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 Transport and Storage Corp (TTS, 台灣通運倉儲) yesterday unveiled its first electric tractor unit — manufactured by Volvo Trucks — in a ceremony in Taipei, and said the unit would soon be used to transport cement produced by Taiwan Cement Corp (TCC, 台灣水泥). Both TTS and TCC belong to TCC International Holdings Ltd (台泥國際集團). With the electric tractor unit, the Taipei-based cement firm would become the first in Taiwan to use electric vehicles to transport construction materials. TTS chairman Koo Kung-yi (辜公怡), Volvo Trucks vice president of sales and marketing Johan Selven, TCC president Roman Cheng (程耀輝) and Taikoo Motors Group
Among the rows of vibrators, rubber torsos and leather harnesses at a Chinese sex toys exhibition in Shanghai this weekend, the beginnings of an artificial intelligence (AI)-driven shift in the industry quietly pulsed. China manufactures about 70 percent of the world’s sex toys, most of it the “hardware” on display at the fair — whether that be technicolor tentacled dildos or hyper-realistic personalized silicone dolls. Yet smart toys have been rising in popularity for some time. Many major European and US brands already offer tech-enhanced products that can enable long-distance love, monitor well-being and even bring people one step closer to
RECORD-BREAKING: TSMC’s net profit last quarter beat market expectations by expanding 8.9% and it was the best first-quarter profit in the chipmaker’s history Taiwan Semiconductor Manufacturing Co (TSMC, 台積電), which counts Nvidia Corp as a key customer, yesterday said that artificial intelligence (AI) server chip revenue is set to more than double this year from last year amid rising demand. The chipmaker expects the growth momentum to continue in the next five years with an annual compound growth rate of 50 percent, TSMC chief executive officer C.C. Wei (魏哲家) told investors yesterday. By 2028, AI chips’ contribution to revenue would climb to about 20 percent from a percentage in the low teens, Wei said. “Almost all the AI innovators are working with TSMC to address the
Malaysia’s leader yesterday announced plans to build a massive semiconductor design park, aiming to boost the Southeast Asian nation’s role in the global chip industry. A prominent player in the semiconductor industry for decades, Malaysia accounts for an estimated 13 percent of global back-end manufacturing, according to German tech giant Bosch. Now it wants to go beyond production and emerge as a chip design powerhouse too, Malaysian Prime Minister Anwar Ibrahim said. “I am pleased to announce the largest IC (integrated circuit) Design Park in Southeast Asia, that will house world-class anchor tenants and collaborate with global companies such as Arm [Holdings PLC],”