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.
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