Early clinical trials results of global pharmaceutical and biotechnology companies are positive
Former AstroGeneca Modena Kanshino leads the way
Vaccine development techniques such as viral vectors, DNA, rna, etc.
AstraZeneca enters clinical phase 3, likely to launch within the year
“Developable within a year” vs” “low probability of early development” opinion
A new type of coronavirus infection (corona19) is igniting the speed competition in each country for the development of vaccines. Recently, research institutes and multinational pharmaceutical and biotechnology companies have announced the results of a series of positive clinical trials, raising expectations for early development of vaccines. Some have cautiously raised the possibility of annual supply.
However, there is also a cautious argument that the safety and effectiveness of vaccine candidates has not yet been verified through large-scale clinical trials.
According to the World Health Organization (WHO) on 23 March, there are currently 24 corona-related vaccine trials worldwide. More than 150 vaccine candidates are also available in the preclinical stage.
According to the New York Times’s Coronavirus Vaccine Tracker, astrazeneca, Oxford University, China Sino-Palm, Wuhan Bioproduct Research Institute, China Sinoback Biotech, and Murdoch Children’s Research Institute in Australia are in the three-phase test phase. After completing the second prize, China’s Kansino Biologics was the only one to receive emergency use approval from health authorities. U.S. pharmaceutical companies such as Moderna, Johnson & Johnson, and NovaBacks are currently in clinical phase 2.
To date, uk, US and Chinese companies have been leading the way by announcing positive clinical trial results. The University of Oxford, which is working with AstraZeneca, published the results of an initial clinical trial of the Corona vaccine in the medical journal Lancet on 20 March. As a result of administering vaccine candidate substances (ADZ1222) to 1077 adults in April, the protective neutralizing antibodies and immune T cells increased in the body of all participants. Neutralizing antibodies and T cells are known to play a role in destroying the virus.
U.S. companies are also speeding up vaccine development. Modena announced in the New England Journal of Medicine on 14 March that antibodies to all 45 people were formed in a clinical phase 1 trial of vaccine candidate (mRNA-1273). Pfizer said it succeeded in inducing an immune response, including the formation of neutralizing antibodies, in a second initial clinical trial conducted with German biotech and 60 volunteers.
The results of a joint clinical trial conducted by Chinese pharmaceutical company Kansino Biologics and Chinese military researchers were also announced. Cancino reported in a second clinical trial published in The Lancet that the majority of the test group had a high level of immune response as a result of administering vaccine candidates (Ad5-nCoV) to 506 subjects.
◇Various vaccines such as viral vectors, DNA, RNA, etc. are being developed
Global pharmaceutical and biotechnology companies are using a variety of technologies to develop the Corona 19 vaccine. According to the Food and Drug Administration, various types of corona 19 vaccines are currently being developed around the world, including viral vector vaccines, inactive vaccines, DNA vaccines, RNA vaccines, recombinant vaccines, and virus-like particle vaccines.
Viral vector vaccine is a method of administering the virus antigen gene put in another virus that does not harm the human body. AstraZeneca and China’s Kanshino are making this type of vaccine. AstraZeneca writes chimpanzee adenovirus as a carrier (vector). Cancino uses a denovirus type 5, a human cold virus, as a vector.
DNA vaccines and RNA vaccines are a way to inject genes. This gene produces a protrusion (spike protein) that viruses use when they cling to the human body. Depending on whether the gene is put into a double helix structure DNA or a single strand rna is divided into two types. Modena and Pfizer are developing rna vaccines and U.S. biotech company Innovio is developing a DNA vaccine.
Recombinant vaccine is a method of administering a viral antigen protein made of gene recombinant technology. U.S. pharmaceutical company NovaBacks uses this technology. Inertization vaccine is a traditional technique for administering to kill the virus, china’s sinobaek and sino-palm, etc. are adopting this method.
Experts believe that the technology used by each company could also affect the success or speed of vaccine development in the future.
“AstraZeneca (viral vectors) and Moderna pfizer (RNA) are among the safest vaccines. Even if the vaccine material enters our cells, it cannot be inserted into the genome,” he said, “the DNA vaccine that Inovio is doing may break in our body and be inserted into the genome.”
Professor Sul added, “When inserted into our genome, it can cause mutations over the years, and if we are unlucky, we may have mutations such as cancer, so what technology we use is related to the safety of vaccines and the (verification) period.”
“It is a weakness that modna does not have a vaccine licensed (in the mRNA way) so far,” said Kim, professor of infectious diseases at Ancient Guro Hospital. That’s why there’s a lot of lines on the AstroGeneca side.”
Professor Kim said, “Kanshino is a denovirus vector in humans, and clinical results show that the vaccine rate is relatively low for people who have already had antibodies to a denovirus cold, and the corona 19 virus antibody production rate is relatively low.”
◇”Vaccine release possible within one year” vs” probability is less than 5%
Global pharmaceutical and biotechnology companies are releasing positive clinical trial results on a daily basis, raising expectations that the Corona 19 vaccine could be released early. Assuming that the time it takes for clinical phase 3 is very short to 3-6 months, it is likely that the development is completed within the year.
AstraZeneca plans to conduct large-scale additional clinical trials around the world, including the United Kingdom (10,000), the United States (30,000), Brazil (5,000) and South Africa (2,000). The company expects the vaccine to be released in the UK in September this year and in the US in October.
KanshinoBio obtained the Chinese military’s special award sanction sanction last month. This means that vaccines can be used for military purposes. The company is also reportedly in talks with Brazil and Russia to conduct phase 3 clinical trials overseas.
Modena is scheduled to enter phase 3 from 27. The vaccine candidate (mRNA-1273) that Modena is developing can be approved relatively quickly if successful in clinical trials receiving a fast track designation from the U.S. Food and Drug Administration (FDA). The FDA is in the position of allowing the release if the efficacy of the vaccine being tested is more than 50% higher than the placebo (fake drug). For faster vaccine development, the threshold was lowered from the existing approval criteria (70%).
In a policy discussion on corona 19 drugs and vaccines held on 21 July, the head of the Corona 19 therapeutics and vaccine-related policy discussion sat down for a year to finally confirm that the vaccine was effective by doing three clinical phases, and the safe vaccine will be approved and released on the market in August next year, and it appears that it is possible to appear at the end of this year if we see it in six months in a hurry.”
However, Mr. Muk said, “Objectively, it seems very difficult to pull by the end of this year, and i think it is most reasonable to make a decision based on the situation in which the vaccine was vaccinated for about a year,” he said. And by July next year, 15 vaccines will follow, and the probability of success will be more than 50 percent.”
However, many experts say it is difficult to be optimistic about the situation, given that it typically takes years to develop vaccines.
Professor Kim said, “If you look at the experts’ reports, there is a 7% probability (of success) starting with phase 1, and the really important thing is the three phases (which are going on a large scale) and often sit down in phase 3. It is only a wish to complete the development within one year.”
“It’s almost miraculous that phase 1 and phase 2 data came out in six months, and it’s positive that antibodies are formed and neutralized antibodies, but how much of the actual defensive effect will be seen in phase 3,” he said. It’s all about proving safety and actual defensive effectiveness.”
Professor Sul believes that the probability of the vaccine being developed early is less than 5%. Vaccines are easy to make, but (to complete) takes much longer than the drug,” he said, “if you look at the development of the vaccine in step 10, it is only one step that antibodies occur. Regardless of the antibody making, it should have a protective effect.”
Prof. Sul also mentioned overseas studies that show that the duration of antibodies formed by corona 19 infection is very short, and noted that “if an infection occurs in a situation where the antibody decreases after the vaccine is met, the vaccine may not be effective.”
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