Novavax Delays Vaccine Application to US FDA Again, Plans to Apply in Q4

"FDA Approval Application Delayed for Further Preparation"
South Korea Also Orders 40 Million Doses...Vaccination Within the Year Practically Impossible

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] The American pharmaceutical company Novavax announced that it will postpone its emergency use authorization application for the COVID-19 vaccine to the fourth quarter. Novavax had originally planned to receive approval from U.S. health authorities in the third quarter but delayed it to finalize the approval preparations. As a result, concerns are emerging that vaccination within this year may be difficult in the European Union (EU), South Korea, and other regions that pre-ordered vaccines from Novavax.

According to foreign media such as CNBC on the 5th (local time), Novavax announced that it will postpone its application for emergency use authorization from the U.S. Food and Drug Administration (FDA) for its developed vaccine from the third quarter to the fourth quarter. Stanley Erck, CEO of Novavax, stated at a press conference, "The work to demonstrate consistency in the vaccine manufacturing process to the FDA has not yet been completed," and added, "We are postponing to better prepare the FDA approval application."

Novavax's vaccine has already applied for vaccine use approval in other countries such as India, Indonesia, and the Philippines, and it is known that it plans to apply for emergency use authorization in the UK in September, as well as in Australia and Canada. CNBC reported that the delay in Novavax's application is analyzed to be due to shortages of raw materials and equipment for mass production. Novavax has announced plans to manufacture 100 million doses per month until the third quarter of this year and 150 million doses per month starting from the fourth quarter.

Previously, the 'NVX-CoV2373' vaccine developed by Novavax showed 80-90% preventive efficacy in clinical trials, leading the EU to pre-order 200 million doses and South Korea to order 40 million doses, raising expectations that it would open a new path for vaccine supply. However, with the FDA application postponed to the fourth quarter, it is now considered practically impossible to vaccinate within this year.