CORONAVIRUS/Taiwan FDA reviewing data on Novavax vaccine following EUA request
Taipei, May 14 (CNA) Taiwan's Food and Drug Administration (FDA) on Saturday said it was reviewing the technical data on the Novavax COVID-19 vaccine following the American drugmaker's recent request for emergency use authorization (EUA) in Taiwan.
The EUA request from Novavax actually came several months ago, FDA Director-General Wu Shou-mei (吳秀梅) told CNA, but the data provided at the time had been insufficient, containing only the processing information of the vaccine.
Wu said the company recently made up for the missing information by including data on the vaccine's clinical trials, pharmacology and toxicology. Wu added that health experts will assess the EUA request after completion of its review.
The FDA will aim to complete the review on the Novavax data provided within one month, she added.
On Friday, Novavax released a statement saying its submission included data from two pivotal Phase 3 clinical trials, which enrolled approximately 30,000 participants aged 18 years and older in the United States 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.
According to the Maryland-based company, the most common adverse reactions observed during the trials were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.
Taiwan has not yet received any doses of the Novavax vaccine, though the Central Epidemic Command Center (CECC) announced in March that the country had ordered around 2 million doses of the vaccine through the global vaccine sharing initiative COVAX.
Commenting on the recent EUA reapplication by Taiwan-based United Biomedical Inc. (UBI) Asia for its COVID-19 vaccine, Wu said the company has every right to do so, but it is necessary for it to 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 the COVID-19 virus failed to meet the standards laid out by the Taiwan FDA.
At the time, the company said it would present new findings to the Taiwan FDA to have its EUA application reviewed again, which it did in March this year.
However, there have been reports that UBI Asia was still unable to come up with data that can prove its vaccine can effectively prevent severe illness and death from COVID-19, and that its EUA application could once again be rejected after the June 30 deadline.
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