Health officials have decided not to grant Taiwan’s United Biomedical Inc. (UBI) COVID-19 vaccine emergency use authorization. That was the word from Central Epidemic Command Center officials at their daily press conference on Monday.
Taiwan offers the possibility of Emergency Use Authorization (EUA) for COVID-19 vaccines that have completed Phase II trials. At least half of the people who take the vaccine should go on to develop antibodies to fight COVID-19. In addition, the level of antibodies present in the blood should be at least as high as the level produced by the AstraZeneca vaccine.
Officials say the UBI vaccine was not able to meet the two standards for an EUA set by Taiwan’s Food and Drug Administration. That’s why Taiwan's Advisory Committee on Immunization Practices (ACIP) decided against authorization.
Of 21 experts on the committee, 17 voted against granting an EUA, while 4 asked for more data.
The UBI vaccine finished Phase II trials and has been approved to proceed to Phase III trials. The company plans to hold those trials in India.
Taiwan has already granted an EUA to another Taiwan-made vaccine, produced by Medigen Vaccine Biologics Corporation. Results from that vaccine showed it provoked antibody levels three times higher than AstraZeneca.
The Medigen vaccine is already an option on Taiwan’s national vaccine registration system.
When the UBI and Medigen vaccines were still in Phase II trials, Taiwan's government signed contracts to purchase at least 5 million doses from each of the companies.