The new coronavirus pneumonia vaccine, when will they be ready?

In the real world, scientists and doctors don’t have Aladdin’s lamp in their hands this is the third science piece about this new coronavirus pneumonia. As I mentioned in the first science, when a new type of infectious disease, the number of cases and the number of deaths is still rising rapidly, the subconscious question is, “When is there a special drug?” “When is there a vaccine? “。

These problems are of course very natural, drug treatment disease, vaccine prevention of disease, if there are these two things in hand, in theory any infectious disease can be easily solved by us.

Unfortunately, in the real world, scientists and doctors don’t have Aladdin’s lights in their hands.

In the real world, even if the development of new drugs and vaccines is in full swing in the first place, with significant resources invested and green light released, there is little chance that it will play a decisive role before the outbreak ends. This is certainly not to say that new drugs and vaccine development should not be done, very should! But perhaps their greatest value is to help us fight the possible future resurgence of the epidemic.

The new coronavirus pneumonia vaccine, when can we wait?

In the real world, one possibility is that, as the outbreak subsides, the resources invested in new drugs and vaccines will shrink dramatically, and even if developed, it is likely that they will not find enough people to do clinical tests (quite simply, infectious diseases are gone where you can find a large number of infected people to do the tests), and then no more.

This is certainly not to say that we are helpless in the face of infectious diseases. In my first science, I emphasized that isolation, this ancient and crude method, can actually help us fight all infectious diseases, especially the very infectious diseases (the milder infectious diseases are not impossible, but generally consider the balance of social costs, will not take such extreme measures).

As long as the source of infection is isolated, cut off transmission routes, protect vulnerable people, then the new coronavirus pneumonia, the infectious disease will be restrained in the short term.

And to fight pneumonia caused by viral infection, clinicians have long had a mature system of methods, high-intensity support therapy plus antiviral therapy, the vast majority of patients can be effective lying.

You might be curious: it doesn’t seem to be right? What kind of good news do I see in the news these days? Scientists from different research institutions have found a lot of special drugs, and vaccine development is not said to be very soon?

Yes, there’s a lot of news. Let me list a few briefly:

Beijing Health and Care Commission said that a special anti-AIDS drug Clite (Lopinave / Litonavir) may be effective for the new coronavirus pneumonia, the drug has also entered the National Health and Reform Commission’s treatment program (third and fourth version). Wang Guangfa, director of the first hospital of Peking University infected with new coronavirus pneumonia, was able to recover from this medicine.

The team at Fudan University in Shanghai has developed an antiviral spray that is said to be effective in preventing new coronavirus infection and has been used by first-line medical staff.

A team of researchers at Peking University’s School of Basic Medicine used an artificial intelligence drug screening system to find a variety of potential drugs, especially the commonly used drug Mushutan, which may be able to fight virus invasion.

The team from Shanghai University of Science and Technology and the Shanghai Institute of Medicine of the Chinese Academy of Sciences also screened 30 old drugs that could prevent the virus from invading.

A team from Tsinghua University Medical College began the work of vaccine research and development, it is said that the construction of recombinant chimpanzee adenovirus cloning successfully started, initially with the basis for assessing the immunogenicity of the vaccine, planned to start production within two months;

A team at the University of Hong Kong claims to have isolated a local virus strain in Hong Kong for the development of a vaccine, and the next step will be animal testing, followed by human trials, which have been widely circulated in the mainland under the headline “Hong Kong scientists have successfully developed a vaccine”;

Wait, wait…

Similar news I think you must have seen that, according to these news reports, we already have the special effects against the virus (Creech), will have more special effects drugs (such as Mushutan, etc.), and the development of the vaccine is in full swing, may have a chance to market in a few months.

Isn’t that good? Does this mean that our country’s scientists and doctors are very effective, effective, fighting the new coronavirus pneumonia soon will have a weapon of god?

No.

Not only is it, but I’m also afraid of these “scientific advances” flooding the headlines. If these messages are really seen and accepted by decision makers, they could seriously affect our fight and prediction of the outbreak.

The reason is very simple, drugs are good, vaccines are good, their development, production, application is a basic law, is a basic time needs! In a strong good desire, more resources, and then urgent real needs, there is no way to get around.

I’m not going to talk about too many technical details about drug and vaccine development here. In general, they all include preclinical research – human clinical trials – and the three essential links in the formal promotion and application of the program.

Preclinical studies include all necessary research done in the laboratory, including finding candidate drug molecules, testing for various safety and efficacy in cell and animal models, separating viruses from patients, preparing vaccines for large-scale cultured virus strains, testing vaccines on animal models, and more. Only in this link through a variety of tests of drug molecules and vaccines, can go to the next step, testing in the human body. Here the reason is very simple, let’s say, human life, we have to at least roughly prove that a thing is non-toxic harmless and useful, in order to give people use, especially patients?

Well, let’s assume that scientists in this segment can do the experiment at full capacity, and soon get the basic data. Harder core, more time-consuming stuff is coming: human clinical trials! We also need to find a group of people (healthy people, and sick people) to actually try out drugs and vaccines, and then continue to observe the level of drugs, side effects, and effects in these people. Only if this small group of people really proves effective can it be widely used in larger groups.

And because of the nature of human clinical trials, you don’t want to go any faster and no wheretheyed at this stage.

Recruiting subjects takes time; it takes time for a screening subject to ensure that each of them meets the requirements of a clinical trial; it takes time to take medication or inject a vaccine under strict monitoring, and then monitor the various physiological indicators of these people at a high density; and it takes long enough to see if the effect is really significant. Whether the vaccine is really protective (knowing that antibodies will take weeks to show up after a normal vaccination); it will take long enough to see if the drug and the vaccine are not long-term toxic… There is little room for acceleration in all these things.

Let’s just imagine, should have recruited 1,000 people for testing, you only used 50 people, then large-scale application, harm once magnified hundreds of thousands of people died what to do? Should have measured three different concentrations of you only measured one, and finally found that the concentration is too high poison dead people how to do? Originally such a month to see long-term toxicity, you only waited two weeks, the result of large-scale application after the third week a lot of people poisoning how to do?

Again, preclinical research – human clinical trials – formally promote the application of these three links simply can not be bypassed. Before the formal roll-out, preclinical research – human clinical trials – eliminated more than 99% of the candidate drugs – either found them useless or found that they were more toxic than good. Even this time, scientists can sift through several potentially useful, fast-track human clinical trials (we’ll discuss The Case of Creight below) and have a high success rate – historical data are not much higher – less than 10 percent of all drugs entering clinical trials are actually approved for market.

So in the real world, if it’s not a hundred thousand urgent diseases, it will take 10-15 years to develop a new drug and a new vaccine. Even if the outbreak is as rapid as the spark must be all green light, in some less critical links to do some omission and relaxation, not a few years time can not get new drugs and new vaccines!

Let’s compare another particularly serious viral infection, the Ebola virus.

A vaccine for the Ebola virus has been developed in humans, rVSV-ZEBOV, which is officially approved for release by the end of 2019. The World Health Organization personally took part and approved it at the fastest speed ever – for the reason, of course, the outbreak. But even so, the human clinical trial of the vaccine took two years to complete, launched in late 2014, recruited tens of thousands of subjects from different countries in Africa, and until the end of 2016 it was convincingly proven to be safe and effective. (https://en.wikipedia.org/wiki/RVSV-ZEBOV_vaccine)

The Ebola virus has not yet been officially approved for drugs, but it is true that two drugs, although not officially approved, have been used on a small scale (REGN-EB3 and mAb114). This is certainly a no-brainer to respond to an outbreak, but note that both drugs have been in human clinical trials for nearly 2 years (early 2018-end 2019). (https://www.sciencemag.org/news/2019/08/finally-some-good-news-about-ebola-two-new-treatments-dramatically-lower-death-rate)

I think the Ebola case speaks for it: no matter how serious the disease is, no matter how urgent our desire for new drugs and vaccines is, the pattern of new drugs and vaccines cannot be overcome. Even if Chinese scientists are faster than the world’s leading pharmaceutical research and development institutions, 1-2 years or more is a minimum requirement, even if Chinese government agencies work with unorthodox and seamless cooperation.

This means that in this new coronavirus pneumonia epidemic, as long as the isolation and other public health measures are effective, new drugs are good, new vaccines are good, there is little chance of a role.

Then you might say, well, in theory I believe you, but since the disease is so serious, can’t we take a risk? We’re just too scared, we’re just willing to try new drugs that may still be at risk, okay?

Not really.

In the face of disease, it is really difficult for individuals to resist the temptation to try new drugs and vaccines. But in practice, the decision should not be made by an individual at all! In the medical knowledge threshold has been very high today, an ordinary lay man simply does not have enough knowledge reserves to judge a thing without serious verification in the end how much good to themselves, there is no benefit, how much harm, whether they can bear this disadvantage. Too easy to enter the acute illness disorderly medical treatment, broken cans, dead horses as a live horse disorderly medicine things.

Do you remember the Fukushima earthquake grabbing iodized salt? Do you remember the SARS era when you grabbed the blue root? The truth is that if you were really eating iodized salt and drinking plate blue root at that time, you were more likely to have a problem with your body than you would have been actually exposed to SARS…

Specific to this outbreak, just now we mentioned that the AIDS drug Crech is a good example.

As far as I know, after the news of director of North Dawang Guangfa, after it was written into the health and health committee guidelines, there have been a large number of front-line doctors and patients began to urge the use of this drug.

But what they probably don’t know is whether the drug can treat the new coronavirus pneumonia, and the evidence is extremely limited! It was taken out this time on the only possible basis that hong Kong scholars tried the drug in more than 40 patients during SARS in 2004 and found that it had worked well to reduce the risk of death (Chu CM et al Thorax 2004). But even the study itself has raised serious questions from many scientists (Stockman LJ et al PLoS Med 2006). And it is not useful for this new virus, there is no human clinical data support! In contrast, even in small-scale trials, doctors observed serious side effects such as adverse heart reactions, gastrointestinal reactions, abnormal blood sugar, pancreatitis, elevated blood lipids, liver damage, and so on. Considering that many seriously ill patients themselves carry a lot of basic metabolic and cardiovascular diseases, these side effects are all the more alarming.

Of course, Director Wang Guangfa’s case does give us some confidence that the drug may actually work. But in medical practice, the preferred evidence is to design and execute rigorous randomized controlled clinical studies, followed by high-quality observational studies, and so on, the reference to individual cases must be a huge discount. Considering that many patients with neo-coronavirus pneumonia can heal themselves, and many patients can recover well after supporting treatment, it is very difficult to judge the extent to which Director Wang’s situation is related to drugs. The Ebola drug actually provides a counterexample: in 2014 two Americans were infected with the Ebola virus and were treated in the United States, when U.S. doctors tried a drug called ZMapp that was not yet officially available and undergoing clinical research in humans. Two patients were later discharged from the hospital, but ZMapp found nothing in subsequent research! (Doctors estimate that the hospital’s strong support ive therapy may have saved them.

Want to really find out whether this medicine is really applicable to this new coronavirus pneumonia patients, is not more good for them than bad, also need time!

Doctors in China have applied for a truly serious human clinical study in Wuhan (Cao Bin et al., “a randomized, open, controlled study evaluating the efficacy and safety of the 2019 new coronavirus infection in hospitalized patients with the combined standard treatment of Lopina Velitonawe), Hopefully, we can tell you as soon as possible whether the drug is really a legendary special effect, but until then, blind use is likely to come at a cost.

So does Coolidge, and other so-called “special effects drugs” are even more so, not to mention vaccines.

Again, no matter how serious the disease is, no matter how urgent our desire for new drugs and vaccines is, the pattern of new drugs and vaccines cannot be overcome. It may seem like a hurry to shorten the time and standard of research at will, but it may pay a painful price that none of us can accept!

The last thing I want to say is: Why? Why is it so crowded during this time that rumors of new drugs and vaccines are so crowded?

These things are naturally the headlines for the news media and for ordinary people.

But What I don’t understand is, Chinese scientists, why are you so anxious?

Don’t they understand the rules of new drugs and vaccine development?

Don’t they know that the cycle of the so-called special drugs they claim, their own vaccine development, may not be reliable at all, or that they simply can’t do in the short term?

Allow me to extend a little more. In addition to news about new drugs and vaccines, Chinese scientists have been scrambling to publish a series of so-called “research papers” in recent times, from “the host of the new coronavirus is snakes and otters” to the virus’s “particular vulnerability to Asian men” and a variety of unreliable mathematical models of the prevalence of the disease.

One of the things that gives me a whole feeling is a word

“Urgent.”

There is no excuse for the scientists to carry out their research quickly.

We also do have the power to explore any scientific issues of interest to us.

At this special moment, we should also devote our full efforts to infectious disease research, how much investment is worth it.

For possible new drugs and new vaccines, actively do preclinical research, accumulate enough data and actively apply for rigorous clinical trials, and strive to find a few things that are beneficial to patients for the benefit of the common people – of course, very, very good thing.

And even if these results can not be used in this outbreak, as long as they can be painstakingly studied, these results will certainly help humans to better understand infectious diseases, if the disease returns, their value is immeasurable.

But I really want to ask:

Do we really need to publish research papers so quickly that research is not sufficient, the quality of the data is low, but it is easy to catch the eye and even mislead the public?

Do we really need to give the media the so-called new vaccine, which is almost impossible to develop quickly, so that the people of the country can have false hopes and gratitude to you?

New drugs new vaccine is also good, new scientific discovery is good, can we be down-to-earth, follow the scientific law to do, until the data can convince themselves, convince peers, and then issue papers, on the media?

Where do we go as scientists who feed our Chinese people, as a group of people who know more about the laws of science than the general population, where has our historical responsibility and social responsibility gone?

Allow me to stress once again that no matter how serious the disease is, no matter how urgent our desire for new drugs and vaccines is, the pattern of new drugs and vaccines cannot be overcome. It may seem like a hurry to shorten the time and standard of research at will, but it may pay a painful price that none of us can accept!