Warp-Speed Covid-19 Vaccine Development: Beneficiaries of Maturation in Biopharmaceutical Technologies and Public-Private Partnerships

Abstract

It is anticipated that effective vaccines will enable the resumption of social and economic normalcy. Current calls for masking, social distancing and other restrictive measures for the public-good are difficult to enforce and are unstainable. As ~2-4% of the 50 million SARS-CoV2-infected have succumbed to Covid-19, the US department of Health and Human Services has organized a public-private partnership called Operation Warp Speed (OWS) to develop, produce and deliver 300 million doses of safe and effective vaccines with a January 2021 target. While a majority of the 300+ Covid-19 vaccine candidates are in various stages of preclinical and early-stage clinical testing, 6 clinical candidates are supported with over 10 billion USD plus integrated resources under the OWS agenda. This unprecedented approach is investing in the manufacture of product candidates ahead of product approval. It is enabled by new gene and recombinant pharmaceutical platform technologies that are accelerating the clinical study timeline from ~10 to less than 1 year. It is anticipated that one or more of the 6 candidates under the OWS initiative will be safe, effective and provide a sustained immune response to prevent infection and disease progression. This way, social and economic activities could return to normalcy.

Keywords: Biopharmaceutics; Biotechology; Covid-19; Formulation; Gene therapy; SARS-CoV2; Vaccines.

Fig. 1

Accelerated vaccine development timeline for current Covid-19 vaccine candidates compared to a typical vaccine clinical study to product approval exemplified by a shingles vaccine called Singrix, which gained FDA licensing approval in 2017. Shingles, a painful outbreak on skin is caused by the reactivation of a previous exposure to a Herpes virus called Varicella Zoster or VZ. An immune response against viral glycoprotein antigen E or gE has been shown to provide protection. Current general consensus is that a SARS-CoV2 virus antigen called Spike protein or S Antigen, referred to as S–Ag, is a candidate antigen for most vaccine candidates under development. The timeline and 3 phases of shingles vaccine clinical development is presented along with a submission of the data assembled in the Biologic Licensing Application or BLA leading to the final approval of a product license by the Food and Drug Administration (FDA) presented for Shingrix. Based on the Operation Warp Speed (OWS) schedule, which targets a January 2021 completion of clinical studies for the funded Covid-19 vaccine candidates, the clinical development timeline is compressed and anticipated to be less than 1 year or 10-times the speed for average new vaccine development, particularly for candidates using a novel vaccine delivery platform.