Development and Production of SARS-CoV2 Biologicals and Vaccines
Document text
Principal Investigator: Jason Gall Organization: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES Fiscal Year: 2023 Award: $5,062,451 Funding agency: National Institute of Allergy and Infectious Diseases Coronavirus vaccines and protein reagents will be developed at the VPP. The vaccines may be manufactured through the VCMP for human clinical trials in compliance with current Good Manufacturing Practices (cGMP) and released for use in human clinical trials in healthy human volunteers. These vaccines may confer broad immunity across the beta-coronaviruses and against multiple strains / variants. If these trials demonstrate safety and immunogenicity of these vaccines in human trials, further evaluation may take place in larger (Phase 2) trials which will necessitate production of the clinical trial materials (CTM) at larger scale. Vaccines under development include mRNA-based vaccines. The VPP is also leading a research collaboration with Afrigen Biologics and Vaccines, focused on exchanging scientific expertise that may be used to make mRNA vaccines, including the production of pDNA in support of Afrigens CoV vaccine. Terms: <2019 novel corona virus><2019 novel coronavirus><2019-nCoV><Biologic Products><Biological Agent><Biological Products><COVID-19 virus><COVID19 virus><Clinic><Clinical Trials><CoV-2><CoV2><Collaborations><Dedications><Development><Evaluation><Good Manufacturing Process><Good manufacturing practice><Human><Human Volunteers><Immunity><Influenza Vaccines><Laboratories><Modern Man><NIAID><National Institute of Allergy and Infectious Disease><Phase><Phase 1/2 Clinical Trial><Phase I/II Clinical Trial><Placebos><Production><Proteins><RNA vaccine><RNA-based vaccine><Reagent><Research><SARS corona virus 2><SARS-CO-V2><SARS-COVID-2><SARS-CoV-2><SARS-CoV2><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Safety><Severe Acute Respiratory Coronavirus 2><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome related corona virus 2><Sham Treatment><Techniques><Testing><Vaccine Production><Vaccines><Variant><Variation><Wuhan coronavirus><beta CoV><beta coronavirus><betaCoV><betacoronavirus><biologics><biopharmaceutical><biotherapeutic agent><clinical material><coronavirus disease 2019 virus><coronavirus disease-19 virus><coronavirus vaccine><developmental><flu vaccine><flu virus vaccine><full scale manufacturing><hCoV19><influenza virus vaccine><large scale manufacturing><large scale production><mRNA vaccine><mRNA-based vaccine><manufacture><manufacturing facility><manufacturing plants><manufacturing process><mass production><nCoV2><produce vaccines><production plants><programs><sham therapy><vaccine against coronavirus><vaccine against flu><vaccine against influenza><vaccine immune response><vaccine immunogenicity><β CoV><β coronavirus><βCoV>