Novavax Delays US Vaccine Approval Again... Government Says "No Change to Q3 Vaccination Goals"

Insufficient Evidence of Manufacturing Process Consistency
Approval Application to be Submitted in Q4 After Supplementation

[Image source=Reuters Yonhap News]

[Asia Economy reporters Seo So-jung and Lee Hyun-woo] 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 was originally expected to receive approval from U.S. health authorities in the third quarter but delayed the application to finalize preparations for approval. As a result, concerns are rising 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, said 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."

Previously, the ‘NVX-CoV2373’ vaccine developed by Novavax drew attention by revealing results showing over 90% efficacy in phase 3 clinical trials. South Korea has signed a supply contract for 40 million doses (enough for 20 million people). However, with the FDA application postponed to the fourth quarter, it is now considered practically impossible to vaccinate within this year.

The South Korean government planned to import up to 20 million doses from Novavax by the third quarter and a cumulative 40 million doses within the year, but since Novavax has not yet applied for approval domestically or from the U.S. FDA, import in the third quarter seems difficult. The Ministry of Food and Drug Safety stated, "Preparations for approval are complete, but Novavax has not yet submitted an application."

Despite setbacks in importing Novavax vaccines, the government expects no difficulty in achieving the goal of first-dose vaccination for 36 million people by the third quarter. Jeong Eun-young, head of the Vaccine Import Office at the Central Disaster and Safety Countermeasure Headquarters of the Ministry of Health and Welfare, said, "Even excluding Novavax vaccines, it is possible to vaccinate 36 million people with the supply volume in the third quarter."

Kim Ki-nam, head of the Vaccination Planning Division at the COVID-19 Vaccination Response Promotion Team, stated, "The original plan was to complete first-dose vaccination for 70% of the population by the end of September, but the goal is to achieve this earlier, before the Chuseok holiday." Since most vaccines in the third quarter are Pfizer and Moderna, the plan is to complete most second doses between late October and early November.

This content was produced with the assistance of AI translation services.