Medigen Vaccine Biologics Corp’s (高端疫苗) phase 3 clinical trials for an enterovirus 71 vaccine completed the immunogenicity data “unblinding” on Saturday, with the results meeting Taiwan’s regulatory standard, the company said yesterday.
The vaccine has a high efficacy against the virus, which can cause hand, foot and mouth disease, Medigen said in a Taiwan Stock Exchange filing.
The trial results showed that antibody levels one month, six months and one year after two vaccine shots were higher than health authorities’ requirements, the company said.
Photo: Chen Yung-chi, Taipei Times
“The unblinded data showed the vaccine’s neutralizing antibody assay has qualified the Food and Drug Administration’s accelerated approval mechanism, and Medigen plans to file new drug applications for the vaccine after completing the clinical trial reports,” it said.
The phase 3 trials — conducted in Taiwan and Vietnam with 3,000 participants — evaluated the efficacy, safety, immunogenicity, cross protection and lot-to-lot consistency of the vaccine used for children under six years old.
The vaccine aims to reduce the risk posed by the virus, which causes one of the most prevalent infectious diseases in Taiwan, China and Southeast Asia, Medigen chief executive officer Charles Chen (陳燦堅) told a news conference at the Taipei Exchange yesterday.
The company plans to apply for local approval at the end of this quarter or early next quarter, Chen said, adding that he hopes that the vaccine would be regularly administered starting next year.
Medigen plans to produce 1 million doses annually for the domestic market, where the drug would be introduced first, Chen said.
For the Vietnamese market, 3 million to 5 million doses would be produced, as the virus is more widespread there, he said.
Local suppliers of Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) appear to be divided over whether they should follow the chipmaker and also set up production facilities in the US, after TSMC announced that it would increase its investment in Arizona. While some TSMC suppliers, including clean-room design service provider United Integrated Services Co (漢唐集成), have set up plants in the US, others, such as IC testing and analysis provider Materials Analysis Technology Inc (閎康科技), have hesitated to make the move because of high production costs in the US. TSMC on Tuesday announced that it would increase its planned US$12 billion investment in
Netherlands-based ASML Holding NV, a leading global supplier of semiconductor production equipment, is considering bringing its European suppliers to Taiwan, doubling down on its supply-chain deployment in the country, Vice Premier Shen Jong-chin (沈榮津) said yesterday. That follows ASML’s announcement that it would build manufacturing facilities in New Taipei City’s Linkou District (林口) to support international customers and the development of the semiconductor industry. RELOCATION Shen did not disclose details about ASML’s new efforts to relocate European supply chains to Taiwan. ASML is to begin construction on the New Taipei City project in July, Shen said during a speech at a technology forum
MORE ADVANCED CHIPS: The company is planning to build a second, 3-nanometer fab in Arizona, TSMC said ahead of a ‘tool-in’ ceremony at its first plant near Phoenix Apple Inc is to be the biggest customer of Taiwan Semiconductor Manufacturing Co’s (TSMC, 台積電) new Arizona factories, Apple CEO Tim Cook wrote on Twitter yesterday. “Apple silicon unlocks a new level of performance for our users. And soon, many of these chips can be stamped ‘Made in America.’ The opening of TSMC’s plant in Arizona marks a new era of advanced manufacturing in the US — and we are proud to become the site’s largest customer,” he wrote. Cook’s tweet came as TSMC held a “tool-in” ceremony for its US$12 billion wafer fab in Arizona on Tuesday, which marked the beginning
Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) is to build a wafer fab deploying 1 nanometer (nm) process technology at the Longtan (龍潭) campus of Hsinchu Science Park (新竹科學園區), Hsinchu Science Park Bureau Director-General Wayne Wang (王永壯) said yesterday. The bureau completed a pilot project in the middle of last month for the third expansion phase of the Longtan Science Park (龍潭科學園區) in Taoyuan to accommodate the new TSMC plant, Wang told a news conference. The pilot expansion project has been submitted to the National Science and Technology Council, which would next forward the project to the Cabinet for approval, Wang said. “The efforts