企業公關與危機管理 實務演練

演練日期 2020 年 6 月 18 日 ●公關人員 ●媒體記者 ●新聞稿撰寫

第七組
出席組員 【班級：國企三甲 學號：AIB107714 姓名：卓曉芝】
【第 7 組】 【班級：國企三甲 學號：AIB107709 姓名：吳頡琳】
【班級：國企四甲 學號：AIB106711 姓名：許芷綾】

Q : Taiwan's domestic vaccines may not be available in late July as

媒體記者發問 expected, and while the Taiwanese government has tied their
& 公 關 人 員 launch to international recognition. What can you say to the public
about the delayed vaccine?
現場回覆
A : This is a new coup to create our own domestic vaccines, a new
breakthrough tends to have obstacles, so we are trying our best to find
the solution and keep growing. We hope our vaccine substantially can
help Taiwan. Because I believe in Taiwan’s ability.

Q : So according to the confirmation Taiwan will launch their own

vaccine before, now what further action can the government take to
make Taiwan vaccine approved international requirements?

A : According to the EUA review standards of Taiwan’s FDA, the agency

will look into the immunogenicity data of 200 Taiwanese recipients of
AstraZeneca shots in March. It will then use the data as a comparison to
evaluate whether the efficacy of the MVC vaccine is equivalent to those
approved by the big international players.The development also raised
concerns that the home-grown vaccine might not be available to be rolled
out by late July, as President Tsai has promised it will be reviewed in
accordance with international standards.

精簡新聞稿
Taiwanese COVID vaccine dealt blow as US FDA hesitates to
approve immunobridging: Report

TAIPEI (Taiwan News) — Taiwan's domestic vaccines may not be

available in late July as expected, and while the Taiwanese government
has tied their launch to international recognition, the U.S. Food and Drug
Administration has lingering concerns about the immunological bridging
approach.

Taiwanese vaccine maker Medigen Vaccine Biologics Corp announced

on June 10 that it had completed the phase two clinical trials for its
vaccine candidate, with the results meeting the safety and efficacy
standards set by Taiwan’s Food and Drug Administration (FDA) for an
emergency use authorization (EUA). The application for the EUA is
currently underway.

On May 18, three weeks before MVC announced its unblinded immunogenicity
data, President Tsai Ing-wen ( 蔡 英 文 ) expressed confidence that the home-
grown vaccine would be made available by the end of July. However, doubts
mounted as experts saw the schedule set by the government as "unlikely."

On Thursday (June 17), sources familiar with the matter told UDN that
the U.S. FDA had responded to a request from Taiwan's Center for Drug
Evaluation (CDE) to greenlight “immunobridging” prior to MVC's
unblinding for the phase two trials on June 10.

The American agency replied that it was "still discussing approaches to

immunobridging and an official position at this time is not possible."
Following an announcement from the U.S. FDA on May 25 that it may
decline to review EUA submissions for COVID-19 vaccines, the latest
development threatens to dash the last hope of securing
acknowledgment from the organizations that set global drug standards.

So far, vaccines from Pfizer, Moderna and Johnson & Johnson have
been authorized for emergency use in the U.S., according to Reuters.

Advisory Committee on Immunization Practices convenor Chong Inn-wen (鍾飲

文 ) declined to comment on the latest reports, citing confidentiality. However,
he said there has yet to be an international consensus on the adoption of
immunobridging. Chong added that the European Union and South Korea are
leaning towards giving immunobridging a try, and the U.S. FDA has yet to shut
the door on the approach.