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.
Merida Industry Co (美利達) has seen signs of recovery in the US and European markets this year, as customers are gradually depleting their inventories, the bicycle maker told shareholders yesterday. Given robust growth in new orders at its Taiwanese factory, coupled with its subsidiaries’ improving performance, Merida said it remains confident about the bicycle market’s prospects and expects steady growth in its core business this year. CAUTION ON CHINA However, the company must handle the Chinese market with great caution, as sales of road bikes there have declined significantly, affecting its revenue and profitability, Merida said in a statement, adding that it would
MARKET LEADERSHIP: Investors are flocking to Nvidia, drawn by the company’s long-term fundamntals, dominant position in the AI sector, and pricing and margin power Two years after Nvidia Corp made history by becoming the first chipmaker to achieve a US$1 trillion market capitalization, an even more remarkable milestone is within its grasp: becoming the first company to reach US$4 trillion. After the emergence of China’s DeepSeek (深度求索) sent the stock plunging earlier this year and stoked concerns that outlays on artificial intelligence (AI) infrastructure were set to slow, Nvidia shares have rallied back to a record. The company’s biggest customers remain full steam ahead on spending, much of which is flowing to its computing systems. Microsoft Corp, Meta Platforms Inc, Amazon.com Inc and Alphabet Inc are
RISING: Strong exports, and life insurance companies’ efforts to manage currency risks indicates the NT dollar would eventually pass the 29 level, an expert said The New Taiwan dollar yesterday rallied to its strongest in three years amid inflows to the nation’s stock market and broad-based weakness in the US dollar. Exporter sales of the US currency and a repatriation of funds from local asset managers also played a role, said two traders, who asked not to be identified as they were not authorized to speak publicly. State-owned banks were seen buying the greenback yesterday, but only at a moderate scale, the traders said. The local currency gained 0.77 percent, outperforming almost all of its Asian peers, to close at NT$29.165 per US dollar in Taipei trading yesterday. The
The US overtaking China as Taiwan’s top export destination could boost industrial development and wage growth, given the US is a high-income economy, an economist said yesterday. However, Taiwan still needs to diversify its export markets due to the unpredictability of US President Donald Trump’s administration, said Chiou Jiunn-rong (邱俊榮), an economics professor at National Central University. Taiwan’s exports soared to a record US$51.74 billion last month, driven by strong demand for artificial intelligence (AI) products and continued orders, with information and communication technology (ICT) and audio/video products leading all sectors. The US reclaimed its position as Taiwan’s top export market, accounting for
RSS