BioNTech announces first patient dosed in Phase 2 clinical trial of mRNA-based BNT111 in patients with advanced melanoma
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BioNTech SE (NASDAQ: BNTX, "BioNTech" or "the Company"), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). The study is evaluating the Company's therapeutic cancer vaccine candidate BNT111 in combination with Libtayo® (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma.
CureVac provides update on Phase 2b/3 trial of first-generation COVID-19 vaccine candidate, CVnCoV
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CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced results of the second interim analysis of its international pivotal Phase 2b/3 study in approximatively 40,000 subjects (the HERALD study) of CureVac's first-generation COVID-19 vaccine candidate, CVnCoV.
U.S. government purchases additional 200 million doses of Moderna's COVID-19 vaccine
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Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the U.S. government has purchased an additional 200 million doses of Moderna's COVID-19 vaccine, including the option to purchase other COVID-19 vaccine candidates from Moderna's pipeline.
Novavax COVID-19 vaccine demonstrates 90% overall efficacy and 100% protection against moderate and severe disease in PREVENT-19 Phase 3 trial
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Novavax, Inc. (Nasdaq: NVAX), today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial.
Pfizer and BioNTech to provide 500 million doses of COVID-19 vaccine to U.S. government for donation to poorest nations
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Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced plans to provide the U.S. government at a not-for-profit price 500 million doses of the companies' COVID-19 vaccine, 200 million doses in 2021 and 300 million doses in the first half of 2022, to further support the multilateral efforts to address the surge of infection in many parts of the world and to help end the pandemic.
Valneva completes Phase 3 trial recruitment for its inactivated COVID-19 vaccine candidate
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Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced that it has completed recruitment for the pivotal Phase 3 trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
Pfizer and BioNTech receive first authorization in European Union for COVID-19 vaccine in adolescents
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Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the Conditional Marketing Authorization (CMA) for COMIRNATY® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. This follows the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group.
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- Moderna announces emergency use listing granted by the World Health Organization for its COVID-19 vaccine
- Moderna announces additional investments to increase global supply for COVID-19 vaccine to up to 3 billion doses in 2022
- CureVac Swiss AG initiates rolling submission process for mRNA-based COVID-19 vaccine candidate, CVnCoV, with Swissmedic
- Valneva switches focus to bilateral discussions to supply its inactivated, adjuvanted COVID-19 vaccine candidate VLA2001