Last week Moderna’s experimental COVID-19 vaccine entered phase II clinical trial and dosed initial participants in a 600-patient study. The Phase III trial begins in July and includes a study of 30,000. The Fast Track designation and the start of the Phase II trial means that mRNA-1273 may be the first vaccine to be approved and launched for the Covid-19 pandemic, as it is the only vaccine that has received FDA approval to initiate a Phase II trial, therefore placing it ahead of all other candidate Covid-19 vaccines in development.
An mRNA facility has a multitude of advantages including being smaller, cheaper and faster to scale up, in comparison to traditional biological production lines. However, ingredients for an mRNA vaccine are also very specialized, requiring production of mRNA and encapsulation inside lipid nanoparticles for delivery to humans.
Moderna is clearly very confident in its ability to develop a Covid-19 vaccine. However, there is also the issue of getting the vaccine to the public in an efficient manner. Upon finding a vaccine, Moderna would face enormous pressure to produce the vaccine as quickly as possible. Lonza is preparing to mitigate these challenges.