Taiwan’s Food and Drug Administration (FDA) has approved emergency use authorization (EUA) for the nation’s first locally-made COVID-19 vaccine.
After a day-long discussion on July 18, a panel of 21 experts determined that the Medigen vaccine is at least as good as AstraZeneca, in terms of its ability to produce antibodies. The panel also says that the Medigen vaccine poses no serious safety concerns.
In the end, just one person voted against an EUA for the Medigen vaccine.
Normally vaccines need to pass three rounds of testing before they can be presented for emergency use authorization. But the government fast-tracked the application process ahead of phase III trials, which would produce data about the vaccine’s efficacy.
Officials say they sped up the process in light of the pandemic and the urgent need for vaccines. They say that in lieu of vaccine efficacy data, they looked at the levels of antibodies the vaccines produce in the body.
Taiwan’s government has already ordered 5 million doses from Medigen, and 5 million from another domestic manufacturer – UBI Pharma – which is still awaiting authorization.