Presenting what it said was a leaked internal document, the Chinese Nationalist Party (KMT) caucus yesterday accused the Food and Drug Administration (FDA) of “following the president’s script” on emergency use authorization (EUA) of COVID-19 vaccines.
Calling the content of the document “shocking,” KMT caucus secretary-general Cheng Li-wen (鄭麗文) demanded that President Tsai Ing-wen (蔡英文) and Minister of Health and Welfare Chen Shih-chung (陳時中) explain the “ugly truth” behind the EUA approval process.
On the same day the caucus held a news conference to discuss the document, the FDA granted an EUA to Medigen Vaccine Biologics Corp to begin mass production of its COVID-19 vaccine.
The document is from an internal meeting of the FDA on June 17, but its contents were updated the day before, Cheng told an online news conference, adding that it includes a timeline of events from the agency’s expert advisory meeting from May 28 to Aug. 31.
On June 25, it shows the agency convening a panel to discuss approving an EUA, ostensibly for Medigen’s vaccine, followed by the completion of 2 million doses by Aug. 31, she said.
The timeline fully corresponds with Tsai’s goal of offering locally developed vaccines by this month, with 2 million doses being administered by the end of next month, she added.
This shows that the FDA was following the president’s script, exposing the EUA process as mere theatrics devoid of scientific basis, Cheng said.
The document also shows that Medigen has already begun manufacturing vaccines, one to three batches of which have been inspected by the FDA, she said.
However, 82 percent of those reviewed failed inspection, Cheng said, speculating that after discovering this roadblock, Tsai delayed EUA approval until this month.
The president drafted this script with Chen, even vowing publicly that domestic vaccines would be available by this month, but she did not expect that Medigen could fall short, Cheng said.
Nearly all the tested vaccines were below standard, but despite knowing this, the government still signed a contract with Medigen for 5 million doses, she added, asking what would happen if the firm cannot deliver on its contractual obligations.
Separately yesterday, Democratic Progressive Party caucus director-general Liu Shyh-fang (劉世芳) said that the EUA was granted by an overwhelming majority of 18 to one, dispelling any rumors regarding the circumstances of its approval.
Vaccines are politically neutral and do not belong to whomever is in power, she said, urging the opposition to focus on improving the vaccine coverage rate instead of politicizing the issue.
Additional reporting by CNA
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