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Drugs and vaccines for coronavirus. Current state of research

Coronavirus/ COVID- 19 still attacks. Another week of my self-isolation and working with offspring at my side has passed.  I have started getting used to it, so maybe I shall not get crazy  after all. Although you never know because from time to time I read  internet  or listen to the radio (I have not had TV for years now). Coronavirus pandemics  everywhere. Sometimes there is news about drugs and vaccines for coronavirus  but the impression one gets is that only a few companies are working on them.  That’s why I decided to check myself what is the REAL and current state of research on drugs and vaccines for COVID-19. How many clinical  studies are being conducted and  where? And most of all: when are we going to see their  results?

 

 

 

 

DRUGS AND VACCINES FOR CORONAVIRUS:  728 CLINICAL TRIALS

 

 

To start with, there are far more than just  a few companies in the world are working on a COVID-19  medicine or vaccine. The most up-to-date data, from the 10th of April 2020 show that there are 728 clinical  trials related to coronavirus being conducted globally at the  moment.

 

Drugs and vaccines for coronavirus. Current state of clinical research.

 

The number and the current status of clinical trials on drugs and vaccines for coronavirus globally. The status from the 10th of April 2020.  

 

 

 

For comparison, only 6 days ago, on the 4th of April this was  almost  300 trials less. Please check Polish  version on this post from the 5h of April to find out yourself – the diagrams are in English.   

New research and clinical trials are coming at a cosmic pace. Which is  good news for  you, me and the rest of humanity, of course.

 

 

ONLY 37 CLINICAL TRIALS ON THE COVID-19 VACCINE

 

 

 

 

Unfortunately, most studies are currently being conducted on the drug, not the vaccine. The data from the 10th of Aprils show that just 37 clinical studies being conducted now are  vaccine tests.

Moreover, the overwhelming majority of the clinical  trials over the vaccines have not gone beyond phase II clinical trials yet.  Here, I only remind you  briefly that healthy volunteers are involved in phase I and patients suffering from an illness participate in  phase II and III of clinical studies.

Returning to the current state of research on drugs and vaccines for coronavirus, as you can see from the diagram above, we are much closer to the development of a  drug than a vaccines.

This is mainly due to the fact  that some anti-virus drugs which have been  either in clinical  trials or  even already registered for use, are being tested now as potential cures for coronavirus.  As  you  have noticed, the  diagram above displays also  phase IV clinical studies. These are so called “observational  trials” during which one  observes the effects of  medicines which  have been registered and approved for use already.

 

 

coronavirus

 

 

 

 

 

DRUGS AND VACCINES FOR CORONAVIRUS: WHO AND WHERE IS WORKING ON A DRUG? 

 

 

 

 

 

 

 

Despite that there are 728 clinical trials on drugs and vaccines for coronavirus at the moment, only… 175 potential drugs have been reported so far.   I please mind that  164 of them are still in a preclinical phase. This means they have not left laboratories yet (including test on animals).

Okay, so who and where is working on these drug for coronavirus??

The answer is quite easy to predict: primarily pharmaceutical companies from the USA and besides them also  the Chinese, Canadians, the Japanese, the  British  (including  GlaxoSmithKline)  and  very recently also Germans and Italians have joined the  race for   COVID-19  medicine or a vaccine.

Details in the diagram below:

10APR2020: status of clinical studies on drugs and vaccines for coronavirus
Who and where is conducting clinical studies on drugs and vaccines for coronavirus globally. The status from the 10th of April 2020.

 

 

 

 

 

DRUGS AND VACCINES FOR CORONAVIRUS: ARE THE CHINESE THE CLOSEST TO DEVELOP A DRUG FOR COVID-19 ?

 

 

 

 

 

 

All right, so numerous companies are working on dugs against coronavirus  but who is the closest to succeed?

In my opinion: the Chinese. To be more specific,  Ascletis Pharma Inc, a  Hong Kong-registered biotechnology company  which is the only one having a potential medicine in a phase III study. Again, please compare the diagram  on the development of COVID-19 drugs included in the Polish  version of this post.

Ascletis are exploring the possibility of treating patients with  coronavirus with danoprevir, a drug which  has proved to be  effective in modern treatment of hepatitis type C.

In a nutshell:  danoprevir  prevents the multiplication of the  virus causing   hepatitis type C by preventing the translation of the genetic information of the virus into a specific protein structure.  This means  the virus cannot “connect” to the human body to multiply in it freely.

Here I say  huge and laud “pardon” apologizing all experts on hepatitis type C and  viruses if I have  mixed something or simplified too much, just let me know in the comments.

Important that, danoprevir  can make life difficult for the coronavirus just like the hepatitis wirusowi  virus. Or at least that’s what the bosses of Ascletis Pharma Inc.say.

National quarantine in Poland - keep  your distance, please
National quarantine in Poland – keep your distance, please

 

 

 

 

 CAN THE RESEARCH ON DRUGS AND VACCINES FOR CORONAVIRUS

 BE ACCELERATED FROM AN ORGANIZATIONAL PERSPECTIVE? 

 

 

 

 

 

Conducting clinical trials on medicines and medical device is heavily regulated organizationally,  ethically and legally.

For instance it is impossible to omit any  phase of a clinical study over a new drug if one wants it be successfully approved  for usage.

The question is: if in this a very unique situation, it would be possible to speed up somehow  the  clinical  studies in COVID-19 drugs?

So far, the answer is not too much, but that can change.

On the 18th of March  the International Coalition of Medicines Regulatory Authorities  (ICMRA) held a virtual meeting of its members to discuss the course of COVID-19 related studies.      Experts from the World Health Organization (WHO) , representatives of the European Commission and the European Medicines Agency (EMA) also  joined this discussion.    You can read the main points and conclusions of the deliberations yourself by clicking this link.

Experts were skeptical about skipping  phases of clinical trials for coronavirus studies, although they  were not against some simplification after all.

For instance if an animal testing proves promising, it can be allowed to start  test on humans   simultaneously, provided appropriate informed consents are obtained. The experts also suggested to perform the initial phase I  clinical testing rather on  younger volunteers.

 

 

 

 

 

 

Coronavirus- when we shall get back to normality?

 

 

 

 

 

 

 

CAN THE RESEARCH ON DRUGS AND VACCINES FOR CORONAVIRUS

 BE ACCELERATED FROM A LEGAL PERSPECTIVE?

 

 

 

 

 

And  how about the legal side of clinical  studies?  Maybe here one can count on some serious acceleration  in legal assessment of the documentation  required to  issue a permission  to  register and start  COVID-19  related study?

Well, the main problem is that there is no  global clinical trial registration system (i.e. confirmation that the study has a positive ethical and legal assessment).

For now, every country in the world regulates the process of registering research on its own and in line with its applicable laws. The international  regulations will not  help us here.

For example, the Polish  registration authority , i.e. the President of the Office for Registration of Medicines, Medical Devices and Biocidal Products (the President of the Office), communicated  on the 23rd of March that the pandemics state would not  affect the form  of  the proceeding, documentation or signature of documents submitted to the President of the Office. The regulations of Polish Act on Pharmaceutical Law and The Code of Administrative Procedure (CAP)  will need to be observed  – no  changes here.  To make it even more interesting, due to additional anti-coronavirus laws which have been processed   by Polish Parliament and have become effective very recently,  the  procedure in front of the President of The Office can actually take longer than  before the epidemics with  none consequences for the Office as a representative of the public administration.

Luckily  for  the Poles, neither the provisions of the CAP, pharmaceutical law nor this new anti-coronavirus   legislation  prohibit the President of the Office to accelerate  the assessment  of the application for an administrative permission  on a conduct of a clinical trial for a drug or vaccine for coronavirus.

And the President of the Office apparently intends to use such a possibility because in the communication of 17 March  the Office asked   all the documents  related to COVID-19 studies  are  marked  by  adding   the note “concerns the sars-cov-2 coronavirus” on the front page

The President stressed that such a designation “will help the Office’s staff to give priority to cases related to the SARS-CoV-2 coronavirus.

Of course, this is just a declaration. But let’s stick to that.

As a consolation, I  have not seen so far any really solid declarations on accelerating the approval process for a COVID-19 study from any  country specific regulatory authority. US FDA  has stated they will follow 24-hour-long revision and assessment of  coronavirus related documents under their CTAP (Coronavirus Treatment Acceleration Program)   but if they  do not  manage to do so, then, as far as I am aware, there will be no consequences.

We shall see what the future brings.

Best regards, Prawstoria.

P.S. When creating this post,  I used publicly available data published and updated by the Pharmaintelligence.com  an on-web service specializing in gathering  and processing of information for the pharmaceutical industry. All reports I have used are free and publicly available. However, the materials are published only in English and Japanese.

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