United Biomedical Inc (聯亞生技) yesterday announced that the interim analysis of phase 2 trials for its COVID-19 vaccine, UB-612, showed that the jab’s safety and immunogenicity met the drugmaker’s expectations.
United Biomedical would submit a final report to the Food and Drug Administration (FDA) by the end of this month and apply for emergency use authorization, UBI Pharma Inc (聯亞藥業) spokesperson Vivien Fan (范瀛云) told an online news conference on behalf of the firm’s parent company.
The announcement came after Medigen Vaccine Biologics Corp (高端疫苗) on June 10 said it was seeking FDA’s emergency use authorization for its COVID-19 vaccine after reporting positive phase 2 trial results.
United Biomedical is planning to complete phase 2 trial data unblinding in late November and is considering conducting phase 3 trials in India, aiming to recruit 11,000 participants, Fan said.
UB-612 is a multitope protein/peptide-based vaccine. United Biomedical on Feb. 26 started enrolling participants for the phase 2 trials and completed the enrollment phase on May 18.
The drug was administered to 3,850 participants in the multi-regional, randomized, double-blinded and placebo-controlled study, the company said.
They were divided into three age groups: twelve to 18 years, 19 to 64 years, and 65 and older, it said, adding that one in every seven participants was administered a placebo.
Fan said that phase 2 trial results indicated that UB-612 was safe, as no adverse reactions were recorded throughout trials.
The vaccine showed no significant side effects, as 1.93 percent of participants who received UB-612 had a fever, compared with 1.81 percent in the placebo group, she said.
Among those who received the vaccine, 37.47 percent reported feeling tired, compared with 38.34 percent in the placebo group, Fan said.
Among those who received UB-612, 17.01 percent reported having a headache, 35.69 percent reported sore muscles and 10.23 percent said they had diarrhea, compared with 18.63 percent, 17.72 percent and 9.95 percent respectively for those who were given a placebo, she added.
Immunogenicity results were promising, as 95.65 percent of trial participants in the 19-to-64 age bracket showed a COVID-19 specific immune memory 28 days after receiving the second dose of the vaccine, she said, adding that the figure was 88.57 percent for older participants.
The geometric mean titer (GMT), which indicates the level of neutralizing antibody response, was 102.3, United Biomedical said, adding that the result met its expectations based on phase 1 trials.
The GMT figure also showed lot-to-lot consistency, meeting the FDA’s standards for emergency use authorization, it said.
The phase 2 trials also indicated a similar degree of GMT figure when tested for the Delta variant of COVID-19, the company added.
POWERING UP: PSUs for AI servers made up about 50% of Delta’s total server PSU revenue during the first three quarters of last year, the company said Power supply and electronic components maker Delta Electronics Inc (台達電) reported record-high revenue of NT$161.61 billion (US$5.11 billion) for last quarter and said it remains positive about this quarter. Last quarter’s figure was up 7.6 percent from the previous quarter and 41.51 percent higher than a year earlier, and largely in line with Yuanta Securities Investment Consulting Co’s (元大投顧) forecast of NT$160 billion. Delta’s annual revenue last year rose 31.76 percent year-on-year to NT$554.89 billion, also a record high for the company. Its strong performance reflected continued demand for high-performance power solutions and advanced liquid-cooling products used in artificial intelligence (AI) data centers,
SIZE MATTERS: TSMC started phasing out 8-inch wafer production last year, while Samsung is more aggressively retiring 8-inch capacity, TrendForce said Chipmakers are expected to raise prices of 8-inch wafers by up to 20 percent this year on concern over supply constraints as major contract chipmakers Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) and Samsung Electronics Co gradually retire less advanced wafer capacity, TrendForce Corp (集邦科技) said yesterday. It is the first significant across-the-board price hike since a global semiconductor correction in 2023, the Taipei-based market researcher said in a report. Global 8-inch wafer capacity slid 0.3 percent year-on-year last year, although 8-inch wafer prices still hovered at relatively stable levels throughout the year, TrendForce said. The downward trend is expected to continue this year,
Vincent Wei led fellow Singaporean farmers around an empty Malaysian plot, laying out plans for a greenhouse and rows of leafy vegetables. What he pitched was not just space for crops, but a lifeline for growers struggling to make ends meet in a city-state with high prices and little vacant land. The future agriculture hub is part of a joint special economic zone launched last year by the two neighbors, expected to cost US$123 million and produce 10,000 tonnes of fresh produce annually. It is attracting Singaporean farmers with promises of cheaper land, labor and energy just over the border.
US actor Matthew McConaughey has filed recordings of his image and voice with US patent authorities to protect them from unauthorized usage by artificial intelligence (AI) platforms, a representative said earlier this week. Several video clips and audio recordings were registered by the commercial arm of the Just Keep Livin’ Foundation, a non-profit created by the Oscar-winning actor and his wife, Camila, according to the US Patent and Trademark Office database. Many artists are increasingly concerned about the uncontrolled use of their image via generative AI since the rollout of ChatGPT and other AI-powered tools. Several US states have adopted
RSS