Has the coronavirus vaccine been found?!
Why do the media constantly report on successes in the field of medicine, and there are very few successes themselves?
Semyon Yesilevsky, site.ua
On February 24, biomedical company Moderna announced that it had developed a vaccine against the new coronavirus (SARS-CoV-2) in record time – just 42 days after the virus genome was decoded.
The statement, you must agree, is loud and in a day or two catchy headlines appeared in the news in the style of "A new deadly virus has been defeated!". In fact, not everything is so unambiguous (tm) and this is a great reason to talk again about what clinical trials are, how they are conducted and why there are thousands of news about new breakthrough discoveries in medicine, and only a few new drugs.
Necessary educational program
Let's start with what Moderna has developed. This company specializes in the development of so-called mRNA vaccines, but to figure out what it is, you need to go from afar.
From a school biology course, you should remember what mRNA is... I'm kidding, kidding, of course you don't remember anything. Matrix RNA is an intermediary molecule to which genetic information from DNA is temporarily copied in order to synthesize the protein encoded in it. If you want, this is a "working tracing paper" from a protein drawing. Ultimately, it is the protein that does the "useful work" in the cell, and it is to the proteins of bacteria and viruses that immunity is developed during illness or during vaccination.
The classic vaccine in a very, very rough approximation works like this. An antigen is injected into the body – a protein of a bacterium or virus, or a piece of it that allows you to identify this pathogen – so to speak, its passport. The immune system produces antibodies against this protein, recognizing it by the key-lock principle and subsequently begins to identify the pathogen and destroy it. It is important that a ready-made pathogen protein or part of it is injected into the body.
The idea of mRNA vaccines is more sophisticated. We take not the finished protein of the pathogen, but the mRNA with which it is synthesized, i.e. not the part itself, but the drawing for it. This mRNA is injected into the body. It should be noted here that cells, in principle, do not care where the mRNA came from – from their own cell nucleus or from outside. The machinery of protein synthesis in this sense is as stupid as a door: they brought a drawing – they made a detail. Where did the drawing come from, we are generally purple. This is what all viruses use: they slip their mRNA to the infected cell in order to develop their proteins to the detriment of those that the cell needs for life.
The mRNA introduced from the outside causes cells to synthesize what is encoded in it, namely, a piece of viral or bacterial protein. Next, an immune response is formed to this protein by exactly the same mechanism as with conventional vaccination.
How is such a two-stage mechanism better? At least by the fact that such a vaccine can be developed as quickly as possible. As soon as the genome of a new virus is sequenced, you can immediately make mRNAs for different viral proteins from it and start testing them. To do this, you do not need to grow the virus itself (which can be extremely difficult, long and expensive). It is not even necessary to synthesize the protein itself – the body will do it for us for free. In addition, there is no immune response to mRNA, which makes such a vaccine devoid of local inflammatory reactions and other unpleasant side effects.
There are, of course, disadvantages. RNA is an unstable and very fragile molecule. It is difficult to store it, and in the body it is very quickly cleaved by nucleases, so delivering it inside cells is still a task that there are no ready–made working approaches to which today.
In the dry residue, mRNA vaccines are a new and very hype topic on which hundreds of laboratories around the world graze. In particular, in addition to Moderna, Creative Biolabs and scientists from the Tongji University Medical School in Shanghai announced the work on the mRNA vaccine from SARS-CoV-2, and the Chinese rolled out the first experimental sample of the vaccine even earlier.
The Curse of Clinical Trials
Unfortunately, all the prototypes of SARS-CoV-2 vaccines created to date are developments at the zero stage of preclinical trials. This is the level at which in vitro (in vitro) and laboratory animal studies are conducted. Their goal is to identify if the candidate substance has any activity at all and if it is not toxic. Phase 0 studies help to understand whether it is worth investigating this substance further or not.
Then the clinical trials themselves begin, of which there are 4 phases. In particular, in the first phase, the drug is given to a small group of volunteers to understand whether it is possible to inject it into the human body at all, i.e. the toxicity and tolerability of different doses are tested again, but at the level of the human body. In a good way, phase 1 is not yet about the effectiveness of a drug or vaccine - it just turns out whether it is more or less tolerated by the body or not. At this stage, 90% of all candidate substances are eliminated.
Actually, the effectiveness begins to be investigated already at stage 2, where the group of subjects increases to hundreds of people. If the effectiveness is available, and safety is confirmed, then phase 3 begins – those randomized controlled multicenter studies are the gold standard of evidence–based medicine. And only after that, the candidate substance becomes a medicine.
Less than 1% of all candidate substances survive to this bright moment. In particular, none of the mRNA vaccines have even passed stage 1 yet. That is, before their possible clinical use – as before the moon squat.
By the way, after the sensational news, Moderna increased its market capitalization on the NASDAQ exchange by a fantastic 28% (!) – to $ 8.6 billion. At the same time, this company is not bigpharma at all, it is an independent biotechnology company that has 17 (!) different mRNA vaccines, including for certain types of cancer, in development and at the early stages of clinical trials (stages 0 and 1). Tellingly, Moderna still does not have a single registered drug. In general, there is a rather skeptical attitude towards this company. They are very similar to banal babblers who skillfully hype in front of venture investors on the fashionable topic of mRNA vaccines, but they have never demonstrated anything really working yet.
Why do scientists rape journalists so often
Another interesting effect in the media sphere is connected with this. Thousands of substances undergo preclinical (zero) stage and the first stage of clinical trials annually. Pharmaceutical companies and scientific groups around the world bake them like pies. As soon as a new promising substance appears, the developers immediately make a loud press release (you have to report for grant money). The media immediately pick it up, reinterpret it, supply it with clickbait and jaundice, and it turns out "a cure for cancer has been developed" or "a vaccine for coronavirus has been found." In general, the classic case of "a scientist raped a journalist."
The joke is that if the media does not write about the results of phases 0 and 1, then they will have nothing to write about at all. Successful drugs that have passed at least phase 2 – units per year. At this, there is no way to make a constant stream of thematic news, no way to catch up with views and no likes to collect. So the poor journalists have to report every couple of days about a new drug, which then dissolves forever in the world ether.
Conclusions:
- There is no vaccine against coronavirus to date, and it is not a fact that it will appear soon.
- There are several competing developments of mRNA vaccines that have entered the first stage of clinical trials. According to statistics, less than 1% of all candidate substances pass it, i.e. the probability that we will still receive the vaccine is much less than a percent.
- The next time you see the news that a vaccine has been developed, look for information about the phase of clinical trials. If you do not see "phase 2 has passed", then you can immediately close and not read – there is a bunch of such good for a ruble on a market day.
Portal "Eternal youth" http://vechnayamolodost.ru