Tue, Aug 17, 2021 page1

• United Biomedical fails to gain authorization

  • By Lee I-chia / Staff reporter
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  Domestic firm United Biomedical Inc’s (聯亞生技) COVID-19 vaccine, UB-612, failed to obtain emergency use authorization from the Food and Drug Administration (FDA), the Central Epidemic Command Center (CECC) said yesterday.

  FDA Director-General Wu Shou-mei (吳秀梅) said a meeting was held on Sunday to review United Biomedical’s proposal to manufacture its COVID-19 vaccine.

  The company’s clinical trials found that the vaccine met safety standards, but it did not generate enough neutralizing antibodies against SARS-CoV-2 to meet the standards set by the FDA specialists’ panel, she said.

  

  The Food and Drug Administration building is pictured in Taipei on Aug. 28 last year.

  Photo: Lin Hui-chin, Taipei Times

  Twenty-two specialists attended the meeting, and among the 21 who voted, four voted to hold further discussions after the company provided more information and 17 voted against granting emergency use authorization, Wu said.

  United Biomedical is planning to conduct phase 3 clinical trials in India, the FDA said.

  Chan Ming-hsiao (詹明曉), director of the Center for Drug Evaluation’s Division of New Drugs, said that the FDA and the CECC have over the past one-and-a-half years offered weekly supervision to domestic vaccine makers, assisting them in meeting the requirements for legal and technical data review.

  Technical data review items include aspects of chemistry, manufacturing and control, to ensure the safety and stability of the vaccine, he said, adding that additional data on its pharmacology and toxicology were reviewed human clinical trials were conducted.

  Chan said domestic companies were asked to enroll at least 3,000 participants in its clinical trials, and follow up on the safety information for at least a month after the participants received their last vaccine dose.

  Using immunobridging to compare the efficacy of the new vaccines with the AstraZeneca vaccine, the FDA specialists’ panel set two standards that domestic vaccines must meet to obtain emergency use authorization, he said.

  The levels of neutralizing antibodies produced in participants of the United Biomedical clinical trial failed to comply with the non-inferiority standard, Chan said.

  As the government had procured 5 million doses of United Biomedical’s COVID-19 vaccine in advance, the CECC was asked if the firm’s failure to obtain emergency use authorization would further affect the nation’s vaccine shortage.

  Minister of Health and Welfare Chen Shih-chung (陳時中), who heads the CECC, said the government has procured more vaccine doses than needed, so if United Biomedical’s vaccine had obtained emergency use authorization, more people would have been vaccinated earlier, but there would still be enough doses to meet local demand even without it.

  The FDA yesterday announced that one batch of the Moderna vaccine, or 99,000 doses, and four batches of the Medigen vaccine, or 261,766 doses, have passed lot release testing.

  Including the 261,766 doses, there are now a total of 614,204 Medigen doses available to be administered, Chen said.

  Chen said the 605,359 people who had registered to receive the Medigen vaccine between Monday next week and Sunday next week could start booking their vaccination appointments from 10am yesterday.

  As of 5pm, about 49.95 percent had already booked an appointment, he said.

  Separately, Presidential Office spokesman Xavier Chang (張惇涵) said that President Tsai Ing-wen (蔡英文) had yesterday booked an appointment to receive the Medigen vaccine on Monday next week.

  Vice President William Lai (賴清德) had planned to be inoculated with the United Biomedical vaccine, but he would now register for the Medigen vaccine, Chang added.

  Additional reporting by CNA
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