CDC reported effectiveness of 2-Dose BNT162b2 mRNA vaccine in preventing SARS-CoV-2 infection among children
On Mar. 11, 2022, the BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine was recommended by the Centers for Disease Control and…
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Pfizer initiated phase 2/3 study of novel COVID-19 oral treatment in pediatric participants
On Mar. 9, 2022, Pfizer announced that it had initiated a Phase 2/3 study, EPIC-PEDS (Evaluation of Protease…
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Gilead reported phase 2/3 interim data evaluating safety, tolerability and clinical outcomes of Veklury (Remdesivir) in pediatric patients with COVID-19
On Feb. 11, 2022, Gilead Sciences announced new data from an interim analysis of its ongoing, Phase 2/3…
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Veklury (Remdesivir) retained antiviral activity against Omicron, Delta and other emergent SARS-CoV-2 variants
On Feb. 11, 2022, Gilead Sciences announced new data from an interim analysis of its ongoing, Phase 2/3…
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Novavax announced positive results of COVID-19 vaccine in pediatric population of PREVENT-19 phase 3 clinical trial
On Feb. 10, 2022, Novavax announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, achieved its primary effectiveness…
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InteliSwab COVID-19 rapid tests receive U.S. FDA authorization for pediatric use
On Jan. 31, 2022, OraSure Technologies announced that its InteliSwab COVID-19 rapid tests had been authorized by the…
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FDA approved Veklury (Remdesivir) for treatment of non-hospitalized patients at high risk for COVID-19 disease progression
On Jan. 20, 2022, Gilead Sciences announced that the U.S. Food and Drug Administration had granted expedited approval…
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Pfizer received U.S. FDA Emergency Use Authorization for novel COVID-19 oral antiviral treatment
On Dec. 22, 2021, Pfizer announced that the U.S. Food and Drug Administration (FDA) had authorized the emergency…
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FDA authorized long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individuals
On Dec. 8, 2021, the U.S. Food and Drug Administration issued an emergency use authorization for AstraZenecaﾒs Evusheld…
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SIGA announced Health Canada regulatory approval of Oral TPOXX
On Dec. 1, 2021, SIGA Technologies announced that Health Canada had approved oral TPOXX (tecovirimat) as an extraordinary…
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Biotechnology | COVID-19 | Diagnostics | Infectious Disease | Vaccine | WHO
Global progress against measles threatened amidst COVID-19 pandemic
On Nov. 10, 2021, the World Health Organization (WHO) announced that while reported measles cases had fallen compared…
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Moderna filed to expand the conditional Marketing Authorization for COVID-19 vaccine in the EU to include children ages 6-11 years
On Nov. 9, 2021, Moderna announced that it has submitted for a variation to the conditional marketing authorization…
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Pfizer and BioNTech provided U.S. Government an additional 50 million pediatric doses of COVID-19 vaccine
On Oct. 28, 2021, Pfizer and BioNTech announced that the U.S. government had purchased 50 million more doses…
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LogicBio Therapeutics announced early clinical trial results demonstrated first-ever in vivo genome editing in children
On Oct. 18, 2021, LogicBio Therapeutics announced clinical trial results that demonstrated the first-ever in vivo genome editing…
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Pfizer and BioNTech submitted data to EMA for vaccination of children 5 to <12 years of age with COMIRNATY
On Oct. 18, 2021, Pfizer and BioNTech announced that the European Medicines Agency’s Committee for Human Medicinal Products…
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Biotechnology | FDA | HIV | Therapeutics
U.S. FDA approved expanded indication of Gilead’s Biktarvy for Treatment of HIV-1 in pediatric populations
On Oct. 18, 2021, Gilead Sciences announced that the Food and Drug Administration had approved a new low-dose…
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Washington University School of Medicine in St. Louis led pediatric COVID-19 vaccine trial launched
On Oct. 6, 2021, Washington University School of Medicine announced the start of a pediatric COVID-19 vaccine clinical…
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FDA broadened existing EUA of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19
On Jul. 29, 2021, Incyte announced the U.S. Food and Drug Administration (FDA) had broadened the Emergency Use…
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NIH COVID-19 testing initiative funded additional research projects to safely return children to in-person school
On Jul. 2, 2021, the National Institutes of Health (NIH) announced funding five additional projects to identify ways…
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Study suggested no association between antiseizure drugs used during pregnancy and neurodevelopmental problems in children at age 2
On Jun. 7, 2021, the National Institutes of Health announced new findings published in JAMA Neurology that suggested…
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Chimerix received U.S. FDA approval for TEMBEXA (brincidofovir) for treatment of smallpox
On Jun. 4, 2021, The U.S. Food and Drug Administration (FDA) approved Chimerix’s Tembexa (brincidofovir) tablets and oral…
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Scientists discovered a new genetic form of ALS in children
On Jun. 1, 2021, in a study of 11 medical-mystery patients, an international team of researchers led by…
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Pfizer and BioNTech received first authorization in European Union for COVID-19 vaccine in adolescents
On May 28, 2021, Pfizer and BioNTech announced that the Conditional Marketing Authorization for COMIRNATY in the European…
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GSK and Vir Biotech announced sotrovimab (VIR-7831) received EUA from the US FDA for treatment of mild-to-moderate COVID-19 in high-risk adults and paediatric patients
On May 26, 2021, GlaxoSmithKline and Vir Biotechnology announced the U.S. Food and Drug Administration (FDA) granted an…
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Merck announced positive topline results from phase 3 pediatric studies for investigational 15-valent pneumococcal conjugate vaccine
On May 20, 2021, Merck announced V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, met its primary immunogenicity…
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Scientists discovered rare genetic condition that attacks kids’ immune systems
On May 19, 2021, Megan A. Cooper, MD, PhD, an associate professor of pediatrics at Washington University School…
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Gene therapy restored immune function in children with rare immunodeficiency
On May 10, 2021, the National Institutes of Health (NIH) reported that an investigational gene therapy can safely…
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Novavax initiated pediatric expansion for phase 3 clinical trial of COVID-19 vaccine
On May 3, 2021, Novavax announced that it had initiated a pediatric expansion of its Phase 3 clinical…
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BC Study Reports Baby’s first poop predicted risk of developing allergies
On Apr. 29, 2021, researchers at the University of British Columbia (UBC) announced a study published in Cell…
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Moderna announced an increased global supply for COVID-19 vaccine to up to 3 billion doses in 2022
On Apr. 29, 2021, Moderna announced it was making new funding commitments to increase supply at its owned…
