Will Moderna’s COVID-19 vaccine be introduced in H1?

Final approval after evaluation by Final Inspection Committee on the 21st… coincides with Korea-U.S Summit event

Preparations in progress prior to vaccine rollout including vaccine mock delivery training… and GC Pharma's safety checks on its logistics center in Ochang

Samsung Biologics a likely CMO candidate… would need to receive approval for domestic manufacturing

The process for the rollout of Moderna COVID-19 vaccine in the first half of this year is gaining momentum.

 

As the possibility obtaining marketing authorization for the imported vaccines on Friday(21st) is high, its rollout in the first half of the year is promising due to the Korea-US Summit event.

 

In addition, the overall inspection of the distribution channels that were conducted prior to the introduction of the vaccine, including the simulation vaccine delivery training and safety inspection of GC Pharma’s logistics center in Ochang, have added strength to the possibility of Moderna’s vaccine being introduced in the first half of this year On April 12th, GC Pharma had submitted an application for the approval of Moderna’s COVID-19 vaccine.

 

On May 13th, the Central Pharmaceutical Affairs Council (CPAC) concluded that it was reasonable to grant approval of Moderna’s vaccine for use in adults 18 years or older as a two-dose schedule.

 

CPAC is a legal advisory board of the Ministry of Food and Drug Safety (MFDS), and the ministry is known to generally follow CPAC’s recommendations.

 

However, in the case of COVID-19 treatments and vaccines, the MFDS receives three separate independent evaluations before granting final approval.

 

The last expert meeting, by the ‘Final inspection Committee,' is scheduled to be held on the 21st next month.

 

Considering that the Final Inspection Committee followed CPAC’s decision for AstraZeneca, Pfizer, and Janssen COVID-19 vaccines as well as Celltrion’s COVID-19 treatment, unless a major issue comes up, the Moderna vaccine is also likely to be granted approval.

 

The MFDS will hold a meeting with the Final Inspection Committee to finalize the labeling details and decide whether to approve the marketing authorization of the vaccine.

 

As the Korea-U.S Summit is scheduled on the same day, industry officials predict that the government will use the summit as an opportunity to approve the Moderna vaccine and announce its rollout schedule in Korea.

 

Also, there have been media reports that 50,000 doses of the vaccine will arrive in Korea in the last week of May.

 

If the vaccine is imported this month, the government’s announcement of releasing the vaccine in Korea in the 2nd half of this year will come true.

 

In the case of the Moderna vaccine, as the company prioritized its U.S.

 

supply, the rollout schedules in other countries were expected to be delayed by one quarter.

 

This was why there had been strong expectations that the vaccine will be introduced in the third quarter rather than the second quarter.

 

However, the mock delivery training for Moderna vaccines and the joint safety inspection conducted at GC Pharma’s logistics center in Ochang have supported the possibility that the introduction of the Moderna vaccine may be more imminent in Korea.

 

In the case of these imported Moderna vaccines, the drug substance of the Moderna vaccine was first produced at the Lonza plant in Switzerland, then filled and finished by a Spanish pharmaceutical company.

 

After its arrival in Korea, GC Pharma will take over its distribution as the license holder.

 

Apart from the imported vaccines, the CMO deal for producing the Moderna vaccine in Korea is expected to be announced during the Korea-U.S.

 

Summit period.

 

The popular prospect is that Samsung Biologics will be the CMO that fills and finishes the solution in Korea.

 

On such expectations, Samsung Biologics had publicly stated that “nothing has been finalized.” However, considering that the company drew a firm line on the rumors of a CMO deal for the Pfizer vaccine stating that “it is not true,” the rather unclear position of Samsung Biologics has added fuel to the rumor.

 

Also, as John Rim, the CEO of Samsung Biologics will be at the South Korea-U.S.

 

Summit, this also had added strength on the possibility of the company being the CMO for Moderna.

 

However, even after a CMO deal, it would take some time for the CMO to actually produce the vaccines, as pharmaceuticals manufactured in Korea are required to receive a separate approval from the MFDS.

 

The vaccines that passed the CPAC review this month were imported vaccines, therefore a separate approval is required for domestically manufactured products.

 

AstraZeneca had also submitted two applications for its vaccine; one for the manufacture and marketing authorization of its products manufactured by its CMO SK Bioscience, and the other for the import authorization of products manufactured outside of Korea, including those from Italy.