Taipei, United Biomedical Inc. became the second Taiwanese COVID-19 vaccine developer to receive Food and Drug Administration (FDA) approval to begin a phase 2 clinical trial, the regulator said in statement released on Friday.
The FDA said a meeting of experts was held on Wednesday to review the results of the company’s phase 1 trial and approve the trial to enter phase 2, which will be able to go ahead after the required technical documents are submitted to and approved by the Ministry of Health and Welfare.
Wu Ming-mei (吳明美), deputy head of the FDA’s Medical Products Division, said the results of the phase 1 trial of the company’s UB-612 vaccine candidate show that it meets safety and immunogenicity criteria.
She noted that the FDA has been working with local vaccine developers on both the regulatory and technical sides at every stage to shorten development time, while safety and quality remain its top priority.
Meanwhile, the company said in a statement also released on Friday that it plans to recruit 3,850 volunteers for its phase 2 trial of UB-612, a multitope protein/peptide-based vaccine, which, according to a report published in November on its animal experimentation, consists of components designed for the induction of high neutralizing antibodies and broad T-cell responses against SARS-CoV-2 — the coronavirus that causes COVID-19.
The company is aiming to recruit at least 3,000 people within a month and to complete the recruitment in March so that it can submit the results of the phase 2 trial to the FDA in mid-June at the earliest, it added.
The company also highlighted the fact that the vaccine does not require very low temperature storage like the Pfizer/BioNTech vaccine, which was the first to be approved for general vaccination in several Western countries.
The phase 2 trial, the company said, will be conducted among three age groups: 12-18 years old, 19-64 years old and 65 years old and above, at 11 hospitals across Taiwan.
Hwang Kao-pin (黃高彬), a deputy superintendent at China Medical University Hospital, will be the principal investigator of the phase 2 trial, according to the company.
United Biomedical is the second company to which the FDA has given a green light to the phase 2 trial in the development of COVID-19 vaccines in Taiwan.
Medigen Vaccine Biologics Corp. was the first local company to enter phase 2 trial for its COVID-19 vaccine candidate, after it received FDA approval on Dec. 30.
Under the FDA program to support local vaccine development, companies can receive a maximum NT$300 million (US$10.7 million) in additional government funding if they enroll their first participant in the second phase of their clinical trials by Dec. 31, and up to NT$240 million if they miss that deadline but enroll their first participant by Jan. 31.
Source: Focus Taiwan News Channel