First RSV vaccine Arexvy to soon be released in Korea

Its lot release fee has been set

MFDS approves new type of biological drug...Supply scheduled to begin in May

With the release date of the first RSV (respiratory syncytial virus) vaccine in Korea confirmed the MFDS has also set a fee for its national lot release approval.

 

GSK Korea announced that it will launch the RSV-LRTD vaccine ‘Arexvy’ in May.

 

Once the pharmaceutical company releases the vaccine, full-scale vaccination is expected to become possible from June.

 

Arexvy is the first RSV vaccine in Korea approved by the Ministry of Food and Drug Safety in December last year for the purpose of preventing lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and over.

 

According to industry sources on the 1st, the MFDS also set a national lot release approval fee for the first supply of RSV vaccine in Korea.

 

According to the “Partial Amendment to the Notification of Fees for Permits for Medicines, etc.,” the MFDS has set a national lot release approval fee upon the approval of a new type of biological drug.

 

The new fees have been set at KRW 895,000 for electronic civil services and 995,000 won for in-person and mail civil services for respiratory syncytial virus vaccines (recombinant).

 

National Lot Release is a process in which the MFDS comprehensively evaluates the results of the MFDS's inspection and the manufacturer's manufacturing and testing results for each manufacturing lot of a biological drug to once more ensure that the quality of the biological drug is verified before it is released on the market.

 

Last year, the government agreed on the need to consider the introduction of RSV vaccines into the NIP (National Immunization Program).

 

In a written inquiry during the National Assembly's audit last year, the Korea Disease Control and Prevention Agency said, “Currently, there are no RSV vaccines approved in Korea,” and “We will closely monitor the situation, including the MFDS's approval, related research, and overseas trends, and consider the need to introduce it into the NIP ahead of its domestic approval through expert consultations.” According to the medical community, the number of patients hospitalized for LRTD due to RSV in Korea last year was about 11,000, which is not a small number, and the condition is even more fatal for the elderly and infants.

 

When adults are infected with RSV, they may have no symptoms or recover after experiencing cold-like symptoms, but in the case of the elderly with weak immunity, it can lead to pneumonia, chronic obstructive pulmonary disease, and congestive heart failure.

 

Although Arexvy is the first RSV vaccine to be commercialized in Korea, Pfizer's Abrysvo and Moderna's mRESVIA are awaiting MFDS approval.