Domestic approval of EU-approved Novavax is imminent

The MFDS recently set up major test items for lot release

If the permit policy is followed within 40 days, the end of this month will be possible

The quarantine authorities will carry forward 40 million domestic supplies next year

As the European Union (EU) approved the conditional sale of the NovaVax COVID-19 vaccine, attention is being paid to when it will be approved in Korea.

 

As the MFDS is known to be preparing for Novavax's approval for national lot release, analysts say that approval is imminent in Korea.

 

On the 20th, the European Commission (EMA) approved the conditional sale of the COVID-19 vaccine developed by Novavax.

 

A few hours ago, the European Medicines Agency (EMA) recommended conditional sales approval.

 

The EMA recommended approval for the use of the vaccine to prevent COVID-19 over the age of 18.

 

Novavax was found to have a preventive effect of 90% in clinical trials of about 45,000 people in the United States, Mexico, and the United Kingdom.

 

Side effects are also mostly mild symptoms such as pain in the inoculation site, muscle pain, and fatigue.On the 17th, Novavax, which is produced in India, was approved for emergency use by the WHO.

 

Approval screening is currently underway in Korea.

 

On the 15th of last month, SK Bioscience, a consignment producer in Korea, applied for permission to manufacture and sell items to the MFDS.

 

However, while EU-approved products are multi-use vials, domestic products have different methods which is PFS type.

 

As it has been approved by the WHO and the EMA, the MFDS is also expected to speed up approval.

 

The MFDS has established a policy to process the COVID-19 vaccine as soon as possible.

 

Existing licensed AstraZeneca and Pfizer vaccines were approved within 40 days of application.

 

Therefore, it is predicted that permission can be obtained at the end of this month, around 40 days after application.

 

Some analysts say that the MFDS has recently set up a major test item for Nuvaxovid PFS, and that approval may be imminent.

 

This is because the national lot release is the last quality inspection for the market after approval of biological products such as vaccines.

 

The MFDS is planning to proceed with the national lot release of the COVID-19 vaccine within 20 days of approval as soon as possible.

 

Even if it is approved at the end of the year, it will be difficult to use it immediately in Korea.

 

It is interpreted that it will only be available at the end of the third inoculation because the third vaccination is being conducted with Pfizer or Moderna.

 

Hong Jung-ik, head of the COVID-19 vaccination response vaccination management team, also said in a media briefing on the 21st, "The entire amount of Novavax vaccines signed this year will be carried over," adding, "If approved by the MFDS, we will apply for supply next year."