The Ministry of Health and Welfare should hold a public hearing on the standards that are to be used to review emergency use authorization (EUA) applications for COVID-19 vaccines, New Power Party (NPP) Legislator Chen Jiau-hua (陳椒華) said yesterday.
Chen was hosting an online news conference after two domestic COVID-19 vaccine developers, Medigen Vaccine Biologics Corp and United Biomedical Asia, disclosed the results of their double-blind studies on June 10 and Sunday respectively.
Both companies said that they would apply for EUAs from the Food and Drug Administration (FDA) based on the results.
Photo courtesy of New Power Party Legislator Chen Jiau-hua
The review for Medigen’s EUA application would not begin until the end of next month, as it has been asked to provide more information about its vaccine studies, the administration said.
The ministry has treated review of EUA applications as “nothing more than child’s play,” as the standards to review the applications only consist of three pages, she said.
They include required technical information about COVID-19 vaccines, as well as standards to be applied to review EUA applications and the effectiveness of vaccines.
“How can the FDA review emergency use authorizations for vaccines with so many details missing?” she asked.
Chen said that she had asked to examine the standards to be used to review EUA applications when she questioned Minister of Health and Welfare Chen Shih-chung (陳時中) in a legislative plenary session earlier this month.
The ministry could consult the general guidelines for EUA applications for COVID-19 vaccines published by the WHO in November last year, which consist of 10 pages, Chen added.
“The ministry’s review of EUA applications from Medigen Vaccine Biologics and United Biomedical Asia cannot be blank authorizations. It must apply standards comparable to those set by the WHO,” she said.
The ministry is also obligated to explain to the public why a researcher at Academia Sinica who was previously involved in a study funded by Medigen was able to serve on the EUA review committee, Chen said.
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