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
GREATER NUMBER: The sorties might have been a response to the US and the EU expressing concern on Friday over China’s ‘provocations’ in the Taiwan Strait Twenty-five Chinese military aircraft and four naval ships were detected around Taiwan from 6am Saturday to 6am yesterday, including eight airplanes that had crossed the median line of the Taiwan Strait and another two that entered Taiwan’s air defense identification zone (ADIZ). The People’s Liberation Army (PLA) aircraft that entered Taiwan’s southwestern ADIZ were a Y-8 anti-submarine plane and a BZK-005 uncrewed aerial vehicle, the Ministry of National Defense said. The aircraft that flew across the median line include two Sukhoi Su-30 fighter jets, four J-16 multipurpose fighters and two J-10 jets, the ministry’s official Web site showed. Taiwan’s armed forces monitored the
Mask easing: Teachers are allowed to take their masks off while lecturing indoors, but students should keep theirs on, as COVID-19 measures ease this week The Ministry of Education (MOE) yesterday released new on-campus COVID-19 prevention guidelines, stating that masks can be taken off while exercising, singing, dancing, performing, taking photographs, dining, drinking, video and voice recording, hosting events, presenting speeches and lecturing outdoors. Large outdoor events organized by schools should comply with the mask regulations issued by the Central Epidemic Command Center (CECC), it added. The new guidelines came into effect yesterday, and people in Taiwan are no longer required to wear masks outdoors for the first time since May 19 last year. The CECC announced the easing of the mask mandate on Monday, adding that it
LUNAR NEW YEAR PEAK: Taiwanese who are in China should get vaccinated and consider returning early, as infection rates are expected to increase, the CECC said China faces five major problems once COVID-19 begins spreading there, with a peak in infections likely during the Lunar New Year holidays, Deputy Minister of Health and Welfare Victor Wang (王必勝), who heads the Central Epidemic Command Center (CECC), said yesterday. Wang wrote on Facebook that according to the center’s data, the increasing number of COVID-19 cases in China is worth noting, as the new Omicron subvariants BF.7 and BA.5.2 spreading in China are highly infectious and are more transmissible than the previously dominating Omicron subvariants. “The virus cannot be eliminated even under China’s strict control measures,” he wrote. “Its policy
‘SEXUAL ASSAULT’: Taipei prosecutors said that cooperation agreements between Taiwan and the Czech Republic grant Czech officials protection against prosecution The Taipei District Prosecutors’ Office yesterday reaffirmed that it would not charge a Czech official with sexual assault because he is protected by diplomatic immunity. The office released a statement saying it has verified that the man works for the Czech Economic and Cultural Office Taipei’s foreign affairs corps and is thereby protected from criminal prosecution. A foreign graduate student in Taiwan had filed a complaint alleging that the section head of the Czech Economic and Trade Section had sexually assaulted her on April 21 last year. The woman said the Czech official had invited her to his home and then forced her
RSS