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.
LOOKING TO GROW: A survey showed that 71 percent of executives at chipmakers said that they aim to increase their global workforce this year An overwhelming majority of semiconductor executives expect revenue to grow this year, driven mainly by automotive applications that are putting wireless communications to the backseat, a survey released yesterday by global consultancy firm KPMG showed. Eighty-one percent of respondents said that their company’s revenue would increase over the next year, and half of them said they expect growth of more than 10 percent, the survey of 151 global semiconductor executives last quarter showed. Although lower than last year’s 95 percent and 68 percent respectively, the findings are encouraging in light of recent economic uncertainty, inflation, monetary tightening and geopolitical tensions, a KPMG
TAKING OFF: Net profit soared 29.5 percent annually last year to a record NT$15.37 billion, as GlobalWafers received record-high prepayments from customers, it said Semiconductor inventory corrections should end next quarter, paving the way for a pickup in demand in the second half of this year, GlobalWafers Co (環球晶圓) said yesterday. As a majority of its customers believe demand would bounce back in the second half, the world’s No. 3 silicon wafer maker said it is keeping most of its factories fully utilized to ensure sufficient supply. “Our customers have committed to take those wafers. They only requested to push back shipments by a month or two,” GlobalWafers chairwoman Doris Hsu (徐秀蘭) told an investors’ teleconference. “Overall industry inventory adjustment should be mostly resolved in the second
The London Metal Exchange (LME) discovered bags of stones instead of the nickel that underpinned a handful of its contracts at a warehouse in Rotterdam, the Netherlands, in a revelation that would deliver another blow to confidence in the embattled exchange. The amount of metal represents just 0.14 percent of live nickel inventories on the LME, worth about US$1.3 million at current prices, so the immediate effect on the metals markets is limited. However, the shock announcement has much wider implications. In an industry riddled with scandals, the LME’s contracts are viewed as unquestionably safe. The news that even a few of
Oil on Friday posted its worst weekly loss since the early months of the COVID-19 pandemic as banking turmoil poisoned investor sentiment. West Texas Intermediate for April delivery dropped 2.36 percent to US$66.74 per barrel, falling 12.96 percent for the week, the largest drop in almost three years. Brent crude for May delivery fell 2.32 percent to US$72.97, posting a weekly loss of 11.85 percent. The failure of Silicon Valley Bank and troubles at Credit Suisse Group AG drove investors from risk assets, with oil-options covering accelerating the sell-off. “Crude action this week reminded many of how quickly the commodity can be decimated by
RSS