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.
Taiwanese paleontologists have discovered fossil evidence that pythons up to 4m long inhabited Taiwan during the Pleistocene epoch, reporting their findings in the international scientific journal Historical Biology. National Taiwan University (NTU) Institute of Ecology and Evolutionary Biology associate professor Tsai Cheng-hsiu (蔡政修) led the team that discovered the largest snake fossil ever found in Taiwan. The single trunk vertebra was discovered in Tainan at the Chiting Formation, dated to between 400,000 and 800,000 years ago in the Middle Pleistocene, the paper said. The area also produced Taiwan’s first avian fossil, as well as crocodile, mammoth, saber-toothed cat and rhinoceros fossils, it said. Discoveries
INCREASED CAPACITY: The flights on Mondays, Wednesdays, Fridays and Sundays would leave Singapore in the morning and Taipei in the afternoon Singapore Airlines is adding four supplementary flights to Taipei per week until May to meet increased tourist and business travel demand, the carrier said on Friday. The addition would raise the number of weekly flights it operates to Taipei to 18, Singapore Airlines Taiwan general manager Timothy Ouyang (歐陽漢源) said. The airline has recorded a steady rise in tourist and business travel to and from Taipei, and aims to provide more flexible travel arrangements for passengers, said Ouyang, who assumed the post in July last year. From now until Saturday next week, four additional flights would depart from Singapore on Monday, Wednesday, Friday
WATCH FOR HITCHHIKERS: The CDC warned those returning home from Japan to be alert for any contagious diseases that might have come back with them People who have returned from Japan following the World Baseball Classic (WBC) games during the weekend are recommended to watch for symptoms of infectious gastroenteritis, flu and measles for two weeks, the Centers for Disease Control (CDC) said. Flu viruses remain the most common respiratory pathogen in Taiwan in the past four weeks and the influenza B virus accounted for 55.7 percent of the tested cases, exceeding the percentage of influenza A (H3N2) infections and becoming the local dominant strain, CDC Epidemic Intelligence Center Deputy Director Lee Chia-lin (李佳琳) said at a news conference on Tuesday. There were 82,187 hospital visits for
Alumni from Japan’s Kyoto Tachibana Senior High School marching band, widely known as the “Orange Devils,” staged a flash mob performance at the Grand Hotel in Taipei yesterday to thank Taiwan for its support after the Great East Japan Earthquake. The show, performed on the earthquake’s 15th anniversary, drew more than 100 spectators, some of whom arrived two hours before the show to secure a good viewing spot. The 26-member group played selections from “High School Musical,” “Beauty and the Beast,” and their signature piece “Sing Sing Sing” and shouted “I love
RSS