CORONAVIRUS/President Tsai Ing-wen to get locally developed COVID-19 vaccine

Taipei, July 28 (CNA) President Tsai Ing-wen (蔡英文) said Wednesday she will get vaccinated with the COVID-19 vaccine proposed by Taiwan-based Medigen Vaccine Biologics Corp., which controversially obtained emergency use authorization (EUA) in Taiwan on July 19.

Neither the president nor Vice President Lai Ching-te (賴清德) has been vaccinated against COVID-19, and they have expressed their intention to receive domestically developed vaccines to boost public confidence in them.

In a Facebook post, Tsai said she registered to get her first shot through the government's COVID-19 vaccination appointment system, which allows people to indicate their vaccine preferences and make an appointment to get a shot when a vaccine becomes available.

Tsai said she opted for the Medigen vaccine, one of three options now available along with the AstraZeneca and Moderna vaccines on the system, even though Medigen has yet to deliver any doses or provid a delivery schedule.

"(The government) will only supply vaccines that are safe, effective, legitimate and aligned with scientific standards," Tsai said, in an apparent effort to back the Medigen vaccines.

Medigen was granted an EUA for its COVID-19 vaccine by the Taiwan Food and Drug Administration (FDA) last week, but the approval came without Medigen having to present any Phase 3 clinical trial efficacy data showing it could protect people in real-life situations.

Approval was given because the neutralizing antibodies generated in Medigen vaccine recipients compared favorably to those generated in AZ vaccine recipients, a concept known as immunobridging.

The concept has been discussed internationally, but no consensus or standards have been reached on its use. Taiwan is the first country to use it for vaccine approvals.

Taiwan's government has contracted to purchase 5 million doses of Medigen vaccines, which require two doses to be administered 28 days apart to people aged 20 and over.

Meanwhile, Lai said he planned to receive vaccines produced by another Taiwanese company, United Biomedical, Inc., Asia, which has not yet been granted an EUA for its COVID-19 vaccine in Taiwan, according to the Presidential Office spokesman Xavier Chang (張惇涵).

United Biomedical presented the data from its Phase 2 clinical trials and submitted an EUA application to the Taiwan FDA at the end of June, hoping to follow in Medigen's footsteps.

The FDA said this week, however, that the company needs to submit more documents before the agency can begin with the review.