Presenting what it said was a leaked internal document, the Chinese Nationalist Party (KMT) caucus yesterday accused the Food and Drug Administration (FDA) of “following the president’s script” on emergency use authorization (EUA) of COVID-19 vaccines.
Calling the content of the document “shocking,” KMT caucus secretary-general Cheng Li-wen (鄭麗文) demanded that President Tsai Ing-wen (蔡英文) and Minister of Health and Welfare Chen Shih-chung (陳時中) explain the “ugly truth” behind the EUA approval process.
On the same day the caucus held a news conference to discuss the document, the FDA granted an EUA to Medigen Vaccine Biologics Corp to begin mass production of its COVID-19 vaccine.
The document is from an internal meeting of the FDA on June 17, but its contents were updated the day before, Cheng told an online news conference, adding that it includes a timeline of events from the agency’s expert advisory meeting from May 28 to Aug. 31.
On June 25, it shows the agency convening a panel to discuss approving an EUA, ostensibly for Medigen’s vaccine, followed by the completion of 2 million doses by Aug. 31, she said.
The timeline fully corresponds with Tsai’s goal of offering locally developed vaccines by this month, with 2 million doses being administered by the end of next month, she added.
This shows that the FDA was following the president’s script, exposing the EUA process as mere theatrics devoid of scientific basis, Cheng said.
The document also shows that Medigen has already begun manufacturing vaccines, one to three batches of which have been inspected by the FDA, she said.
However, 82 percent of those reviewed failed inspection, Cheng said, speculating that after discovering this roadblock, Tsai delayed EUA approval until this month.
The president drafted this script with Chen, even vowing publicly that domestic vaccines would be available by this month, but she did not expect that Medigen could fall short, Cheng said.
Nearly all the tested vaccines were below standard, but despite knowing this, the government still signed a contract with Medigen for 5 million doses, she added, asking what would happen if the firm cannot deliver on its contractual obligations.
Separately yesterday, Democratic Progressive Party caucus director-general Liu Shyh-fang (劉世芳) said that the EUA was granted by an overwhelming majority of 18 to one, dispelling any rumors regarding the circumstances of its approval.
Vaccines are politically neutral and do not belong to whomever is in power, she said, urging the opposition to focus on improving the vaccine coverage rate instead of politicizing the issue.
Additional reporting by CNA
The brilliant blue waters, thick foliage and bucolic atmosphere on this seemingly idyllic archipelago deep in the Pacific Ocean belie the key role it now plays in a titanic geopolitical struggle. Palau is again on the front line as China, and the US and its allies prepare their forces in an intensifying contest for control over the Asia-Pacific region. The democratic nation of just 17,000 people hosts US-controlled airstrips and soon-to-be-completed radar installations that the US military describes as “critical” to monitoring vast swathes of water and airspace. It is also a key piece of the second island chain, a string of
A magnitude 5.9 earthquake that struck about 33km off the coast of Hualien City was the "main shock" in a series of quakes in the area, with aftershocks expected over the next three days, the Central Weather Administration (CWA) said yesterday. Prior to the magnitude 5.9 quake shaking most of Taiwan at 6:53pm yesterday, six other earthquakes stronger than a magnitude of 4, starting with a magnitude 5.5 quake at 6:09pm, occurred in the area. CWA Seismological Center Director Wu Chien-fu (吳健富) confirmed that the quakes were all part of the same series and that the magnitude 5.5 temblor was
Taiwan will now have four additional national holidays after the Legislative Yuan passed an amendment today, which also made Labor Day a national holiday for all sectors. The Chinese Nationalist Party (KMT) and Taiwan People’s Party (TPP) used their majority in the Legislative Yuan to pass the amendment to the Act on Implementing Memorial Days and State Holidays (紀念日及節日實施辦法), which the parties jointly proposed, in its third and final reading today. The legislature passed the bill to amend the act, which is currently enforced administratively, raising it to the legal level. The new legislation recognizes Confucius’ birthday on Sept. 28, the
The Central Weather Administration has issued a heat alert for southeastern Taiwan, warning of temperatures as high as 36°C today, while alerting some coastal areas of strong winds later in the day. Kaohsiung’s Neimen District (內門) and Pingtung County’s Neipu Township (內埔) are under an orange heat alert, which warns of temperatures as high as 36°C for three consecutive days, the CWA said, citing southwest winds. The heat would also extend to Tainan’s Nansi (楠西) and Yujing (玉井) districts, as well as Pingtung’s Gaoshu (高樹), Yanpu (鹽埔) and Majia (瑪家) townships, it said, forecasting highs of up to 36°C in those areas
RSS