Working Paper Communication Version 1 This version is not peer-reviewed

Developing a Low-Cost and Accessible COVID-19 Vaccine for Global Health

Version 1 : Received: 31 March 2020 / Approved: 31 March 2020 / Online: 31 March 2020 (22:41:36 CEST)

How to cite: Hotez, P.J.; Bottazzi, M.E. Developing a Low-Cost and Accessible COVID-19 Vaccine for Global Health. Preprints 2020, 2020030464 Hotez, P.J.; Bottazzi, M.E. Developing a Low-Cost and Accessible COVID-19 Vaccine for Global Health. Preprints 2020, 2020030464

Abstract

There is an urgent need to advance safe and affordable COVID-19 vaccines for low- and middle-income countries of Asia, Africa and Latin America. Such vaccines rely on proven technologies such as recombinant protein-based vaccines to facilitate its transfer for emerging market vaccine manufacturers. Our group is developing a two-pronged approach to advance recombinant protein-based vaccines to prevent COVID-19 caused by SARS CoV2 and other coronavirus infections. One vaccine is based on a yeast-derived (Pichia pastoris) recombinant protein comprised of the receptor binding domain (RBD) of the SARS-CoV formulated on alum, and referred to as the SARS-CoV 219-N1 Vaccine. Potentially this vaccine could be used as a heterologous vaccine against COVID-19. A second vaccine specific for COVID-19 is also being advanced using the corresponding RBD of SARS-CoV-2. The first antigen has already undergone cGMP manufacture and is therefore “shovel ready” for advancing into clinical trials, following vialing and completing required GLP toxicology testing. Evidence for its potential efficacy to cross-protect against SARS-CoV-2 includes cross-neutralization and binding studies using polyclonal and monoclonal antibodies. Evidence in support of its safety profile include our internal assessments in a mouse challenge model using a lethal mouse adapted SARS strain, which show that SARS-CoV RBD 291N1 (when adsorbed to Alhydrogel®) does not elicit significant eosinophilia or eosinophilic lung pathology. Equally important, we summarize a robust set of published studies linking eosinophilic immunopathology to virus-vectored vaccines. These include vaccinia and modified vaccinia virus Ankara constructs, rather than recombinant protein-based vaccines. Together these findings suggest that recombinant protein-based vaccines based on the RBD warrant further development to prevent SARS, COVID-19 or other coronaviruses of pandemic potential.

Subject Areas

COVID-19, SARS 2; coronavirus

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