Moderna’s mRNA COVID-19 Vaccine ready for Phase II as vaccine development picks up pace

Following the news that Moderna’s mRNA COVID-19 vaccine candidate received FDA approval to start Phase II clinical studies;

Philipp Rosenbaum, PhD, Infectious Diseases Analyst at GlobalData, a leading data and analytics company, offers his view:

“With plans to start Phase III trials in early summer, Moderna’s ambitious timeline leaves some skepticism, as no data has been published to date. mRNA-based vaccines have yet to be proven to work in humans, and the history of vaccine development shows that setbacks and roadblocks are almost certain.

“Companies that have begun clinical trials of their COVID-19 vaccine candidates include BioNTech, which partnered up with Pfizer to develop its mRNA vaccine; and Oxford University’s Jenner Institute, which recently teamed up with AstraZeneca for the development and production of the viral vector vaccine, ChAdOx1.

“Inovio Pharmaceutical’s COVID-19 DNA-vaccine candidate INO-4800’s Phase I trial has a scheduled end date of April 2021, and Inovio’s novel delivery method using dermal electroporation has not yet been proven successful. Furthermore, several vaccine candidates started clinical studies in China, including CanSino Biologics’ recombinant vector vaccine, as well as Sinovac’s and Sinopharm’s inactivated virus vaccines.

“All of these developments increase the chance for a successful vaccine to emerge. However, the timeframe to global mass-market readiness for such a vaccine remains unclear. Successful candidates would first need to be distributed to healthcare workers and the high-risk population. At this early stage in vaccine development, it is hard to predict which vaccine candidate will be successful and the first to be widely available, but a launch in 2020 is very optimistic.”

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