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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 ...
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 ...
[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.
LONDON (Reuters) -The European Commission has secured deals with Pfizer and several European drugmakers to reserve capacity to make up to 325 million vaccines per year in case of a future global ...
When used as drugs, the International Nonproprietary Names (INNs) end in -mab. The remaining syllables of the INNs, as well as the column Source, are explained in Nomenclature of monoclonal antibodies. Types of monoclonal antibodies with other structures than naturally occurring antibodies.
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 ...
Pfizer was founded in 1849 as "Charles Pfizer & Company" by Charles Pfizer and Charles F. Erhart, [5] two cousins who had immigrated to the United States from Ludwigsburg, Germany. The business produced chemical compounds, and was headquartered on Bartlett Street [ 6 ] in Williamsburgh, New York where they produced an antiparasitic called ...
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.