Prolonged Suspension of Infant Vaccine Supply... Anxious Parents Struggling

GSK Vaccine Supply Halted for 4 Months Due to Approval Delays
Concerns Persist Despite Recommendations for Alternative Vaccines

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Lee Chun-hee] Kim Jin-hee (32, female), who has a 6-month-old infant, has been busy recently trying to find the vaccine her child needs to be vaccinated with. She cannot obtain the DTaP (diphtheria, tetanus, pertussis) vaccine, which must be administered every two months as part of the national immunization program.

Kim’s daughter received the ‘Infanrix’ vaccine from GlaxoSmithKline (GSK), but the domestic supply of Infanrix is currently suspended. She has checked all nearby hospitals and inquired on mom cafes, but other parents are also complaining that they cannot get the vaccine. Hospitals are recommending ‘alternative vaccines’ and cross-vaccination, but Kim is reluctant, saying, "Isn’t there a possibility of side effects?"

Since GSK’s vaccine supply was suddenly halted in October last year, confusion has continued at vaccination sites. Among the nine vaccine types with supply suspension, two types of DTaP, PCV (pneumococcal), HPV (human papillomavirus), and Tdap (tetanus, diphtheria, pertussis) vaccines are part of the national immunization program. Especially, DTaP and PCV vaccines must be administered multiple times to infants under one year old, so if the supply suspension continues, vaccination schedules will inevitably be disrupted. Fortunately, alternative vaccines for these exist, but ideally, vaccines from the same manufacturer are preferred.

GlaxoSmithKline (GSK)'s DTaP vaccine 'Infanrix'

The reason for the vaccine supply suspension is the update work on the Common Technical Document (CTD). During related work by the Ministry of Food and Drug Safety, CTD issues were found in GSK vaccine products and corrections were requested. It was initially expected that the related work would be completed around January, but it has not yet been finished, delaying supply. An industry insider said, "I understand that the approval changes are being significantly delayed," adding, "There were cases where incomplete documents led to rejections, and full normalization is expected no earlier than May."

There are also predictions that some products may not resume supply even by May due to additional supplementation requests from the Ministry of Food and Drug Safety. A ministry official stated, "We requested supplementation for ongoing approval applications, and once the company submits the supplementary materials, we will review them as quickly as possible," adding, "Many have already completed the approval changes." GSK said that they are aiming for the fastest possible supply in consultation with relevant agencies but cannot specify a clear supply timeline.

An official from the Korea Disease Control and Prevention Agency explained, "Under the current situation, there will be no supply issues until June or July, and for some products, until the end of this year," adding, "We will continue efforts to ensure there are no supply disruptions in case GSK’s supply is further delayed."

This content was produced with the assistance of AI translation services.