On March 27th, the World Health Organization announced that vaccine development in COVID-19 will take at least 65,438+02 to 65,438+08 months. However, in order to speed up, some scientists started the idea of "overtaking in corners". On March 26th, Nature published an article on the front page of official website, saying that some scientists put forward radical suggestions to infect a few healthy volunteers with coronavirus in order to speed up vaccine research and development, so as to quickly detect the vaccine.
Niryal, director of the Center for Population Bioethics at Rutgers University and the main author of the preprint, pointed out in the article that if all the research participants are exposed to pathogens, researchers can not only rely on fewer volunteers, but more importantly, they can get results in a shorter time. This can greatly speed up the time of vaccine approval and potential use.
The longest time needed to test the vaccine is the third stage of efficacy test. Eyal introduced the steps of the test: first, ensure that the candidate vaccine is safe and can complete the immune response in the human body. Then, young and healthy low-risk people were selected as volunteers and given candidate vaccines or placebos in two groups respectively. After waiting for the immune response, the subjects were exposed to the virus. The researchers closely followed the subjects and found signs of infection as soon as possible. Then, check whether the vaccine group is better than the placebo group.
Eyal believes that this research can be done safely and ethically. The risk of exposure of healthy volunteers to the virus is lower than expected. He said: "For some people, joining this research may even be safer than waiting for infection and trying to rely on the ordinary health care system."
"Humans have made many important choices out of altruism. Participating in such research is actually potentially rational-even from a selfish point of view. " Eyal praised the volunteers who participated in the test as "brave". He firmly believes that vaccines are the only way to get rid of the shackles between economic stagnation and mass death.
However, in fact, vaccine development has its own cycle. Because vaccines are for healthy people, vaccines have higher safety standards than drugs for treating diseases. Under normal circumstances, it takes about 8 to 20 years to develop a vaccine for a disease, and even longer for complex diseases. In addition, the vaccine needs to be tested for safety and effectiveness in animals before it can enter human trials. The rapid spread and high mortality rate in COVID-19 have brought great pressure to the society and researchers. Under this pressure, is it really feasible to speed up vaccine research and development by "streamlining the process"?
Although there is no clear answer to this question, in some countries, scientists have really taken action. According to the Daily Express reported on March 23rd, British volunteers voluntarily contracted respiratory virus to help develop COVID-19 vaccine. These volunteers volunteered to become human infection control models, received virus injections, and were tested for vaccines and drugs. Dr. Andrew Catchpole, a scientist who participated in the experiment, said: "We inoculate healthy volunteers with human coronavirus, and we will track their onset time and then let them recover."
Previously, on March 16, in order to develop a vaccine against COVID-19 as soon as possible, scientists at the Kaiser Permanent Washington Institute in Seattle injected the first dose of experimental COVID-19 vaccine to healthy volunteers. A total of ***45 volunteers participated in the experiment and will receive the second injection one month later. Jennifer Haller, the first volunteer to receive vaccination, said: "Now people feel helpless. This is an excellent opportunity for me to do something. "
The candidate vaccine code is mRNA- 1273, which was developed by the National Institutes of Health and Moderna, a biotechnology company in Massachusetts. This vaccine was prepared in about 6 weeks after the COVID-19 gene sequence was published, and entered the first phase clinical trial in less than 10 week, although the animal experiment has not been completed.
In addition, another vaccine being developed by Moderna and Inovio Pharmaceutical Company in Plymouth, Pennsylvania, is being tested in animals, and at the same time, a phase I clinical trial in humans is being conducted. "In non-emergency situations, it may be carried out in a more continuous way. But in the current situation, many things are going on in parallel. " Barney Graham, deputy director of the Vaccine Research Center of the National Institutes of Health, said.
The reliability of directly entering human trials without relevant data of animal experiments has not been proved. It cannot be ruled out that the newly developed vaccine will bring other diseases to healthy people. Some researchers found that in a SARS vaccine study reported in 2004, the vaccinated ferrets showed destructive inflammation in the liver after being infected with the virus. Scientists say that it is relatively safe to test the candidate vaccine on animals to rule out the possibility of disease enhancement, and then test it on people.
Whether the "simplified research and development" version of the vaccine will bring other diseases to human beings is a problem that we have to face up to and pay attention to. Tan Desai, Director-General of the World Health Organization, said on the 27th that in the history of medicine, many drugs were effective on paper or in test tubes, but in fact they were ineffective or harmful to human body. He said: "We must rely on evidence, there is no shortcut."
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