The Ministry of Health and Welfare should hold a public hearing on the standards that are to be used to review emergency use authorization (EUA) applications for COVID-19 vaccines, New Power Party (NPP) Legislator Chen Jiau-hua (陳椒華) said yesterday.
Chen was hosting an online news conference after two domestic COVID-19 vaccine developers, Medigen Vaccine Biologics Corp and United Biomedical Asia, disclosed the results of their double-blind studies on June 10 and Sunday respectively.
Both companies said that they would apply for EUAs from the Food and Drug Administration (FDA) based on the results.
Photo courtesy of New Power Party Legislator Chen Jiau-hua
The review for Medigen’s EUA application would not begin until the end of next month, as it has been asked to provide more information about its vaccine studies, the administration said.
The ministry has treated review of EUA applications as “nothing more than child’s play,” as the standards to review the applications only consist of three pages, she said.
They include required technical information about COVID-19 vaccines, as well as standards to be applied to review EUA applications and the effectiveness of vaccines.
“How can the FDA review emergency use authorizations for vaccines with so many details missing?” she asked.
Chen said that she had asked to examine the standards to be used to review EUA applications when she questioned Minister of Health and Welfare Chen Shih-chung (陳時中) in a legislative plenary session earlier this month.
The ministry could consult the general guidelines for EUA applications for COVID-19 vaccines published by the WHO in November last year, which consist of 10 pages, Chen added.
“The ministry’s review of EUA applications from Medigen Vaccine Biologics and United Biomedical Asia cannot be blank authorizations. It must apply standards comparable to those set by the WHO,” she said.
The ministry is also obligated to explain to the public why a researcher at Academia Sinica who was previously involved in a study funded by Medigen was able to serve on the EUA review committee, Chen said.
TRAFFIC SAFETY RULES: A positive result in a drug test would result in a two-year license suspension for the driver and vehicle, and a fine of up to NT$180,000 The Ministry of Transportation and Communications is to authorize police to conduct roadside saliva tests by the end of the year to deter people from driving while under the influence of narcotics, it said yesterday. The ministry last month unveiled a draft of amended regulations governing traffic safety rules and penalties, which included provisions empowering police to conduct mandatory saliva tests on drivers. While currently rules authorize police to use oral fluid testing kits for signs of drug use, they do not establish penalties for noncompliance or operating procedures for officers to follow, the ministry said. The proposed changes to the regulations require
The Executive Yuan yesterday announced that registration for a one-time universal NT$10,000 cash handout to help people in Taiwan survive US tariffs and inflation would start on Nov. 5, with payouts available as early as Nov. 12. Who is eligible for the handout? Registered Taiwanese nationals are eligible, including those born in Taiwan before April 30 next year with a birth certificate. Non-registered nationals with residence permits, foreign permanent residents and foreign spouses of Taiwanese citizens with residence permits also qualify for the handouts. For people who meet the eligibility requirements, but passed away between yesterday and April 30 next year, surviving family members
China Airlines Ltd (CAL) yesterday morning joined SkyTeam’s Aviation Challenge for the fourth time, operating a demonstration flight for “net zero carbon emissions” from Taiwan Taoyuan International Airport to Bangkok. The flight used sustainable aviation fuel (SAF) at a ratio of up to 40 percent, the highest proportion CAL has achieved to date, the nation’s largest carrier said. Since April, SAF has become available to Taiwanese international carriers at Taipei International Airport (Songshan airport), Kaohsiung International Airport and Taoyuan airport. In previous challenges, CAL operated “net zero carbon emission flights” to Singapore and Japan. At a ceremony at Taoyuan airport, China Airlines chief sustainability
‘ONE CHINA’: A statement that Berlin decides its own China policy did not seem to sit well with Beijing, which offered only one meeting with the German official German Minister for Foreign Affairs Johann Wadephul’s trip to China has been canceled, a spokesperson for his ministry said yesterday, amid rising tensions between the two nations, including over Taiwan. Wadephul had planned to address Chinese curbs on rare earths during his visit, but his comments about Berlin deciding on the “design” of its “one China” policy ahead of the trip appear to have rankled China. Asked about Wadephul’s comments, Chinese Ministry of Foreign Affairs spokesman Guo Jiakun (郭嘉昆) said the “one China principle” has “no room for any self-definition.” In the interview published on Thursday, Wadephul said he would urge China to
RSS