Taiwan’s approach to evaluating the efficacy of COVID-19 vaccine candidates has not been used by any other country as a basis for granting emergency use authorization (EUA), Minister of Health and Welfare Chen Shih-chung (陳時中) said on Friday.
During a legislative hearing, Taiwan People’s Party Legislator Ann Kao (高虹安) questioned Chen about review standards for issuing EUAs for domestic COVID-19 vaccines, which the Food and Drug Administration (FDA) published on Thursday.
While Taiwan’s domestically developed vaccine candidates have completed phase 1 and 2 clinical trials, none of them have begun larger phase 3 trials — which are typically the standard for determining efficacy. FDA guidelines allow EUAs to be issued without phase 3 trials, by instead analyzing phase 2 results through immunobridging, which uses the immune response measured in clinical trial participants to infer the overall level of protection a vaccine would provide.
Photo courtesy of the Kaohsiung City Government Department of Health via CNA
Critics say that this approach, which is based on the potency levels of neutralizing antibodies found in clinical trial participants, cannot be used to accurately determine a vaccine’s efficacy.
Kao asked Chen whether Taiwan would be the first country to grant an EUA using immunobridging as a substitute for efficacy data obtained in phase 3 clinical trials.
Initially, Chen said that he could not speak to the approaches being adopted by regulators in other countries, adding that immunobridging has been a topic of discussion in the WHO.
When pressed, Chen said that “there are currently no approvals of this type.”
“If that is the case, then this is genuinely frightening,” Kao said. “Taiwan has purchased 10 million [local] vaccines, enough to give to 5 million people.”
“If the efficacy of the domestic vaccines does not meet expectations, then these people are like the emperor with no clothes — completely without protection,” she said.
Russia and China have approved COVID-19 vaccines for use before they entered phase 3 trials or before efficacy data from those trials had been published, but Taiwan would be the first country to grant an EUA using the immunobridging approach, Chen said.
Debate on the FDA’s standards has grown, following Medigen Vaccine Biologics’ announcement on Thursday that it would soon apply for an EUA, after becoming the first local vaccine maker to “unblind” results of its phase 2 clinical trials.
The FDA’s review would compare the neutralizing antibody potency levels of Medigen trial participants with those from a control group of 200 recipients of the AstraZeneca vaccine in Taiwan, Chen said.
As data from the AstraZeneca group is pending, the EUA review would likely begin later this month, Chen said, adding that there would be no pressure on the FDA and no deadline for when it should be completed.
In a follow-up question, Kao said that the US Food and Drug Administration had publicly broadcast its EUA review meetings for the Moderna COVID-19 vaccine, and asked Chen if Taiwan would be willing to do the same.
Chen said that he would respect whatever decision the vaccine review committee made on the matter, but added that there are no plans to broadcast the proceedings.
If Medigen’s vaccine is granted an EUA and if plans to use immunobridging, with phase 3 trials to be conducted later, gain traction internationally, the vaccine would have a chance of being approved by the WHO, Chen said.
Even without international recognition, Taiwanese would not be prohibited from entering other countries based on what vaccine they receive, although quarantine procedures might differ, he added.
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