[Q&A] Flu Vaccine, Why Suspend All Despite Partial Issues? "Precautionary Measure Considering On-Site Confusion"

Government Procurement Contract Vaccine Distribution Wholesalers Partially Exposed to Room Temperature
Potential Quality Issues in Some of 5 Million Doses... Two-Week Inspection Underway

Amid the temporary suspension of the national free influenza vaccination program, a notice for free flu vaccinations is posted at a hospital in Seoul on the 22nd. The Korea Disease Control and Prevention Agency announced in a press release on the 21st, "We plan to temporarily suspend the national influenza vaccination program starting today due to issues found in the distribution process of the contracted influenza supplier."/Photo by Kim Hyun-min kimhyun81@

[Asia Economy Reporter Choi Dae-yeol] This year’s influenza (flu) national vaccination program was suspended on the 22nd. The program had initially started about two weeks ago on the 8th, targeting children under 12 years old, and was scheduled to begin vaccinating children aged 13 to 18 from this day.

The national vaccination program is provided free of charge to children and the elderly with low immunity. The government estimates the required vaccine quantity based on the expected epidemic period each year and secures vaccines through contracts with suppliers. The supplier was transporting vaccines nationwide when it was reported to authorities that the vaccines were not stored according to regulations during the process. Upon receiving the report in the afternoon of the previous day, the Korea Disease Control and Prevention Agency (KDCA) abruptly suspended all flu vaccinations with only a few hours remaining before the scheduled vaccinations. The following Q&A clarifies the situation.

How much of the vaccine was problematic?

It concerns a portion of 5 million doses (1 dose equals one vaccination). This year, a total of 29.64 million doses of flu vaccine are supplied domestically, covering about 57% of the Korean population, of which 18.44 million doses are designated for public use. Public use includes vaccines for children aged 6 months to under 18 years and seniors aged 62 and above under the national vaccination program, as well as vaccines for pregnant women, local government purchases, and the Ministry of National Defense. Among the public use supply, 12.59 million doses were contracted to be supplied by the pharmaceutical distributor Sinseong Pharm.

For children aged 13 to 18, whose vaccinations were to begin on this day, some of the 12.59 million doses supplied under the contract were to be administered. The quantity supplied to frontline regions and medical institutions in time for the vaccination schedule was 5 million doses, and some of these are suspected to have been exposed to room temperature. The vaccines, which should have been stored and transported frozen, were reportedly left at room temperature or not kept within the required temperature during transport by vehicle. This situation was recorded and reported.

Why is exposure to room temperature a problem?

Quality control is crucial for biopharmaceuticals like vaccines. There are specific refrigeration temperature standards (2~8℃) that distributors must maintain during delivery. Temperature changes are monitored in real-time via thermometers attached to vehicles to ensure strict management. Exposure to room temperature can compromise quality. It means the protein content responsible for the vaccine’s efficacy may decrease, which can affect the vaccine’s effectiveness. The KDCA and the Ministry of Food and Drug Safety will review potential side effects with experts.

Why suspend all vaccinations if only some are problematic?

To minimize confusion among the public and frontline medical institutions. Apart from the 5 million doses already supplied, about 7 million doses can be supplied immediately, but the government took a proactive and decisive measure to completely exclude the possibility of mixing problematic vaccines at the site. The government plans to conduct quality tests on the 5 million doses supplied earlier over the next two weeks to determine whether they can be used as is or must be discarded. Vaccines for children under 12, which were supplied earlier this month, can still be administered immediately, but they were also suspended together to prioritize safety.

Are infants vaccinated a few days ago at risk?

The vaccines previously supplied differ in distribution channels and transport companies from the problematic vaccines. For infants aged 6 months and older and children under 12, vaccinations started on the 8th using vaccines already supplied to each medical institution, not from the contracted batch. The medical institutions then claim costs accordingly. About 118,000 people were vaccinated over two weeks, and no adverse events have been reported so far. The 5 million doses of problematic vaccines were just being supplied and had not yet been administered. Authorities stated there are no quality issues arising from the production process.

On the afternoon of the 22nd, a pharmaceutical transport vehicle was parked at the headquarters of Sinseong Yakpum located in Gochon-eup, Gimpo-si, Gyeonggi Province. On the 21st, the government temporarily suspended free influenza (flu) vaccine vaccinations after receiving a report that the cold storage temperature was not properly maintained during the distribution process of Sinseong Yakpum's flu vaccines.

Will delayed vaccination schedules fail to prevent the flu epidemic?

This year, to prepare for COVID-19, which has symptoms similar to the flu, the national vaccination target was expanded and started about a month earlier than usual. Last year, vaccinations began in mid-October. Although quality testing will take about two weeks, health authorities said they are preparing to resume vaccinations immediately once safety is confirmed. The outlook that the flu epidemic will be milder than usual due to COVID-19 is somewhat positive. Maintaining social distancing and personal hygiene helps suppress infectious disease outbreaks. In the Southern Hemisphere, where June to August is summer for Korea, the flu season starts around June and July-August, but this year’s flu epidemic was milder than in the past.

If quality issues are confirmed, will there be a vaccine shortage in Korea?

It is not impossible. In the worst case, if all 5 million doses are discarded, that would represent about 10% of the entire Korean population. Flu vaccines are not medicines that can be prepared immediately as they require preparation from early in the year for autumn supply. Domestic production for export amounts to about 3.4 million doses (based on quadrivalent vaccines), but these are already contracted for supply to international organizations like UNICEF and developing countries.

However, considering that the actual vaccination rate among adults who pay for vaccines is about 30-40% annually, the possibility of a domestic vaccine shortage causing a crisis or having to purchase expensive vaccines from abroad is very low. Vaccines from the paid vaccination segment could be purchased and administered to children or the elderly. In this case, issues such as supplier negligence, compensation for losses, and budget procurement will be key. The government stated, “Regarding whether to discard the vaccines, we will confirm the extent of the problem based on quality test results and devise appropriate measures.”