Researchers at the University of Oxford say they can have several million doses of their new corona vaccine available as early as September, if they get the right permit.
According to the World Health Organization, a vaccine is the only way to stop the new coronavirus sars-cov-2 and covid-19, the disease caused by the virus.
Currently over 80 vaccines are under development and several are already being tested in the context of clinical trials.
Although it has been record-breaking to take the first steps towards a vaccine against the new corona virus, it is not as certain that it will be quick to reach an approved variant.
WHO hopes to have a completed vaccine within 12 to 18 months. In that case, it would be record-breaking, since it usually takes between 10 and 15 years on average.
What kind of vaccine is being developed?
New Technology has gone through the five main traces of a vaccine against SARS-cov-2: virus vector vaccine, DNA vaccine, RNA vaccine, attenuated vaccines and protein-based vaccines. Several of these techniques have never been tested on a large scale before. (Read more about the different main tracks in the fact box below).
This is the World Health Organization WHO's compilation vaccine candidates against covid-19, from April 20.
Derek Lowe who blogs for the scientific journal Science Translational Medicine has looked into the vaccines which is most at the forefront. Here, among other things, there are Chinese Cansino Biologics Ad5-nCov, which has already been tested in phase 1, that is, on healthy, voluntary subjects.
Cansino Biologics may be the first to start trials in phase 2, where a vaccine against sars-cov-2 is tested on the actual target group. (For more on the different phases of vaccine development, see the fact box below).
Which vaccines are being developed in Sweden?
Researchers at Karolinska Institutet develop a DNA vaccine against sars-cov-2.
For both DNA and rna vaccines, the genetic code for parts of the virus particle that speeds up the body's immune response is developed. These vaccines thus contain sequences that encode antigens from the virus, such as the “spike protein” of the current corona virus that the virus uses to invade our cells. The idea is that it is our own cells that produce the vaccine.
According to KI professor Matti Sällberg, who is part of the research group developing a DNA vaccine against the new corona virus, one of the advantages of the technology is that the vaccine can be produced on a large scale and is very stable, which is an advantage in mass vaccination. The disadvantage is that it is not enough to put DNA vaccine in a syringe and inject it. Another step is required for the vaccine to be absorbed by the cells, for example an electric shock.
There are no DNA vaccines approved for humans yet.
A finished vaccine in September?
Researcher at the University of Oxford states that they can have several million doses of its vaccine against the new coronavirus sars-cov-2 available as early as September, if they receive permission from the relevant authorities. By the end of May, the researchers should have tested their vaccine on over 6,000 people and hope to be able to prove soon and again that it is both safe and effective.
In trials of six monkeys, all should have been healthy 28 days after receiving the current vaccine and then exposed to large amounts of the virus. However, this does not mean that it has the same effect on people.
Britain launches trials on people
In the United Kingdom, a research group at Oxford University on April 23 started testing a vaccine against the new virus in humans.
The UK is said to have invested the most money so far of all countries, in pursuit of a vaccine against the new corona virus.
The research group at Oxford University has received the equivalent of just over SEK 250 million to carry out their clinical studies of a vaccine.
The British government has also given the equivalent of just over SEK 280 million to a study at Imperial College London that will start a smaller phase-2 study, where the vaccine is tested on the thinking target group.
Inovio initiates phase 1 studies
Two companies in the United States were the first to initiate clinical trials of potential vaccine candidates against SARS-cov-2 in humans. One is the pharmaceutical company Inovio Pharmaceuticals in Pennsylvania, which announced in early April that the US FDA has approved them to begin a Phase 1 trial. This means that the company can start testing its vaccine candidate on volunteers, adults and healthy people.
Inovio has chosen to use the mers vaccine to manufacture a vaccine against sars-cov-2. This enabled the company to begin work on the new vaccine as soon as the DNA sequence for the new corona virus was published by Chinese researchers in January.
“Once we got the DNA sequence of the virus, we could build our vaccine in just three hours” said Inovios CEO Joseph Kim when he attended a meeting in March with US President Donald Trump and his special task force (“task force”) for questions about the new corona virus.
The Bill and Melinda Gates Foundation supports Inovio's efforts.
The first results of Inovio's clinical trials are expected to be completed by the end of the summer.
Modern first with tests on people
The American pharmaceutical company Moderna became the first to test a vaccine candidate against the new human coronavirus. On March 16, the company began a phase 1 study with 45 healthy, voluntary adults.
Modern develops a rna vaccine. It is similar to DNA vaccine, as it also uses part of the genetic code from parts of the current virus to trigger the body's immune response. The RNA is injected and translated into protein in the cytoplasm. It is our own cells that produce the vaccine.
RNA vaccine has worked in animal experiments and several candidate vaccines against other diseases have undergone smaller clinical studies in humans. But there are no approved rna vaccines yet.
Here's how the company describes in a video how their vaccine works:
(Embed) https://www.youtube.com/watch?v=qJlP91xjvsQ (/ embed)
The entire gene sequence for sars-cov-2 is published
This weekend, January 10-11, Chinese scientists publish the new corona virus full gene sequence. It will be the start of the development of a new vaccine against the virus, which causes the disease covid-19.
How to research vaccine
In normal cases, it usually takes an average of 10-15 years of research and development before a vaccine can be used. This is partly due to the fact that there are a number of steps that the work has to go through:
1. Basic research
In this phase, researchers have seen that the vaccine can be useful, and have found a promising antigen. Now the researchers want to investigate what practical properties the potential vaccine can have.
2. Preclinical development
Here, the researchers study the potential new vaccine in a lab environment and make an initial assessment of its function and safety. Normally, this phase can last for several years. It is also only a small proportion of the vaccine candidates who pass this phase.
3. Clinical development
Phase 1: Studies on voluntary participants
After the preclinical part, the vaccine should start testing in humans. The first step is to test the vaccine on a small scale on volunteers. Here, the researchers want to find out if the vaccine is safe for humans and see what immune response it produces. The researchers want to get a picture of how the vaccine should be dosed and what side effects can occur. This stage can take about a year.
Phase 2: Studies in the real target group
When the trials of the voluntary group are complete and prove to be promising, it is time to study the vaccine in the real target groups. Here, the researchers study, among other things, the immune response to the vaccine in detail, the number of doses and what is an optimal vaccination schedule. This phase can last for a few months or for several years.
Phase 3: Large-scale vaccine studies
When researchers have found that the vaccine is safe and effective, it is time for large-scale studies, on people who belong to the intended target group. The results should be analyzed and followed up, and the safety of the vaccine undergone careful testing. This means that this phase can normally take months or years. Here you can submit an application for permission to use the product on people.
Phase 4: Monitoring after the sale is approved
The vaccine is now approved and has started to be used. Now the effect and safety of the vaccine and its impact on the population group will be followed up. To look at the efficacy and safety of the vaccine is done as long as the vaccine is used.
Five different ways to vaccine against covid-19
Viral Vector Vaccines
Virus vectors are viruses that have been modified to express antigens from the current disease-causing virus, without becoming ill. The vaccine thus triggers an immunological reaction that leads to the formation of antibodies.
For both DNA and rna vaccines, the genetic code for parts of the virus particle that speeds up the body's immune response is developed. Thus, these vaccines contain sequences that encode antigens from the virus, such as the “spike protein” of the current corona virus. The idea is that it is our own cells that produce the vaccine.
Similar to DNA vaccine, when you also use some of the genetic code from parts of the current virus to trigger the body's immune response. The RNA is injected and translated into protein in the cytoplasm. It is our own cells that produce the vaccine.
Rna vaccines have worked in animal experiments, and several candidate vaccines for, for example, HIV, Zika and influenza have undergone smaller clinical studies in humans. But there is no approved rna vaccine yet.
Here it is about weakening (attenuating) virus so that it both activates the body's immune response directly but also gets into the cells and makes a copy of itself there. The vaccine causes a mild infection, without us getting sick, so that we form antibodies against the virus. The MPR vaccine, which is given against measles, mumps and rubella, is one such vaccine.
Here, protein is derived from the virus in question and is often combined with an adjuvant, which increases our ability to form antibodies. The vaccine thus triggers an immune response that leads to the formation of antibodies.