VACCINES DATA ANALYSIS
COVID-19: First Vaccines in Clinical Trials
An updated review on vaccine development around COVID-19
Vaccination is one of the most effective ways to prevent diseases, and therefore one of our greatest hopes at the moment. However, unless an already existing one proves to be effective, their development requires a significant amount of money and time that very few countries or companies can afford.
According to the latest WHO report, released last Saturday, there are 70 vaccines under development across the world. Only 3 of them are on ongoing clinical trials and a few more are just about to start their own.
This article will review the most recent advances around vaccines for COVID-19.
We will see where are they being developed, their significance compared to all clinical trials, how many voluteers are they planning to enroll in their experiments and how far they are from completion.
How many Vaccines are planning to go or on ongoing Clinical Trials?
As stated in my previous article, a useful criterion for tracking the most recent advances towards treatment development is monitoring ongoing clinical trials.
When it comes to vaccines, we should notice that there are 8 different vaccines in a total of 11 clinical trials.
This represents only 5.26% of the total number of trials aiming for treatment, as we can see in this chart.
Where are they being developed?
As we can see in this map, there are only 5 countries involved in vaccines clinical trials, and from the 11 clinical trials, 8 are concentrated in two countries: USA and China. The rest of them are distributed between UK, Netherlands and Canada, with only one each.
The 8 Vaccines on Clinical Trails
Now that we know where they are being developed, we can start focusing on each of them individually. First of all, let’s present them.
From this list, the only ones whose clinical trials have already started are the ones developed by CanSino Biologics, Moderna Therapeutics and Inovio Pharmaceuticals, which are the ones mentioned in WHO’s report, and also BCG, which was not mentioned. As we can see, this last one has the most clinical trials registered at the moment.
Secondly, another important aspect that we should take into account is in which Phase each trial is. This is a useful way to measure how far each vaccine is in its development pathway.
As we can see in this chart, apart from BCG, only one of them could reach a pure phase 2 clinical trial. When in Phase 1, scientists try to determine the vaccine’s safety. As soon as they are confident it is safe, it moves to the next phase where they test if its effectiveness in a small group of people. The only one that seems to have reached this far is the one developed by CanSino Biologics.
Some of them, such as the ones developed by the University of Oxford and Geno-Immune Medical Institute, have proposed combined phase 1 and 2 clinical trials. This is a useful strategy that tries to shorten the path by accomplishing many objectives in less time than when they are done separately.
Finally, the last thing we can measure is the number of people that these trials plan to enroll:
Again, we can see that BCG keeps standing out from the others. This was predictable at this point since it is the only one with larger clinical trials. We can see that all the other ones involve very few people in comparison.
Now that we have gone through all this data, we can do a brief description of each of these vaccines
BCG
The 100-year tuberculosis vaccine seems to be the most popular in this group. With 3 ongoing clinical trials and more than 5000 people involved, its revival spread across the news during the pandemic.
There are two reasons that explain its novel “popularity”. The first one is that it is the only old vaccine in the group, so scientists know it is safe to use. Secondly, it had some previously known “off-target” beneficial effects that might apply to COVID-19.
Its potential protective effects combined with its already known safety profile explain why BCG was chosen to protect health workers.
As we mentioned before, it was not included in WHO’s report, maybe because current hopes are not for it to be a cure, but to be the first line of protection for those who are most exposed.
CanSino Biologics Inc.
This Chinese company was the first one to move its novel vaccine to phase II last week. According to this disclosure they presented to the Hong Kong Stock Exchange, the decision was made based on the preliminary safety data of their Phase 1 clinical trial, which was not revealed.
As we could see in the last graphic, 500 people will be part of its new clinical trial which estimated completion date is at the beginning of 2021.
Moderna Therapeutics
The first participant of Moderna’s mRNA-1273 Phase 1 study was dosed on March 16th. The trial aims to enrol 45 healthy adult volunteers in the next six weeks.
Even though the vaccine, if proven effective, is not likely to be available for at least 12–18 months, the company stated that it could be accessible in case of emergency in the fall of 2020. Besides, they confirmed that they are scaling up their manufacturing capacity toward the production of millions of doses per month. More information available on their website.
Inovio Pharmaceuticals
Inovio’s INO-4800 DNA vaccine, backed up by Bill and Melinda Gates Foundation among others, started the first dosing for their 40 healthy volunteers last week. Each participant will receive two doses four weeks apart, and the initial immune response and safety data are expected by late summer.
This company has some prior experience on coronavirus vaccines since it has previously completed a Phase 1 study for MERS, which showed promising results. This wisdom allowed them to scale up quickly and produce “thousands of doses” of INO-4800 in a few weeks.
Oxford University
The clinical trial behind this third vaccine, called ChAdOx1 nCoV-19, has just stopped recruiting volunteers due to the enormous amount of applications they received in the last few days.
During the trial, scientists will randomly divide participants to receive the vaccine or a control injection to assess the vaccine’s safety profile and also if healthy people can be protected from COVID-19 or not. As before, the estimated completion date is in the beginning of next year.
Symvivo Corporation
This Canadian company was the last one to submit a clinical trial proposal. The study of this vaccine, called bacTRL-Spike-1, aims to enroll 84 people, with 63 receiving the active vaccine and 21 placeboes. Its estimated start date is at the end of the current month, and its full completion is projected for the end of next year.
Shenzhen Geno-Immune Medical Institute
This Chinese medical institute is the only one with more than one vaccine proposed for a clinical trial. In fact, their aAPC was the first one to appear in the clinical trials database. Both studies are still recruiting volunteers.
Final Thoughts
There are at least 70 projects related to vaccine development for COVID-19, of which only 4 are on ongoing clinical trials. Apart from BCG, all of them are still in the early stages and most have yet not proven to be safe. Even though the amount of research going on is huge, there is still a long journey ahead until a vaccine is commercially available for everyone.
As we could see, vaccine development represents a small percentage of the total amount of clinical trials that aim for treatment. This may mean that our hopes should not be in vaccines for the short term but in other types of treatments.
However, the immense number of projects being carried out shows us that the possibility of a vaccine being released sometime in the future is real.
Database
- National Library of Medicine: Clinical trials on COVID-19. https://clinicaltrials.gov/ct2/results?cond=COVID-19. Studies aiming for a treatment were filtered and updated until the 9th of April.
