The Chinese Nationalist Party (KMT) yesterday filed a lawsuit against Minister of Health and Welfare Chen Shih-chung (陳時中) and Food and Drug Administration (FDA) Director Wu Shou-mei (吳秀梅) alleging corruption in the decision to issue an emergency use authorization (EUA) for the COVID-19 vaccine developed by the Medigen Vaccine Biologic Corp (高端疫苗生物製劑).
The FDA had bypassed standard procedures and, in broad defiance of public and international opinion, decided to approve the vaccine, the KMT said.
Citing FDA data, KMT caucus secretary-general Cheng Li-wun (鄭麗文) said that Medigen started producing vaccines last month, before it received the EUA, which is evidence that the company was given assurances that its vaccine would be approved and made available for use by next month.
“We have become the only nation to approve an EUA for a vaccine that has not passed phase 3 clinical trials,” Cheng said.
Medigen yesterday said that it had received approval to conduct phase 3 clinical trials on 1,000 people in Paraguay.
KMT Chairman Johnny Chiang (江啟臣) cited the vaccine approval process in the US, saying that the process is recorded and that its review processes are transparent.
Taiwan, on the other hand, had not recorded the review process, he said, adding that the public does not know who attended the meeting, or what kind of opposition was voiced.
“We have set the lowest bar for vaccine approval worldwide,” Chiang said.
KMT Disciplinary Committee director Yeh Ching-yuan (葉慶元), who is the party’s legal representative, said that the procedures to approve domestic vaccines went against past practice, despite Taiwan having access to international vaccines and having no immediate need for them.
The FDA was guilty of corruption as it forced through the approval of the EUA by replacing half of the academics on the panel of specialists, Yeh said.
In response, Democratic Progressive Party caucus secretary-general Lo Chih-cheng (羅致政) said that the legislature would declassify and make public the minutes of the specialists’ meeting within two weeks.
At the specialists’ meeting, 18 members voted to approve the vaccine, one voted for further discussion after asking for more information and one voted to not approve the vaccine, Wu said on Monday, adding that the convener of the meeting was not allowed to vote.
Under the EUA, the company must provide a safety report every month, she said.
MEDIGEN: The vaccine must also be reviewed by the Advisory Committee on Immunization Practices before it is added to the national vaccination program An emergency use authorization (EUA) for Medigen Vaccine Biologics Corp’s (高端疫苗) COVID-19 vaccine — MVC-COV1901 — for people aged 20 and older was issued by the Food and Drug Administration (FDA) yesterday. Minister of Health and Welfare Chen Shih-chung (陳時中) said a specialists’ meeting was held at the FDA on Sunday to review Medigen’s application to manufacture and distribute its COVID-19 vaccine, and the panel approved it. FDA Director Wu Hsiu-mei (吳秀梅) said the meeting consisted of 21 specialists from the fields of chemistry, manufacturing and controls, pharmacy, toxicology, clinical medicine, public health, law and medical ethics. There were no major concerns over
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