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?
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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[2]. 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[3].
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[4], 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[5]. 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[6]. 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[7]. 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.
production phase
It is not easy to produce vaccines. the flu vaccines, for example, Still grown in chicken eggs[8]. 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.
Approval stage
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[9]. 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.
More of the topic in Hayadan:
20 תגובות
Regarding the last sentence in the article - "And let's face it: by that time, everyone may already be vaccinated naturally".
This requires the assumption that herd vaccination is in place, but there have been recent reports of cases of re-infection. You shouldn't put all your cards on it.
It seems to me that what you did not talk about is a simple and cheap product if produced in large quantities of a quick test of minutes
She was able to separate the sick from the healthy and thereby significantly slow down the infection.
If you have information about this, it is more important at the moment than finding vaccines that do not know when they will actually arrive.
I would appreciate it if you would consider it
Thanks
Avi Sasson
Why do you say "the infamous FDA"? Is it because the FDA, clothing for the Israeli Ministry of Health, does not round corners? Because you are Israeli and expect to round corners at the price of risking human life?
To remind you, if you knew this at all, Israel "the genius" of the church in 2013 new jaundice vaccine for babies. A vaccine that the FDA did not approve, but the Israeli Ministry of Health is the smartest of all. After 3 years it turned out that it was a defective vaccine, and in addition it contained a lethal amount of aluminum. Hundreds of thousands of babies born in Israel in 2013-2016 received a defective vaccine that damaged their nervous system, to one degree or another.
Here is an example of why the rotten Israeli Ministry of Health is "known to have used it". If you were wondering, by the way, those guilty of the defective vaccine were not sent to prison, they were not fired, but they were promoted.
Research idea: did people who were exposed to avian coronavirus develop immunity, fully or partially?
Covid 19?
So apparently there is nothing to build on a vaccine in the next two years, but what about finding a cure? Discovering a cure will also be a solution because it will make the virus an easy virus for the entire world population. We would be happy to read a similar article regarding the attempts to reach the drug. Maybe there the situation is more optimistic.
Another optimistic scenario:
There will be a mutation of the virus that is contagious but without symptoms. A bit of Apache at most.
This mutation could simply be injected into the entire population and that would be the vaccine.
Another optimistic scenario:
There will be a mutation of the virus that is contagious but without symptoms. A bit of Apache at most.
This mutation could simply be injected into the entire population and that would be the vaccine.
What about quick and accurate tests?
Could this not be a worthy alternative?
Sorry. The previous link mistakenly does not refer to the beginning of the video. It is recommended to watch from the beginning of course.
Who needs the third step anyway? When you have a self-interested dictatorship, you can skip it.
https://www.youtube.com/watch?v=B6Ey8ervE18
(How nice if it turns out that the same disdain for research methodology that brought us this trouble(*) will also help get rid of it)
(*) Yes, I think the virus was created in a laboratory for research purposes and accidentally "escaped" from it, but it will take you two hours to be convinced or not
https://www.youtube.com/watch?v=q5SRrsr-Iug&t=2215s
Is it possible to use antibodies developed by patients who have recovered? Isn't that equivalent to donating blood?
In short, if you are from the pessimistic percentage of the company and you are invested in the stock market, you should carefully consider whether to leave and come back in two years.
Let's hope that the technology will overcome the difficulty of finding a vaccine already in the coming year - for the optimists we have built.
In the end it is a question of risk management and here there are two options:
1. Hope for a semi-optimistic scenario as written in the eye-opening article above.
2. The second scenario is not far from the one that happened a hundred years ago with the Spanish flu. Here you can use technology that has been developed over a hundred years, such as Shin Bet training, isolation of at-risk populations and, above all, strong public discipline. A combination of these steps may cause the virus to fade by itself within a year or so.
And here comes the million dollar question, is it better to risk and allow people to develop antibodies themselves? Recent evidence suggests that the effectiveness of immune system antagonists is temporary and hence the Swedish model has failed. On the other hand, within a hundred years we have evolved from a local economy and almost an autocracy to a worldwide collective or to a small global one. And going back in time to an almost absolute shutdown as was the case during the Spanish flu could also be devastating. Therefore, in prudent risk management, one should take a pessimistic and not the most pessimistic scenario and calculate between a worse alternative and a worse one.
Thanks for an enlightening article, even if it is quite pessimistic and realistic. What about a combination of scenarios: vaccination for several percentages of the population together with a percentage of people who have recovered and thus we will reach the vaccination of the herd? And what about each experimenter having himself a small "laboratory", and after a short time he will donate antibodies to his entire family? Is such a thing realistic? You have to think outside the box of factories that produce dishes for all humanity.
All the scenarios are not exactly joy-inducing, perhaps heart-wrenching, from bad to very bad to very very bad,
By and large, we are left with the same technology that people had 100 years ago during the Spanish flu, but the truth is that this is a technology that does work, but unfortunately only in countries such as Taiwan because it has an element of discipline of the general population, the basis of this technology is a mask, disinfection, and keeping a distance, and the additional step is surveillance and isolation after each Anyone who comes in contact with a confirmed patient and here lies our problem in all these parameters we fail, quite amazing,
The modern technologies that exist now can only treat the symptoms and this requires a great effort by a skilled and large medical team, and here is our next problem, the medical system on normal days is stretched to the limit
One look at an ordinary boarding school in Israel, where people are thrown like dogs in the corridor, waiting hours for the emergency department, is clear
the bleak picture, such a system can only give a good answer to a small amount of infected people who need supportive care, because we are failing with the only measures that almost exist (there is also a shutdown) the medical system will begin to collapse as soon as the number of people supported rises a little above normal and we have already seen this in one of the hospitals, no Of course, they forgot to blame the medical staff, but that's the problem, very skilled people don't come from Mars, it takes time to train,
So you get people who are doing their best which is not the maximum that can be reached, but we have not yet reached the bottom of the pit because it can also be much worse like in Bergamo where people get sick and are told in a hospital that they have nothing to come to because there is no more room and they die at home just like in naval epidemics intermediate,
We must always remember that under the facade of the modern setting there is also a medieval reality where despite all our amazing abilities people continue to die of cancer and all kinds of other incurable diseases at least today
where you stand in front of the specialist doctor and you realize that behind him there are no more sisters-in-law he did the best he could that the expertise he has in this matter is to explain to the sick person that he does not have much time left to walk under the sky of the earth, and this is exactly what we will get with the corona if we do not use the maximum of the available means us
We will get the hell of the Middle Ages, one of the conclusions in the article and from the entire story of the Corona that there are things that take a long time in technological development and knowledge if you did not invest money, efforts and education (yes education) in time and that was many years ago, there are no faces that come out of the hat, you are just like the people of the Middle Ages. And all you have left is crying for your loved ones, your relatives or yourself, even the quarantine is only effective for the duration of the quarantine, but it is not limited in time
It must come with the exit from it at the right time with a continuation of crazy strictness at the hypochondriac level of every detail, masks on the elbow do not work, masks on the throat and chin do not work either, even masks that the nose peeks into are reduced to only the spray of speech, just as eyeglasses do not Helpers with you put them on the head instead of the eyes, more tips despite our closeness to dogs we don't cool ourselves with the tongue so the instruction to take off the mask when it's hot didn't exactly contribute to the fight against Corona because basically the entire Israeli summer is boiling,
And we are not the only country that is hot, but there are countries in the Far East that is not what will make them take off the mask, there is another interesting thing in our districts that there is a greater fear of telling a child in the first grade to put on a mask from catching Corona, the fear is so great that no one has imagined that the child can also be told Wear a mask in the garden
So everyone sits together and infects each other and in the end also infects the father and mother, the grandfather and the grandmother, the uncle and the aunt, and then we get dismal results, in conclusion, if you want to fight this, you have to learn from the best and that is Taiwan since the beginning of the epidemic without closure, the number of patients is less than half of the patients we had in one day yesterday
, to mention yesterday we also had 8 dead and this number will rise to tens of hundreds and more than a thousand if we don't stop the
The tsunami of pain now, either Taiwan or Iran, the choice is in our hands.
It is likely that there will not be a vaccine because there is no vaccine for similar diseases. If so, the virus may change because it is very common and therefore the chance that it will change is great.
You didn't mention anything about how many success rates the vaccine has....with a 50-60% vaccine that pushed it into a corner with step shortcuts and new technologies, who would want to try and be the guinea pig?!?
Is it possible to inoculate against the chopchiks on the face of the virus? Corona and a few more
Dangerous viruses, including the flu that kills many people every year.
My humble opinion [I will give] that there is a difference between Sars and March and between Covid-19
Obsessed with "tourism".
There is graceful, there is luxury and there is excessive-unnecessary-harmful as the main goal.
And as in the prayer of Alkalists Anonymous - they must be distinguished.
Roy, I delved into the information about the vaccine, but it sounds like there are a number of exceptions in the development of this vaccine:
1. There is the involvement of countries that do not pay attention to the safety of the examinees, such as China and India. If they shorten times and processes while putting (their) public at risk and in the end a vaccine whose safety is proven will be obtained, it will still be used in the western world as well.
2. It is easy to find volunteers who will risk their health for the sake of creating the vaccine and the American authorities, including the FDA, are willing, to a certain extent, to speed up processes, especially bureaucratic processes.
3. Huge sums are invested and the number of researchers on the matter is enormous.
I agree with every word, but there is news: the US government has invested 1.6 billion dollars to establish a production system that will prepare 100 million vaccine doses for one of those vaccines that are currently being developed. It is likely that they will continue and invest the same amount for another 50-70 vaccines in development. The calculation is simple: you can invest 200-300 billion dollars to produce vaccines that have been tested and proven to be successful in monkeys, but have not yet been tested in humans, in the hope that one of them will succeed. This will save at least half a year and maybe even a year until the vaccine reaches the population. If one of the vaccines succeeds, the gamble will pay off big, boosting the US economy by trillions. If the bet fails - it doesn't matter. The situation will be simply horrible. What is clear is that there will be no export of the vaccines from the USA until the entire population there is vaccinated.
In Israel, a scientific organization should be established that will prepare several plans for several types of vaccines - each type and its production facilities, prepare facilities with clean rooms in the necessary space, prepare work teams and train them, buy raw materials, etc. For each type of vaccine, check what are the bottlenecks that delay the production in large quantities and make some investments in advance. Then when it becomes clear that there is a successful vaccine, start producing it. Such a preparation could save about half a year in bringing the vaccine to the population. The problem with the current political situation is that it is not clear to me if there is a possibility for such a move.