We now have a preprint with a great deal of data on the first mRNA coronavirus vaccine candidate from the Pfizer/BioNTech effort. This is actually the first real data set on any of the genetic vaccines, since Moderna’s paper on their Phase I trial has not yet appeared (all we had was a brief press release) and a brief press release is all we got from Inovio’s DNA vaccine work as well.
So what do we have today? It looks like good news.
But back to these latest results: I agree with the paper’s conclusion, which says that its findings “ are encouraging and strongly support accelerated clinical development and at-risk manufacturing “. So far, so good, and remember, these folks have three more mRNA vaccines coming along simultaneously. I very much await Moderna’s paper on their Phase I mRNA results for comparison – it’s been six weeks since the press release, guys, an eternity in Covid-time. Bring on the data, everyone!
Genetic vaccines like this are a new technology. Such rapid development and scale up of a vaccine would categorically not be possible without them. This is truly an amazing milestone.
So, what is at-risk manufacturing? It means they are starting the very difficult process of making millions of doses, before the Phase 3 studies, and that puts it at risk if the Phase 3 fail or the vaccine does not get approval.
One interesting feature of genetic vaccines is that they may reduce the risk of at-risk manufacturing. Much of the work done to scale this vaccine up might be transferable to the other mRNA vaccines, merely by changing the sequence payload on the same manufacturing process. At least in principle, that is possible, though precise technical and regulatory details are likely in flux at this time.