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Author: Mark Toshner, Director of Translational Biomedical Research, University of Cambridge.
I’m a clinical trial fanatic. I constantly hear people talk about the “seven to ten years” it takes to develop a vaccine and the danger of speeding up the process. The word that keeps coming up is “rushed” and that makes the average person nervous about the safety of the vaccine. So, as a clinical trials doctor, I’ll tell you what I’ve been doing for most of these ten years – and that’s not much.
I am not lazy. I submit grant applications, I have them turned down, I submit them again, I wait for a review, I submit them again elsewhere, sometimes in a cycle of desperation. When I have the opportunity to finance the trials, I spend months submitting to ethics committees.
I wait for the regulators, I deal with personnel changes within the pharmaceutical company and a “shift of focus” away from my trials, and finally, if I am very lucky, I spend time setting up tests: find positions, training, panic because recruiting is bad, find more sites. So I usually have more regulatory problems, and finally, if my “stash of luck” isn’t exhausted, I may or may not have valid evidence.
At this point, the trial may be delayed due to questions about cost effectiveness or any other obstacles. I won’t even go into the details of what happens with “preclinical” studies, those before human processes.
Ten years to develop a vaccine is a bad thing
So the next time someone is concerned about the astonishing speed with which vaccine testing has taken place, point out that ten years is not a good thing, it’s a bad thing. They are not ten years because this is certain, they are ten difficult years to fight indifference, commercial imperatives, bad luck and bureaucracy. All of these represent obstacles in processes that we have now proven to be “easy” to overcome.
You just need unlimited money, smart, highly motivated people, all of the global testing infrastructure, an almost unlimited pool of selfless and wonderful test volunteers and sane regulators. With all of this and a global pandemic killing people every second, it turns out we can do amazing things. A revolution in how we test that, come to think of it, may not be all that surprising given our ability to innovate when we really need it.
And we really need it: necessity is the mother of invention. Security was not compromised. All tests have gone through the correct “stages” or processes of any normal drug or vaccine. Hundreds of thousands of the best of us volunteered and received an experimental vaccine. The world watched it so closely that when one person got sick, we all discussed it.
To date, there has not been a single COVID vaccine-related death and only a handful of potentially serious events. Imagine watching everyone in a small town for six months and reporting every heart attack, stroke, neurological condition, or anything that could be considered serious. How surprising is that? It was a triumph of medical science.
I haven’t even mentioned the calendar serendipity that all of this happened at a time when sequencing all of a person’s or virus’s genes is so routine that nobody cares. concern. This has given a boost to preclinical science, needed as a cornerstone for several new technologies. And it happened at the right time to exploit them.
At this time, three vaccines have already broken the silence and proved more effective than we hoped. The level was set by the regulators at around 50%. Moderna and Pfizer reported 95% effectiveness, and the University of Oxford reported 90% effectiveness for a particular dosing regimen. Safety data is yet to come, but the vaccine record is excellent and I am optimistic.
None of this is intended to minimize the challenges that still lie ahead. Again, that doesn’t mean vaccines don’t have safety questions that still need to be answered. However, it is a triumph of good practices and great people. I am confident that when regulators review safety and efficacy data, closely observed by all concerned scientists around the world, vaccines will only be used if their benefits clearly outweigh the risks – and you should also be confident.
Mark Toshner, Director of Translational Biomedical Research, University of Cambridge.
This article has been translated and republished by The Conversation, under a Creative Commons license. Read the original article.
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