Medigen Vaccine Biologics Corp (高端疫苗) on Tuesday said it has begun manufacturing its experimental COVID-19 vaccine, which it hopes to offer once it obtains an emergency use authorization (EUA).
The company has started producing antigens for its vaccine and filling them at a plant in Hsinchu, company spokesperson Leo Lee (李思賢) said by telephone.
“We hope to be able to offer our COVID-19 vaccine immediately after the Food and Drug Administration [FDA] greenlights it,” Lee said, declining to reveal how many doses the company has manufactured.
Photo: Huang Mei-chu, Taipei Times
President Tsai Ing-wen (蔡英文) has said that locally developed COVID-19 vaccines are expected to be available in July.
Medigen is running a phase 2 clinical trial of its experimental vaccine with 3,752 participants, who had been given the second shot by the end of last month, Lee said, adding that it plans to evaluate the drug’s efficacy at the end of this month.
The firm in the middle of next month would submit to health authorities its interim analysis report and hopes to gain the EUA soon, he said.
Asked if it is wise to start production when the FDA might change the vaccine formula, Lee said that the chances of that are slim, as the regulator reviewed the formula after the phase 1 trials.
“We expect two potential conclusions from the regulator’s review next month: pass or fail,” Lee said.
Medigen tested three doses of its vaccine — low, medium and high — in the phase 1 trials, with the medium dose showing the best potential, so the phase 2 trials only use the medium dose, he said.
“Even if the FDA concludes that the medium dose is not strong enough, the formula does not need to be changed, as the issue could be solved by giving people a third shot,” Lee said.
Medigen has not found serious adverse reactions or vaccine-associated enhanced diseases among participants in the phase 2 trials, it said.
An independent data monitoring committee said that its candidate is safe at a meeting on May 8, Medigen said.
Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) would not produce its most advanced technologies in the US next year, Minister of Economic Affairs J.W. Kuo (郭智輝) said yesterday. Kuo made the comment during an appearance at the legislature, hours after the chipmaker announced that it would invest an additional US$100 billion to expand its manufacturing operations in the US. Asked by Taiwan People’s Party Legislator-at-large Chang Chi-kai (張啟楷) if TSMC would allow its most advanced technologies, the yet-to-be-released 2-nanometer and 1.6-nanometer processes, to go to the US in the near term, Kuo denied it. TSMC recently opened its first US factory, which produces 4-nanometer
GREAT SUCCESS: Republican Senator Todd Young expressed surprise at Trump’s comments and said he expects the administration to keep the program running US lawmakers who helped secure billions of dollars in subsidies for domestic semiconductor manufacturing rejected US President Donald Trump’s call to revoke the 2022 CHIPS and Science Act, signaling that any repeal effort in the US Congress would fall short. US Senate Minority Leader Chuck Schumer, who negotiated the law, on Wednesday said that Trump’s demand would fail, while a top Republican proponent, US Senator Todd Young, expressed surprise at the president’s comments and said he expects the administration to keep the program running. The CHIPS Act is “essential for America leading the world in tech, leading the world in AI [artificial
REACTIONS: While most analysts were positive about TSMC’s investment, one said the US expansion could disrupt the company’s supply-demand balance Taiwan Semiconductor Manufacturing Co’s (TSMC, 台積電) new US$100 billion investment in the US would exert a positive effect on the chipmaker’s revenue in the medium term on the back of booming artificial intelligence (AI) chip demand from US chip designers, an International Data Corp (IDC) analyst said yesterday. “This is good for TSMC in terms of business expansion, as its major clients for advanced chips are US chip designers,” IDC senior semiconductor research manager Galen Zeng (曾冠瑋) said by telephone yesterday. “Besides, those US companies all consider supply chain resilience a business imperative,” Zeng said. That meant local supply would
Servers that might contain artificial intelligence (AI)-powering Nvidia Corp chips shipped from the US to Singapore ended up in Malaysia, but their actual final destination remains a mystery, Singaporean Minister for Home Affairs and Law K Shanmugam said yesterday. The US is cracking down on exports of advanced semiconductors to China, seeking to retain a competitive edge over the technology. However, Bloomberg News reported in late January that US officials were probing whether Chinese AI firm DeepSeek (深度求索) bought advanced Nvidia semiconductors through third parties in Singapore, skirting Washington’s restrictions. Shanmugam said the route of the chips emerged in the course of an
RSS