One of Taiwan’s locally produced COVID-19 vaccines has been approved for Emergency Use Authorization (EUA). If it passes the review by the Advisory Committee on Immunization Practices, the new vaccine could be administered in limited quantities starting in August.
The Central Epidemic Command Center announced on Monday that Taiwan’s Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a COVID-19 vaccine produced by Taiwan-based Medigen Vaccine Biologics.
The decision was made by a panel of 21 experts who held a vote on whether to approve the vaccine on Sunday. Eighteen members voted to approve, one opposed, and one asked for more data.
The new vaccine will also be reviewed by the Advisory Committee on Immunization Practices before it can be added to the national vaccination program. Once it’s approved, a small number of doses could be administered starting August.
Taiwan’s FDA Director Wu Shou-mei said the AstraZeneca vaccine was chosen for comparison with the Medigen vaccine because it was the only vaccine available in Taiwan at the time of testing. The tests found that the geometric mean titer (GMT) level of neutralizing antibodies in participants who got the Medigen vaccine was 3.4 times higher than those who received the AstraZeneca vaccine. The other key result was the vaccine’s sero-response rate, which is the percentage of people who generate an immune response. That was 95.5 percent, which is higher than the required 50 percent.
Wu said the Medigen vaccine is suitable for adults aged 20 and older, and each person needs two doses at least 28 days apart. Medigen must also provide a safety report every month and a report on the vaccine’s effectiveness after being administered in Taiwan and other countries after one year.