Michelle McMurry-Heath6:34
Well, let's be clear: there is no excuse for where we find ourselves today. My mother-in-law lives in Germany, and she had an appointment in the middle of December for when she was going to get her first COVID vaccine. This is unbelievable that we would put this much attention into developing the vaccines, because all of the content of the vials cannot be used because we cannot organize our response. It is astounding, and it is heartbreaking to watch this. There's no excuse for this. This is not rocket science. We've done mass vaccination programs before, and the CDC has been saying for months what would be necessary for the states to be able to actually deliver the vaccine, get shots in arms. But they weren't given the resources, they weren't given the attention it deserved. So states are just now this week getting their hands on the resources they need. We've been speaking to governors across the country, and we heard from one governor who said, 'Well, I have boxes of the vaccine delivered on...' All the doses of the vaccine, particularly important in a two-dose vaccine situation, you need to be able to track who's had the vaccine. But it's also critically important because, lest we forget, these vaccines are authorized under Emergency Use Authorization, which by definition means we don't yet know everything about what we'll see when the vaccine goes into the majority of the population. So it's important to track all of that information so that we can fully understand it. Now, that being said, I don't want anyone to mistake my words. These vaccines have been under more scrutiny than any vaccines in history. They've been in tens of thousands of people before they were ever released across the country, and we have the utmost confidence in BIO in... We have learned a tremendous amount. So when it comes to preventing the next pandemic, when it comes to even preventing the next iteration of COVID because we know it's constantly mutating and evolving, we are incredibly prepared. The platforms that have shown success, for example the mRNA platform that has been used in both the Pfizer and Moderna vaccines, are revolutionary in that they will forever change how we think about developing new vaccines. We also, I think, have learned a lot about early warning systems and how seriously we need to take those early calls and the public health measures that work and don't work. But the things I think we've learned that are most impactful don't even have to do with... on the solution and having a market for that solution at the end of the day that will deliver cures faster and better to patients. That's what I hope we don't lose sight of. The FDA showed amazing flexibility in the context of COVID. Manufacturers said, 'What normally takes me two to four weeks to get a response to FDA in a formal letter, now I'm able to get them on the phone and really able to work in real time towards adapting our plans to make sure they meet FDA's demands.' We should never settle for less again, but that's going to take resourcing the FDA to be able to have that high-touch and rapid response approach. We've also seen, interestingly enough, that we need a... one did not, and the federal approach didn't necessarily save time. So we need to look at our national clinical trial networks and ask ourselves why they are not more easily mobilized for these massive public health concerns, and why is it so hard to get diverse patient populations through them. These are critically important questions that we are just starting to ask, but they'll be very important not just for infectious diseases but for every disease out there that's awaiting a cure.