Immunobridging remains a feasible way of determining vaccine efficacy, even if the US does not yet have an official stance on the matter, the Ministry of Health and Welfare said yesterday.
The Food and Drug Administration (FDA) on Thursday last week said it would adopt the alternative approach in lieu of phase 3 trial data when evaluating emergency use authorization (EUA) for locally developed COVID-19 vaccines.
Immunobridging compares the efficacy of an approved vaccine with a trial one by measuring the concentration of neutralizing antibodies in each group of recipients.
Photo courtesy of the Executive Yuan
For a domestic vaccine to be approved, those who received the vaccine in phase 2 trials must present an antibody concentration at least as high as that found in 200 Taiwanese who have received both doses of the AstraZeneca vaccine.
Immunobridging was proposed by the WHO earlier this year and is supported by the EU, South Korea and other nations, Minister of Health and Welfare Chen Shih-chung (陳時中) said last week, although he also acknowledged that no other countries have issued this type of EUA.
However, local media have questioned international acceptance of the method, citing a statement from the US FDA.
The US regulator made the comment in response to an inquiry sent on May 20 by the Center for Drug Evaluation about the feasibility of immunobridging replacing phase 3 trials, the Chinese-language United Daily News reported.
In the message, the US FDA said an official position is not yet available, as it is “still discussing approaches to immunobridging,” the newspaper said, calling it a “slap in the face” and clear reproach of the method.
Centers for Disease Control (CDC) Deputy Director-General Chuang Jen-hsiang (莊人祥) yesterday confirmed that the CDC sent messages to US, Japanese, EU and other health authorities seeking their opinions on immunobridging.
However, the current controversy is only a matter of differing interpretations, he told reporters at the daily COVID-19 pandemic briefing.
The US regulator was unable to respond because it has not yet reached a clear conclusion, he said.
Washington was also relatively conservative about the method during a WHO meeting on May 26, but the UK, South Korea and other nations said they would accept it, while the EU voiced conditional approval, Chuang added.
Deputy Minister of Health and Welfare Hsueh Jui-yuan (薛瑞元) also weighed in, telling reporters after an Executive Yuan meeting that Washington cannot have an official stance because it is still discussing the matter.
However, this does not negate the method’s feasibility, Hsueh added.
Additional reporting by CNA
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