‘Introduced 40 million doses in Korea’ Novavax Corona Vaccine… FDA approval application postponed again

US pharmaceutical company Novavax has again delayed the application for emergency use approval in the country of the novel coronavirus infection (COVID-19) vaccine ‘NVX-CoV2373’. The Korean government previously signed a supply contract with Novavax for 40 million doses of the coronavirus vaccine within this year and was scheduled to introduce it from the third quarter of this year, but as the US Food and Drug Administration (FDA) application for emergency use approval is delayed, concerns over the supply of the vaccine are growing.

According to Reuters on the 5th (local time), Novavax originally planned to apply to the FDA for emergency use of a coronavirus vaccine in the third quarter of this year, but announced that it would be postponed to the fourth quarter.

Novavax chief executive Stanley Ark said, “It is important to complete the validation work to demonstrate to the FDA the consistency of the vaccine manufacturing process.”

The Novavax coronavirus vaccine drew much attention as it showed a preventive effect of more than 90% in phase 3 clinical trials in June. However, it has delayed approval due to difficulties in obtaining the raw materials and equipment needed to produce the vaccine.

“Despite significant clinical data, Novavax is lagging behind competing vaccine manufacturers such as Pfizer and Johnson & Johnson,” Reuters said.

Novavax has already applied for approval for vaccine use in India, Indonesia and the Philippines. It is expected to apply for emergency use authorization to the World Health Organization (WHO) this month.

“We plan to file an application for approval in the UK in September and submit relevant documents to Australia and Canada within a few weeks,” Erck told Reuters.

Novavax plans to produce 100 million doses per month in the third quarter of this year and 150 million doses per month in the fourth quarter of this year. “Now it seems that we have definitely overcome the supply problem, and we are able to produce[the vaccine]on a large scale,” said Erck.

Korea has signed a contract with Novavax to supply 40 million doses of vaccine. Initially, the Korean government was planning to introduce the Novavax vaccine contract sequentially from the third quarter, but as the emergency use approval application was delayed, the related schedule became unclear.