The Buddhist Compassion Relief Tzu Chi Foundation’s application to import 5 million doses of the BioNTech COVID-19 vaccine will not be considered alongside similar requests tendered by the Yonglin Foundation and Taiwan Semiconductor Manufacturing Co (TSMC) due to differences in their applications, Executive Yuan spokesperson Lo Ping-cheng (羅秉成) said yesterday.
The Tzu Chi Foundation on Wednesday submitted an application to the Food and Drug Administration (FDA), after the Executive Yuan on Friday last week authorized the YongLin Foundation and TSMC to represent the government to purchase vaccines from BioNTech.
After evaluations, the proposals by TSMC and the YongLin Foundation are more feasible and have a greater “chance” of success, Lo told a news conference at the Executive Yuan in Taipei.
Photo courtesy of the Buddhist Compassion Relief Tzu Chi Foundation
The Tzu Chi Foundation’s application is not being merged with the other two due to differences with each application, he said, without elaborating.
International purchases of vaccines are complicated and it is vital to develop a model that has a greater chance of success, Lo said.
None of the applications included an “authorization notice” from the original manufacturer, BioNTech.
It is rare that the first tender of an application includes a manufacturer’s authorization, FDA Director-General Wu Shou-mei (吳秀梅) said on Wednesday, adding that it would look into the Tzu Chi Foundation’s application and ask it to provide any missing documents.
The Tzu Chi Foundation has said that it cannot obtain the manufacturer’s authorization unless the government first approves its application.
Tzu Chi Foundation executive director Yen Po-wen (顏博文) said that it has followed the government regulations and would do its best to provide whatever documents are required.
Should a purchase proceed, vaccines would be directly imported to Taiwan from Germany, Yen said.
Yen denied a rumor that the Tzu Chi Foundation canceled a news conference to announce its vaccine purchase plan after on Monday receiving a call from the Presidential Office.
Chinese Nationalist Party (KMT) Legislator Wen Yu-hsia (溫玉霞) on Monday made the allegation, although the Presidential Office has denied exerting pressure on the Tzu Chi Foundation.
The Tzu Chi Foundation said that it has three reasons for purchasing BioNTech vaccines.
First, it believes that it is the most effective vaccine against COVID-19; second, the manufacturer can supply sufficient doses in an emergency situation; and third, it is the only vaccine on the market that can be administered to 12 to 17-year-olds.
Vaccine import regulations say that applicants must do so through a pharmaceutical company and application must include eight pieces of documentation: plans and methods of execution; a pharmaceutical insert; the amount imported and why the amount was requested; proof of transport and storage at adequate temperatures; the date of vaccine provision; authorization from the original manufacturer; vaccine expiry dates; and proof of pre-market clearance in foreign countries, the Central Epidemic Command Center said last month.
Additional reporting by Wu Liang-yi
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