The Food and Drug Administration (FDA) yesterday said it was reviewing the technical data on the Novavax COVID-19 vaccine following the US drugmaker’s request for emergency use authorization (EUA).
The request was filed several months ago, but the data provided at the time had been insufficient, containing only the vaccine’s processing information, FDA Director-General Wu Shou-mei (吳秀梅) said.
The company recently provided the missing information by including data on the vaccine’s clinical trials, pharmacology and toxicology, Wu said, adding that health experts would assess the request once its review is complete.
Photo: Reuters
The FDA aims to complete the review on the Novavax data within one month, she said.
Novavax said in a statement on Friday that its submission includes data from two pivotal Phase 3 clinical trials, which enrolled about 30,000 participants aged 18 years or older in the US and Mexico.
“In both trials, the vaccine demonstrated efficacy with a reassuring safety profile. Serious and severe adverse events were low in number, and balanced between vaccine and placebo groups,” Novavax said.
The most common adverse reactions observed during the trials were headache, nausea or vomiting, myalgia, arthralgia, pain or tenderness at the injection site, fatigue and malaise, the company said.
Taiwan has not yet received any doses of the Novavax vaccine, although the Central Epidemic Command Center in March said that the nation had ordered about 2 million doses through the global vaccine sharing initiative COVAX.
Separately, commenting on Taiwan-based United Biomedical Inc (UBI) Asia’s reapplication for an EUA for its COVID-19 vaccine, Wu said the company has every right to do so, but it must provide new information and evidence before the review process can move forward.
UBI Asia’s original EUA request was rejected on Aug. 16 last year after a measure of its UB-612 vaccine’s ability to neutralize SARS-CoV-2 failed to meet FDA standards.
The company at the time said that it would present new findings to the FDA to have its EUA application reviewed again, which it did in March.
An increase in Taiwanese boats using China-made automatic identification systems (AIS) could confuse coast guards patrolling waters off Taiwan’s southwest coast and become a loophole in the national security system, sources familiar with the matter said yesterday. Taiwan ADIZ, a Facebook page created by enthusiasts who monitor Chinese military activities in airspace and waters off Taiwan’s southwest coast, on Saturday identified what seemed to be a Chinese cargo container ship near Penghu County. The Coast Guard Administration went to the location after receiving the tip and found that it was a Taiwanese yacht, which had a Chinese AIS installed. Similar instances had also
GOOD DIPLOMACY: The KMT has maintained close contact with representative offices in Taiwan and had extended an invitation to Russia as well, the KMT said The Chinese Nationalist Party (KMT) would “appropriately handle” the fallout from an invitation it had extended to Russia’s representative to Taipei to attend its international banquet last month, KMT Chairman Eric Chu (朱立倫) said yesterday. US and EU representatives in Taiwan boycotted the event, and only later agreed to attend after the KMT rescinded its invitation to the Russian representative. The KMT has maintained long-term close contact with all representative offices and embassies in Taiwan, and had extended the invitation as a practice of good diplomacy, Chu said. “Some EU countries have expressed their opinions of Russia, and the KMT respects that,” he
VIGILANCE: The military is paying close attention to actions that might damage peace and stability in the region, the deputy minister of national defense said The People’s Republic of China (PRC) might consider initiating a hack on Taiwanese networks on May 20, the day of the inauguration ceremony of president-elect William Lai (賴清德), sources familiar with cross-strait issues said. While US Secretary of State Anthony Blinken’s statement of the US expectation “that all sides will conduct themselves with restraint and prudence in the period ahead” would prevent military actions by China, Beijing could still try to sabotage Taiwan’s inauguration ceremony, the source said. China might gain access to the video screens outside of the Presidential Office Building and display embarrassing messages from Beijing, such as congratulating Lai
Four China Coast Guard ships briefly sailed through prohibited waters near Kinmen County, Taipei said, urging Beijing to stop actions that endanger navigation safety. The Chinese ships entered waters south of Kinmen, 5km from the Chinese city of Xiamen, at about 3:30pm on Monday, the Coast Guard Administration said in a statement later the same day. The ships “sailed out of our prohibited and restricted waters” about an hour later, the agency said, urging Beijing to immediately stop “behavior that endangers navigation safety.” Ministry of National Defense spokesman Sun Li-fang (孫立方) yesterday told reporters that Taiwan would boost support to the Coast Guard