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.
‘DENIAL DEFENSE’: The US would increase its military presence with uncrewed ships, and submarines, while boosting defense in the Indo-Pacific, a Pete Hegseth memo said The US is reorienting its military strategy to focus primarily on deterring a potential Chinese invasion of Taiwan, a memo signed by US Secretary of Defense Pete Hegseth showed. The memo also called on Taiwan to increase its defense spending. The document, known as the “Interim National Defense Strategic Guidance,” was distributed this month and detailed the national defense plans of US President Donald Trump’s administration, an article in the Washington Post said on Saturday. It outlines how the US can prepare for a potential war with China and defend itself from threats in the “near abroad,” including Greenland and the Panama
A wild live dugong was found in Taiwan for the first time in 88 years, after it was accidentally caught by a fisher’s net on Tuesday in Yilan County’s Fenniaolin (粉鳥林). This is the first sighting of the species in Taiwan since 1937, having already been considered “extinct” in the country and considered as “vulnerable” by the International Union for Conservation of Nature. A fisher surnamed Chen (陳) went to Fenniaolin to collect the fish in his netting, but instead caught a 3m long, 500kg dugong. The fisher released the animal back into the wild, not realizing it was an endangered species at
The High Prosecutors’ Office yesterday withdrew an appeal against the acquittal of a former bank manager 22 years after his death, marking Taiwan’s first instance of prosecutors rendering posthumous justice to a wrongfully convicted defendant. Chu Ching-en (諸慶恩) — formerly a manager at the Taipei branch of BNP Paribas — was in 1999 accused by Weng Mao-chung (翁茂鍾), then-president of Chia Her Industrial Co, of forging a request for a fixed deposit of US$10 million by I-Hwa Industrial Co, a subsidiary of Chia Her, which was used as collateral. Chu was ruled not guilty in the first trial, but was found guilty
DEADLOCK: As the commission is unable to forum a quorum to review license renewal applications, the channel operators are not at fault and can air past their license date The National Communications Commission (NCC) yesterday said that the Public Television Service (PTS) and 36 other television and radio broadcasters could continue airing, despite the commission’s inability to meet a quorum to review their license renewal applications. The licenses of PTS and the other channels are set to expire between this month and June. The National Communications Commission Organization Act (國家通訊傳播委員會組織法) stipulates that the commission must meet the mandated quorum of four to hold a valid meeting. The seven-member commission currently has only three commissioners. “We have informed the channel operators of the progress we have made in reviewing their license renewal applications, and
RSS