Clinical trials in other nations could be used to prove vaccine efficacy and safety according to international standards, the Food and Drug Administration (FDA) said yesterday, in response to accusations that a Medigen application to import a South Korean influenza vaccine was approved without full clinical trials in Taiwan.
The government flu shot program that began on Oct. 2 for the first time included a fourth quadrivalent flu vaccine from South Korean drugmaker GC Biopharma imported by Medigen.
Chinese Nationalist Party (KMT) Legislator Wang Hung-wei (王鴻薇) on Monday said that she had requested that the Ministry of Health and Welfare provide records of Medigen’s application, including clinical trial results, but was rejected on the grounds that they are “trade secrets.”
Photo: Su Chin-feng, Taipei Times
“The only trials conducted in Taiwan were on people aged 20 to 50, with other trials all conducted in South Korea,” she wrote on Facebook, asking how the public can trust vaccine safety if the trial data remain opaque.
At a news conference in Taipei yesterday, FDA Deputy Director Cheng Hwei-fang (陳惠芳) detailed the vaccine approval process used to approve all six available brands.
There is no requirement that clinical trials are conducted in Taiwan, only within Asia, Cheng said.
Taiwan is also more stringent than South Korea, which allows children six months and older to receive the GC Biopharma flu vaccine, compared with three years and older in Taiwan, she said.
When studied through an internationally recognized method of assessing “ethnic factors in the acceptability of foreign clinical data,” the South Korean data were determined to be insensitive to ethnic factors and could therefore be considered in the review process, she added.
Medigen also submitted information obtained from GC Biopharma’s clinical trials conducted in three age groups — three to 18, 19 and older, and 65 and older — Cheng said.
The other approved flu vaccines were similarly determined to be insensitive to ethnic factors and did not require local clinical trials, she said.
As for the refusal to publicize Medigen’s application, Cheng said the FDA has an obligation to maintain the confidentiality of trade secrets under Article 40-1 of the Pharmaceutical Affairs Act (藥事法), and that the data constitute “trade secrets” as defined in the Trade Secrets Act (營業秘密法).
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