Novavax Delays Vaccine Usage Application to Q3... Will Vaccine Supply Be Disrupted Again?

Novavax COVID-19 Vaccine
[Image source=AFP Yonhap News]

[Asia Economy Reporter Lee Chun-hee] Novavax has announced that it will apply for emergency use authorization of its COVID-19 vaccine in the US and Europe later than expected, in the third quarter, raising concerns about vaccine supply difficulties.

On the 10th (local time), Novavax stated in its first-quarter earnings report that it plans to submit applications for emergency use authorization of its COVID-19 vaccine to regulatory authorities such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) of the European Union (EU), and the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the third quarter.

Previously, Stanley Erck, chairman of Novavax, appeared on CNBC and expressed hope to receive FDA approval within this month, leading to expectations that the application would be submitted within this month. However, the timing has been delayed.

On the same day, Novavax also lowered its monthly vaccine production forecast to 100 million doses by the third quarter and 150 million doses by the end of this year. Initially, the goal was to produce 150 million doses per month by the third quarter, but difficulties in securing raw materials and equipment for production led to the reduction of the target.

Currently, the South Korean government has committed to procuring 20 million doses (40 million shots) of the Novavax vaccine. Although supply was initially expected in the second quarter, full-scale introduction is now anticipated in the third quarter. Authorities aim to additionally procure 2.71 million doses of vaccines, including Janssen and Moderna, by June and are focusing on securing vaccines.

The Novavax vaccine introduced domestically will be produced in South Korea by SK Bioscience through technology transfer. This is the first domestic production of a COVID-19 vaccine via contract development and manufacturing organization (CDMO) through technology transfer, rather than simple contract manufacturing organization (CMO).

Meanwhile, authorities announced that 438,000 doses of the Pfizer vaccine will be imported into the country via air freight around 1:35 a.m. on the 12th, followed by the shipment of AstraZeneca (AZ) vaccines from SK Bioscience’s plant in Andong on the 14th.

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