COVID-19 vaccine by NovaVax is approved in Korea

The prevention rate is 90.4%

Permission to submit the final clinical results after the final inspection committee on the morning of the 12th

COVID-19 vaccine by NovaVax was approved for domestic items on the 12th.

 

At the final inspection committee held on the same day, experts judged that the Novavax vaccine had a sufficient effect on preventing COVID-19.

 

The MFDS announced on the 12th that SK Bioscience has decided to approve the product on the condition that it submits a final report on the clinical trial results for the COVID-19 vaccine Nuvaxovid PFS, which has applied for approval for manufacturing and sales items.

 

Nuvaxovid PFS is a gene recombinant COVID-19 vaccine developed by Novavax in the U.S.

 

and manufactured by SK Bioscience in Korea from undiluted to complete.

 

The main active ingredient is the same as a vaccine (10 vials packed with doses) conditionally licensed in EUA by 30 countries including Europe and WHO.

 

The newly approved vaccine can be immediately inoculated with a single dose PFS injection that contains one dose per vaccine without dilution.

 

Storage conditions are 5 months in refrigeration (2-8°C).

 

The MFDS evaluated that the vaccine is meaningful in that it was manufactured in a gene recombination method with existing national vaccination experience, that it is convenient to store, transport, and inject, and that the types of vaccines that can be selected in the medical field have expanded.

 

The MFDS began reviewing in advance from April 29 last year.

 

A total of four data were submitted, including clinical trials conducted in Australia, the United States (clinical phase 1/2), South Africa (clinical phase 2), the United Kingdom (clinical phase 3), and the United States (clinical phase 3).

 

As a result of analyzing the people who were confirmed with COVID-19 after 7 days of the second vaccination in clinical trials, about 89.7% of the preventive effect was found in British clinical trials, 10 in the vaccine group and 96 in the control group.

 

In clinical trials in the United States, 14 vaccine groups and 63 control groups showed a preventive effect of about 90.4%.

 

In addition, according to the evaluation of neutralizing antibodies that induce preventive effects by binding to the surface of the COVID-19 virus to neutralize the infectivity of the virus, compared to before vaccination, antibodies more than quadrupled from two weeks after vaccination.

 

The final inspection committee for Novavax vaccine held on the 12th

Abnormal cases predicted after vaccination (local, systemic) include tenderness, injection site pain, erythema, and swelling, most of which are mild to moderate, and were lost within one to three days of occurrence.

 

The MFDS went through a triple advisory process consisting of experts to enhance the expertise and objectivity of the licensing process.

 

Starting with the verification advisory group on the 29th of last month, the Central Pharmaceutical Review Committee on the 6th and the final inspection committee on the morning of the 12th were held.

 

The final inspection committee judged that most of the reported abnormalities were generally good as predicted abnormalities related to vaccination.

 

In addition, the review based on the submitted clinical trial data concluded that the preventive effect of the vaccine was sufficient.