United Biomedical Inc Asia (聯亞生技) on Sunday urged the government to give its COVID-19 vaccine candidate, UB-612, a second chance, after its application for emergency use authorization (EUA) was denied last week.
Company founder Wang Chang-yi (王長怡) said that the Food and Drug Administration’s (FDA) standards for granting an EUA were hastily devised and outdated.
In assessing the effectiveness of a vaccine candidate, the FDA only considers the virus neutralizing antibodies — expressed as geometric mean titers (GMTs) — but the reaction of T-cells should also be part of the equation, Wang said.
Photo: CNA
The FDA should compare the effectiveness of the UB-612 vaccine and the AstraZeneca vaccine against the Delta variant of SARS-CoV-2, given that the variant is the most contagious, she said.
“It would be deeply regrettable to deny people access to such a good vaccine because of hastily devised EUA standards,” Wang said.
Despite the setback, the firm remains committed to seeking international approval for its COVID-19 vaccine candidate, she said.
United Biomedical said that it would soon appeal the FDA’s decision not to grant an EUA for the UB-612 vaccine.
The FDA respects the company’s right to appeal, it said, adding that it would review the application and decide whether another meeting of experts would be necessary.
On Monday last week, the FDA said that a majority of the experts had on Sunday voted not to grant the company an EUA.
To be granted an EUA, a vaccine must have a seroconversion rate of more than 50 percent, with GMTs at least equal to two-thirds of the level found in recipients of the AstraZeneca vaccine.
The FDA decided to test the antibody concentrations against people who had been inoculated with the AstraZeneca vaccine, because there is no globally recognized method for measuring GMTs or an accepted standard for what GMT level indicates effective protection.
The interim results of the company’s phase 2 clinical trials, released in late June, show that participants in the 19 to 64 age group had a seroconversion rate of 95.65 percent, meaning that 95.65 percent of participants produced neutralizing antibodies.
At the time, the company said that the GMT level was 102.3, while the GMT level of the AstraZeneca vaccine was 187.9, according to the FDA.
The comany had said that it would continue its phase 2 clinical trials in Taiwan and that its parent company, United Biomedical Inc, would re-evaluate the benefits of conducting phase 3 clinical trials.
At Sunday’s news conference, Wang did not say whether the company was proceeding with its plan to begin phase 2/3 efficacy trials in India, which were expected to have 11,000 participants.
The company would conduct phase 3 clinical trials in India for its “next-generation” COVID-19 vaccine, named “UB-613,” she said, without elaborating.
Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) last week recorded an increase in the number of shareholders to the highest in almost eight months, despite its share price falling 3.38 percent from the previous week, Taiwan Stock Exchange data released on Saturday showed. As of Friday, TSMC had 1.88 million shareholders, the most since the week of April 25 and an increase of 31,870 from the previous week, the data showed. The number of shareholders jumped despite a drop of NT$50 (US$1.59), or 3.38 percent, in TSMC’s share price from a week earlier to NT$1,430, as investors took profits from their earlier gains
In a high-security Shenzhen laboratory, Chinese scientists have built what Washington has spent years trying to prevent: a prototype of a machine capable of producing the cutting-edge semiconductor chips that power artificial intelligence (AI), smartphones and weapons central to Western military dominance, Reuters has learned. Completed early this year and undergoing testing, the prototype fills nearly an entire factory floor. It was built by a team of former engineers from Dutch semiconductor giant ASML who reverse-engineered the company’s extreme ultraviolet lithography (EUV) machines, according to two people with knowledge of the project. EUV machines sit at the heart of a technological Cold
Taiwan’s long-term economic competitiveness will hinge not only on national champions like Taiwan Semiconductor Manufacturing Co. (TSMC, 台積電) but also on the widespread adoption of artificial intelligence (AI) and other emerging technologies, a US-based scholar has said. At a lecture in Taipei on Tuesday, Jeffrey Ding, assistant professor of political science at the George Washington University and author of "Technology and the Rise of Great Powers," argued that historical experience shows that general-purpose technologies (GPTs) — such as electricity, computers and now AI — shape long-term economic advantages through their diffusion across the broader economy. "What really matters is not who pioneers
TAIWAN VALUE CHAIN: Foxtron is to fully own Luxgen following the transaction and it plans to launch a new electric model, the Foxtron Bria, in Taiwan next year Yulon Motor Co (裕隆汽車) yesterday said that its board of directors approved the disposal of its electric vehicle (EV) unit, Luxgen Motor Co (納智捷汽車), to Foxtron Vehicle Technologies Co (鴻華先進) for NT$787.6 million (US$24.98 million). Foxtron, a half-half joint venture between Yulon affiliate Hua-Chuang Automobile Information Technical Center Co (華創車電) and Hon Hai Precision Industry Co (鴻海精密), expects to wrap up the deal in the first quarter of next year. Foxtron would fully own Luxgen following the transaction, including five car distributing companies, outlets and all employees. The deal is subject to the approval of the Fair Trade Commission, Foxtron said. “Foxtron will be
RSS