Novavax
2022 - 5 - 14Taiwan FDA reviewing data on Novavax vaccine following EUA ... (Focus Taiwan News Channel)
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 ...
Wu added that health experts will assess the EUA request after completion of its review. 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. "In both trials, the vaccine demonstrated efficacy with a reassuring safety profile.
Novavax applies for emergency use authorization in Taiwan (Taiwan News)
Food and Drug Administration to finish reviewing documents in 1 month | 2022-05-14 16:00:00.
FDA Director-General Wu Shou-mei (ๅณ็งๆข ) was cited as saying the administration will strive to finish reviewing all documents within a month. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups.โ Once the FDA is done reviewing the documents, it will gather experts for a meeting to review its EUA application.
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