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
‘SMEAR CAMPAIGN’: The ‘Global Times’ accused the DPP of offering politicians in Somaliland bribes and promoting Taiwanese independence by funding US think tanks The Ministry of Foreign Affairs yesterday denounced China’s Global Times for disseminating disinformation about Taiwan, after the Chinese state-run newspaper claimed that the Democratic Progressive Party (DPP) has been bribing Somaliland politicians. Taiwan in August last year inaugurated the Taiwan Representative Office in the Republic of Somaliland, which is the nation’s only representative office whose title uses just the name “Taiwan.” The East African country also established a representative office in Taipei, despite the absence of formal diplomatic relations. The Chinese-language Global Times on Monday accused the DPP of offering Somaliland politicians and their families considerable bribes, citing anonymous sources. The International Cooperation
Phase 2 clinical trial results of the Medigen Vaccine Biologics Corp’s COVID-19 vaccine on Wednesday were published on the Web site of The Lancet: Respiratory Medicine, in an early preview before publication. The study paves the way for other nations to issue emergency use authorizations or produce the Medigen vaccine, given The Lancet’s credibility as a highly respected medical journal with a rigorous peer-review process, Medigen’s international affairs director Lien Chia-en (連加恩) said. Lien said that the study is important as it proposes methods for converting international units for efficacy comparisons. The methods have been used for correlating the efficacy of hepatitis B
Ambassador Theaters on Tuesday announced that its Breeze Center cinemas in Taipei’s Songshan District (松山) would close late this month after screening thousands of major Hollywood movies and local favorites over two decades. Ambassador Theaters, one of the largest cinema chain operators in Taiwan, said that Oct. 25 would be the last day the Breeze Center cinemas screen movies, adding that its lease expires on that day. “We sincerely appreciate the support and recognition from audiences in Taipei over the past 20 years,” the company said. “We look forward to seeing you again in the future.” The cinemas started operating in 2001, upon
BUMPING AROUND: A total of 143 people sustained fall injuries at MRT stations or inside trains over eight months, with a majority caused by ‘distracted walking’ Taipei Rapid Transit Corp yesterday urged people to avoid looking at their phones when walking, saying 73 cases of “distracted walking injuries” had occurred in the Taipei Mass Rapid Transit (MRT) system from January to August. As the local COVID-19 situation has been brought under control, passenger traffic has been increasing, reaching about 1.5 million rides per day last month, the company said. However, many passengers have been looking at their phones as they walk through MRT stations, which can lead to collisions with other passengers or injury from falling down stairs. A total of 143 people sustained fall injuries at MRT stations