The health authorities recently suspended the national program of giving free flu vaccines as some of them were exposed to room temperature during delivery.
Pharmaceutical industry officials expressed diverse arguments on who was responsible for the mishap and whether the program’s halt was the right call.
Some drug distributors said that brief exposure to room temperature would not have affected the vaccines' safety and that the suspension of the vaccination program caused excessive public anxiety.
The Korea Disease Control and Prevention Agency (KDCA) and the Ministry of Food and Drug Safety are conducting quality tests on 5 million doses of the first batch of influenza vaccines, distributed by Shinsung Pharm. The government expects that the test results will come out in two weeks.
KDCA said it would put safety verification as the top priority and make a prudent decision on whether to resume the free vaccination.
“We received a report that there was a problem in the delivery process and concluded that we had to stop the national flu vaccination temporarily,” an official at KDCA said. “Even if test results show that there was no safety problem in the vaccines, we took a preemptive measure because flu vaccination is particularly important in the Covid-19 crisis.”
However, officials at vaccine manufacturers and drug distributors offered split views on the government’s decision. Some officials said the discontinuation of the national vaccination against the seasonal flu was not necessary.
They said the 5 million doses of the flu shots were inactivated instead of live attenuated ones, meaning that they were not sensitive to temperature. Also, the inactivated vaccines passed the accelerated stability test, one of the tests for long-term preservation. The accelerated stability test provides evidence that vaccines could remain stable and safe under an environment outside the preservation conditions.
“Vaccine manufacturers already ran accelerated stability tests, considering the possibility of the vaccines being exposed to room temperature,” a pharmaceutical industry source said. “The core issue is to figure out how long the vaccines were mishandled and whether the safety has been compromised,” he added.
He worried that missing the point of the problem could cause misunderstanding and distrust in the overall vaccine distribution system.
However, some other industry officials supported the government’s decision to halt the program.
“It is the first time in Korea that free flu vaccines were exposed to room temperature. The government made the right decision,” an official at a drugmaker said.
He admitted that killed vaccines were less sensitive to temperature than live vaccines. However, the accelerated stability tests taken autonomously at company levels are insufficient to confirm that vaccines are safe at room temperature, he noted.
“It is important to check the authorities’ investigation results and see how long the vaccines were at room temperature,” he added.
An official at the food and drug safety ministry also refuted the claim that the vaccines could have been safe during room temperature delivery.
“It is true that temperature criteria are different for a variety of vaccines. But if the vaccines could stay stable at room temperature, the government must have had it reflected on quality standards,” the ministry official said. “Even if the vaccines had such a property, suppliers should comply with the (delivery) standards.”
Despite the controversy, Shinsung Pharm, the vaccine distributor, is responsible for the vaccine delivery fiasco.
Just two months ago, the KDCA (then KCDC) and the food and drug safety ministry released vaccine preservation, delivery, and management guidelines.
The guidelines state that distributors must maintain the proper temperature during the storage and transportation of the vaccines. Also, to keep the low temperature, they should use ice packs, ice boxes, and plastic buffers (bubble wrap or styrofoam pieces), according to the guidelines.
In the bidding contract, Shinsung Pharm set the optimum temperature for vaccine storage at 2-8 degrees Celsius.
An official at Shinsung Pharm admitted that it was the company’s fault to cause trouble in the free flu shot program. “We’re waiting to face punishment. It was our fault that vaccines were mishandled,” he said. “As we learned lessons hard this time, we promise to deliver the second batch of the vaccines safely.”
The government plans to provide 19 million free flu shots for children between six months and 18 years old, pregnant women, and those aged 62 or older. Of them, Shinsung Pharm is to supply 11.8 doses. If the initial schedule goes as planned, the company will start distributing 6.8 million free flu vaccines for the elderly first in October.