Development and Production of SARS-CoV2 Biologicals and Vaccines

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications & trials

Abstract

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.