Research, editing : Gan Yung Chyan, KUCINTA SETIA
Video Screenshots of UBI Asia's second press conference on its covi vaccine UB-612
UBI Asia CEO Conference on the next step of UB-612 after its EUA was not approved: https://news.tvbs.com.tw/live/news4live/9172
News (32)
Reactions from Taiwan FDA to UBI Asia's second press conference
The Director of Taiwan Food and Drug Administration Wu Xiumei said that UB-612's failure to pass the EUA review is the result of expert discussions. If UBI Asia experts have other ideas, they can mention it. However, the Food and Drug Administration has not received any complaints. She emphasized that the current review benchmark is here. Experts have already reviewed it, and UBI Asia originally knew what the current review criteria are, and the neutralizing antibody titer produced by UB-612 is the future standard.
News (33)
EUA failed, the board of directors of UBI Asia re-approved, Taiwan's so bold to use Wuhan strain to do EUA is outdated
Image: Wang Changyi, chairperson of UBI Asia, pointed out that the Taiwan government's EUA only uses a "single point in time" immune bridging method, and the use of the Wuhan strain for EUA is outdated. She said bluntly, "Why is Taiwan so bold, no one in the world dares to do this." (The picture is taken from the UBI Asia's Press Conference)
UBI Asia's vaccine UB-612 did not pass the government’s Emergency Use Authorization (EUA). The immune bridging method of "single time point", and the EUA with Wuhan strain is out of date. Wang Changyi said bluntly, "How can Taiwan be so bold, no one in the world dare to do this."
Wang Changyi said that UB-612 is designed to strengthen the multi-site peptide of T cell immunity and the B cell immunity of S1-RBD protein. It is specially designed to be a subunit vaccine composed of multiple immune barriers. It is the world's first anti-COVID-19 vaccine. Multiple epitope protein/peptide vaccines are now facing the threat of Delta variants regardless of Europe, the United States or Southeast Asia. The Wuhan strain and the London strain have become historical terms.
UB-612 not only produces long-lasting neutralizing antibodies, with a half-life of 195 days, while Moderna is only 90 days. Especially for the Delta variant, it still retains the neutralizing antibody titer similar to the original Wuhan strain, which helps prevent Delta. The ravages of Taiwan are "like the army, navy, and air force fighting the enemy together. It's not just a missile and it's all right." It's a vaccine that can protect a human being in all directions.
Moreover, the original goal of UB-612 vaccine was to play the International Cup, which can supply more than 100 million people with jabs. The second clinical phase is to use 2000 liters of fermentation tanks for the production of raw materials, and 2-8 degrees C can be used for transportation and storage. A low-cost strategic vaccine, with safety as the first priority in its initial design, UB-612 is a love vaccine that will not cause thrombosis or myocarditis, or if the vaccine is given today, it will be gone tomorrow.
She said that the government only announced the EUA review standard on 10 June 2021, which is based on a single immune bridging that focuses on neutralizing antibodies. It only uses a single bridging, and uses the AZ vaccine as the only comparison standard to reject the EUA of UB-612. She said excitedly, "This is a one-sided, localized immunity, and there is no way to fully evaluate immunity."
UBI Asia described it as if you have to pass many exams before you graduate, you can graduate without one exam, and the use of soccer is not suitable for refereeing American football. The government EUA only adopts a "single point of time" immune bridging method. It is judged that the success or failure of a vaccine is a great loss to human beings and Taiwan.
Wang Changyi calls upon relevant government agencies to adjust the EUA review standards on a rolling basis to give Taiwan and the world a chance to obtain good vaccines.
News (34)
UBI Asia to carry out clinical trial of UB-613 next-generation vaccine in India
She revealed that UBI Asia’s UB-613 vaccine clinical trial is planned to be carried out in India. It will always be deployed ahead of schedule, and the country will also deploy ahead of schedule. The Wuhan strain is used for EUA, which is out of date. UBI Asia is a good domestic vaccine manufacturer but the government does not allow its vaccines to be shipped. She said, "Other countries find it strange.".
News (35), 27/8/21
Approval of the FDA EUA standard one-sided, UBI Asia: All materials will be prepared to apply for re-examination
Reporter : Ye Weichen
Image : UBI Asia Founder Wang Changyi. (Photo/Provided by UBI Asia)
As a domestic manufacturer of coronavirus vaccines, UBI Asia was not as good as the MVC-COV1901 emergency use authorization threshold set by the Food and Drug Administration. It must prove that neutralizing antibodies are not listed in the AZ vaccine, founder of UBI Asia Wang Changyi even criticized the Food and Drug Administration for being too one-sided at the press conference on 22 August.
Today (27 August), UBI Asia issued a press release statement, and apologized for the trouble caused by the Minister of Health and Welfare and other officials. In addition, relevant data and documents will be compiled to apply for re-examination.
In the statement of UBI Asia, the founder of the group, Dr. Wang Changyi said the company has invested in the development of biological products, especially monoclonal antibody drugs and vaccines. The company spare no effort to promote the development, internationalization and talent cultivation of Taiwan’s biotechnology industry.
Since covid ravaged the world last year, Wang Changyi also responded to the government's call to lead UBI Asia to invest in the development of the covi vaccine UB-612. She emphasizes that clinical trials have proved to be effective in stimulating T cell and B cell immunity although the Phase II clinical trial showed that the neutralizing antibody produced by the UB-612 vaccine was tested at a single time point in the original Wuhan virus strain, and a slight gap did not meet the EUA standard.
However, its neutralizing antibody against Delta variant (Covi72) has not significantly decreased compared with other major vaccine products compared with the Wuhan strain. It should be effective against the world's most difficult and rapidly expanding Covi72.
Regarding that on the day of the press conference, Wang Changyi said that the EUA review standards of the Food and Drug Administration were too one-sided, which caused troubles for officials at all levels of the Ministry of Health and Welfare, Food and Drug Administration, Center for New Drug Evaluation (CDE) or related units.
Wang Changyi also apologized but was worried about the approaching Covi72. At the national level, Taiwan is very likely to fall into the next wave of epidemic crisis.
UBI Asia emphasized that Wang Changyi affirms and appreciates Chen Shizhong, Minister of Health and Fu, Wu Xiumei, Director of Food and Drug Administration, Liu Mingxun, Chief Executive Officer of CDE, and other units since June 2020 to launch an unprecedented weekly consultation meeting on the issue of UB-612 vaccine.
Mass production and quality analysis, pre-clinical and clinical trial design and other links have given many professional advice and assistance to colleagues in the development of covi vaccines. UBI Asia will sort out relevant anti-Covi72 strains and other data in the near future, and send them to CDC and the Food and Drug Administration for re-examination, so that UB-612 can be put into the anti-epidemic ranks.
Central Epidemic Commander Chen Shizhong also said in an exclusive interview with senior media person Huang Guangqin today that domestic vaccines will be protected but specific manufacturers do not need to be protected because vaccines must be injected into the body, and the future of responsible decision-making must be responsible. .Both companies are well aware of the EUA's conditions, methods, and reasons. Everyone has set the rules of the game together. If there are any doubts about these, they will be raised during the set period.
News (36), 30/08/2021
EUA Vaccine Expert Review Meeting revealed that UB-612 has the opportunity to fight against Delta, and the T cell response is the characteristic
Reporter : Lin Huiqin / https://news.ltn.com.tw/news/life/breakingnews/3654753
The domestic-made UBI Asia vaccine UB-612 failed to achieve Emergency Use Authorization (EUA). The Food and Drug Administration of the Ministry of Health and Welfare today announced the records of the expert review meeting, although the neutralizing antibody titer and serum antibody positive conversion rate failed to achieve the curative effect. The evaluation criteria failed to pass, but many experts believe that the neutralizing antibody titer for the Delta variant strain is not greatly reduced, and it has the opportunity to fight against Delta, and the appearance of T cell immune response is also a major feature. Unfortunately, there is a lack of convertible vaccine protection evaluation. The FDA requires further information. If the third phase of clinical trials proves sufficient protection, there will still be opportunities for public use.
Although UB-612 failed to obtain the EUA because it failed to meet the efficacy evaluation criteria, the review experts still affirmed two major characteristics. The first is the potential to fight against Delta. Many people mentioned that the titers of neutralizing antibodies to Alpha and Delta will not decrease significantly, which will be a future opportunity. However, at present, countries have not yet agreed on the number of multiples and clinically meaningful threshold data. The results are difficult to infer that it has clinical protection. It is also believed that if the protection of the antibody against the original Wuhan strain is insufficient, although the reduction of the mutant strain is not large, the protection is still insufficient, and the data shows that the effect against Beta (the South African mutant strain) is also poor.
Secondly, many experts believe that it is a feature of UB-612 that can trigger a virus-specific T cell immune response. Unfortunately, no further information can be used to evaluate the T cell immune conversion to evaluate the protection of the vaccine. It is recommended that further information should be collected. It is difficult to judge whether to add points after the data or research results are evaluated.
However, some experts also pointed out that although the titers of the neutralizing antibodies of UB-612 are low, they have a longer half-life, which may be related to the T cell effect, but it still needs to be confirmed.
Other experts believe that the T cell response is mainly to assist the immune function to eliminate virus-infected cells, and the most important protection of vaccines is to rely on neutralizing antibodies to prevent the virus from entering the cells for the first time. In addition, referring to the results of Israeli research, it is true in the world data, neutralizing antibodies have a certain importance in preventing breakthrough infections. If enough neutralizing antibodies are not produced, infections may still occur. Therefore, the neutralizing antibodies are too low to determine the protection.
In addition, in addition to the low neutralizing antibody titers that failed to meet the standard, the review experts also mentioned that the positive conversion rate of serum antibodies of UB-612 in elderly subjects over 65 years old was only 89%, which means that 1 out of 9 patients reached the standard. There is no basic immune response, and the neutralizing antibody titer of elderly subjects is lower than that of the overall subjects, and the protection of the population over 65 years old may not be sufficient.
However, most experts believe that if the Phase III clinical trial of UB-612 in India proves sufficient protection, there will still be opportunities for the people to use the new vaccine.
News (37) to (42) / https://www.ntdtv.com/gb/2021/08/21/a103196073.html / Image : Zeng Zhuowen (Video Screenshot)
News (37)
Biden government virus traceability report will be released at the end of the month
Hong Kong current affairs commentator Zeng Zhuowen predicted that the Biden administration's report on the pulmonary virus will be released on 26 August 2021. He said that many things have happened before. For example, CNN broke the news earlier that the US Intelligence Agency had obtained a large amount of DNA data and genetic data of the Wuhan pneumonia virus. CNN estimates that the U.S. Intelligence Agency found virus data in the cloud and is now using the Department of Energy’s supercomputer to analyze the data urgently in order to catch up with the 26 August report.
In addition, on 2 August, a senior senator from the Republican Party also published a report on the traceability of SARS-CoV-2 from the Wuhan laboratory. The purpose is actually to narrow the scope.
Why use a supercomputer? Zeng Zhuowen analyzed that the supercomputer was originally used by the Department of Energy to study nuclear weapon sandbox deductions, "because most of the data is very powerful, with thousands of Terabytes. That means that the data is large enough to use a carrier such as a snowball. It’s such a huge amount of data.”
He believes that there should be many amazing secrets in it. “If the data results are analyzed, we will know whether Wuhan pneumonia (novel coronavirus pneumonia, COVID-19, covid) is caused by the Wuhan virus. Out of the laboratory? There may also be other terrorist experiments in China."
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Republican lawmakers report pressure Biden to direct Wuhan virus laboratory
On 2 August 2021, the Republican research team of the US House of Representatives took the lead in publishing a supplementary report to the final report on the origin of SARS-CoV-2 (covi, CCP virus). As early as 21 September 2020, the Republican team published a report on Wuhan pneumonia virus that “a large amount of evidence shows that SARS-CoV-2 has leaked from a laboratory of the Wuhan Institute of Virology before 12 September 2019. It was accidentally leaked at the time. The virus, or the genetically manipulated virus sequence, may have been collected in a cave in Yunnan Province between 2012 and 2015."
Zeng Zhuowen bluntly stated that the purpose of the report is actually to narrow the scope and put pressure on the Biden administration. The report stated that the Wuhan pneumonia virus did not come from the Wuhan seafood market or seafood market, but must come from the Wuhan virus laboratory. Is the difference between intentional or unintentional? Is it intentionally released as a biochemical weapon or accidentally leaked?
Zeng Zhuowen said, "Even if it was accidentally leaked, the CCP's concealment of the epidemic and indulging those people to spread drugs everywhere has caused more than 200 million people around the world to be infected, and 4 to 5 million people have died, which means that the scope has been narrowed. Forcing Biden to report on 26 August, he must go in the direction of the Wuhan Virus Laboratory."
News (39)
If it is confirmed that the virus is leaked by the CCP, the CCP will not be able to compensate for a hundred years
Regarding the preliminary sanctions proposed in the Republican report, Zeng Zhuowen said that in the future, Chinese laboratories will not be allowed to access Western materials, especially research in American academic journals; and the CCP will be prohibited from buying Western biochemical instruments in the future. "In the future, it (the CCP) will not be able to obtain these materials, nor will it obtain those tools, and it will not be able to conduct experiments in this area in the future. Right? So the report on 26 August is very important."
"The whole world will wait and see. If it is published and it is confirmed that China has released these viruses, then the whole world will ask China (the Chinese Communist government) to lose money or apologize, right? Lost money should probably be one trillion. I don’t know if it’s enough. It’s either 10 billion or 1 trillion, or China can’t pay for 100 years. So with Xi Jinping’s character and style, he will not apologize, nor will he lose money. ."
Zeng Zhuowen said that it is necessary to pay close attention to the development of the situation. The latest news is that the TV2 in Denmark broke the news. A documentary showed that Peter Ben Embarek, the research leader of one of the WHO team, said that there is a laboratory closest to the Wuhan market, a laboratory belonging to the Chinese Center for Disease Control and Prevention, and even more suspicious of the Wuhan virus laboratory, because he said that the employees there do not know how to deal with the coronavirus. Very suspicious, when he went to China for investigation that day, he also received a lot of obstruction. Zeng Zhuowen believes, "In short, the direction is to move toward China (the CCP) spreading drugs."
News (40)
The Chinese Communist Party once again released fake news, which was exposed by the outside world one by one
There are less than two weeks left until US President Biden asked the intelligence agencies to hand over the CCP virus traceability report. Recently, the Chinese Communist Party’s official media has turned its attention to the US "Fort Detrick Biological Laboratory". At the regular press conference, it was claimed to be the source of the CCP virus.
Zeng Zhuowen said that many fake news sent by the Chinese Communist Party have been exposed one by one. He gave examples of "People's Daily" and "Observer Network" falsely claiming that a Swiss scientist and biologist, Edward Wilson, had become a political tool of the United States in the work of virus traceability. However, it was immediately exposed by the Swiss Embassy in China that there was no such person as Edward Wilson in Switzerland, and there was no so-called essay as claimed by the People’s Daily.
Zeng Zhuowen also cited as an example that Zhao Lijian, the spokesperson of the Ministry of Foreign Affairs of the Communist Party of China, wronged the United States at the end of July, saying that in 2019, the reserve female soldier of the U.S. Army, Benassi, was ordered to go to bicycle to sow drugs when she went to Wuhan to participate in the Military World Games in October 2019. But Benassi said in an interview with CNN that she and her husband did not have any illness at all, let alone Wuhan pneumonia virus, and they did not have any illness after the examination. She said that when she went to Wuhan to participate in the sports meeting in October 2019, she was not infected but she was injured while participating in the competition. She insisted on going to receive treatment after the competition.
After the vaccine, the death and injury data are serious, and the mutant virus was born because of the vaccine.
Viruses are of course dangerous, but some people think that vaccines are more dangerous than viruses. Zeng Zhuowen analyzed actual data and said that according to the US CDC, FDA, that is, the Vaccine Adverse Event Reporting System (VAERS) under the US Food and Drug Administration, on 7 July, according to the daily data, the number of deaths after vaccination was 11,000, another 1,000 women had miscarriages, and 9,200 were disabled. Zeng Zhuowen pointed out that this number may be the tip of the iceberg. Because according to the 2011 report of the U.S. Department of Health, many serious vaccine side effects were not reported, perhaps only 1% were reported. "So if 11,000 people died, it could actually be a million deaths. We don’t know, do we? Of course the CDC in the United States denies it."
There are similar data in Europe. Zeng Zhuowen said that EudraVigilance under the European Union has a mechanism to analyze the adverse effects of vaccines or other drugs, which is part of the European Union's Drug Administration. According to their data in July, after playing Pfizer, Modena, BioNTech, and Oxford AstraZeneca vaccines, the number of deaths was 19,000 and 1.8 million were injured. Of these, half of them were seriously injured, or 900,000 people were seriously injured.
Another French expert and Nobel Prize in Medicine Professor Luc Montagnier pointed out that the vaccine itself produces a variant virus. Zeng Zhuowen explained that the mutant virus was produced as a result of the vaccine, and his theoretical basis was this antibody (anti-body dependence enhancement) dependence enhancement effect. "That is to say, these vaccines will stimulate the human body to produce antibodies, but those antibodies will stick to the Wuhan pneumonia virus. After sticking, it becomes the carrier of the virus, making the virus stronger and more mutated."
News (41)
Graphene oxide used in vaccines is a high-risk ingredient
The University of Almeria in Spain has a group of Spanish scientific researchers who, in their own name, published a report at the end of June that they have studied the structure of Pfizer vaccines and other vaccines with a microscope. They compare a chemical drug called graphene oxide. It is found by comparison that the original structure on both sides is the same. Zeng Zhuowen explained, “Graphene oxide is highly toxic. According to Dr Jane Ruby, she is a pharmacy researcher. When she was interviewed by Stew Peters TV in the United States, she revealed that graphene oxide is a kind of nanoparticle, which is very small and can penetrate. Cells that hurt the liver, kidneys, lungs, heart, and spleen can cause inflammation and even cytokine storms, which can lead to allergic inflammation and death throughout the body."
Zeng Zhuowen also said that Karen Kingston, a former employee of Pfizer and a pharmacy analyst, broke the news in an interview with US online media Stew Peters TV on 28 July that Pfizer’s vaccine, the so-called mRNA vaccine, extracts part of the virus’s DNA and becomes the mRNA vaccine. It contains a chemical fat, polyethylene glycol resin, and the main ingredient in polyethylene glycol resin is graphene oxide. "What's the use of this chemical fat? It is to stabilize the vaccine, because this kind of mRNA vaccine is very fragile. It will die if the temperature is higher. Human saliva and nasal mucus can kill it, so use this chemical fats stabilize it."
Where can I find this chemical fat, polyethylene glycol resin? Zeng Zhuowen said that it was actually found at Sinopeg, a Chinese chemical product company. According to Sinopeg's webpage, graphene oxide can be used as energy storage. According to Karen Kingston, this chemical is also used in some experiments. What experiment? This is the experiment that Tesla boss Elon Musk and Bill Gates are doing. They are trying to connect the human brain to the Internet.
Zeng Zhuowen went on to say that graphene oxide can be used in hydrosols. Hydrosol is an intermediary that connects the human brain to the network. "The main component of the hydrosol is graphene oxide. Graphene oxide can be controlled by electromagnetic fields to turn it into a positive electrode. After it becomes a positive electrode, it will be troublesome and indestructible. So Karen Kingston said that this kind of thing is a biochemical weapon and is genocidal. Biochemical weapons."
News (42)
Vegetarianism can be exempted from vaccination on religious grounds
At present, many employees of CNN, Facebook and Google have been fired for not being vaccinated. Zeng Zhuowen said that many hospitals also have to force employees to get vaccinated, and they will be fired if they do not get vaccinated. Some European countries, like Italy, cannot enter restaurants without a vaccine passport. Hong Kong also has "travel with peace of mind", and Hong Kong should restrict customs clearance in the future. "Maybe they won't let you leave the country if you don't fight the poisonous vaccine in the future, and you will still. Italy and many European cities, the United Kingdom shouldn't have such a thing."
How can we not get the vaccine? Zeng Zhuowen pointed out that Mr. Will Tuttle, an internationally renowned pioneer of vegetarianism, recently stated in public that he used religious grounds to exempt from immunization. "Those who believe in Buddhism must observe the five precepts, and the first precept is not to kill. For example, the Shurangama Sutra says that "people who eat meat will fall into evil ways and suffer immeasurable suffering." "The Sutra", the Buddha told Kassapa, "The meat-eaters will fall into the hell of the nose", so people who believe in the Buddha cannot be vaccinated. Why? Because Pfizer and Moderna both use monkeys and mice for the first stage of clinical testing." "If the U.S. Equal Opportunity Regulations can be used in the U.S., religious beliefs do not accept vaccines."
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