thevaccinereaction--2020-05-25--Pfizer and BioNTech Begin Human Clinical Trials of COVID-19 Vaccine in U.S.

Pfizer , Inc. of New York and BioNTech SE of Mainz , Germany have announced that human clinical trials for an experimental COVID-19 vaccine they have co-developed , known as BNT162 , have begun in the United States.1 As part of a global clinical development program , the first human subjects in the U.S .
Phase I and Phase clinical II trials of BNT162 received doses of the experimental vaccine at New York University ’ s Robert I. Grossman School of Medicine in New York City and University of Maryland ’ s School of Medicine in Baltimore , Maryland.2 In @ @ @ @ @ @ @ launched the first human clinical trials of BNT162 in Germany with the goal of testing 200 healthy volunteers between the ages of 18 and 55 years.3 According to Albert Bourla , CEO of Pfizer , “ The short , less than four-month time frame in which we ’ ve been able to move from preclinical studies to human testing , is extraordinary.
” 1 Phase 1 and Phase 2 clinical trials are designed to be randomized , placebo-controlled , observer-blind , dose-determining and vaccine candidate-selection studies in healthy adults.4 These trials are expected @ @ @ @ @ @ @ immunogenicity and potential efficacy of four different SARS-CoV-2 messenger RNA vaccine candidates using a two-dose or single-dose schedule , at up to three different dose levels and in three age groups ( 18 to 55 years old , 65 to 85 years old and 18 to 85 years old ) .4 Each trial participant will receive one of four vaccine candidates—BNT162a1 , BNT162b1 , BNT162b2 , BNT162c2 or a placebo.4 Each vaccine candidate represents a different mRNA format and target antigen.3 Two of the four vaccine candidates are nucleoside modified mRNA ( modRNA @ @ @ @ @ @ @ uridine containing mRNA ( uRNA ) , and the fourth vaccine candidate uses self-amplifying mRNA ( saRNA ) .3 Each mRNA format is combined with a lipid nanoparticle ( LNP ) formulation.3 Bourla said that if one or two variations of the candidate vaccine appear successful , the companies plan on expanding human trials to a large-scale study with thousands of participants by September 2020.5 He stated : Pfizer and BioNTech are racing against two other biotechnology companies , CureVac and Moderna , which are also in the clinical trial stage of developing @ @ @ @ @ @ @ mRNA Vaccines May Come with Serious Side Effects Messenger RNA ( mRNA ) vaccines , which have never been licensed for use in humans , inject cells with mRNA , usually within lipid nanoparticles , to stimulate cells in the body to become manufacturers of viral proteins.7 According to researchers at University of Pennsylvania and Duke University , mRNA vaccines have potential safety issues , including local and systemic inflammation and stimulation of auto-reactive antibodies and autoimmunity , as well as development of edema ( swelling ) and blood clots.8