TAIPEI (Taiwan News) — U.S. biotechnology company Novavax has submitted an emergency use authorization (EUA) application for its COVID-19 vaccine to the Food and Drug Administration (FDA) for review, CNA reported on Saturday (May 14).
FDA Director-General Wu Shou-mei (吳秀梅) was cited as saying the administration will strive to finish reviewing all documents within a month. Aside from the information on the vaccine’s manufacturing process, the FDA has also received technical documents on its pharmacologic and toxicologic features as well as clinical trial reports.
Once the FDA is done reviewing the documents, it will gather experts for a meeting to review its EUA application.
Novavax made the announcement about its application on its website on Friday (May 13), writing that its submission included data from two phase-three clinical trials, the results of which were published in the New England Journal of Medicine. “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.”
As COVID continues its spread in Taiwan, authorities have urged the public to get vaccines in order to lower the risks of severe symptoms and death.
In April, Central Epidemic Command Center Commander Chen Shih-chung (陳時中) said Taiwan was planning to purchase 2 million doses of Novavax vaccines through COVID-19 Vaccines Global Access. However, at the time, Chen said the date for delivery of the vaccines was still uncertain.