Will special imports be applied for vaccine introduction?

likely to refer to overseas approval cases same as Remdesivir

Public opinion is growing as the number of COVID-19 confirmed cases is recording the highest every day, and the FDA also urgently approves Pfizer's mRNA-based COVID-19 vaccine following the first vaccination in the UK.

 

Some criticized Korea for failing to preemptively secure a vaccine unlike other advanced countries.

 

It takes some time to get official approval, so it is analyzed that it may be a special import like the last COVID-19 treatment Remdesivir.

 

On the 14th, the Commissioner of KDCA, Jeong Eun-kyeong, at a briefing on the outbreak of COVID-19 in Korea, said, “We are continuing to introduce vaccines developed overseas.

 

We are in consultation with pharmaceutical companies about the amount of additional supplies other than the already secured for 44 million people.” In addition, "At least two or more are currently reviewing and discussing the contract with the goal of completing the contract by the end of the year.

 

It is expected that the supply will be the fastest since AstraZeneca vaccine is produced in Korea, and other vaccines are still negotiating with regard to delivery timing." The total amount of COVID-19 vaccines that the government said to have secured so far is for 44 million people.

 

The COVAX Facility provided for 14 million people, AstraZeneca, Pfizer, and Modena provided for 10 million people, respectively, and Janssen provided for 4 million people.

 

And, Kovax Facility and AstraZeneca have completed the contract.

 

The government is planning to introduce COVID-19 vaccine with the aim of vaccinating next March as soon as possible.

 

It takes too little time to get official approval in Korea.

 

In the case of the AstraZeneca vaccine, which has been contracted with the government, the MFDS is undergoing an expedited review process, but the phase III clinical trial has not been completed.

 

The MFDS plans to complete the approval within 40 days as soon as possible, but considering the release of the national lot, it must apply for a permit in January at the latest.

 

Currently, it is not known when the clinical trials of the AstraZeneca vaccine will end.

 

That is why the Korean government will find a way to use it before formal approval, which takes time, as the US and UK have urgently approved the vaccine.

 

It means that we have no choice but to use the special import system.

 

Special import is a system in which the head of the MFDS imports drugs that are not approved in Korea through importers in order to cope with a public health crisis situation such as an infectious disease pandemic.

 

In June, COVID-19 treatment, Remdesivir was introduced in Korea through this system.

 

At that time, the KCDC (currently The KDCA) requested special import from the MFDS according to the Clinical Committee for New Infectious Diseases proposal, and the MFDS received special import for Remdesivir after deliberation by the National Essential Medicines Stable Supply Council (Disease Management Subcommittee).

 

Decided.

 

It took only 4 days from the request of the KCDC to the decision.

 

It is also the fastest way to introduce the COVID-19 vaccine in Korea.

 

The MFDS can also relieve the burden of expedited screening if it is first introduced through special import and then a formal permit review is conducted.

 

In the case of Remdesivir, it has been granted a conditional permission for Phase III within about 50 days after the decision of special import.

 

The MFDS official also said, "The way to get emergency approval like the United States or the United Kingdom is to go through the special import procedure," he said.

 

"But there must be a request from the KCDA." However, as the special import has not been officially reviewed, it is expected to refer to the approval of advanced overseas regulatory agencies.

 

For example, the US FDA, European EMA, or WHO approval is likely to be the standard.

 

The first AstraZeneca vaccine, which is likely to be introduced, can be referred to other developed countries or WHO approval, even if FDA approval is late.

 

Vaccines by Pfizer and Moderna have not yet been contracted, and the supply timing is uncertain, so it is expected that it will be difficult to request special imports from Korea even if the UK or the US has approved them.