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[248] [249] Following the EUA issuance, BioNTech and Pfizer continued the Phase III clinical trial to finalize safety and efficacy data, leading to application for licensure (approval) of the vaccine in the United States. [246] [34] [153] On 10 May 2021, the US FDA also authorized the vaccine for people aged 12 to 15 under an expanded EUA.
National regulatory authorities have granted full or emergency use authorizations for 40 COVID-19 vaccines.. Ten vaccines have been approved for emergency or full use by at least one stringent regulatory authority recognized by the World Health Organization (WHO): Pfizer–BioNTech, Oxford–AstraZeneca, Sinopharm BIBP, Moderna, Janssen, CoronaVac, Covaxin, Novavax, Convidecia, and Sanofi ...
Abdala, technical name CIGB-66, is a COVID-19 vaccine developed by the Center for Genetic Engineering and Biotechnology in Cuba. [2] This candidate, named after a patriotic drama by Cuban independence hero José Martí , is a protein subunit vaccine containing COVID-derived proteins that trigger an immune response. [ 3 ]
How COVID‑19 vaccines work. The video shows the process of vaccination, from injection with RNA or viral vector vaccines, to uptake and translation, and on to immune system stimulation and effect. Part of a series on the COVID-19 pandemic Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom. COVID-19 (disease) SARS-CoV-2 (virus) Cases Deaths ...
Pfizer was founded in 1849 as "Charles Pfizer & Company" by Charles Pfizer and Charles F. Erhart, [7] two cousins who had immigrated to the United States from Ludwigsburg, Germany. The business produced chemical compounds, and was headquartered on Bartlett Street [ 8 ] in Williamsburgh, New York where they produced an antiparasitic called ...
Mangipudy said Pfizer produced 3 billion doses of the COVID-19 vaccine in 2021 and expects to produce 4 billion this year, and the company has pledged 2 billion doses to low- and middle-income ...
The Food and Drug Administration on Friday approved Pfizer’s treatment for a rare genetic bleeding disorder, making it the company’s first-ever gene therapy to win clearance in the U.S.
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...