WebDec 2, 2024 · NCT04368728, EUCTR2024-002641-42 Phase 2/3. Argentina, Brazil, Germany, South Africa, Turkey, United States of America. Total Enrollment: 43,998. Official Trial Registration: NCT04368728 (Opens in new tab/window) EUCTR2024-002641-42 (Opens in new tab/window) EUCTR2024-001038-36, NCT04380701 WebDec 31, 2024 · The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions: A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of …
There Is Currently NO Fully Licensed Covid Vaccine on the US …
WebJul 28, 2024 · NCT04368728. Funding Statement. Supported by BioNTech and Pfizer. Author Declarations. I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes. The details of the IRB/oversight body that provided approval or exemption for the research described … WebAug 26, 2024 · Pfizer Trial NCT04368728 . Ages included: 12 and older Number of people (all ages): 43,998 Clinical trial phase: Phase 2/3; What the trial is looking at: The trial is looking to determine the safety and tolerability of this vaccine.Researchers are also analyzing the vaccine's ability to trigger an immune response and how well it works at … christina hendricks engaged to george bianc
VIA ELECTRONIC FILING - Vaccine Impact
WebHere we report the available safety, tolerability and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose-escalation study (ClinicalTrials.gov identifier NCT04368728) among 45 healthy adults (18-55 years of age), who were randomized to receive 2 doses-separated by 21 days-of 10 μg, 30 μg or 100 μg of BNT162b1 ... Webof diverse populations, and whether FDA’s Expanded Access Program could provide an opportunity to facilitate access to investigational products. Discussion at the public … WebAug 23, 2024 · U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov Our STN: BL 125742/0 . BLA . APPROVAL . BioNTech … christina hendricks everclear