Monday, November 22, 2021

Medigen's vaccine EUA in Australia, Taiwan anti-cancer drug technology transfers

 Research, editing : Gan Yung Chyan, KUCINTA SETIA

News on disease control, democracy, Myanmar, CCP

News (1)

MVC COVID-19 Vaccine gets admission ticket to EUA in Australia

   


The Australian Drug Administration (Therapeutic Goods Administration, TGA) announced today (22 November 2021) that after comprehensive consideration of vaccine information and the severity of the epidemic, it has decided to grant Taiwan vaccine producer Medigen’s MVC COVID-19 Vaccine (MVC-CoV1901 "examination qualification" (Provisional determination). Medigen said that this qualification is a key step in applying for an Australian vaccine emergency use license (provisional approval is similar to EUA), which means that Medigen is qualified to speed up the review process of Australia's inspection and registration of MVC-CoV1901.

Gao said that it has started to prepare the application documents and will formally apply to the TGA for emergency vaccine approval as soon as possible, hoping to speed up the acquisition of international certification. As for how long it will take for the TGA to review, it is currently unknown.

In response to the covid epidemic, Australia’s TGA has successively granted review qualifications to AZ, Pfizer, Modena, Johnson & Johnson and Novavax. A total of 5 vaccine factories have undergone accelerated review. Taiwan’s MVC-CoV1901 is currently the sixth to obtain covi vaccine certified by TGA.

Gao said that according to the TGA's regulations for covi vaccines, whether it is the first time to apply for an emergency vaccine license, or the age of the population to expand the use of the vaccine after the vaccine is marketed, the review process must be verified through qualification verification.

Medigen pointed out that Australia’s TGA is highly credible among the global medical regulatory authorities. It is not only one of the 36 Stringent Regulatory Authorities defined by the World Health Organization, but also one of the top ten advanced medical countries recognized by the Republic of China's inspection and registration regulations certification unit. In the process of formulating international medical regulations related to covid, Australia's TGA is also a participating member of the "ICMRA International Drug Regulatory Authority Alliance", the "Access Consortium Alliance", and the "European Union COVID-19 Vaccine and Therapy Committee". 

Australia TGA announcement link

News (2)

MVC-CoV1901 is approved by Australia and Medigen will be able to apply for emergency 

Australian Medicines Agency stated that MVC-CoV1901 has been licensed in Australia. Medigen can send a document to apply for an emergency authorization for the covi vaccine, but there are currently 4 countries that can allow Taiwanese to enter the country without isolation for Medigen vaccination, namely, New Zealand, Palau, Indonesia and Belize.


News (3)

The National Health Institute's new anti-cancer drug technology transfers next year, Taiwan and Australia will synchronize human clinical trials

  

Image : Zhang Junyan, Director of the Institute of Biopharmaceuticals of the National Health Institute, Ke Junbei, Director of Langqi Biomedical, Chen Qiuhong, General Manager of Langqi Biomedical, Xie Xingbang, Researcher of the Institute of Biopharmaceuticals of the National Health Institute, and Wu Xiuying, Director and Secretary of the National Health Institute (left to right). (Photo by reporter Qiu Zhirou)



The National Institutes of Health announced today (22 November 2021) that the new drug R&D team of the Institute of Biotechnology and Medicine has successfully developed the "multi-target kinase clinical drug DBPR114", which has been confirmed by animal experiments to be effective in the treatment of pancreas of more than 8 types of cancer, including visceral cancer. Related drug technology has been transferred to Langzi Biomedical Co., Ltd. in September 2021. It is expected that the first phase of human clinical trials will be completed in Taiwan and Australia in 2022. The three will be completed within 6 years at the earliest Phase trial application for listing.

Xie Xingbang, a researcher at the Institute of Biotechnology and Medicine of the National Health Institute, pointed out that DBPR114 has significant pharmacodynamic activity on animal models of tumor growth, including human pancreatic cancer, oral cancer, gastric cancer, liver cancer, colorectal cancer, bladder cancer, and prostate cancer as well as acute myeloid leukemia, etc., It is particularly effective in liver, gallbladder, and gastrointestinal cancers. This drug was also approved by the United States and Taiwan in 2017.

Zhang Junyan, director of the Institute of Biopharmaceuticals of the National Health Institute, said that cancer is different from general diseases and is more difficult to treat. The main reason is that tumor growth and survival depend not only on a receptor or a signal pathway mutation or loss, but in the past cancer drugs usually only targeted a single target attempt to kill tumor cells.

Zhang Junyan further explained that the research team used protein kinase as the target and used high-speed parallel synthesis technology and drug structure design to develop a small molecule drug DBPR114. This new drug can simultaneously inhibit multiple cancer cell proliferation necessary message transmission pathways and is a cancer treatment, thus bringing cancer patients new hope of recovery.

Xie Xingbang also added that multi-target drugs are more effective than single-target drugs in inhibiting tumor growth, and low doses can achieve the inhibitory effect. For example, at a low concentration of 0.1 to 100 nanometers (nM), it can inhibit at least 15 types of cancer. The activity of protein kinase can also overcome the problem of drug resistance and avoid cancer recurrence.

Chen Qiuhong, general manager of Langqi Biomedicine, said that the first phase of the clinical trial will carry out the best dose test. It is planned to accept cases of Asians and Whites in Taiwan and Australia next year. It is estimated that 40 cases will be accepted, and the objects of acceptance are not limited to cancer but it needs to meet the conditions of advanced solid tumor patients, current standard treatment failure, and good physical condition, and it should be administered once a week.

Xie Xingbang also stated that it will take about 2 years for the Phase 1 clinical results to be released. The Phase 2 clinical trials are expected to be planned based on the phase 1 cancers with significant efficacy. The Phase 2 and 3 clinical trials will each take about 2 years. It is estimated that all clinical trials can be completed in 6 years at the earliest.

News (4)

Fauci says definition of "fully vaccinated" could be changed

Reporter : Jack Phillips, The Epoch Times PREMIUM

The definition of “fully vaccinated” could be changed by federal health officials to include COVID-19 booster doses if their data support it, said White House pandemic adviser Anthony Fauci on Sunday.

While speaking to ABC’s “This Week,” Fauci said that medical officials are still considering the necessity of the booster shot and he personally would not change the definition for what constitutes “fully vaccinated.”

“We’re going to take a look right now at what the durability is of the booster,” Fauci said. “We’re going to follow people who get boosted.”

He added: “People should not be put off by the fact that as time goes by and we learn more and more about the protection that we might modify the guidelines. That’s what we’ve been saying all along.”

Fauci added that his agency will “just follow and let the data guide [our] policy, and let the data guide [our] recommendations.”

As of now, the definition of fully vaccinated is two shots of a Pfizer or Moderna vaccine series or one shot of the Johnson & Johnson vaccine, according to the Centers for Disease Control and Prevention (CDC).

If boosters display the same waning protection as the initial vaccine regime, “and the data shows we need to do it more often, then we’ll do it,” Fauci said, “but we want to make sure we get the population optimally protected and you do whatever you need to do.”

His comments on Sunday contrast with previous public statements he said about booster doses.

During an appearance at the 2021 STAT Summit, Fauci said that “a booster isn’t an add-on, and a booster is a part of what the original regimen should be … so that when we look back on this, we’re going to see that boosters are essential for an optimal vaccine regimen.”

On Nov. 19, a CDC vaccine advisory panel recommended in a unanimous vote that all U.S. adults can get booster doses for both Moderna’s and Pfizer’s vaccines. Previously, only certain individuals could receive the shot. CDC Director Rochelle Walensky signed off on the recommendation.

Earlier that week, the Food and Drug Administration (FDA) expanded the emergency use authorization for the Pfizer and Moderna booster doses for all adults.

Booster doses of the Johnson & Johnson vaccine, a shot that uses an adenovirus rather than mRNA technology, were approved under an emergency use authorization for all adults in mid-October. Around the same time, the CDC also approved people who got the J&J shot to mix-and-match booster doses.

The Democrat governors of New Mexico and Connecticut recently suggested that they will change the definition of a complete COVID-19 vaccination to include boosters. In some countries such as Israel, vaccine passports—which are mandated to enter gyms, restaurants, and other venues—would expire six months after the second dose.

“We are analyzing what we can do to create those incentives—and potentially mandates—for making sure that people are fully vaccinated, which means three vaccines,” New Mexico Gov. Michelle Lujan Grisham said.

As of Friday, more than 59 percent of the U.S. population has been fully vaccinated, according to CDC data.

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News (5)
ASEAN invites Minister from NUG to Climate Conference
Source : The Irrawaddy / Image : Web Screenshot

The Association of Southeast Asian Nations (ASEAN) has for the first time invited a minister from Myanmar’s parallel government to an international conference organized by the regional bloc. The move is a significant sign that the 10-member grouping is starting to officially engage with the National Unity Government (NUG), which was formed as the country’s rightful government by elected lawmakers from Myanmar’s ousted National League for Democracy and its ethnic allies after February’s military coup.

Dr. Tu Hkawng, the NUG’s minister of natural resources and environmental conservation, will join the three-day Third Climate Smart and Disaster Resilient ASEAN conference on Tuesday. He will attend the meeting as the minister from Myanmar along with ministers from other ASEAN countries and international experts.

The move came after ASEAN’s attempt to mediate the political crisis sparked by Senior General Min Aung Hlaing’s takeover in February stalled due to his regime’s lack of cooperation with the regional bloc.

In October, the organization excluded Min Aung Hlaing from its summit over his failure to cooperate. On Monday, he was also barred from the ASEAN-China Special summit due to the regional bloc’s opposition.

While it has excluded the junta leader from its summits, ASEAN had until recently continued to invite the regime’s cabinet ministers to participate in ASEAN-related meetings. However, the regime minister’s name was nowhere to be seen on the announcement of Tuesday’s climate change meeting. Instead, Dr. Tu Hkawng’s name appeared, with the title “Minister, Myanmar.”

The NUG minister told The Irrawaddy that he took the move as ASEAN’s recognition of the NUG as the rightful government of Myanmar.

“I will have a chance to discuss as a minister along with others from ASEAN member states. I take it as a success [for the NUG],” he said.

ASEAN has not made a statement on Dr. Tu Hkawng’s inclusion.

Ref: https://www.irrawaddy.com/news/burma/asean-invites-minister-from-myanmars-shadow-civilian-govt-to-climate-conference.html

News (6) to (13) / Reporter : Jayanta Kalita, Delhi / First published in The Irrawaddy

News (6)

CCP enforces land border protection law from January 2022

In October 2021, CCP China passed a law aimed at enhancing border protection. However, what stands out from this piece of legislation is that it allows the use of blockades and “police apparatus and weapons” against intruders.

The development comes amid an 18-month-long standoff between the CCP People’s Liberation Army (PLA) and the Indian military along the Line of Actual Control (LAC), the de facto border between the two nuclear-armed neighbours.

The two militaries had a bloody faceoff in eastern Ladakh’s Galwan Valley in June 2020, resulting in 24 casualties. Despite multiple rounds of military and diplomatic-level talks, a resolution to this impasse is unlikely anytime soon.

China shares a 3,488-km land border with India running from the latter’s Arunachal Pradesh state in the east to the Union Territory of Ladakh in the west.

This is the first time that China has enacted such a border law, which the communist country will enforce from January 2021.

News (7)

Land protection law by PLA General Zhao Zongqi who initiated border crisis with India

So, who is actually the architect of this piece of legislation? Well, it was proposed by the Foreign Affairs Committee of China’s parliament. Although this is supposed to be a domestic land border law, the fact that the proposal came from the committee indicates the potential cross-border ramifications of this legal mechanism. Besides, there is an India connection to it.

The law seems to be, at least partially, the brainchild of former PLA General Zhao Zongqi, who is now the deputy chairman of the Foreign Affairs Committee. Gen. Zhao was the PLA Western Theater Command chief, and he was the one who initiated the 2017 Doklam crisis and the Galwan skirmishes last year.

“So, there is a person who is in the Foreign Affairs Committee, who was dealing with the land related issues and obviously he may have substantial say in the law formulation,” said China expert Professor Srikanth Kondapalli.

“He [Gen. Zhao] mentioned some time ago that in the 1970s and ’80s he used to go on foot on the Line of Actual Control with India—of course, on their side of the border. So, as a practitioner and as a military officer, he was posted in those areas. He may have some views on the land border law, which may have been incorporated,” maintained Prof. Kondapalli from Jawaharlal Nehru University, New Delhi.

News (8)

China and Bhutan signed MoU to end their border dispute on 14 October 2021

On 14 October, China and Bhutan signed a memorandum of understanding (MoU) to end their border dispute. Beijing announced the new border law on 23 October. In the past, India also signed several MoUs with China but the dispute is still not resolved. Nevertheless, the latest MoU does indicate some kind of agreement between China and Bhutan.

This means that out of its 14 land neighbors, it is only with India that China does not have a territorial dispute resolution mechanism. China shares a total of 22,000 km of land borders with these countries.

News (9)

China shares land borders with 13 other countries

However, Beijing may not be looking solely at India when it comes to the border law. The fact that China shares land borders with 13 other countries needs to be kept in mind as well.

Prof. Kondapalli said each of these land borders has a unique set of problems. For instance, China’s northeast border with Russia is plagued by the smuggling menace. The Central Asia-China borders need to be watched for Uighur militants who could foment troubles in Xinjiang region. Similarly, the Myanmar-China border is notorious for the smuggling of drugs and small arms while the India-China LAC faces the post-Galwan uncertainty.

Article 4 of the new law mentions China’s sovereignty and territorial integrity as sacred and inviolable. This assertion is something new, especially when one looks at it from Indian perspectives. The LAC is a de facto border and the dispute over the border is still unresolved. Previously, Beijing had termed this as a disputed border but now it is asserting sovereignty.

News (10)

Transition from disputed territory to sovereignty narrative for CCP

“You can claim sovereignty if you have a bilateral agreement. If you don’t have a bilateral agreement, it is a disputed territory. So, the transition from disputed territory to sovereignty narrative, in China, in this land border law as well suggests we have some company coming up in the future. Constant company for the near future,” Prof. Kondapalli said.

News (11)

CCP's land protection law covers flood control

Article 10 of the law talks about border defense construction. It also mentions flood control. Needless to say, there has been a discord between India and China over the flow of the Brahmaputra river, which is known as Yarlung Tsangpo in China’s Tibet region.

News (12)

Genuine concerns over CCP's dam-building spree

China has been constructing some 26 dams at the Namcha Barwa in southeastern Tibet, known for the “great bend” of the Yarlung Tsangpo. India has genuine concerns over China’s dam-building spree, as it could impact the flow of the Brahmaputra in the country’s northeastern region.

The land border law aims to provide a legal basis for China’s construction activity in the Tibet region.

News (13)

New law in line with CCP's maritime law

Earlier this year, Beijing came out with a similar law to protect its maritime boundaries. Both pieces of legislation allow the country’s law enforcement agencies to shoot “intruders”—be it in the Himalayas or the South China Sea.

On 1 February, CCP China’s new Coast Guard Law took effect even as Beijing continues to resort to what is called “gray zone tactics” to assert its claims over the South and East China seas.

This law allows Coast Guard fleets to use lethal force on foreign ships operating in China’s waters, including disputed waters claimed by the communist country.

This essentially means that what CCP “maritime militias” have been doing all these years—to scare away fishermen, people or entities belonging to other claimants from these disputed waters—may soon be replaced with an aggressive push-back policy against other littoral states.

“Like the Coast Guard Law and Maritime Traffic Safety Law promulgated in 2021, the new legislation is passed amid rising tensions between China and its neighbors over territorial disputes. The People’s Liberation Army and the paramilitary People’s Armed Police will have major responsibility for safeguarding [the] land border, combating armed invasion. Both agencies report to the Central Military Commission, which [President] Xi Jinping heads,” said Kalpit A. Mankikar, a Fellow with the Strategic Studies Programme at the Observer Research Foundation, Mumbai.

“The new law permits patrol officers to use weapons against intruders who resort to violence in resisting detention and threaten the safety of life and property of other people. Chinese state media also reported that the law upholds China’s ‘legitimate rights and interests’ over the Tibet-originating transboundary rivers like the Brahmaputra and Mekong,” he said.

“The law’s assertion of full sovereignty over cross-border waters means that China has a declared right to divert as much of the shared waters as it wishes, regardless of downstream impacts. The law, which will kick into effect from 2022, is another use of lawfare where domestic law can facilitate its expansionism,” Mankikar added.

Ref: https://www.irrawaddy.com/opinion/guest-column/chinas-new-border-law-could-further-complicate-boundary-disputes.html

News (15) (Pictorial)

Image : Researcher's Picture

News (16) to (17) / Reporter : Xu Zhijia 

News (16)

National Taiwan University makes a "key antigen" that can deal with Delta mutants 




Good news! National Taiwan University Hospital announced the latest research results on 23 November 2021. It pointed out that the team has designed and made the Delta virus strain RBD trimer, which can be used to develop new vaccines and rapid detection of neutralizing antibodies. National Taiwan University Hospital Children's Hospital is responsible for the research. 

Dean Huang Limin pointed out that the current reagents are all tested against the Wuhan strain but the virus is constantly mutating, and all the measurements are distorted. It must be reshuffled to cooperate with the new virus strain for research and development. Now the team has made the Delta virus strain RBD trimer. It can be used as an antigen, a vaccine, and a neutralizing antibody, and the prototype of the rapid detection of neutralizing antibody is expected to be completed within one or two months.

National Taiwan University Hospital on 23 November announced the development of new adjuvants, new antigens, new administration methods, and rapid detection results of neutralizing antibodies for the second-generation covi vaccine. Huang Limin said that the team looked for a covi vaccine that was already on the market and a protein that can be used on humans, and matched it with NTU’s proprietary mucosal adjuvant technology to develop a nasal spray vaccine. 

Animal experiments have proven effective and have the ability to manufacture in large quantities. Human trials are still going on. In addition, Huang Limin also announced that the research team has made the Delta virus strain RBD trimer, which can produce an anti-Delta vaccine and a reagent that can quickly test neutralizing antibodies. 

 It is pointed out that if neutralizing antibodies are to be tested, it must be carried out in the P3 laboratory but now the team has developed an ELISA kit that can measure the neutralizing antibodies of the Delta virus strain. 

A test of the WHO serum template shows that the Wuhan strain has a high neutralizing antibody, but if it encounters the Delta strain, the antibody will decrease, which can show that the antibody against the Wuhan strain is ineffective against the Delta strain and can correctly reflect the third level experiment, the neutralizing antibody of the chamber. 

Huang Limin also said that it is not too late to make the Delta strain. Wuhan strain is not circulating in the world. All the reagents have to be replaced to open a new brand. The neutralizing antibody rapid detection reagent can also be convenient for vaccine clinical trial manufacturers. Or ordinary people use it, but now they are just research results, and manufacturers and capital are needed to cooperate in order to continue to develop.


News (17)

National Taiwan University develops nasal spray covi vaccine! "This point" is more powerful and can reduce breakthrough infections

Reporter : Xu Zhijia

There is new progress in domestic vaccine research and development! The National Taiwan University Hospital team announced that it has developed a "nasal spray type covi vaccine." It has been confirmed that the effect of animal experiments is not inferior to the traditional intramuscular vaccine.

In experiments, it has been found that the nasal spray type vaccine can generate more drugs than traditional vaccines. The IgA antibody in the respiratory tract allows the virus to attack as soon as it enters, which can reduce the amount of virus and reduce the infectivity, which is expected to reduce breakthrough infections.

Huang Limin, director of the National Taiwan University Children’s Hospital, who is in charge of vaccine research and development, pointed out that in theory, the whole body of the nasal spray vaccine The sexual immune response will not be as strong as the intramuscular vaccine, which means that the side effects will be relatively mild, but there may also be transient local swelling and nerve compression; and the nasal spray vaccine is still awaiting human trials and requires the assistance of the government and manufacturers. Only then have the opportunity to develop and go public. 


Image : The doctor exposed that the brand's known nasal spray vaccine (left) can produce strong IgA in the upper respiratory tract, but the intramuscular vaccine (right) did not. . (Photo/provided by the hospital) 

National Taiwan University Hospital today (23) announced the development of new adjuvants, new antigens, new administration methods, and rapid detection results of neutralizing antibodies for the second-generation covi vaccine. 

Huang Limin said that vaccines have become the key to the prevention of covid. However, RNA vaccines and adenovirus vector vaccines on the market still face some side effects, which makes the development of second-generation vaccines more important, and on second-generation vaccines experts will focus on mucosal (nasal spray) vaccines, intradermal vaccines, and vaccines against new strains.

Huang Limin pointed out that for the current covi infection, it is known that through intramuscular injection of vaccines, only IgG antibodies that can protect the lower respiratory tract can be produced, but the upper respiratory tract will still have viruses, and the biggest problem with the new coronavirus is whether it is asymptomatic or mild. The amount of virus is the same for severe or severe illness. Therefore, the nasal spray vaccine has become a new hope. 

Huang pointed out that the current nasal spray vaccine developed by the research team has been found after animal experiments, except that it can produce almost the same as traditional vaccines. In addition to IgG antibodies, it can also generate IgA antibodies against the upper respiratory tract, which means that it can increase the resistance of the upper respiratory tract, allowing the virus to attack as soon as it enters the body, reducing the amount of virus in the upper respiratory tract, and reducing the infectivity. It is expected to improve the situation of breakthrough infections.

However, the nasal spray vaccine has not yet been tested in humans, and Wang Tinggui, vice president of National Taiwan University Hospital, also called on the country and manufacturers to support the development of the vaccine. 

Huang Limin also said that there are currently 7 nasal spray vaccines in the world that are undergoing clinical testing. From a theoretical point of view, the systemic side effects caused by nasal spray vaccines will be less than injection vaccines, because the focus of nasal spray vaccines is to stimulate. The local immune response is relatively balanced, and the systemic response is not as strong as intramuscular injection. This is also the reason that attracts scientists, but what is more afraid of is local swelling, inflammation, and nerve compression, but this situation will only recover for a short time. However, these are only theories, and the actual situation still has to wait for follow-up experiments to know.


News (18)

AirAsia's VTL flight schedule announced


On 23 November 2021, AirAsia announces its VTL flight schedule as follows:-

AirAsia flight AK711 leaves KLIA for Singapore Changi Airport Terminal 1 at 10.05 am, lands in Singapore at 11.05 am before taking off from Singapore for KLIA at 11.45 am and arriving in KLIA at 12.55 pm daily under flight AK710.



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 Pictures copyright by : Gan Yung Chyan, KUCINTA SETIA