[Reporter's view]Controversy over Novavax vaccine

The government explained that the Novavax COVID-19 vaccine, which had signed a technology transfer contract with SK Bioscience on the 12th, could be supplied as soon as possible in June.

 

The release of this announcement raised controversy over the introduction of the Novavax vaccine, which has not yet been licensed abroad.

 

Eventually, the conservative opposition party criticized using the people as clinical maruta.

 

As the controversy continued, the government was controversial over the introduction of the ax vaccine before approval the day after the announcement.

 

The government explained that the Novavax COVID-19 vaccine, which had signed a technology transfer contract with SK Bioscience on the 12th, could be supplied as soon as possible in June.

 

The release of this announcement raised controversy over the introduction of the Novavax vaccine, which has not yet been licensed abroad.

 

Eventually, the conservative opposition party criticized using the people as clinical subject of experiment.

 

As the controversy continued, the government refuted the day after the announcement that it had never considered pre-licensing the Novavax vaccine.

 

After reading this controversial article, I couldn't help but laugh.

 

It is not possible at all for Korea to introduce a vaccine developed abroad first.

 

There has not been a case of using overseas drugs developed first under the approval of Korean health authorities.

 

All drugs can be sold only after obtaining approval from the MFDS.

 

The same goes for vaccines.

 

However, the MFDS has so far required to attach a certificate of manufacture and sale of the exporting country when applying for a new drug for import.

 

This is to refer to the case of approval of the exporting country.

 

In early April, the MFDS revised the regulations so that the approval results from exporting countries are not attached when applying for a permit for biological products such as vaccines.

 

The reason is that the MFDS can also be independently screened.

 

According to the regulations, domestic permits were possible without the need for overseas approval.

 

However, there is no possibility that an overseas development company such as Novavax will first apply for a license in Korea instead of in large markets such as the US or Europe.

 

SK Bioscience, which has transferred the technology, can also be approved if it has data from a clinical trial conducted by Novavax.

 

Prior to application for overseas approval, clinical trial results are not shared with other companies in which the technology has been transferred.

 

Among the COVID-19 vaccines, the only basis for the special import of Pfizer vaccine was the case of overseas approval such as the United States and Europe.

 

In order for Novavax vaccine to be introduced in Korea before overseas approval, Novavax should prioritize the small market in Korea, and health authorities or experts must approve the introduction of the vaccine without referencing overseas approval.

 

It is unlikely that this will happen.

 

Health authorities are conservative.

 

If safety or effectiveness is uncertain, it will not be introduced.

 

The safest way is to consult foreign cases, especially FDA or EMA.

 

Pfizer and AstraZeneca vaccines will be the same, and will be introduced in the future.

 

Through this controversy, I feel that the media and politics are too concentrated on the success or failure of the government vaccine introduction.

 

Anyway, in a situation where vaccine development with our technology has not been made, it is inevitable to be attracted to foreign companies.

 

Japan, which has a lot of Big Pharma, does not have a vaccine developed in-house, so it is the same situation as Korea.

 

Accordingly, the timing of the introduction and the overall supply and demand issue are uncertain.

 

It seems pointless to question whether the policy is successful or not.

 

The government should also be honest about the current situation and demand patience from the people.

 

The media should also not criticize the government's policy of introducing vaccines.

 

And we have to reflect on why we didn't make the vaccine on time.