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.
A study published by online booking platform Expedia revealed searches for travel to Taipei have ballooned 2,786 percent following the lifting of COVID-19 pandemic travel restrictions due to the city being a “designation dupe” for Seoul. The TikTok trend for duping — referring to substituting a designation for a more inexpensive alternative — helped propel interest in Taipei, it said in a consumer survey titled “Unpack ‘24,” which was conducted from September to October in 14 countries. Location dupes are “every bit as delightful as the tried-and-true places travelers love,” Expedia trend tracker Melanie Fish said of the year’s popular alternatives, which
SAFETY IN REGULATION: The proposal states that Chiayi should assess whether it is viable to establish such a district and draft rules to protect clients and sex workers The Chiayi City Council passed a motion yesterday to assess the viability of establishing a regulated red-light district. The council yesterday held its last session of the year, at which its fiscal 2024 budget was approved, along with 61 other proposals. The proposal to assess the viability of establishing a red-light district was put forward by independent Chiayi City Councilor Molly Yen (顏色不分藍綠支持性專區顏色田慎節). The proposal cited 2011 amendments to the Social Order Maintenance Act (社會秩序維護法), which stipulate that city and county governments can pass autonomous regulations on the sex trade to manage the industry and guarantee industry workers’ rights. A ban on the
A small-scale protest that called on the government to cancel its plan to welcome Indian migrant workers in a bid to tackle Taiwan’s labor shortage was held in Taipei yesterday. During the protest, comprised of a few dozen people staged in front of the Presidential Office on Ketagalan Boulevard, the protest’s chief initiator, a woman identified only as “Yuna” said they wanted the central government to reconsider allowing migrant workers from India to enter Taiwan. Most people in Taiwan had little knowledge about the potential plan to allow in Indian migrant workers until a report in the media last month, she
CHINA illness surge: Of 88 travelers from China, Hong Kong and Macau with respiratory symptoms who were encouraged to get tested upon arrival, 70.6% had the flu Two hundred and sixty people with COVID-19 were hospitalized and 31 deaths related to the virus were reported last week — the highest numbers in four weeks, the Centers for Disease Control (CDC) said yesterday, adding that cases are expected to peak next month. CDC Epidemic Intelligence Center Director Guo Hung-wei (郭宏偉) said that of the 260 people hospitalized last week with moderate to severe COVID-19, 98 percent had not received the Omicron XBB.1.5-adapted COVID-19 vaccine. Among the people hospitalized this year, 78 percent were aged 65 or older, while most of the those who were hospitalized or died have or had