[Reproter's View] Have you forgotten what the MFDS does?

It's not all about getting a vaccine quickly

It was expected that the politics and media would put pressure on the introduction of COVID-19 vaccine, but it is too blatant.

 

They only emphasize rapid introduction forgetting the role of the MFDS in verifying the safety and effectiveness of vaccines.

 

From the time President Trump pressed the US FDA, the independence of the MFDS was expected to be affected.

 

In recent years, the European EMA is also under pressure from each country, and it is in a situation where it is advancing the recruitment of the review committee to approve COVID-19 vaccine, so it is obvious that the drug regulatory authorities in each country are suffering.

 

The MFDS was presented with a deadline altogether.

 

In foreign countries, after urgently approving COVID-19 vaccine, the deadline was officialized in February as politics and the media urged rapid introduction every day.

 

The MFDS seems to have to approve one company’s COVID-19 vaccine after completing the review before February.

 

It is understandable that the current situation is not good, so it is possible to introduce it as early as possible, and this can be considered a special case.

 

However, there was no MFDS in the process of discussion.

 

They don't seem to know that the vaccine can only be approved by the MFDS through systematic screening.

 

No confidence in the regulatory authorities was shown.

 

Some media have ignored the MFDS, asking if the MFDS can review and approve vaccines that are not approved by the US FDA.

 

These reports only dampen the will of the MFDS, which is showing its willingness to independently screen by abolishing the obligation to submit CPP (manufacturing and sales certificates in importing countries).

 

It is difficult to apply the same situation in the UK and the United States, which initially approved COVID-19 vaccine.

 

In that country, the vaccine has undergone clinical trials and has been reviewed through a preliminary review.

 

Nevertheless, the FDA was the first to grant EUA for the vaccine.

 

Chloroquine, COVID-19 treatment that was urgently approved by the FDA, was also withdrawn.

 

As such, emergency approval drugs cannot be fully guaranteed for efficacy and safety like formal approval.

 

Korea does not have an Emergency Use Authorization System (EUA).

 

In case of an emergency, there is a special import or special manufacturing system, but it is difficult in situations where there is no data to verify at all, such as a vaccine developed overseas for COVID-19.

 

This is because clinical trials have never actually been conducted in Korea.

 

It is impossible to get vaccination while skipping the MFDS.

 

Nevertheless, some politicians and the media are misleading as if they could inoculate the people immediately after signing a supply contract.

 

In the future, the MFDS should not be condemned even if the MFDS is delayed in approving COVID-19 vaccine.

 

If the MFDS is pressed as it is now, drug approval is difficult to ensure transparency and national security.

 

Now it depends on the MFDS.

 

Let's first trust the MFDS so that COVID-19 vaccine can be thoroughly verified and brought in.