The Food and Drug Administration (FDA) yesterday issued a special import permit for Paxlovid, an oral antiviral drug developed by Pfizer Inc to treat COVID-19, and the first shipment is expected to arrive before March, the Central Epidemic Command Center (CECC) said.
Pfizer’s import permit application was approved after a specialists’ meeting at the agency yesterday morning, FDA Director Wu Shou-mei (吳秀梅) said.
Having assessed Paxlovid’s therapeutic effect, safety, risks and benefits, and considering the domestic COVID-19 situation and public health demand, the specialists agreed to grant special approval to the drug, according to Article 48-2 of the Pharmaceutical Affairs Act (藥事法), she said.
Photo: Reuters
Pfizer is required to implement a risk management plan during the special permit period to ensure the drug’s safety, she added.
Paxlovid should be administered after a diagnosis of COVID-19 and within five days of the onset of symptoms, for adults who are at high of risk developing severe illness from the virus and children aged 12 or older weighing at least 40kg with mild to moderate symptoms, she said.
The drug is administered as three tablets — two tablets of PF-07321332 (150mg) and one tablet of ritonavir (100mg) — which are packaged together to take orally twice daily for a five-day course, Wu said, adding that not following the course could affect the treatment.
PF-07321332 works by blocking the activity of an enzyme that SARS-CoV-2 needs to multiply, and ritonavir helps slow the metabolism of PF-07321332, allowing it to remain active at higher concentrations in the blood for extended periods, she said.
Minister of Health and Welfare Chen Shih-chung (陳時中), who heads the CECC, said that the ministry has signed a procurement contract with Pfizer to purchase 20,000 courses of Paxlovid, and that the first batch is expected to arrive before March.
Paxlovid is the second oral antiviral COVID-19 medication to obtain a special import permit from the FDA, after the CECC on Wednesday said that a permit was issued to US drugmaker Merck’s Taiwan branch for its molnupiravir antiviral drug.
MISINFORMATION: The generated content tends to adopt China’s official stance, such as ‘Taiwan is currently governed by the Chinese central government,’ the NSB said Five China-developed artificial intelligence (AI) language models exhibit cybersecurity risks and content biases, an inspection conducted by the National Security Bureau (NSB) showed. The five AI tools are: DeepSeek, Doubao (豆包), Yiyan (文心一言), Tongyi (通義千問) and Yuanbao (騰訊元寶), the bureau said, advising people to remain vigilant to protect personal data privacy and corporate business secrets. The NSB said it, in accordance with the National Intelligence Services Act (國家情報工作法), has reviewed international cybersecurity reports and intelligence, and coordinated with the Ministry of Justice Investigation Bureau and the National Police Agency’s Criminal Investigation Bureau to conduct an inspection of China-made AI language
BOOST IN CONFIDENCE: The sale sends a clear message of support for Taiwan and dispels rumors that US President Donald Trump ‘sold out’ the nation, an expert said The US government on Thursday announced a possible sale to Taiwan of fighter jet parts, which was estimated to cost about US$330 million, in a move that an expert said “sends a clear message of support for Taiwan” amid fears that Washington might be wavering in its attitude toward Taipei. It was the first announcement of an arms sale to Taiwan since US President Donald Trump returned to the White House earlier this year. The proposed package includes non-standard components, spare and repair parts, consumables and accessories, as well repair and return support for the F-16, C-130 and Indigenous Defense Fighter aircraft,
CHECKING BOUNDARIES: China wants to disrupt solidarity among democracies and test their red lines, but it is instead pushing nations to become more united, an expert said The US Department of State on Friday expressed deep concern over a Chinese public security agency’s investigation into Legislator Puma Shen (沈伯洋) for “secession.” “China’s actions threaten free speech and erode norms that have underpinned the cross-strait ‘status quo’ for decades,” a US Department of State spokesperson said. The Chongqing Municipal Public Security Bureau late last month listed Shen as “wanted” and launched an investigation into alleged “secession-related” criminal activities, including his founding of the Kuma Academy, a civil defense organization that prepares people for an invasion by China. The spokesperson said that the US was “deeply concerned” about the bureau investigating Shen
‘TROUBLEMAKER’: Most countries believe that it is China — rather than Taiwan — that is undermining regional peace and stability with its coercive tactics, the president said China should restrain itself and refrain from being a troublemaker that sabotages peace and stability in the Indo-Pacific region, President William Lai (賴清德) said yesterday. Lai made the remarks after China Coast Guard vessels sailed into disputed waters off the Senkaku Islands — known as the Diaoyutai Islands (釣魚台) in Taiwan — following a remark Japanese Prime Minister Sanae Takaichi made regarding Taiwan. Takaichi during a parliamentary session on Nov. 7 said that a “Taiwan contingency” involving a Chinese naval blockade could qualify as a “survival-threatening situation” for Japan, and trigger Tokyo’s deployment of its military for defense. Asked about the escalating tensions
RSS