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.
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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.
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