[June 12, 2020] The quest to produce a viable, safe vaccine to halt the COVID-19 pandemic and be able to meet an aggressive schedule for the roll out of millions of doses by the close of 2020 has become a worldwide endeavor, with 10 announced potential candidates. These vaccine developers are recruiting and enrolling participants in clinical studies: Moderna & National Institute of Allergy & Infectious Diseases (NIAID) in Phase II; BioNTech & Pfizer in Phase I/II; Inovio Pharmaceuticals in Phase I; University of Oxford & AstraZeneca in Phase II/III; CanSino Biologics in Phase II; Wuhan Institute of Biological Products and Sinopharm in Phase I/II; Beijing Institute of Biological Products and Sinopharm in PhaseI/II; the Phase I/ II of Sinovac Biotech soon progresses to Phase III trials in partnership with Instituto Butantan, based in Brazil; Novavax in Phase I/II; and Institute of Medical Biology and Chinese Academy of Medical Sciences’ Phase I trial.
Although, the WHO lists more than 100 candidates in preclinical programs, these are primarily test articles which are not in the clinical trial process, as yet. For example, the Janssen Pharmaceutical Companies (of Johnson & Johnson) have recently identified a lead candidate for a SARS –COV-2 vaccine [Ad26.COV2-S recombinant]. Their search for a vaccine candidate has relied upon partnership and collaboration with Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health & Human Services (DHHS), and Beth Israel Deaconess Medical Center (BIDMC).
Conventional vaccine development has proved, in past years, to be an extremely slow, time consuming and financially costly process, with few if any successes – most especially for enigmatic pathogens such as MERS, SARS, and now SARS-COV-2, which causes COVID-19.
Phase I trials begin with testing the vaccine candidate in healthy volunteers for safety, which may involve testing multiple doses (dose-range findings). In a Phase II study, participants are subjects who are ill with the condition being studied. Phase II tests for efficacy and grades the side effects of the test article, i.e. severe adverse events (SAEs) or adverse events (AEs). Phase III studies are undertaken to confirm and expand on the effectiveness and safety results of the Phase I and Phase II studies. As well, this latter phase evaluates the risks and benefits of the test article and how it may compare to standard therapies, if such exist.
This past week, vaccine developer, Moderna issued news that may accelerate its trial phase testing of a promising vaccine candidate. The U.S. Food & Drug Administration (FDA) has approved the company’s protocol to begin Phase III trials as early as next month. As with many of the other advanced vaccine candidates, Moderna’s mRNA-1273 uses an emerging biotechnology platform. Its mRNA-1273 delivers a genetic sequence into a host cell, and co-opts the host machinery such that it expresses antigens for antiviral protection. https://clinicaltrials.gov/ct2/show/NCT04405076?cond=COVID-19&fund=01&draw=4&rank=27
In collaboration with BARDA, Moderna was one of the few American Companies conducting vaccine clinical trials to receive funding through the Trump initiative Operation Warp Speed (OWS), which seeks to perform each and every aspect of vaccine development for COVID-19 in record time of 18 months or less.
The Medical Project 