Medigen Vaccine Biologics Corp’s (高端疫苗) board of directors yesterday approved a proposal to conduct a phase 3 clinical trial of its COVID-19 vaccine in Europe, it said yesterday.
The final stage of human tests, if approved by the European Medicines Agency (EMA), would mark a big milestone in the COVID-19 vaccine development of Medigen, which has so far completed phase 1 and 2 clinical trials in Taiwan and is conducting a small phase 3 clinical trial in Paraguay.
Medigen in July consulted the EMA about conducting clinicial trials of its vaccine and it received a “positive response” from the agency, the company said in a statement.
Photo: Bloomberg
The EMA advised the company to conduct a phase 3 clinical trial directly in Europe instead of phase 1 or phase 2 trials, as the European regulator took into account that Medigen had completed earlier-stage human tests of the vaccine in Taiwan, company spokesman Leo Lee (李思賢) told by telephone.
The company is to finalize its design for the protocols of the phase 3 clinical trial in the near term and would apply to the EMA for permission to go ahead with it.
Although Medigen had researched how a third shot would bolster immunity by giving tens of participants in Taiwan a third dose, the company would still give two doses to those enrolled in its phase 3 trial in Europe, Lee said.
The number of participants in the clinical trial in Europe is expected to be 4,000 or fewer, and the trial would be conducted in multiple locations in multiple countries in Europe, it said.
“If everything goes smoothly, the clinical trial would begin in November and yield preliminary results in the first quarter next year,” Lee said.
It is possible that Medigen would be able to conduct an immunobridging study to compare the levels of antibodies in people who have received a Medigen vaccine against those who have been given one of the vaccines approved in Europe, the company said.
So far, the EMA has approved four COVID-19 vaccines for use in Europe: Pfizer-BioNTech, Moderna, AstraZeneca and Johnson & Johnson; the first two are developed by the messenger RNA technology while the latter two are adenovirus-based vaccines, the EMA’s Web site showed.
Medigen’s vaccine is a protein-subunit vaccine, developed by the recombinant technology; the vaccine comprises recombinant spike protein of SARS-CoV-2 as the antigen to help a person’s body recognize the real virus if the person becomes infected, company data showed.
UNCONVINCING: The US Congress questioned whether the company’s Chinese owners pose a national security risk and how the app might influence young users TikTok chief executive officer Shou Chew (周受資), confronted with an unforgiving, distrustful US Congress, tried to give answers in his testimony on Thursday that avoided offending either the US government or China. However, his evasiveness left Congress unsatisfied, with representatives hungrier than ever to punish TikTok for ties to its parent company ByteDance Ltd (字節跳動), based in Beijing. He did not bring his company any closer to a resolution. Politically, TikTok is in a tougher spot. Its executives had been discussing divesting from ByteDance to resolve US national security concerns, people familiar with the matter told Bloomberg. However, China this week said
The Investment Commission yesterday approved a Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) application to invest an additional US$3.5 billion in its Arizona subsidiary to manufactured advanced chips. The world’s largest contract chipmaker’s board of directors last month approved the funding project after TSMC started moving manufacturing equipment into the fab in December last year in preparation for the production of 4-nanometer chips next year. TSMC said it has also commenced the second phase of facility construction in Arizona. The second fab is to produce semiconductors using 3-nanometer technology in 2026. Altogether, TSMC plans to spend US$40 billion on the Arizona fabs, doubling its
KEY SECTOR: Taiwan’s new chip legislation is insufficient, and a more strategic ‘chip act’ that covers the whole semiconductor ecosystem is needed, MediaTek’s chairman said MediaTek Inc (聯發科) chairman Rick Tsai (蔡明介) yesterday urged the government to formulate a state semiconductor strategy and comprehensive “chip act” that includes local chip designers and smaller-scale semiconductor companies, as they are facing intensifying competition from China. The government is playing an increasingly important role in safeguarding the local semiconductor industry’s competitiveness, given that the US, the EU and Japan are offering hefty subsidies and significant tax incentives to build semiconductor capacity domestically, as they have realized the strategic importance of semiconductors, Tsai said. To implement such a program, the government should take steps to finance a “chip act,” Tsai said
Microsoft Corp has threatened to cut off access to its Internet search data, which it licenses to rival search engines, if they do not stop using it as the basis for their own artificial intelligence (AI) chat products, people familiar with the dispute have said. The software maker licenses the data in its Bing search index — a map of the Internet that can be quickly scanned in real time — to other companies that offer Web search, such as Apollo Global Management Inc’s Yahoo and DuckDuckGo. Last month, Microsoft integrated a cousin of ChatGPT, OpenAI’s AI-powered chat technology, into Bing. Rivals
RSS