Coronavirus Vaccine Development....Phase III A-Go-Go.

AllYourTechIsNow
BioVille


From the US CDC's website on vaccine development:

...Clinical (vaccine) development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.

Many vaccines undergo Phase IV....studies after the vaccine is approved and licensed...


As Derek Lowe, our go to drug development guy, notes, large scale clinical trials for a number of potential coronavirus vaccines are on the near horizon:

...What we’re seeing now is the plan for entering large-scale human trials. The Wall Street Journal‘s Peter Loftus broke the news of the overall plan in the US: Moderna’s candidate was said to be going into Phase III in July, followed by the Oxford/AstraZeneca effort in September, with Johnson & Johnson’s vaccine to follow. But J&J now says that they’re moving up the timetable and negotiating with the NIAID for Phase III trials before then. Moderna has selected 100 micrograms as the Phase III dose, which is what was expected based on their earlier results. Meanwhile, AZ says that they will be scaling up the manufacturing of the Oxford vaccine during the trials themselves, on a risk basis, and it would not surprise me at all to see other companies doing something similar. They’ll basically have to – if one or more of these vaccines reads out well in Phase III, you’d want to get to dosing people as quickly as possible...


So.

Does this mean that the end of the pandemic nigh?

Dr. Lowe suggests you would crazy to bet on it, at least at the moment:

...The next few months, then, are not going to be dull. Politics aside, the organization and execution of all these trials will be a huge and complex effort, as mentioned, and when the numbers start coming out of them we’re going to surely be taken by surprise. That’s what clinical trials do; this won’t be different. I’m expecting sudden reversals, and sudden bursts of hope, despair, and confusion. None of us have ever seen anything like what’s coming, and I hope we never have another opportunity to see anything like it again!...


As for that 'politics aside' business?

Well, if a certain politician can make a big deal about garbage treatments, is there any reason to think he won't pull the trigger early on a vaccine?

Especially if, say, an election is looming?


______
Lowe also has an update on antibody development work....Unlike viruses and vaccines, this is something I actually know something about...The data so far are interesting but it's still early days, although the clinical trial data will soon start to come out there as well.


.