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.
US-based tech giant Google said yesterday that its efforts to build four underseas cables to connect Taiwan with the world had created more than 64,000 jobs and generated about US$26 billion in GDP for Taiwan as of 2021. The US company has transformed Taiwan into a strategic cloud infrastructure hub in the world. The four undersea cables are part of the company’s investments in cloud infrastructure in Taiwan, and on the back of the undersea cables, a data center and a Google Cloud Region, which is a geographic area in which Google provides infrastructure and services for deploying applications, Google said in
Huawei Technologies Co (華為) largely omitted mention of its controversial Mate 60 smartphone series at a grand showcase of its new consumer products yesterday. The Shenzhen-based company would increase smartphone production in response to demand, said consumer division chief Richard Yu (余承東), without naming the handset triggering that surge. The Mate 60 Pro earned international notoriety with its advanced made-in-China processor last month, causing concern in Washington about Huawei’s progress toward developing in-house chipmaking capabilities despite US trade curbs. Huawei’s new phones have fired up the company’s sales and were among the top sellers in China in the week before Apple Inc’s
SLUMP: The electronics, machinery and traditional industries posted the largest decline in the past year; overall, sectors showed gains over the previous month Taiwan’s industrial production index decreased 10.53 percent year-on-year to 91.38 last month, falling for a 15th consecutive month on an annual basis, as weak global economic growth continued to weigh on end-market demand and investment momentum, the Ministry of Economic Affairs said on Saturday. The industrial production index gauges output in Taiwan’s four main industries: manufacturing, electricity and gas supply, water supply, and mining and quarrying. Last month’s decline was the smallest contraction since March when the index dropped 16.03 percent from a year earlier. On a monthly basis, the index rose 7.28 percent, marking a second straight month of improvement,
Micron Technology Inc on Wednesday predicted a steeper loss than anticipated in the current quarter, indicating that an industry slump is still weighing on the largest US maker of memory chips. The company projected a fiscal first-quarter loss of as much as US$1.14 a share, excluding some items. Analysts had estimated a US$0.96 loss. On the bright side, revenue is expected to start recovering in the period. Micron predicted sales of US$4.2 billion to US$4.6 billion, compared with an estimate of US$4.21 billion. For Micron and competitors Samsung Electronics Co and SK Hynix Inc, this year has been brutal. Customers in their