It is impossible to talk about the future return to routine after the virus, without mentioning the long-awaited vaccine - the one we have been promised since the beginning of the year that will arrive in the coming months. or until the end of the year. or early next year. or in the end. or never at all. When might it arrive?
It is impossible to talk about the future return to routine after the virus, without mentioning the long-awaited vaccine - the one we have been promised since the beginning of the year that will arrive in the coming months. or until the end of the year. or early next year. or in the end. or never at all.
In short, everyone is talking about a vaccine, no one is talking about a strategy. This is not surprising. It is very difficult to predict when (and whether) we will succeed in finding a vaccine for an existing disease. It is all the more difficult to talk about a new disease, which we do not yet fully understand how the virus that causes it works. Still, futurists are supposed to be experts in studying futures, especially in situations of extreme uncertainty. Therefore, in this entry I would first like to describe the way in which vaccines are developed in normal days, and based on the information to build two scenarios - optimistic and pessimistic - for the development of the vaccine. Both scenarios are based on the estimates presented In the impressive opinion article of Stuart A. Thompson in the New York Times in late April.
Last but not least, at the end of the post I will review two more extreme scenarios, one for the better and one for the worse.
The journey is on the way to the vaccine
The idea behind vaccines is very simple: we want to make the body develop antibodies against certain building blocks of the virus. In this way, as soon as the virus penetrates the body of the vaccinated, it will encounter antibodies that are already present in the bloodstream and are just waiting to stick to it and neutralize it, or at least an immune system that already knows it and can jump into action and develop antibodies against it in a very short time.
Simple, right? In principle, yes. However, as always happens in biology, there are plenty of challenges on the way to realization. We need to understand which building blocks that make up the virus trigger the body's most effective immune response. You have to find the right way to inject this building block into the body without it being destroyed within minutes in the bloodstream, and thus the body will not have time to develop an immune response against it. And of course, you have to make sure that the vaccine itself will not harm the body in any way. And these are just some of the problems that vaccine developers have to deal with.
All these problems - and many others - result in the average vaccine being developed in a laboratory There is only a 6 percent chance of reaching the market in the end. And this is even in a situation where we often understand the disease it is intended to prevent - which is clearly not the case with the new corona virus. Developing vaccines was and still is a difficult, tedious and especially long operation. The time required to develop an average vaccine is 10.7 years. The vaccine developed in the shortest time ever was the Ebola vaccine, which reached the market in only five years.
The process takes so long because it is divided into several steps:
The academic research phase
Researchers in the laboratories propose ideas for possible vaccines, test them on computer models and on animals, and choose the most successful material to send to clinical trials in humans. This stage can take many years, but we are lucky with the new corona virus: It is very similar to the original SARS virus that spread in Asia almost twenty years ago, so we have a better understanding of its structure than if it were a completely new virus. And what is more important, the pharmaceutical companies and the governments are not waiting for scientists to formulate a successful theory that describes the way of infection of the virus, and there are at least 112 vaccines (as of the moment of publication of the record) that are in the development process - and most likely the vast majority of them will fail because that did not pass the rigorous preliminary testing process in the laboratory. But if even one succeeds - we won.
For all these reasons, it was determined that the academic research phase for the new corona virus is not going to take any time at all.
The preclinical stage
At this point, a small factory is dedicated to producing large enough quantities of the vaccine for the clinical trials. The process takes about two and a half years, but it can be accelerated by a year or so by opening the clinical studies as soon as there are enough vaccines for the first stage.
In the optimistic scenario, then, it was determined that the duration of the preclinical phase would be only one year. In the pessimistic scenario, two and a half years.
The three phases of clinical studies
Clinical studies are divided into three phases. In the first stage, the safety of the virus is tested on a small number of subjects - no more than a few dozen. In the second stage, the effectiveness of the virus is tested on several hundred subjects. And in the third stage - on thousands. Each stage is separated by several months, during which the researchers go over the results and ask the authorities for permission to proceed to the next stages. Together, the three stages take almost four years normally.
The good news is that there is a willingness on the part of the authorities to consider conducting overlapping clinical trials: to test the safety and efficacy on the same subjects, for example, and at the same time. This can happen, but you should take into account that there is a good reason why we are examining the safety of vaccines, because experimental vaccines from the past could lead to the opposite result, and make the disease more deadly. So yes - safety must still be observed, and any skipping of steps may lead to long-term damage. And if that is not enough, since we cannot deliberately infect volunteers with the virus, the experiments will have to take place on people in areas where the virus is still spreading. If the epidemic subsides in the coming months, the clinical trials will also proceed more slowly.
Even in the most optimistic scenario, the fulfillment of all three stages will still take almost a year - and, as mentioned, a dizzying speed compared to the situation so far. The positive side is that once a certain vaccine proves its effectiveness and safety in the first and second stages, it may be given immediately to the populations at the highest risk: to the teams that are supposed to treat the sick, and possibly to the elderly as well.
In the pessimistic scenario, the stages will still be shortened, but the difficulty in finding subjects in the right environments where the virus is still spreading will lead to them taking two full years.
The construction phase of the factories
We successfully completed the third stage, and we have a vaccine. Hooray! But now it is necessary to produce several hundreds of millions - and perhaps billions - of portions. This is not an easy task. It is necessary to build entire factories that will be dedicated specifically to the production of the vaccine - a task that usually takes around five years. What else? Philanthropists like Bill Gates started investing in the establishment of such enterprises already today, In order for them to be ready the moment we discover the successful vaccine. It costs them a great deal of money - billions of dollars, to be exact - but the result will be that these plants will be ready for mass production as early as 2023. That is, about two years from now.
It is not easy to produce vaccines. the flu vaccines, for example, Still grown in chicken eggs. Other vaccines produce viruses that are grown in a controlled manner, on human cell cultures, and that have to infect the cells and multiply - processes that require time. And all of this happens in factories in a highly controlled manner, when any mistake or contamination can cause the entire factory to be shut down for a long period of time.
Vaccination may be unusually successful. He may be the greatest gift given to humanity since the Bible of the Flying Spaghetti Monster. But none of this changes anything when you get to the production stage. According to the assessment of the New York Times, the production of the vaccine in the required quantities will take approximately two years given the existing technologies.
And here we are at the stage that everyone loves to hate, where the vaccine has already passed all the stages of clinical trials, is starting to be produced in huge quantities in factories that already exist and are just waiting for it... and only the American Food and Drug Administration - the infamous FDA - is asking for a few more months to go through all the results the experiments and make sure everything is kosher. And it is actually very logical and appropriate. It is possible to shorten the stages of clinical trials. You can speed up the whole process. Everything is acceptable. But it is impossible for millions of people to receive a vaccine that has not been carefully tested by the authorities first, to make sure that it will not harm the people it is supposed to protect.
Getting approval from the FDA requires around a year, but in the current situation the authority will surely press the gas and shorten the testing time to only six months, both in the optimistic and the pessimistic scenario. Why nothing less than that? Because she is going to be under unusual pressure, when 112 vaccine developers demand that she test their vaccine.
Summary so far
Let's start with the good news: in both the optimistic and the pessimistic scenario, it is quite possible that already in 2021 we will get to see initial vaccinations that will be given to thousands of doctors and nurses who will work directly with corona patients in every country. Perhaps grandparents will receive the same vaccine at the end of 2021, or during 2022. The reason is that populations at risk will get the vaccine before everyone else - and maybe much before everyone else. Children in Africa, however, will have to wait a few more years before they can benefit from the vaccine themselves.
In the optimistic scenario, it will take about four and a half years until there are enough vaccine doses in the world for every person to receive one. In the pessimistic scenario, we will only see the vaccine in seven years, in 2028, mainly due to difficulties in opening and operating more than a hundred factories that are supposed to produce small amounts of vaccines for the clinical trials.
But these two scenarios do not refer to two 'wild cards' - two extraordinary possibilities that may still materialize. The first is that we are unable to create a vaccine for the virus. The second is that we will use a new method for creating vaccines that has never been successfully tried before - but can shorten the times significantly.
Pessimistic extreme scenario: no vaccine
In the most pessimistic extreme scenario, we simply fail to create a vaccine for the virus in the next decade. Let's face it: it won't be that big of a surprise. Nevertheless, it is a new virus (despite its genetic similarity to SARS) and a disease we have never encountered before. You should also keep modesty and remember that there is still no vaccine of any kind for the corona viruses, and that there are many diseases for which we have not yet developed an effective vaccine. This may also happen in the case of the new corona virus.
Is this scenario plausible? At this point, the enthusiastic futurist in me jumps in, the one who believes in tomorrow's technologies and exponential medicine, and shouts that there is no way that with all the amazing tools that modern science gives us, we will not find a vaccine for this disease. But the biologist, who spent many years in the research laboratories, and knows very well how big the gaps in our knowledge still are in everything related to biology and medicine, immediately pours cold water on him. The bitter truth is that there is a very real chance that a vaccine will simply not be found in the next decade. I have no way to estimate this chance, because again - a new virus, a new disease, etc. - but it is important that we know it exists.
Optimistic extreme scenario: mRNA vaccines
It is time to mention the new concept in the field of vaccines: that of mRNA vaccines. These vaccines do not rely on injecting the building blocks of the virus into the body, but on injecting its genetic material. The same genetic material is supposed to penetrate into the cells in the body, causing them to produce - temporarily and safely - the building blocks of the virus, which will be released into the bloodstream and cause the body to develop immunity.
Why is this method so important? Mainly because it does not require factories to grow the virus - a task that requires a lot of time, money and supervision - but can be done more efficiently and cheaply, by creating parts of the virus's genetic code in a laboratory. In principle, any biological laboratory in the world could become a tiny factory for the production of vaccines.
The problem is that despite the great enthusiasm for this new-old technology, no mRNA vaccine has ever been approved for use. The Moderna company is currently trying to develop such a vaccine, and has even started conducting clinical trials, But there is a lot of skepticism about the results she has released in the meantime. Still, one can hope.
If the mRNA vaccines really succeed, then the duration of the production of large quantities of the vaccine - which should take two years - will be shortened to only a few months. The preclinical phase will also be shortened to a few months. Last but not least, it would be possible to decentralize production from giant factories to smaller private laboratories. The longest stages will be the testing and approval stages, and if we combine all the other stages we will get a forecast of about two years until a vaccine is produced that can reach everyone.
A real summary
If you read the news, you are probably exposed every morning to a new message about "a promising vaccine developed by a reputable laboratory!"
So where are all those promising vaccines?
At best, they are only now entering the clinical trial stages. And only very few of them will really realize the great promise that the press - and the PR bodies of the laboratories and companies - attributed to them.
I hope this record helps to think in a more balanced and serious way about the subject of vaccines. Like everyone else, I too would like to see the virus vaccine appear tomorrow morning. And there is really a chance that by the end of the year we will already have a primary vaccine that will begin to be given to medical personnel. But we have to be realistic and understand the limitations of the science and technology we have today. Even in the most optimistic extreme scenario, the citizens of the world as a whole will not benefit from a vaccine against the virus for another two long years.
And let's face it: by that time, everyone may already be naturally vaccinated.
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