none of the world’s premier innovative biopharmaceutical companies, we\ncollaborate with health care providers, governments and local communities to\nsupport and expand access to reliable, affordable health care around the\nworld. For over 175 years, we have worked to make a difference for all who\nrely on us. We routinely post information that may be important to investors\non our website at www.Pfizer.com. In addition, to learn more, please visit us\non www.Pfizer.com and follow us on X at @Pfizer and @Pfizer\nNews, LinkedIn\n(https://www.globenewswire.com/Tracker?data=YT293xqJ_fXHpKXvYzsaLJVvSlHDA3dM7syGIbejBNFbnlcjH0w-i75LpI4ddJvtR5GfWc3op5DCHQ87Mks2SEDcOMJxaU6ZD1i3Pyz8F5y0LyKS-IxGKy5-1WfNQn3TKVNYBx-TR87PF14ufN1MZJNdKL_REtLP466zwLVLmiPRVbzfdnGEIxRFy-3aUje-47jUCVpq8wE-X1BX1qnKVPKqW5lWMbgtZgfuG_64UObudN_81JxZ3sgea2EMbHnmDDqoLuNN7XF_78CB0ORL9Q-TI0sOzcCJjGP58x2jJJ-eZJj-wVniAVaEkRSRyMJF1vVlel30hzvZfBfyXc4jpQ==), YouTube\n(https://www.globenewswire.com/Tracker?data=x5UN0efaXBx0bf0oLNEaiLgQP3Lzg13MEoG9d18yqMvoXm0NjuRt1D4ePxVfUpB3ZPddPAeEVNmYwEo81POwjNNodTDQPrDjA7I5Urc4Bwr6BXfegmYNn9EBb3qvPMOayDlmTn4oIo-uduRTlxG5zXSdYpMxBpuLzSmVt78NbIjUT9Ivqt7G8bChzQY_Te6lmHPBFJwmpFOENDIr7K2Y4xQ9_aZ0yBWz6pfGkg_izzUJz0KPCYP4R8s7X1_ct2ec7qZGcGc3OGBu5p6_ulKPCo4XrQvZfwX9zulDl4e3vwQauYbkaw71peXIWm2fW-FD) and\nlike us on Facebook at Facebook.com/Pfizer\n(https://www.globenewswire.com/Tracker?data=i9viFz4nHyh3I8l2SAxP8dUjT2GtkyQwVCUe9GhQsVNXeD5PaFLKxMbwpBJq59kG9Z99Q5Q97Mdz5YBiLgMmSmO9AHwpQzRX8yqpfSe223_XtwAWg3vTk0Lr5LqLicxV4HWuCdjUmFKu_aPRUDCwHZSic-NEsbEtgPUIWjaU4uuEkg0-SzxjzVnjUM0fQFvYOkQMaHbT0cXHAuRDZSwvb64I5OyYLZUOqs4ux91e6miVQRWlB0NaDe8GJnRC44T3bcxOON6ZJGrrsk56hldlju7SmNL1a8K3SMK8aS7g7ey5TheFszMmyQYOXNywG_W73wPJOUgugQD4DI6sqYiOnif0XUIk4J1UkxRz9Zdg430=).\n\nAbout Valneva SE\nWe are a specialty vaccine company that develops, manufactures, and\ncommercializes prophylactic vaccines for infectious diseases addressing unmet\nmedical needs. We take a highly specialized and targeted approach, applying\nour deep expertise across multiple vaccine modalities, focused on providing\neither first-, best- or only-in-class vaccine solutions.\nWe have a strong track record, having advanced multiple vaccines from early\nR&D to approvals, and currently market three proprietary travel vaccines.\nRevenues from our growing commercial business help fuel the continued\nadvancement of our vaccine pipeline. This includes the only Lyme disease\nvaccine candidate in advanced clinical development, which is partnered with\nPfizer, the world’s most clinically advanced Shigella vaccine candidate, as\nwell as vaccine candidates against other global public health threats. More\ninformation is available at www.valneva.com.\n\nPfizer Disclosure Notice \nThe information contained in this release is as of August 14, 2026. Pfizer\nassumes no obligation to update forward-looking statements contained in this\nrelease as the result of new information or future events or developments.\n\nThis release contains forward-looking information about an investigational\nLyme disease vaccine candidate, PF-07307405, and a collaboration between\nPfizer and Valneva for PF-07307405, including their potential benefits, the\nresults of the Phase 3 VALOR clinical trial and a Marketing Authorization\nApplication (MAA) for PF-07307405 pending with the European Medicines Agency ,\nthat involves substantial risks and uncertainties that could cause actual\nresults to differ materially from those expressed or implied by such\nstatements. Risks and uncertainties include, among other things, the\nuncertainties inherent in research and development, including the ability to\nmeet anticipated clinical endpoints, commencement and/or completion dates for\nour clinical trials, regulatory submission dates, regulatory approval dates\nand/or launch dates, as well as the possibility of unfavorable new clinical\ndata and further analyses of existing clinical data, as well as uncertainties\nregarding the future of the Lyme disease vaccine program; the risk that\nclinical trial data are subject to differing interpretations and assessments\nby regulatory authorities; whether regulatory authorities will be satisfied\nwith the design of and results from our clinical studies; whether and when\napplications may be filed in any other jurisdictions for PF-07307405; whether\nand when the MAA or any such other applications that may be filed may be\napproved by regulatory authorities, which will depend on myriad factors,\nincluding making a determination as to whether the product’s benefits\noutweigh its known risks and determination of the product’s efficacy and, if\napproved, whether PF-07307405 will be commercially successful; decisions by\nregulatory authorities impacting labeling, manufacturing processes, safety\nand/or other matters that could affect the availability or commercial\npotential of PF-07307405; uncertainties regarding the ability to obtain or\nmaintain recommendations from vaccine advisory or technical committees and\nother public health authorities and uncertainties regarding the commercial\nimpact of any such recommendations; risks and uncertainties related to changes\nto vaccine or other healthcare policy in the U.S. or elsewhere; challenges\nrelated to public vaccine confidence or awareness; whether our collaboration\nwith Valneva will be successful; risks and uncertainties related to issued or\nfuture executive orders or other new, or changes in, laws or regulations;\nuncertainties regarding the impact of COVID-19 on Pfizer’s business,\noperations and financial results; and competitive developments.\n\nA further description of risks and uncertainties can be found in Pfizer’s\nAnnual Report on Form 10-K for the fiscal year ended December 31, 2025 and in\nits subsequent reports on Form 10-Q, including in the sections thereof\ncaptioned “Risk Factors” and “Forward-Looking Information and Factors\nThat May Affect Future Results”, as well as in its subsequent reports on\nForm 8-K, all of which are filed with the U.S. Securities and Exchange\nCommission and available at www.sec.gov and www.pfizer.com.\n\nValneva Forward-Looking Statements\nThis press release contains certain forward-looking statements relating to the\nbusiness of Valneva, including with respect to the initiation, progress,\nresults, and timing of regulatory review of vaccine candidates. In addition,\neven if the actual results or development of Valneva are consistent with the\nforward-looking statements contained in this press release, those results or\ndevelopments of Valneva may not be sustained in the future. In some cases, you\ncan identify forward-looking statements by words such as “could,”\n“should,” “may,” “expects,” “anticipates,” “believes,”\n“intends,” “estimates,” “aims,” “targets,” or similar words.\nThese forward-looking statements are based largely on the current expectations\nof Valneva as of the date of this press release and are subject to a number of\nknown and unknown risks and uncertainties and other factors that may cause\nactual results, performance or achievements to be materially different from\nany future results, performance or achievement expressed or implied by these\nforward-looking statements. In particular, the expectations of Valneva could\nbe affected by, among other things, uncertainties and delays involved in the\ndevelopment and manufacture of vaccines, unexpected clinical trial results,\nunexpected regulatory actions or delays, competition in general, currency\nfluctuations, the impact of the global and European credit crisis, and the\nability to obtain or maintain patent or other proprietary intellectual\nproperty protection. Success in preclinical studies or earlier clinical trials\nmay not be indicative of results in future clinical trials. In light of these\nrisks and uncertainties, there can be no assurance that the forward-looking\nstatements made in this press release will in fact be realized. Valneva is\nproviding this information as of the date of this press release and disclaims\nany intention or obligation to publicly update or revise any forward-looking\nstatements, whether as a result of new information, future events, or\notherwise.\n\nPfizer Media Contacts: \nPfizerMediaRelations@Pfizer.com\n\nPfizer Investor Relations: \nIR@pfizer.com\n\nValneva Media Contacts: \n+33 (0)6 4516 7099 \nCommunications@valneva.com\n\nValneva Investor Relations: \n+1 917 815 4520 \ninvestors@valneva.com\n\n# # #\n\n(1) Pfizer and Valneva Announce Lyme Disease Vaccine Candidate Demonstrates\nStrong Efficacy in Phase 3 VALOR Trial. Pfizer. March 23, 2026. Accessed July\n2026. Available from:\nhttps://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-valneva-announce-lyme-disease-vaccine-candidate.\n(2) Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize\nLyme Disease Vaccine, VLA15. April 2020. Accessed July 2026. Available\nfrom: https://www.pfizer.com/news/press-release/press-release-detail/valneva_and_pfizer_announce_collaboration_to_co_develop_and_commercialize_lyme_disease_vaccine_vla15.\n(3) Valneva and Pfizer Enter into Equity Subscription Agreement and Update\nTerms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15.\nJune 20, 2022. Accessed July 2026. Available\nat: https://www.pfizer.com/news/press-release/press-release-detail/valneva-and-pfizer-enter-equity-subscription-agreement-and.\n(4) ClinicalTrials.gov. An Efficacy, Safety, Tolerability, Immunogenicity, and\nLot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine\n(VLA15) (VALOR). Last Updated June 2026. Accessed August 2026. Available from:\nhttps://www.clinicaltrials.gov/ct2/show/NCT05477524.\n(5) Stanek G, Wormser GP, Gray J, Strle F. Lyme borreliosis. Lancet.\n2012;379(9814):461-473. doi:10.1016/S0140-6736(11)60103-7.\n(6) Burn L, Tran TMP, Pilz A, et al. Incidence of Lyme borreliosis in Europe\nfrom national surveillance systems (2005–2020). Vector Borne Zoonotic Dis.\n2023;23(4):156‑171. doi:10.1089/vbz.2022.0071\n(7) Kugeler KJ, Schwartz AM, Delorey MJ, et al. Estimating the frequency of\nLyme disease diagnoses, United States, 2010-2018. Emerg Infect Dis.\n2021;27(2):616-619. doi:10.3201/eid2702.202731\n(8) Centers for Disease Control and Prevention. Signs and Symptoms of\nUntreated Lyme Disease. Updated May 15, 2024. Accessed July 2026. Available\nfrom: https://www.cdc.gov/lyme/signs-symptoms/index.html.\n(9) Steere AC, Strle F, Wormser GP, et al. Lyme borreliosis. Nat Rev Dis\nPrimers. 2016;2:16090. doi:10.1038/nrdp.2016.90.\n(10) Centers for Disease Control and Prevention. Press Kit: Understanding Lyme\nand Other Tickborne Diseases. Updated June 26, 2024. Accessed July 2026.\nAvailable from\nhttps://www.cdc.gov/ticks/communication-resources/press-kit.html.\n\nAttachment\n*     FINAL Lyme EMA Technical Validation Press Release_8.13.26_EN\n(https://ml-eu.globenewswire.com/Resource/Download/a7d8b8b1-cec2-496d-b403-c131c02c558e)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/04f398df-96ac-4b7a-8544-2a2ce2495778)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXbcryXk","title":"Pfizer and Valneva’s Lyme Disease Vaccine Candidate Marketing Authorization Application Validated by European Medicines Agency","author":"Globe Newswire","ticker":"PFE","created":"2026-08-14T05:00:00.417Z","tickers":["PFE","VALN","VLS"],"exchange":"NYSE","article_body":"* Submission based on favorable efficacy and safety results from Phase 3 VALOR\ntrial\nNEW YORK & LYON, France, August, 14, 2026 Pfizer Inc. (NYSE: PFE) and Valneva\nSE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the European\nMedicines Agency (EMA) has validated the Marketing Authorization Application\n(MAA) for PF-07307405, the companies’ 6-valent outer surface protein A\n(OspA)-based Lyme disease vaccine candidate and will begin its assessment of\nthe application.\n\nThe application is based on encouraging efficacy of more than 70% observed in\nthe Phase 3 VALOR\n(https://www.globenewswire.com/Tracker?data=94NMu-Ed2WJO2C0bL8thnlJhIOVZiX3ychd_AnC4qadVvaZeE4bN0j641mIYwIvERswiJL0fFY-ENd2VeUZkKJFFBe2j7zYzCv3g7Pzq8JF-A5P1Adf-7e8sOfl6uKTsYzbUNGg_eC751rMS1KgF6WPppxx0BM1hqEn46Yqd2SQYnSg3SJ2_QAt6X36YVo_bvmsAY514PiIRX1mir2lEJrPZvZLLpVT47Gfj0JZ5hQg=)\n“Vaccine Against Lyme for Outdoor Recreationists” clinical trial\n(NCT05477524\n(https://www.globenewswire.com/Tracker?data=KnjRNkcdmDo__qTfXe714JNSjcGNn7QNsvvbdZYMLb4cHiaa6bFi3HPymw0Hdbe4Wc-l3JA39tLk4UaMi4ji3AC-R9YT_tI-ucqMH8dQ6kVFvayXivch_HVYBSGn6x0PW99DFbTIGfR4HEeJIO5Ke_6TL50xt8n79bO6WVnmcBgvtjVaKb2Wmh4TdQjFToEzeSlCFCD1HegNdEwr9NMCb-dByAZ8wzOhG68tykLU8tGYWOXhhj3aQ801vo8erUooXBFyaR4NkhTTKFd53x66eC6wrpX8uhryA9nw7qWsibAOmhpb-bv4hHShmW3iTaipBkra44bJX1wOsyifv35gcqxpB3v5etjEqHR-_52Br2w=)),\nwhich investigated whether the vaccine candidate, PF-07307405, prevented Lyme\ndisease cases in individuals aged five years and older. The vaccine was well\ntolerated in the trial, with no safety concerns identified.0F(1)\n\n“I’m proud of the progress we have made with our Lyme disease vaccine\ncandidate and excited about the opportunity to potentially bring the first\nvaccine of its kind to Europe. I look forward to collaborating with the EMA as\nthis vaccine candidate advances through the review cycle,” said Annaliesa\nAnderson, Ph.D., Senior Vice President and Chief Vaccines Officer, Pfizer.\n“Lyme disease remains the most common vector-borne illness in Europe,\naffecting more than 100,000 people each year. When left untreated, it can lead\nto serious and potentially long-lasting complications involving the skin,\njoints, nervous system, and heart. We believe vaccination has the potential to\nprovide an important new layer of protection against this debilitating disease\nand help people continue to enjoy the outdoors with greater confidence.”\n\n“We would like to thank and congratulate our partner Pfizer for the\nsignificant progress achieved towards delivering a potential vaccine solution\nin the fight against Lyme disease. MAA acceptance represents a major\nmilestone, especially considering that more than 200 million people live in\nLyme disease risk areas in Europe,” said Thomas Lingelbach, CEO and Board\nmember of Valneva.\n\nDeveloped in collaboration between Pfizer and Valneva,1F(2)(,)2F(3) the\ninvestigational 6-valent OspA-based Lyme disease vaccine has been evaluated\nfor its efficacy, safety, tolerability, immunogenicity, and manufacturing lot\nconsistency.(4) The companies entered into a collaboration and license\nagreement in April 2020 for the co-development of PF-07307405 and for Pfizer\nto exclusively manufacture and commercialize PF-07307405, assuming regulatory\nsuccess.(2)(,)(3)\n\nAbout Lyme disease vaccine candidate, PF-07307405\nThere are currently no approved human vaccines for Lyme disease. PF-07307405\nis the current Lyme disease vaccine candidate which has advanced the furthest\nalong the clinical development timeline, with two pivotal Phase 3 trials\ncompleted. This investigational multivalent protein subunit vaccine uses an\nestablished mechanism of action for a Lyme disease vaccine that targets the\nouter surface protein A (OspA) of Borrelia burgdorferi, the bacteria that\ncause Lyme disease. When a person is immunized with PF-07307405, their body\ncreates antibodies against six Borrelia OspA serotypes. As the tick feeds on\nthe vaccinated person, these antibodies are ingested by the tick as part of\nits blood meal. Binding of vaccine-induced antibodies to OspA\non Borrelia inside the tick inhibits the bacterium’s ability to leave the\ntick, preventing it from being transmitted to the human host. The vaccine\ncandidate covers the six most prevalent OspA serotypes expressed by\nthe Borrelia burgdorferi sensu lato species in North America and Europe.\n\nAbout VALOR \nThe VALOR trial was a multicenter, placebo-controlled, randomized,\nobserver-blinded trial conducted at sites in areas of high incidence of Lyme\ndisease across the U.S., Canada, and Europe.3F(4) 9,437 trial participants\naged 5 years and older were randomized 1:1 into two trial groups and received\nfour doses of either PF-07307405 or a saline placebo – one dose administered\nat months 0, 2, and 5-9, followed by a fourth dose one year later, shortly\nbefore the start of the following Lyme disease season (season 2).(4)\n\nAbout Lyme Disease\nLyme disease is a systemic infection caused by Borrelia burgdorferi sensu\nlato bacteria that are transmitted to humans by the bite of\ninfected Ixodes ticks.4F(5) It is considered the most common vector-borne\nillness in the Northern Hemisphere.5F(6)(,)6F(7) The U.S. Centers for Disease\nControl and Prevention (CDC) has estimated that approximately 476,000 people\nin the U.S. are diagnosed and treated each year and 132,000 cases are reported\nannually in Europe from countries with surveillance systems.7F(8) Early\nsymptoms of Lyme disease (such as a gradually expanding erythematous rash\ncalled erythema migrans or other nonspecific symptoms like fatigue, fever,\nheadache, mild stiff neck, muscle and joint pains) are often overlooked or\nmisinterpreted. Left untreated, the disease can disseminate and cause more\nserious chronic complications affecting the skin, joints (arthritis), the\nheart (carditis), or the nervous system.(7)(,)8F(9) The medical need for\nvaccination against Lyme disease is steadily increasing as the geographic\nfootprint of the disease widens.9F(10)\n\nAbout Pfizer: Breakthroughs That Change Patients’ Lives \nAt Pfizer, we apply science and our global resources to bring therapies to\npeople that extend and significantly improve their lives. We strive to set the\nstandard for quality, safety and value in the discovery, development, and\nmanufacture of health care products, including innovative medicines and\nvaccines. Every day, Pfizer colleagues work across developed and emerging\nmarkets to advance wellness, prevention, treatments and cures that challenge\nthe most feared diseases of our time. Consistent with our responsibility as\none of the world’s premier innovative biopharmaceutical companies, we\ncollaborate with health care providers, governments and local communities to\nsupport and expand access to reliable, affordable health care around the\nworld. For over 175 years, we have worked to make a difference for all who\nrely on us. We routinely post information that may be important to investors\non our website at www.Pfizer.com. In addition, to learn more, please visit us\non www.Pfizer.com and follow us on X at @Pfizer and @Pfizer\nNews, LinkedIn\n(https://www.globenewswire.com/Tracker?data=YT293xqJ_fXHpKXvYzsaLJVvSlHDA3dM7syGIbejBNFbnlcjH0w-i75LpI4ddJvtR5GfWc3op5DCHQ87Mks2SEDcOMJxaU6ZD1i3Pyz8F5y0LyKS-IxGKy5-1WfNQn3TKVNYBx-TR87PF14ufN1MZJNdKL_REtLP466zwLVLmiPRVbzfdnGEIxRFy-3aUje-47jUCVpq8wE-X1BX1qnKVPKqW5lWMbgtZgfuG_64UObudN_81JxZ3sgea2EMbHnmDDqoLuNN7XF_78CB0ORL9Q-TI0sOzcCJjGP58x2jJJ-eZJj-wVniAVaEkRSRyMJF1vVlel30hzvZfBfyXc4jpQ==), YouTube\n(https://www.globenewswire.com/Tracker?data=x5UN0efaXBx0bf0oLNEaiLgQP3Lzg13MEoG9d18yqMvoXm0NjuRt1D4ePxVfUpB3ZPddPAeEVNmYwEo81POwjNNodTDQPrDjA7I5Urc4Bwr6BXfegmYNn9EBb3qvPMOayDlmTn4oIo-uduRTlxG5zXSdYpMxBpuLzSmVt78NbIjUT9Ivqt7G8bChzQY_Te6lmHPBFJwmpFOENDIr7K2Y4xQ9_aZ0yBWz6pfGkg_izzUJz0KPCYP4R8s7X1_ct2ec7qZGcGc3OGBu5p6_ulKPCo4XrQvZfwX9zulDl4e3vwQauYbkaw71peXIWm2fW-FD) and\nlike us on Facebook at Facebook.com/Pfizer\n(https://www.globenewswire.com/Tracker?data=i9viFz4nHyh3I8l2SAxP8dUjT2GtkyQwVCUe9GhQsVNXeD5PaFLKxMbwpBJq59kG9Z99Q5Q97Mdz5YBiLgMmSmO9AHwpQzRX8yqpfSe223_XtwAWg3vTk0Lr5LqLicxV4HWuCdjUmFKu_aPRUDCwHZSic-NEsbEtgPUIWjaU4uuEkg0-SzxjzVnjUM0fQFvYOkQMaHbT0cXHAuRDZSwvb64I5OyYLZUOqs4ux91e6miVQRWlB0NaDe8GJnRC44T3bcxOON6ZJGrrsk56hldlju7SmNL1a8K3SMK8aS7g7ey5TheFszMmyQYOXNywG_W73wPJOUgugQD4DI6sqYiOnif0XUIk4J1UkxRz9Zdg430=).\n\nAbout Valneva SE\nWe are a specialty vaccine company that develops, manufactures, and\ncommercializes prophylactic vaccines for infectious diseases addressing unmet\nmedical needs. We take a highly specialized and targeted approach, applying\nour deep expertise across multiple vaccine modalities, focused on providing\neither first-, best- or only-in-class vaccine solutions.\nWe have a strong track record, having advanced multiple vaccines from early\nR&D to approvals, and currently market three proprietary travel vaccines.\nRevenues from our growing commercial business help fuel the continued\nadvancement of our vaccine pipeline. This includes the only Lyme disease\nvaccine candidate in advanced clinical development, which is partnered with\nPfizer, the world’s most clinically advanced Shigella vaccine candidate, as\nwell as vaccine candidates against other global public health threats. More\ninformation is available at www.valneva.com.\n\nPfizer Disclosure Notice \nThe information contained in this release is as of August 14, 2026. Pfizer\nassumes no obligation to update forward-looking statements contained in this\nrelease as the result of new information or future events or developments.\n\nThis release contains forward-looking information about an investigational\nLyme disease vaccine candidate, PF-07307405, and a collaboration between\nPfizer and Valneva for PF-07307405, including their potential benefits, the\nresults of the Phase 3 VALOR clinical trial and a Marketing Authorization\nApplication (MAA) for PF-07307405 pending with the European Medicines Agency ,\nthat involves substantial risks and uncertainties that could cause actual\nresults to differ materially from those expressed or implied by such\nstatements. Risks and uncertainties include, among other things, the\nuncertainties inherent in research and development, including the ability to\nmeet anticipated clinical endpoints, commencement and/or completion dates for\nour clinical trials, regulatory submission dates, regulatory approval dates\nand/or launch dates, as well as the possibility of unfavorable new clinical\ndata and further analyses of existing clinical data, as well as uncertainties\nregarding the future of the Lyme disease vaccine program; the risk that\nclinical trial data are subject to differing interpretations and assessments\nby regulatory authorities; whether regulatory authorities will be satisfied\nwith the design of and results from our clinical studies; whether and when\napplications may be filed in any other jurisdictions for PF-07307405; whether\nand when the MAA or any such other applications that may be filed may be\napproved by regulatory authorities, which will depend on myriad factors,\nincluding making a determination as to whether the product’s benefits\noutweigh its known risks and determination of the product’s efficacy and, if\napproved, whether PF-07307405 will be commercially successful; decisions by\nregulatory authorities impacting labeling, manufacturing processes, safety\nand/or other matters that could affect the availability or commercial\npotential of PF-07307405; uncertainties regarding the ability to obtain or\nmaintain recommendations from vaccine advisory or technical committees and\nother public health authorities and uncertainties regarding the commercial\nimpact of any such recommendations; risks and uncertainties related to changes\nto vaccine or other healthcare policy in the U.S. or elsewhere; challenges\nrelated to public vaccine confidence or awareness; whether our collaboration\nwith Valneva will be successful; risks and uncertainties related to issued or\nfuture executive orders or other new, or changes in, laws or regulations;\nuncertainties regarding the impact of COVID-19 on Pfizer’s business,\noperations and financial results; and competitive developments.\n\nA further description of risks and uncertainties can be found in Pfizer’s\nAnnual Report on Form 10-K for the fiscal year ended December 31, 2025 and in\nits subsequent reports on Form 10-Q, including in the sections thereof\ncaptioned “Risk Factors” and “Forward-Looking Information and Factors\nThat May Affect Future Results”, as well as in its subsequent reports on\nForm 8-K, all of which are filed with the U.S. Securities and Exchange\nCommission and available at www.sec.gov and www.pfizer.com.\n\nValneva Forward-Looking Statements\nThis press release contains certain forward-looking statements relating to the\nbusiness of Valneva, including with respect to the initiation, progress,\nresults, and timing of regulatory review of vaccine candidates. In addition,\neven if the actual results or development of Valneva are consistent with the\nforward-looking statements contained in this press release, those results or\ndevelopments of Valneva may not be sustained in the future. In some cases, you\ncan identify forward-looking statements by words such as “could,”\n“should,” “may,” “expects,” “anticipates,” “believes,”\n“intends,” “estimates,” “aims,” “targets,” or similar words.\nThese forward-looking statements are based largely on the current expectations\nof Valneva as of the date of this press release and are subject to a number of\nknown and unknown risks and uncertainties and other factors that may cause\nactual results, performance or achievements to be materially different from\nany future results, performance or achievement expressed or implied by these\nforward-looking statements. In particular, the expectations of Valneva could\nbe affected by, among other things, uncertainties and delays involved in the\ndevelopment and manufacture of vaccines, unexpected clinical trial results,\nunexpected regulatory actions or delays, competition in general, currency\nfluctuations, the impact of the global and European credit crisis, and the\nability to obtain or maintain patent or other proprietary intellectual\nproperty protection. Success in preclinical studies or earlier clinical trials\nmay not be indicative of results in future clinical trials. In light of these\nrisks and uncertainties, there can be no assurance that the forward-looking\nstatements made in this press release will in fact be realized. Valneva is\nproviding this information as of the date of this press release and disclaims\nany intention or obligation to publicly update or revise any forward-looking\nstatements, whether as a result of new information, future events, or\notherwise.\n\nPfizer Media Contacts: \nPfizerMediaRelations@Pfizer.com\n\nPfizer Investor Relations: \nIR@pfizer.com\n\nValneva Media Contacts: \n+33 (0)6 4516 7099 \nCommunications@valneva.com\n\nValneva Investor Relations: \n+1 917 815 4520 \ninvestors@valneva.com\n\n# # #\n\n(1) Pfizer and Valneva Announce Lyme Disease Vaccine Candidate Demonstrates\nStrong Efficacy in Phase 3 VALOR Trial. Pfizer. March 23, 2026. Accessed July\n2026. Available from:\nhttps://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-valneva-announce-lyme-disease-vaccine-candidate.\n(2) Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize\nLyme Disease Vaccine, VLA15. April 2020. Accessed July 2026. Available\nfrom: https://www.pfizer.com/news/press-release/press-release-detail/valneva_and_pfizer_announce_collaboration_to_co_develop_and_commercialize_lyme_disease_vaccine_vla15.\n(3) Valneva and Pfizer Enter into Equity Subscription Agreement and Update\nTerms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15.\nJune 20, 2022. Accessed July 2026. Available\nat: https://www.pfizer.com/news/press-release/press-release-detail/valneva-and-pfizer-enter-equity-subscription-agreement-and.\n(4) ClinicalTrials.gov. An Efficacy, Safety, Tolerability, Immunogenicity, and\nLot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine\n(VLA15) (VALOR). Last Updated June 2026. Accessed August 2026. Available from:\nhttps://www.clinicaltrials.gov/ct2/show/NCT05477524.\n(5) Stanek G, Wormser GP, Gray J, Strle F. Lyme borreliosis. Lancet.\n2012;379(9814):461-473. doi:10.1016/S0140-6736(11)60103-7.\n(6) Burn L, Tran TMP, Pilz A, et al. Incidence of Lyme borreliosis in Europe\nfrom national surveillance systems (2005–2020). Vector Borne Zoonotic Dis.\n2023;23(4):156‑171. doi:10.1089/vbz.2022.0071\n(7) Kugeler KJ, Schwartz AM, Delorey MJ, et al. Estimating the frequency of\nLyme disease diagnoses, United States, 2010-2018. Emerg Infect Dis.\n2021;27(2):616-619. doi:10.3201/eid2702.202731\n(8) Centers for Disease Control and Prevention. Signs and Symptoms of\nUntreated Lyme Disease. Updated May 15, 2024. Accessed July 2026. Available\nfrom: https://www.cdc.gov/lyme/signs-symptoms/index.html.\n(9) Steere AC, Strle F, Wormser GP, et al. Lyme borreliosis. Nat Rev Dis\nPrimers. 2016;2:16090. doi:10.1038/nrdp.2016.90.\n(10) Centers for Disease Control and Prevention. Press Kit: Understanding Lyme\nand Other Tickborne Diseases. Updated June 26, 2024. Accessed July 2026.\nAvailable from\nhttps://www.cdc.gov/ticks/communication-resources/press-kit.html.\n\nAttachment\n*     FINAL Lyme EMA Technical Validation Press Release_8.13.26_EN\n(https://ml-eu.globenewswire.com/Resource/Download/a7d8b8b1-cec2-496d-b403-c131c02c558e)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/04f398df-96ac-4b7a-8544-2a2ce2495778)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-08-14T05:00:00.478887227Z","server_sent_at_ms":1786683600478},"received_at":"2026-08-14T05:00:00.649Z","source_url":null},"analysis":{"id":"107959","press_release_id":"118972","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":[],"eventType":"regulatory","narrative":"Pfizer and Valneva announced that the European Medicines Agency has validated the Marketing Authorization Application for PF-07307405, their co-developed Lyme disease vaccine candidate.\n\nThe application is supported by Phase 3 VALOR trial data showing more than 70% efficacy in preventing Lyme disease across 9,437 participants aged five and older.\n\nEMA validation confirms the application's completeness and initiates the formal review process, advancing the potential for the vaccine's commercialization in Europe.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"EMA validation marks procedural step forward for Lyme disease vaccine candidate."},"keyFigures":{"drugName":"PF-07307405","phaseOfTrial":"Phase 3","customDimensions":{"efficacy":">70%","trial_participants":9437,"annual_lyme_cases_europe":">100,000","lyme_risk_population_europe":"200 million"}},"quotedText":"I’m proud of the progress we have made with our Lyme disease vaccine candidate and excited about the opportunity to potentially bring the first vaccine of its kind to Europe.","namedEntities":{"people":[{"name":"Annaliesa Anderson","role":"Senior Vice President and Chief Vaccines Officer"},{"name":"Thomas Lingelbach","role":"CEO and Board member"}],"products":["PF-07307405"],"companies":[{"name":"Pfizer Inc.","ticker":"PFE"},{"name":"Valneva SE","ticker":"VALN","relationship":"partner"},{"name":"European Medicines Agency","relationship":"regulatory body"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"EMA validation of the MAA is a standard procedural milestone rather than a binary approval outcome; while it advances the pipeline, it is an incremental step for a mega-cap pharmaceutical company."},"tickerRelevance":{"others":[{"ticker":"VALN","relevance":"partner"}],"primary":"PFE"},"globalImportance":15,"audienceRelevance":35,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"mega-cap","eventGravity":"regulatory_milestone","sectorWeight":"health_care","householdBrandBoost":true}},"event_type":"regulatory","event_type_secondary":["clinical_trial"],"sentiment":"bullish","material_impact_score":2,"narrative":"Pfizer and Valneva announced that the European Medicines Agency has validated the Marketing Authorization Application for PF-07307405, their co-developed Lyme disease vaccine candidate.\n\nThe application is supported by Phase 3 VALOR trial data showing more than 70% efficacy in preventing Lyme disease across 9,437 participants aged five and older.\n\nEMA validation confirms the application's completeness and initiates the formal review process, advancing the potential for the vaccine's commercialization in Europe.","key_figures":{"drugName":"PF-07307405","phaseOfTrial":"Phase 3","customDimensions":{"efficacy":">70%","trial_participants":9437,"annual_lyme_cases_europe":">100,000","lyme_risk_population_europe":"200 million"}},"named_entities":{"people":[{"name":"Annaliesa Anderson","role":"Senior Vice President and Chief Vaccines Officer"},{"name":"Thomas Lingelbach","role":"CEO and Board member"}],"products":["PF-07307405"],"companies":[{"name":"Pfizer Inc.","ticker":"PFE"},{"name":"Valneva SE","ticker":"VALN","relationship":"partner"},{"name":"European Medicines Agency","relationship":"regulatory body"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-14T05:02:22.765Z","global_importance":15,"audience_relevance":35,"importance_components":{"tickerTier":"mega-cap","eventGravity":"regulatory_milestone","sectorWeight":"health_care","householdBrandBoost":true}},"durationMs":142106,"modelName":"glm-4.7"}}