[ad_1]
In The Conversation, Toshner decided to explain what he typically does during those decades of vaccine development. And actually that’s how it works … not much.
“I am not lazy. I submit applications for funding, applications are rejected, I submit them again, I am waiting for an evaluation, I also submit elsewhere. Sometimes the whole carousel turns. When I am lucky and the research receives funding, I have to spend a few months running for the ethics board. I look forward to action from regulators to deal with personnel changes at the pharmaceutical company and “shifting priorities” resulting from my research. And in the long run, if you are very lucky, you will have to spend a lot of time preparing for research: finding research centers, training places, panicking because volunteers choose slowly, looking for more research centers, and finally, if the pot has not yet been used up. you get a promising medical preparation, or you don’t, ”said M. Toshner.
And even then, all research work can come to a halt as companies tackle the problem of profitability and try to get around many other hurdles.
“I’m not even going to talk about how many years it normally takes to do ‘preclinical’ studies, the ones that are done before human studies,” Toshner explained.
Ten years to develop a vaccine is a bad trend
The scientist is determined to explain to anyone who is concerned about the speed of light at which the COVID-19 vaccine was developed that a decade of vaccine development is not good. Because it’s really bad.
The development of the vaccine does not take a decade because it takes a long time to ensure safety. It takes ten years for scientists to successfully break the boundaries of indifference, business imperatives, success, and bureaucracy. Most of that time is spent on processes that, as the developers of the COVID-19 vaccine have shown, are easy and quick to perform with sufficient motivation.
“All that is needed are unlimited resources, a few intelligent and highly motivated people, and a global clinical research infrastructure – almost inexhaustible resources for volunteer research participants and common sense regulatory staff,” Toshner wrote.
When all these conditions are met and a global pandemic claims lives every second, it is possible to do what seems incredible. All clinical trials of COVID-19 vaccines are almost a miracle, they will revolutionize the way clinical trials are conducted. Although this shouldn’t be too surprising, people have almost limitless ingenuity, if there is a strong enough motivation to do so.
And this time the motivation was very strong. The engine of ingenuity has become a necessity. Safety was not sacrificed for the sake of speed. All the studies have passed all the necessary phases and those processes that any vaccine or drug must go through under normal conditions. Hundreds of thousands of the world’s best professionals have dedicated their time and efforts to the development of experimental vaccines. And they were watched very closely by everyone. So carefully, when only one participant was sick, all the experts discussed the case.
To date, no deaths have been reported with COVID-19 vaccines and only a few potentially serious adverse events.
Imagine: for half a year, you monitor every resident of a small town and describe every heart attack, every stroke, every neurological condition, or anything that could become serious. It is not surprising? This is a triumph of medical science, “Toshner admired.
And yet it should be noted that the SARS-CoV-2 virus has spread all over the world just when it is so easy to scan the genes of any human or any virus that no one is surprised.
This capability allowed for an incredibly fast phase of preclinical research, as several new technologies were developed at the same time and simply waited for them to be used.
All three vaccines are now known and their level of efficacy is higher than originally thought.
Drug regulators have raised the efficiency cartel for new vaccines to about 50 percent. But Moderna and Pfizer have reported an efficacy of around 95 percent, and the University of Oxford reported that their vaccine is 90 percent effective under a certain dosage regimen. The data on the safety of these vaccines has yet to be removed, but the vaccine safety data thus far has not been generally poor, so you can expect them to be optimistic.
Toshner says he’s not really trying to downplay the challenges that lie ahead, and he doesn’t mean that there are no questions about vaccine safety that need no answer; it just means that the development of these vaccines is a triumph of good processes and amazing professionals.
“I am confident that when regulators review the safety and efficacy data, which will be closely monitored by any interested scientist around the world, these vaccines will only be used as long as the benefits of their use far outweigh the potential risks,” he said Toshner. He also asked for the public’s confidence in vaccines.
[ad_2]
