Pfizer and BioNTech announced positive early data from clinical trial of Omicron BA.4/BA.5-adapted bivalent booster
On Oct. 13, 2022, Pfizer and BioNTech announced early data from a Phase 2/3 clinical trial (NCT05472038) evaluating…
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Biotechnology | CDC | COVID-19 | FDA
Pfizer and BioNTech received U.S. FDA EUA for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in children
On Oct. 12, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration granted Emergency Use…
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Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster received Health Canada authorization for individuals 12 years of age and older
On Oct. 7, 2022, Pfizer and BioNTech announced that Health Canada had authorized COMIRNATY Original & Omicron BA.4/BA.5…
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Pfizer and BioNTech completed submission to EMA for Omicron BA.4/BA.5-adapted bivalent vaccinebBooster in children 5 through 11 years of age
On Sept. 28, 2022, Pfizer and BioNTech announced they had completed a submission to the European Medicines Agency…
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Biotechnology | COVID-19 | FDA
Pfizer and BioNTech submitted application to U.S. FDA for EUA of Omicron BA.4/BA.5-adapted bivalent vaccine booster in children 5 through 11 years of age
On Sept. 28, 2022, Pfizer and BioNTech announced they have completed a submission to the U.S. Food and…
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Pfizer and BioNTech completed submission to EMA for Omicron BA.4/BA.5 adapted bivalent vaccine
On Aug. 26, 2022, Pfizer and BioNTech announced they had completed a submission to the European Medicines Agency…
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Pfizer and BioNTech announced updated COVID-19 vaccine data supporting efficacy in children 6 months through 4 years of age
On Aug. 23, 2022, Pfizer and BioNTech announced updated efficacy results from a Phase 2/3 trial evaluating a…
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Pfizer and BioNTech announced clinical trial of next-generation vaccine candidate based on enhanced spike protein design
On Jul. 27, 2022, Pfizer and BioNTech announced that the companies had initiated a randomized, active-controlled, observer-blind, Phase…
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Pfizer and BioNTech submitted a variation to EMA for vaccination of children ages 6 months to less than 5 Years with COMIRNATY
On Jul. 8, 2022, Pfizer and BioNTech announced that the companies had submitted a variation to the European…
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Pfizer and BioNTech announced agreement with U.S. Government to provide additional doses of COVID-19 Vaccine
On Jun. 30, 2022, Pfizer and BioNTech announced a vaccine supply agreement with the U.S. government to support…
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Pfizer and BioNTech announced Omicron-adapted COVID-19 vaccine candidates demonstrated high immune response
On Jun. 24 2022, Pfizer and BioNTech announced positive data evaluating the safety, tolerability, and immunogenicity of two…
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BioNTech started construction of first mRNA vaccine manufacturing facility in Africa
On Jun. 23, 2022, BioNTech announced it had reached a milestone in the establishment of scalable mRNA vaccine…
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Pfizer and BioNTech provided update on rolling submission to EMA for potential variant-adapted vaccine
On Jun. 15, 2022, Pfizer and BioNTech announced the European Medicines Agency (EMA) had initiated a rolling review…
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Pfizer-BioNTech COVID-19 vaccine demonstrated strong immune response in children 6 months to under 5 years of age following third dose
On May 25, 2022, Pfizer and BioNTech announced topline safety, immunogenicity and vaccine efficacy data from a Phase…
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Novavax participated in Oxford University Com-COV3 booster trial of COVID-19 vaccines in adolescents aged 12 through 15
On May 25, 2022, Novavax announced it was participating in a stage of the COVID-19 Vaccine Schedule Combinations…
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Pfizer and BioNTech granted U.S. EUA for booster dose of COVID-19 vaccine in children 5 through 11 years of age
On May 17, 2022, Pfizer and BioNTech announced the U.S. Food and Drug Administration expanded emergency use authorization…
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Biotechnology | COVID-19 | FDA | Vaccine
Pfizer and BioNTech submitted application for U.S. EUA for COVID-19 vaccine booster dose in children 5 through 11 years of age
On Apr. 26, 2022, Pfizer and BioNTech submitted an application to the U.S. Food and Drug Administration (FDA)…
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Pfizer and BioNTech received positive CHMP Opinion for COVID-19 vaccine booster in adolescents 12 through 17 years of age in EU
On Feb. 24, 2022, BioNTech announced that the Committee for Medicinal Products for Human Use of the European…
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BioNTech introduced first modular mRNA manufacturing facility to promote scalable vaccine production in Africa
On Feb. 16, 2022, BioNTech announced it had introduced its approach to establishing scalable vaccine production by developing…
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Pfizer and BioNTech updated rolling submission for EUA of COVID-19 caccine in children 6 months through 4 years of Age
On Feb. 11, 2022, Pfizer and BioNTech announced plans to extend their rolling submission to the U.S. Food…
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Pfizer and BioNTech initiated rolling submission for EUA of COVID-19 vaccine in children 6 months through 4 years of age
On Feb. 1, 2022, Pfizer and BioNTech announced that following a request from the U.S. Food and Drug…
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Merck and Ridgeback’s Molnupiravir, investigational antiviral COVID-19 medicine, demonstrated activity against Omicron variant
On Jan. 28, 2022, Merck and Ridgeback Biotherapeutics announced data from six preclinical studies demonstrating that molnupiravir, an…
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Pfizer and BioNTech initiated study to evaluate Omicron-based COVID-19 vaccine in adults 18 to 55 years of age
On Jan. 25, 2022, Pfizer and BioNTech announced the initiation of a clinical study to evaluate the safety,…
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Mixed vaccine schedules offered strong booster responses after two doses of CoronaVac vaccine
On Jan. 24, 2022, the University of Oxford announced that a third booster dose of either the ChAdOx1…
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Pfizer and BioNTech published data from two studies on COVID-19 vaccine-induced antibodies ability to neutralize SARS-CoV-2 Omicron variant
On Jan. 24, 2022, Pfizer and BioNTech announced the publication of new results from two laboratory studies demonstrating…
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Positive results of Pfizer’s phase 3 study exploring co-administration of PREVNAR 20 with Pfizer-BioNTech COVID-19 vaccine released
On Jan. 12, 2022, Pfizer announced positive top-line results from a Phase 3 study describing the safety and…
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BioNTech and InstaDeep developed and successfully tested early warning system to detect high-risk SARS-CoV-2 variants
On Jan. 11, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration had expanded the…
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Pfizer and BioNTech signed global collaboration agreement to develop first mRNA-based shingles vaccine
On Jan. 5, 2022, Pfizer and BioNTech announced a new research, development and commercialization collaboration to develop a…
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Pfizer and BioNTech received U.S. FDA EUA of COVID-19 vaccine booster for individuals 12 years of age and older
On Jan. 3, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration had expanded the…
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Pfizer and BioNTech submit updated longer-term follow-up data of COMIRNATY in adolescents to EMA
On Dec. 23, 2021, Pfizer and BioNTech announced that they had submitted longer-term follow-up data from the companiesﾒ…
