On March 21, according to the science and technology daily, the recombinant new crown vaccine developed by the research team of the Academy of military medicine of the Academy of Military Sciences led by academician Chen Wei started human injection test, and a group of volunteers have been injected.
This means that key progress has been made in the new crown vaccine development race. How long before the new crown vaccine goes on the market? What are the next processes? In the face of public doubt, the reporter of Beijing News interviewed Ding Sheng, Dean of the school of medicine of Tsinghua University and director of ghddi.
He said the human trial of the vaccine was a breakthrough, “like putting a flag on a runway.” But next, the vaccine still needs to be tested for safety and effectiveness evaluation, “at least next year when it is put on the market.”
After the outbreak, Tsinghua pharmaceutical college and ghddi research team led by Ding Sheng devoted themselves to drug research and development. He believes that in response to the epidemic, many teams have invested in research and development, and the current development of drugs and vaccines is accelerating. The more people start, the more people may end up at the end.
“It’s a historic speed and efficiency.” Ding Sheng thinks that the public’s urgent mood can be understood, but from the perspective of scientific laws, we need to have some patience.
5343 words reading takes about 11 minutes
Breakthrough: human trial of vaccine is a node, which will be launched as soon as next year
Beijing News: Recently, the clinical research of the new crown vaccine has entered the human trial stage, and the volunteers recruited in early Wuhan have been vaccinated one after another. Is this an important progress?
Ding Sheng: This is a milestone breakthrough, and it’s a very important step. But this is also an early step in clinical trials, and no more judgment can be made now.
This process has been accelerating. Now it’s like running somewhere, setting up a flagpole and entering a landmark stage. Then we have to observe its safety and effectiveness related indicators.
Beijing News: what will these indicators evaluate?
Ding Sheng: it will take a long time to develop a vaccine. The clinical trial of human body should start from safety test, and then effectiveness test. This is the basis for the vaccine to be available on the market.
Vaccine is a protection for healthy people, and it is widely used in people, not for several people. Therefore, the requirements for vaccine safety are much stricter than those for therapeutic drugs. In addition, whether a vaccine has a protective effect, that is, its effectiveness, also needs a certain period of time for clinical trials.
Beijing News: how to understand the safety of vaccines?
Ding Sheng: to put it simply, the vaccine should not be injected into healthy people. For example, when a vaccine is injected into a healthy part of the human body, it may cause allergies or excessive autoimmune reactions.
Another case is the antigen / pathogen specific adverse reactions. For example, some vaccine studies have found that it can make normal people more susceptible to diseases. This is an immune response called “disease enhancement.”.
Beijing News: how is the validity verified?
Ding Sheng: to verify the effectiveness of a vaccine, it needs to be carried out in the presence of disease infection. If the infection is still occurring, one group of people will receive the vaccine, and the other group (control group) will use “placebo”. Only if the infection rate of the group using the vaccine is significantly reduced, can the vaccine be effective.
The data must show statistically that the infection rate has indeed decreased significantly. Such clinical trials require a large number of people. The lower the infection rate is, the more people are needed in clinic, and the longer the time is, the more effective signal can be seen.