Taiwan’s self-produced vaccine “Medigen” has been administered for a week. As “high-end” is the world‘s first vaccine to replace the third phase of the trial with immune bridging technology and has received emergency authorization from the Taiwan government, the approval of the vaccine has attracted widespread attention, including its effectiveness, safety, international certification, and even the Taiwan version. The possibility of “vaccine diplomacy”.
According to an announcement from Taiwan’s Ministry of Health and Welfare’s Disease Control Agency, as of August 26, more than 400,000 people in Taiwan have received the first high-end vaccine. Four deaths have been reported in the first three days after the official attack. Taiwan’s Minister of Health and Welfare Chen Shizhong said that whether the death case should stop the application of the corresponding batch number depends on the relevant cause and effect and further inspections, because this is an adverse event that needs to be checked.
Some scholars believe that when the “high-end” is on the market, the epidemic in Taiwan is gradually slowing down, and the protectiveness of the vaccine after vaccination requires longer observation.
WHO certification?
Also of concern is the issue of international certification of “high-end” vaccines, including the World Health Organization (WHO) emergency use authorization. Li Bingying, a physician at the National Taiwan University Hospital and honorary chairman of the Taiwan Vaccine Promotion Association, told the BBC that since the WHO does not recognize Taiwan, Taiwan’s self-developed influenza or enterovirus vaccines in the past have been certified by the EU or the US FDA, but have never been approved by the WHO. The organization “direct” certification or procurement, so he judged that it would be difficult for Taiwan’s local vaccines to directly obtain WHO certification.
In 2008, after the successful election of Ma Ying-jeou of the Kuomintang for the presidency, Taiwan became an observer of the World Health Assembly under the name of “Chinese Taipei” and has participated in the meeting every year thereafter. However, after the DPP returned to power in 2016, because the DPP government refused to recognize the “92 Consensus,” the spokesperson of the Taiwan Affairs Office of the State Council of the People’s Republic of China stated that the basis for Taiwan’s participation in international conferences no longer exists. Under pressure from Beijing, the WHO removed Taiwan’s status as an “observer” on the grounds of “one China”.
The “High-end” Vaccine Biologics Co., Ltd. (referred to as High-end Company) cooperated with the Vietnam National Institute of Health and Epidemiology (NIHE) at the end of last year for the second phase of the new crown vaccine trial. At the press conference at that time, Chen Canjian, general manager of the high-end company, said that cooperation with Vietnam is a strategic mutual benefit. He hoped that through Vietnam’s assistance in production and evidence collection, the high-end will be sent to the WHO Covax supply chain mechanism in the future. “Taiwan is not a member of the Association of Southeast Asian Nations (Asean, ASEAN) or WHO. To enter the world, it must take advantage of Vietnam’s international advantages. The vaccine stock solution and semi-finished products are provided, and then filled and produced by the Vietnamese factory. Therefore, the “high-end” has the opportunity to become the target of the WHO-led purchase of the new crown vaccine Covax.” He told Taiwanese media.
The second phase of the “high-end” trial in Vietnam has been completed, and only the third phase of the trial has been confirmed in Paraguay. “High-end” issued a press release in July this year, stating that it has signed a memorandum of cooperation with Paraguay’s Sonson University and the Vietnam National Institute of Hygiene and Epidemiology (NIHE) again, hoping to obtain Vietnam national certification in the future to produce vaccines locally, and Assist in applying for certification from the WHO through Vietnam.
The outside world therefore estimates that whether the “high-end” can obtain Vietnam certification, or be authorized to use the country’s EUA, may have to wait until the high-end obtains the EU EMA certification or the US certification.
Image source,AFP
In 2008, after the successful election of Ma Ying-jeou of the Kuomintang for the presidency, Taiwan became an observer of the World Health Assembly under the name of “Chinese Taipei” and has participated in the meeting every year thereafter. However, after the DPP returned to power in 2016, because the DPP government refused to recognize the “92 Consensus,” the spokesperson of the Taiwan Affairs Office of the State Council of the People’s Republic of China stated that the basis for Taiwan’s participation in international conferences no longer exists. Under pressure from Beijing, the WHO removed Taiwan’s status as an “observer” on the grounds of “one China.”
William Stanton, the former director of the American Association in Taiwan (AIT), gave a political signal at a press conference on “high-end” cooperation with Vietnam in Taipei at the end of last year. It is a close partner of the United States in Asia. The United States is very happy to see the two sides cooperate in epidemic prevention and vaccine development.
In fact, after the “high-end” vaccine was used in Taiwan’s Emergency Authorization (EUA) in July this year, the company also began to contact the WHO.
On August 13, high-end companies were invited to participate in the new crown vaccine conference held by the WHO. Pfizer, China Kexing and Johnson & Johnson and other major vaccine manufacturers were also participating in the conference. In addition to discussing the effectiveness of vaccine mixing, high-end companies were invited to wait for the vaccine manufacturers that were about to go on the market to report experimental data and so on.
Zhao Mingwei, associate professor of toxicology at Chung Yuan Christian University in Taiwan, believes that the definition of international certification is very vague, not as clear as standard medical certification procedures. Most drug certifications are based on results, such as whether they will be re-infected and safety. He said that WHO certification is not the ultimate certification indicator for vaccines, not to mention that the WHO has too many political factors in front of Taiwan. In addition, he said that the “high-end” new crown vaccine still needs to pass the market test, because under the protectionism of vaccines, high-end companies need to accelerate their deployment in the global market, which is also more beneficial for certification.
“Vaccines are most useful when they are effective,” Zhao Mingwei said.
Image source,Getty Images
As of August 25, Taiwan’s new crown vaccine has received more than 10.49 million doses, and the coverage rate of COVID-19 vaccination population is 41.24%.
Bilateral authentication strategy
After the official launch of “high-end” on August 23, how to pass the international certification, whether it can participate in the international “vaccine passport” program, and whether Taiwan will donate “high-end” vaccines to countries with diplomatic relations, and conduct “vaccine diplomacy” and other issues surfaced. .
Chen Canjian, general manager of a high-end company, recently explained to Taiwanese media that at the beginning of the development of the “high-end” new crown vaccine, the goal was to obtain international certification, but all applications must be approved after the country’s emergency use authorization (EUA) is passed. He mentioned that he has been in communication with the European Medicines Agency (EMA), and he currently hopes to apply for EU certification with the data from the expanded Phase II clinical trial. The certification process needs to be reviewed by an EU expert consultation meeting, and then there will be a clearer certification time point. The high-end company set its own goal of completing EU certification in the first half of 2022.
Chen Canjian also said that the experimental reports that countries provide to the EU for application are immunobridging data. The reason is that the vaccines in Europe are almost finished, and it is no longer necessary to provide the EU with the traditional Phase II or Phase III test data.
Li Bingying told the BBC that more than 200 new crown vaccines are currently under development worldwide, and most of them are carried out in the form of immune bridging. This is the current trend of vaccine development. In the past, HPV vaccines have been upgraded from four-valent to nine-valent. Realized by immune bridging.
Li Bingying said that these “pioneer” new crown vaccines (such as Pfizer or AstraZeneca) have already tested 30,000 people with protective antibodies, and the newly developed vaccines only need to adopt immune bridging methods to compare with these pioneer vaccines. , There is no need to do Phase III or Phase IV trials with tens of thousands of people.
He also said that, like many HPV vaccines (also known as cervical cancer vaccines) currently on the market, the US FDA uses immune bridging when the quadrivalent vaccine is about to change to nine. As long as the five extra virus antibodies are no less than the original four, they can be put on the market.
The “high-end” vaccine production technology is a contract with the National Institutes of Health (NIH) to transfer the genetically recombined S-2P spike protein technology to Taiwan to produce the new crown vaccine.
Regarding US certification, Chen Shizhong admitted at a press conference last week that he discussed digital vaccine certification and certification of “high-end” vaccines when meeting with the new director of the American Institute in Taiwan (AIT) Sun Xiaoya (Sandra Oudkirk) on August 19th. He said that the United States attaches great importance to “high-end” vaccines. “After all, high-end vaccines are derived from the scientific results of the National Institutes of Health.”
Image source,Sandee Chan Facebook
Taiwan’s well-known musician Chen Shanni publicly vaccinated high-end.
Taiwan’s version of “vaccine diplomacy”?
In fact, the outside world is also observing whether the Taiwanese government will use the self-produced new crown vaccine as a strategic weapon of “vaccine diplomacy.” In particular, when the Tsai Ing-wen government promotes domestic vaccines, it continues to use “prevention of epidemics as combat” and that vaccines are “strategic weapons” as the argument for promoting self-produced vaccines.
On July 27th, Taiwan’s opposition KMT Chairman Jiang Qichen stated that he had received a telegram of “Wishes to receive our domestic vaccines” issued by the Ministry of Foreign Affairs of Taiwan on July 20. The official document pointed out that Taiwan is discussing “donating high-end vaccines to all friendly nations”. Assist in the fight against the epidemic.”
Image source,Food and Drug Administration, Taiwan.
High-end general manager Chen Canjian told the Taiwan Media Central News Agency that the high-end has been in continuous communication with the European Medicines Agency (EMA) for a period of time, and the goal is to obtain certification from the European Union and other international institutions in the first half of 2022.
Based on this, Jiang Qichen criticized that the “high-end” vaccine passed the EUA on July 19, and it was developed by Telegram on the 20th. The process of donating the vaccine to Taiwan AIA is questionable. He said that foreign aid work is a good thing, “but don’t ruin good things because of vaccine disputes, and don’t let AIA be in a dilemma. AIA has its own EUA standard, which will not be lower than Taiwan. It will also compare international vaccines. , Do not accept? Or problems arise after the attack? It all involves the image of the country.”
However, Taiwan’s Ministry of National Defense think tank “National Defense Security Research Institute” Dr. Su Ziyun analyzed to the BBC that the Taiwan government’s award of the “high-end” vaccine EUA conforms to the drug management innovation spirit of the “100-day mission” of the G7 summit. He believes that this year’s G7 leader’s resolution stated that in the face of the non-traditional threat of COVID-19, international organizations, governments, the scientific community, and the biotechnology industry will be integrated, and vaccine development and testing procedures will be ensured on the premise of ensuring safety and effectiveness. Shorten it to 100 days to deal with emerging biochemical threats. Su Ziyun said that if the “high-end” and other Taiwanese self-produced vaccines are successfully produced, they can meet the goals of emergency relief, giving back to the international community, and humanitarian assistance.
Adrian Esterman, a professor of epidemiology at the University of South Australia in Australia, explained to the BBC in Chinese that because the “high-end” is an immune bridging instead of a phase three trial that passed Taiwan’s EUA, he judged that other countries would consider “high-end” vaccines when considering vaccine passports. You may encounter problems in the future.
Image source,Getty Images
The EU has started using the new crown digital certificate from July 1.