Can COVID-19 vaccine by the COVAX be quickly introduced?

The MFDS, participated in the WHO’s joint review from last October

COVID-19 vaccine developed by Pfizer

The health authorities said that it is possible to quickly introduce COVID-19 vaccine supplied from the COVAX Facility.

 

This is because the MFDS has been participating in the COVAX Facility vaccine joint review since October at the request of the WHO.

 

Pfizer's vaccine was pre-verified on the 31st of last month when the WHO approved Emergency Use Authorization.

 

This is why the government believes that rapid vaccination is possible by receiving the Pfizer vaccine from the COVAX Facility in early February.

 

The MFDS announced in a report from the President on the 25th that it is participating in the joint review of the COVAX Facility’s COVID-19 vaccine at the request of the WHO in October.

 

Pfizer's mRNA vaccine has been reviewed, and 13 items will be reviewed.

 

In fact, on the 31st of last month, the WHO Emergency Use Authorization of the Pfizer vaccine.

 

On the 22nd, it also signed a contract for 40 million doses of Pfizer vaccine for the use of the COVAX Facility.

 

It is expected to be supplied to member countries that have joined the COVAX Facility from February.

 

The case of Korea is also being discussed.

 

Current status of the MFDS

Korea has signed a vaccine supply contract for a total of 1,000 people with COVAX Facility.

 

Among them, 50,000 Pfizer’s vaccines are expected to be introduced first in early February.

 

However, Pfizer’s vaccine has not been approved in Korea, so it is possible to introduce it in an emergency only through special imports.

 

Until now, special imports have been mainly applied to small amounts of imported products such as orphan drugs and essential drugs.

 

However, last year's COVID-19 treatment 'Remdesivir' could be introduced urgently due to an infectious disease.

 

However, it is said that it is impossible to apply special imports for imported vaccines that do not have domestic clinical cases or screening history.

 

In response, the MFDS explained that vaccines supplied from the COVAX Facility can be considered for special imports because Korean examiners participated in the joint review.

 

An official from the MFDS said, “In the case of vaccines supplied through the WHO, examiners of the MFDS have participated in the quality certification evaluation.

 

At the request of WHO, we have been participating in the WHO quality certification evaluation of COVID-19 vaccine since last October.

 

Because I participated in the review, it will be used as a reference when deciding on special import.” It is explained that this situation was also reflected by the MFDS' description of the WHO joint review situation in the data of the President's report.

 

It is interpreted that if the introduction of COVID-19 vaccine is confirmed by the COVAX Facility in early February, it is highly likely to follow special import procedures.

 

Special import is determined by the KCDA through expert advice, etc.

 

Special import is possible after 3-4 days of procedure.

 

Pfizer's vaccine applied for official approval from the MFDS on the 25th.

 

Since it plans to complete the approval review within 40 days with as early as possible, item approval is expected in early March.

 

The government has signed a contract with Pfizer to bring in COVID-19 vaccine doses for 10 million people of the third quarter.